YEAR-END REPORT - 2020 Published 21-Dec-2020 HPTS Issue Brief 12-21-20.3 Health Policy Tracking Service - Issue Briefs Business of Health Business of Health Insurance This Issue Brief was written by Melissa D. Berry, a principal attorney editor on the Publisher's Staff and a member of the Ohio bar. 12/21/2020 I. AFFORDABLE CARE ACT AND INSURANCE COVERAGE ISSUES U.S. Appeals Court Sidesteps Major ACA Ruling (Reuters) - A U.S. appeals court ruled on Wednesday that a component of the Obamacare law is unconstitutional, but dodged a major [FN2] ruling by stopping short of declaring that the rest of the landmark 2010 healthcare statute must also be struck down. The New Orleans-based 5th U.S. Circuit Court of Appeals ruled on a 2-1 vote that the law's individual mandate that directed Americans to obtain health insurance - a provision already gutted by Republican-backed legislation passed in Congress - was unlawful. The court, however, avoided answering the key question of whether the rest of the law can remain in place or must be struck down, instead sending the case back to a district court judge for further analysis. That means the fate of the signature domestic achievement of Democratic former President Barack Obama remains in limbo. Writing for the majority, Judge Jennifer Walker Elrod said that Texas-based U.S. District Court Judge Reed O'Connor must “employ a finer-toothed comb” to determine if the entire law must be struck down. In 2018, O'Connor ruled the entire law was unconstitutional. Elrod wrote that it may be that the law does eventually have to be struck down in full, but “it is no small thing for unelected, life-tenured judges to declare duly enacted legislation passed by the elected representatives of the American people unconstitutional.” The dissenting judge, Carolyn Dineen King, said she would have found that the challengers had no legal standing to bring the lawsuit. She also said the rest of the law could be upheld even if the individual mandate was unconstitutional. The law has drawn Republican ire since its passage. Congressional Republicans tried and failed numerous times to repeal it, and the Trump administration has taken several actions to undermine it. “The 5th Circuit correctly held that the individual mandate is unconstitutional, and we look forward to the opportunity to further demonstrate that Congress made the individual mandate the centerpiece of Obamacare and the rest of the law cannot stand without it,” said Texas Attorney General Ken Paxton, a Republican who leads the legal challenge brought by 18 conservative-led states. President Donald Trump, a Republican, said the decision would not change the current U.S. healthcare system. House Speaker Nancy Pelosi said Democrats would fight Republican efforts to rollback Obamacare. “Tonight's ruling is a chilling threat to the 130 million Americans with pre-existing conditions and every other family who depends on the lifesaving protections of the Affordable Care Act,” she said in a statement. California Attorney General Xavier Becerra, who heads a coalition of 20 Democratic-led states defending the law, said the ruling means Trump “got the gift he wanted ? uncertainty in the healthcare system and a pathway to repeal.” California will appeal the decision to the Supreme Court, a spokeswoman for the state attorney general said. Obamacare has helped roughly 20 million Americans obtain medical insurance either through government programs or through policies from private insurers made available in Obamacare marketplaces. Republican opponents have called the law an unwarranted intervention by government in health insurance markets. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -1- In 2012, the Supreme Court narrowly upheld most Obamacare provisions including the individual mandate, which required people to obtain insurance or pay a financial penalty. The court defined this penalty as a tax and thus found the law permissible under the Constitution's provision empowering Congress to levy taxes. In 2017, Trump signed into law a tax bill passed by a Republican-led Congress that eliminated the financial penalty under the individual mandate. The 2017 law means the individual mandate can no longer be interpreted as a tax provision and is therefore unlawful, the appeals court concluded in Wednesday's ruling. Trump's administration supported the legal challenge and declined to defend the law in court. CMS Announces Enhanced Program Integrity Efforts for the Exchange On December 20, CMS issued the Exchange Program Integrity Final Rule that implements policies aimed at protecting taxpayer dollars by ensuring that Exchange enrollees are accurately determined eligible for premium subsidies. The final rule focuses on strengthening oversight of State-based Exchanges (SBE) and implementing a new requirement that Exchanges conduct regular eligibility verifications with outside data sources at least twice a year. In addition, the rule aligns federal regulations with the statutory requirements of the Patient Protection and Affordable Care Act (PPACA) to help ensure consumers understand the coverage they are buying and also requires Qualified Health Plan (QHP) issuers to send a separate bill and attempt to collect separate payments for the portion of consumers' premiums attributable to certain abortion services for which public funding is prohibited. “Our healthcare programs, including the Exchanges, are evolving rapidly, and our program integrity efforts must keep up,” said CMS Administrator Seema Verma. “Today's final rule drastically improves our ability to pay it right?to make the right payment to the right plan for the right people. The Trump Administration will spare no effort to ensure that taxpayer dollars are only going to those truly eligible.” The final rule addresses several recommendations from the Office of Inspector General (OIG) and the Government Accountability Office (GAO). Those recommendations addressed issues such as weaknesses in the process for determining eligibility for advance payments of the premium tax credit (APTC) and cost-sharing reductions (CSRs) in both the State and Federal Exchanges. To address this issue, the rule strengthens programmatic oversight of SBE program reporting requirements to confirm states are correctly identifying eligible enrollees, including those who are qualified for APTC and CSRs. Specifically, SBEs are required to conduct and submit the results of annual programmatic audits and CMS is finalizing changes that clarify the scope of such audits, including procedures to test eligibility and enrollment transactions to ensure SBEs that operate their own eligibility and enrollment platforms are properly determining consumer eligibility for QHPs, APTC and CSRs. These changes will strengthen CMS's programmatic oversight and the program integrity of SBEs, and better align with CMS's program integrity priorities, providing CMS and states with greater insight into SBE compliance with eligibility and enrollment standards in a more cost-effective manner. The rule also implements safeguards regarding the eligibility and enrollment process across all Exchanges, including SBEs, State- based Exchanges on the Federal Platform (SBE-FPs), and Federally-facilitated Exchanges (FFEs). This includes enhanced periodic data matching that will allow CMS to more frequently identify and resolve issues related to consumers who are dually enrolled in both Medicare and a QHP through the Exchange. This will ensure that people are enrolled in the most appropriate type of coverage for them. Beginning with plan year 2020, CMS will require SBEs to conduct Medicare, Medicaid/CHIP, and as applicable, Basic Health Plan periodic data matching at least twice a year for QHP enrollees who receive subsidies. Through the SBE oversight requirements and improved data verification and audit requirements, CMS will be able to identify and correct eligibility and enrollment issues sooner. Early identification of eligibility and enrollment issues is particularly important for consumers who are eligible for or enrolled in other coverage because it can minimize the time these consumers inadvertently receive tax credits that they will have to pay back later, and mitigate risks that they are paying premiums for a plan they no longer need. The rule includes new requirements to align federal regulations with the statutory requirements of section 1303 of the Affordable Care Act, which prohibits federal funding for coverage of certain abortion services (“non-Hyde abortion services”). Section 1303 specifically prohibits QHPs from using APTC or CSRs to pay coverage of for abortions for which public funding is prohibited. We estimate that 18 states currently have QHP issuers that offer coverage of non-Hyde abortion services. Section 1303 requires these QHP issuers to collect a separate payment from each enrollee for the portion of the consumer's premium attributable to health insurance coverage of these services. The rule better aligns with Congress' intent for QHP issuers to collect two distinct payments, one for the coverage of non-Hyde abortion services, and one for coverage of all other services covered under a QHP. Pursuant to the law, this rule will ensure that taxpayers do not contribute funds to pay for coverage of abortion services for which funding isn't allowed by law, and will alert consumers that their health plan covers abortion services, allowing them to make fully informed decisions about their coverage. The separate billing requirements in the final rule become effective June 27, 2020; the balance of the final rule becomes effective nationwide within 60 days from today. U.S. Appeals Court Upholds Risk Payments to Health Insurers © 2021 Thomson Reuters. No claim to original U.S. Government Works. -2- (Reuters) - A U.S. appeals court upheld the validity of a federal program governing the payment of billions of dollars to insurers under [FN3] the Affordable Care Act, reversing a lower court ruling that had prompted the White House to temporarily suspend payments. Tuesday's 3-0 decision by the 10th U.S. Circuit Court of Appeals in Denver is a victory for insurers that feared the Feb. 2018 lower court ruling and payments suspension could drive up premium costs and cause market turmoil. The appeals court said the Department of Health & Human Services did not act arbitrarily and capriciously in implementing its “risk adjustment” payments program. That program is intended to create incentives for insurers to cover sicker patients, including those with pre-existing conditions, by paying them with money collected from insurers that enroll healthier patients. Circuit Judge Scott Matheson said HHS acted reasonably in using a formula that relied on the “statewide average premium,” or average of applicable premiums that insureds pay health insurers in a state, to calculate collections from or payments to insurers. He said HHS justified its approach over alternatives such as using the plans' own premiums, which it feared could dissuade high-risk plans to lower prices, to make the program “budget-neutral,” where total charges would equal total payments. “Courts cannot second guess an agency's rulemaking decision when it provided reasons for its chosen course of action,” Matheson wrote. Tuesday's decision overturned a ruling by U.S. District Judge James Browning in Albuquerque, New Mexico that had set aside payment rules for 2014 through 2018. The case had been brought by New Mexico Health Connections, which had said the rules were slanted to favor large insurers over “smaller competitors” such as itself. Lawyers for the insurer did not immediately respond to requests for comment. HHS had no immediate comment. The Trump administration announced the payments suspension on July 7, 2018, freezing $10.4 billion for the 2017 benefit year, saying Browning's ruling made it necessary but that it was “disappointed” with the ruling. While the administration has long criticized the Affordable Care Act, it ended the suspension 2-1/2 weeks later to “mitigate some of the uncertainty caused by the New Mexico litigation,” after insurers said the suspension could upset markets. HHS later issued new risk adjustment rules for 2017 and 2018, with additional justifications that Matheson said mooted New Mexico Health Connections' claims for those years. The case is New Mexico Health Connections v U.S. Department of Health & Human Services et al, 10th U.S. Circuit Court of Appeals, No. 18-2186. Democrats ask U.S. Supreme Court to Save ACA (Reuters) - The Democratic-controlled U.S. House of Representatives and 20 Democratic-led states asked the Supreme Court on Friday to declare that the landmark Obamacare healthcare law does not violate the U.S. Constitution as lower courts have found in a [FN4] lawsuit brought by Republican-led states. The House and the states, including New York and California, want the Supreme Court to hear their appeals of a Dec. 18 ruling by the New Orleans-based 5th U.S. Circuit Court of Appeals that deemed the 2010 law's “individual mandate” that required people to obtain health insurance unconstitutional. The petitions asked the Supreme Court, which has a 5-4 conservative majority, to hear the case quickly and issue a definitive ruling on the law, formally called the Affordable Care Act, by the end of June. Texas and 17 other conservative states - backed by President Donald Trump's administration - filed a lawsuit challenging the law, which was signed by Democratic former President Barack Obama in 2010 over strenuous Republican opposition. A district court judge in Texas in 2018 found the entire law unconstitutional. “The Affordable Care Act has been the law of the land for a decade now and despite efforts by President Trump, his administration and congressional Republicans to take us backwards, we will not strip health coverage away from millions of Americans,” New York Attorney General Letitia James said. Obamacare, considered Obama's signature domestic policy achievement, has helped roughly 20 million Americans obtain medical insurance either through government programs or through policies from private insurers made available in Obamacare marketplaces. Republican opponents have called it an unwarranted government intervention in health insurance markets. Congressional Republicans tried and failed numerous times to repeal Obamacare. Trump's administration has taken several actions to undermine it. In 2012, the Supreme Court narrowly upheld most Obamacare provisions including the individual mandate, which required people to obtain insurance or pay a financial penalty. The court defined this penalty as a tax and thus found the law permissible under the Constitution's provision empowering Congress to levy taxes. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -3- In 2017, Trump signed into law tax legislation passed by a Republican-led Congress that eliminated the individual mandate's financial penalty. That law means the individual mandate can no longer be interpreted as a tax provision and therefore violates the Constitution, the 5th Circuit concluded. In striking down the individual mandate, the 5th Circuit avoided answering the key question of whether the rest of the law can remain in place or must be struck down, instead sending the case back to a district court judge for further analysis. That means the fate of Obamacare remains in limbo. The fact that the litigation is still ongoing may make the Supreme Court, which already has a series of major cases to decide in the coming months, less likely to intervene at this stage. Supreme Court to Hear Trump Appeal in ACA Contraception Fight (Reuters) - The U.S. Supreme Court on Friday took up an appeal by President Donald Trump's administration seeking to enforce new federal rules allowing employers to obtain religious exemptions from an Obamacare requirement that health insurance that they provide [FN5] to employees pays for women's birth control. At issue is a challenge by the states of Pennsylvania and New Jersey to the administration's 2018 rule that permits broad religious and moral exemptions to the Affordable Care Act's contraception mandate and expands accommodations already allowed under the 2010 law dubbed Obamacare. The administration has asked the Supreme Court to reverse a nationwide injunction issued by a lower court blocking the rule from taking effect. The administration was joined by the Little Sisters of the Poor, an Roman Catholic order of nuns that is one of the groups seeking an exemption for its employees, although the group does not currently have to comply with the Obamacare mandate due to a separate Colorado court ruling in its favor. Arguments in the case before the high court, which has a 5-4 conservative majority including two justices appointed by Trump, are likely to be in April with a ruling due by the end of June. “The Trump administration's attempt to take away people's insurance coverage for contraception is one of the administration's many attacks on access to abortion and contraception, and we hope the Supreme Court will uphold the lower court's ruling blocking this awful law,” said Brigitte Amiri, a lawyer at the American Civil Liberties Union, which opposes the rule. Mark Rienzi, a lawyer at the Becket Fund for Religious Liberty, which represents the Little Sisters, said he was hopeful the Supreme Court would finally resolve the long-running litigation over religious nonprofit groups, which already reached the Supreme Court once in 2016. “There are plenty of ways to provide people with contraceptives without forcing Catholic nuns to participate,” Rienzi said. The Obamacare contraceptive mandate, part of Democratic former President Barack Obama's signature domestic policy achievement, requires that employer-provided health insurance include coverage for birth control with no co-payment. Previously, many employer- provided insurance policies did not offer this coverage. The blocked Trump rule would allow any nonprofit or for-profit employer, including publicly held companies, to seek an exemption on religious grounds. A moral objection can be made by nonprofits and companies that are not publicly traded. The administration's rule also applies to religiously affiliated universities that provide health insurance to students. In practice, many of these employers can still seek exemptions because of a different injunction issued by a judge in Texas last year that provides similarly broad exemptions to the contraception requirement. LEGAL AUTHORITY The legal question is whether Trump's administration had legal authority to expand the exemption under both the Obamacare law itself and another federal law, the Religious Freedom restoration Act, which allows people to press religious claims against the federal government. The Philadelphia-based 3rd U.S. Circuit Court of Appeals last year upheld a nationwide injunction issued by a district court judge in the lawsuit by New Jersey and Pennsylvania, blocking implementation of the rule. Separately, the San Francisco-based 9th U.S. Circuit Court of Appeals last year upheld a lower court's injunction blocking the rule in a group of 14 states. In the 2016 Supreme Court case, the justices sidestepped a decision on previous rules issued by the Obama administration, sending the dispute back to lower courts. At that time, religious employers including the Little Sisters opposed the government rules. This time, following changes made by the Trump administration, they supported them. Under the Obama rule, religious entities were exempt and an accommodation was created for religiously affiliated nonprofit employers, which some groups objected to for not going far enough. In a 2014 Supreme Court decision involving Christian-owned craft store chain Hobby Lobby Stores Inc, the court said that privately held companies could bring objections to the contraception mandate on religious grounds. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -4- Trump Administration Says California Can't Require Insurers to Cover Abortion (Reuters) - The Trump administration said on Friday that California cannot require health insurers to cover abortions and threatened to [FN6] cut some federal healthcare funds unless it pulls that requirement. The U.S. Department of Health and Human Services (HHS) issued a notice that the state is violating a federal law called the Weldon Amendment. The notice of violation comes as the result of an investigation by HHS' Office for Civil Rights. “No one in America should be forced to pay for or cover other people's abortions,” Roger Severino, director of HHS' Office for Civil Rights, said in a statement. HHS said it could limit some funds the department sends to the state if California does not assure it within 30 days that it will come into compliance with the law. It did not specify which funds or how much it could cut. The announcement comes as U.S. President Donald Trump is expected to be the first American president to attend the annual “March for Life” to be held in Washington on Friday, underscoring his outspoken support for the anti-abortion movement. “Women's health should never be dangled as bait for the sake of political grandstanding,” California Attorney General Xavier Becerra said in a statement. “In California, we will continue to protect our families' access to healthcare, including women's constitutional right to abortion. Nothing changes.” Youngest Children Losing Health Insurance The number of children under 6 without health insurance has increased to over 1 million for the first time since the implementation of the Affordable Care Act in 2014. Child development experts are concerned about increasing rates of lacking health insurance for young children, emphasizing the importance of health care in the first years of life. The earliest years of life are the foundation to the developing brain, cardiovascular, immune and metabolic systems. Medical interventions to correct issues are the most likely to succeed when the patient is a young age. Researchers at Georgetown University's Center for Children and Families recently discovered the falling rates of insurance for the youngest children in the United States during an analysis of census data. “Those years set up the trajectory for health into adulthood,” indicated Dr. Olanrewaju Falusi, an assistant director at the Children's National Hospital in Washington, D.C., and a spokeswoman for the American Academy of Pediatrics. “This is very alarming to me, to say that young children are becoming uninsured at a higher rate.” According to the American Academy of Pediatrics, children should see a physician at least 14 times prior to age 6 for screening tests for speech, hearing and vision, and screening for genetic disorders or trauma and toxic exposure. The U.S. Centers for Disease Control and Prevention recommends that children under 6 receive core vaccinations for hepatitis A and [FN7] B, diphtheria, whooping cough, polio, chicken pox, and measles, mumps and rubella. U.S. Supreme Court Takes Up Democratic Bid to Defend ACA (Reuters) - The U.S. Supreme Court on Monday agreed to hear a politically explosive case on whether Obamacare is lawful, taking up [FN8] a bid by 20 Democratic-led states including California and New York to preserve the landmark healthcare law. The impetus for the Supreme Court case was a 2018 ruling by a federal judge in Texas that Obamacare as currently structured in light of a key Republican-backed change made by Congress violates the U.S. Constitution and is invalid in its entirety. The ruling came in a legal challenge to the law by Texas and 17 other conservative states backed by Republican President Donald Trump's administration. The Supreme Court's decision to intervene means the fate of the law formally called the Affordable Care Act (ACA), the signature domestic policy achievement of Trump's Democratic predecessor Barack Obama, will be up in the air during the ongoing U.S. presidential race. The court is expected to hear arguments and decide the case in its next term, which starts in October and ends in June 2021, meaning a ruling is not likely before the Nov. 3 election in which Trump is seeking a second term in office. “As Texas and the Trump administration fight to disrupt our healthcare system and the coverage that millions rely upon, we look forward to making our case in defense of the ACA. American lives depend upon it,” said California Attorney General Xavier Becerra, a Democrat who is leading the defense of the law. Joe Biden, who served as Obama's vice president and is seeking the Democratic nomination to challenge Trump in the election, said the case illustrates the stakes for healthcare in the presidential race. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -5- “This fall, Donald Trump will be trying to get the Supreme Court to strike down Obamacare - ripping health insurance away from 30 million Americans, ending protections for 100 million more with pre-existing conditions, destroying families and costing a million jobs,” Biden said. The coalition of Democratic-led states have asked the Supreme Court to overturn a Dec. 18 ruling by the New Orleans-based 5th U.S. Circuit Court of Appeals that declared that the law's “individual mandate” that required people to obtain health insurance ran afoul of the Constitution. The 5th Circuit ruling, which did not resolve the question of whether the law should be struck down entirely, came in an appeal of U.S. District Court Judge Reed O'Connor's prior ruling that the entire law must fall. “Without the individual mandate, the entire law becomes unsupportable. The federal government cannot order private citizens to purchase subpar insurance that they don't want, and I look forward to finally settling the matter before the U.S. Supreme Court,” said Texas Attorney General Ken Paxton, a Republican. Trump has said he supports a prohibition on private insurance companies denying coverage to people with pre-existing medical conditions - a provision contained in Obamacare - even as his administration has urged courts to invalidate it. The Justice Department did not immediately respond to a request seeking comment. CHIEF JUSTICE IN THE SPOTLIGHT The Supreme Court has a 5-4 conservative majority that includes two justices appointed by Trump. In 2012, it ruled 5-4 to uphold Obamacare. All five justices in the majority in that case - four liberals and conservative Chief Justice John Roberts - remain on the court. For the law to be struck down this time, Roberts likely would have to reverse course and join the other conservatives. Obamacare has helped roughly 20 million Americans obtain medical insurance either through government programs or through policies from private insurers made available in Obamacare marketplaces. Republican opponents have called the law an unwarranted intervention by government in health insurance markets. The law was signed by Obama in 2010 over strenuous Republican opposition. In the lawsuit led by Texas, O'Connor ruled that the entire law was unconstitutional. The 5th Circuit, while agreeing with O'Connor about the individual mandate, sent the case back to him for reconsideration on whether any parts of Obamacare could be salvaged. The Supreme Court will now decide the issue. In the 2012 case, the Supreme Court upheld most Obamacare provisions including the individual mandate, which required people to obtain insurance or pay a financial penalty. The court defined this penalty as a tax and thus found the law permissible under the Constitution's provision empowering Congress to levy taxes. In 2017, Trump signed into law tax legislation passed by a Republican-led Congress that eliminated the financial penalty under the individual mandate, which gave rise to the Republican lawsuit. The tax law meant the individual mandate could no longer be interpreted as a tax provision and is therefore unlawful, the Republican challengers argued. Trump's administration supported the legal challenge although it has suggested that not all Obamacare provisions need to be struck down. The administration had urged the Supreme Court not to take up the appeal because the 5th Circuit decision was not final. Anthem Issues Updates Regarding COVID-19 Testing and Care to Support Affiliated Health Plan Members On March 17, Anthem's affiliated health plans announced additional updates and resources that can help provide increased access to care, while eliminating costs and helping alleviate the added stress on individuals, families and the nation's healthcare system. These actions are intended to support the protective measures taken across the country to help prevent the spread of COVID-19 and are central to the commitment of Anthem's affiliated health plans to remove barriers to care for their members and support communities through this unprecedented time. Anthem announced the following updates for members of its affiliated health plans: Access to Virtual Care and Development of a Coronavirus Assessment via Anthem's Sydney Care Mobile App: Anthem is working to accelerate the availability of a Coronavirus Assessment on the Sydney Care mobile app, which members can download at no cost. The Coronavirus Assessment is designed based on guidelines from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) to help individuals quickly and safely evaluate their symptoms and assess their risk of having COVID-19. Inputs provided by individual users include symptoms, recent travel and potential contact with anyone with the disease. Based on the results, Anthem members will be able to connect directly to a board-certified doctor via text or secure two-way video via the Sydney Care app who can then recommend care options. Sydney Care is available for Anthem members to download now on Android or iOS. This app should accompany their Sydney Health or Engage benefits app. Coronavirus Assessment functionality is in development and expected to be available within the next week. Additionally, effective immediately, Anthem's affiliated health plans will implement the following changes: Access to Testing and Medical Care: Anthem's affiliated health plans will continue to waive copays, coinsurance and deductibles for the diagnostic test related to COVID-19. In addition, this will be extended to include waiver of copays, coinsurance, and deductibles © 2021 Thomson Reuters. No claim to original U.S. Government Works. -6- for visits associated with in-network COVID-19 testing, whether the care is received in a physician's office, an urgent care center or an emergency department. Access to Medication: Anthem is relaxing early prescription refill limits for members who wish to receive a 30-day supply of most maintenance medications, where permissible. Additionally, Anthem continues to encourage health plan members who have a pharmacy plan that includes a 90-day benefit, to talk to their doctor about whether changing from a 30-day supply to a 90-day supply, of any prescription medicines they take on a regular basis, is appropriate. Members filling 90-day prescriptions can obtain their medications through our home delivery pharmacy and, in some circumstances, select retail pharmacies. Members can call the pharmacy services number on the back of their health plan ID card to learn more. Access to Virtual Care: For 90 days, Anthem's affiliated health plans will waive any member cost share for telehealth visits, including visits for mental health, for our fully insured employer plans, Individual plans, Medicare plans and Medicaid plans, where permissible. Cost sharing will be waived for members using Anthem's telemedicine service, LiveHealth Online, as well as care received from other telehealth providers delivering virtual care. Access to LiveHealth Online as well as virtual care via text is available to members through the Sydney Care app. Self-insured plan sponsors will have the choice to participate in this program. Anthem continues to recommend members use virtual care options when possible, as it can help prevent spread of coronavirus and improve access to care. Virtual care is a safe and effective way for members to see a doctor to receive health guidance related to COVID-19 from their homes via smart phone, tablet or computer. As Anthem continues to closely monitor the COVID-19 developments, we remain committed to all of those we serve. Anthem customers can rest assured that we are taking steps to ensure our operations remain uninterrupted, while ensuring the health and safety of our associates. We are employing social distancing strategies, using teleconference and video conferencing capabilities whenever possible and encouraging work at home where appropriate. Additionally, associates who work in clinical settings and are providing direct care to our members are receiving appropriate guidelines and implementing protocol measures to help minimize risk of exposure when caring for possible COVID-19 patients. CMS Issues Frequently Asked Questions on Catastrophic Health Coverage and the Coronavirus On March 18 the Centers for Medicare & Medicaid Services (CMS) issued Frequently Asked Questions (FAQs) to clarify coverage for the diagnosis and treatment of the Coronavirus Disease 2019 (COVID-19) by catastrophic health plans. A catastrophic health plan generally may not provide coverage of an essential health benefit before an enrollee meets the plan's deductible. Through these FAQs, CMS is announcing that the agency will not take enforcement action against any health issuer that amends its catastrophic plans to provide coverage without imposing cost-sharing requirements for COVID-19 related services before an enrollee meets the catastrophic plan's deductible. CMS encourages states to take a similar enforcement approach. The purpose of this use of CMS' enforcement discretion is to remove barriers and financial disincentives to COVID-19 diagnosis and treatment. The FAQs issued today align with guidance the Internal Revenue Service (IRS) released last week, which provides flexibility to high deductible health plans to provide health benefits for diagnosis and treatment of COVID-19 without application of a deductible or cost-sharing. The link to the related FAQs can be found here: https://www.cms.gov/CCIIO/Resources/Files/Catastrophic-Coverage-of-COVID-19.pdf. U.S. $2 Trillion Coronavirus Relief Package Stops Short of Covering Uninsured (Regulatory Intelligence) - The U.S. Congress' $2 trillion coronavirus relief bill passed by the Senate late Wednesday will require private insurance plans to cover COVID-19 treatment and a potential vaccine in future at no cost, but stopped short of providing or expanding [FN9] health insurance to the uninsured who fail to qualify through other government-aided programs. The Coronavirus Aid, Relief, and Economic Security (CARES) Act, pending a vote at the House of Representatives in debate to begin on Friday, contains fiscal stimulus to boost the economy and help for people worst affected by the COVID-19 outbreak. The bill would provide about $100 billion for hospitals and about $250 billion to expand unemployment insurance. House Speaker Nancy Pelosi had earlier proposed incorporating a clause in the stimulus package that would eliminate cost-sharing for COVID-19 treatment for every individual, including the uninsured, and also cover coronavirus vaccines for all in future. Her proposal would also provide incentives for more states to expand Medicaid to cover more low-income individuals. But on Thursday Pelosi made clear her efforts were focused on swiftly passing the Senate measure. During a press briefing on Thursday, President Donald Trump said White House officials were meeting with health insurance officials during the day. “We're going to take care of our people,” he said, adding they were “starting off by sending big checks” to individuals and families - a provision included in the relief package. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -7- America's Health Insurance Plans, a group of health insurers, said it would continue to work with policymakers on additional steps to ensure more individuals get coverage and are able to afford existing coverage and premiums. They welcomed the stimulus package for the healthcare industry and businesses hit by losses from unexpected closures due to the respiratory virus. “We call on Congress to swiftly take additional action to secure and stabilize coverage for families, businesses, and workers,” Matt Eyles, AHIP's Chief Executive said. Robert Greenstein, president of the Center on Budget and Policy Priorities said lawmakers will need to do “substantially more in subsequent bills” to address urgent needs in areas like health coverage for struggling families. Such steps are now essential to help cover the uninsured through Medicaid or on the healthcare exchanges and those who “still slip through the crack.” U.S. Working on Blueprint for COVID-19 Treatment Costs for Uninsured (Regulatory Intelligence) - The administration of U.S. President Donald Trump said it was working on details of a proposal to directly pay hospitals for treatment costs of those without insurance coverage, amid growing fears that efforts to ease the financial toll of the [FN10] coronavirus infection on the uninsured and underinsured were lagging. “The White House coronavirus task force is working on a proposal for the president to use some of the $100 billion that we're making available to hospitals to compensate the hospitals directly for any coronavirus treatment that they provide to uninsured Americans. We're working out the details of that,” Vice President Mike Pence said at a White House briefing on Thursday. The president is expected to make a final decision Friday on the proposal, which would draw on money allocated for healthcare providers in the $2 trillion coronavirus stimulus package adopted last week. Individuals hospitalized with COVID-19 could face bills averaging between $42,000 and $75,000, depending on the number of other health complications they have, according to nonprofit organization FAIR Health. Health policy experts have feared treatment cost concerns may deter millions of individuals without comprehensive coverage from seeking timely treatment, or leave patients with large medical bills at a time when job losses are peaking. About 28 million Americans are uninsured, while roughly 10 million have reported job losses in the last two weeks. No SEP on federal marketplace yet The Trump administration on Wednesday pulled back from earlier suggestions it would open a COVID-19-related special enrollment period on the federal health exchange. More than 35 states depend on the federal healthcare exchange for their residents to buy coverage on the individual market. States relying on the federal exchange had hoped a special enrollment period would allow more uninsured and underinsured to sign up for more comprehensive coverage. The health insurance industry had also supported the idea, despite the potential of piling on more risk at existing rates. The administration said individuals losing their jobs could check the federal marketplace to see if they qualify for special enrollment. Individuals, however, are required to have had some form of health coverage in their job to qualify for a special enrollment at this time. Many small employers do not provide their employees with coverage. Signing up may also require documentation and evidence of the job and coverage loss - tough to procure in a crisis. More than 35 states have applied for a waiver during the federal emergency period to relax eligibility for state Medicaid enrollment, but there are no standard criteria that would ensure the federal government-assisted program would cover all the uninsured in the state. Families USA, a consumer health advocate, called on the Trump administration to step up federal assistance to state Medicaid programs to 100 percent for uninsured individuals' COVID-19 treatment, and allow Medicaid to cover treatment costs regardless of immigration status. Some insurers step up coverage for patients Some insurers, like Humana, Cigna, and CVS Health's Aetna, have voluntarily offered to cover the costs of COVID-19 treatment for their patients without any cost-sharing requirement, albeit with network restrictions in some cases. Their coverage would apply to all their fully-insured plans, but these carriers have limited to no control over employer-sponsored insurance plans for which they act as administrators. About 61 percent of the country's population gets its coverage through an employer. A spokesperson for Aetna said its decision to cover COVID-19 treatment costs applies to all its fully-insured commercial plans. Self- insured employers will be given an opportunity to opt-out. A spokesperson for Humana said the company is reaching out to self-funded clients to determine their “desired approach,” as it could not make coverage policy changes without their approval. The number of coronavirus cases continues to climb rapidly and on Thursday crossed 1 million worldwide, with about one-fifth of them in the United States. Nearly 6,000 Americans have lost their lives. Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases said, “People need to understand that things will get worse before they get better.” Anthem Waives Cost Share for COVID-19 Treatment © 2021 Thomson Reuters. No claim to original U.S. Government Works. -8- On April 1, Anthem announced it will expand coverage, effective April 1, for members in its affiliated health plans undergoing treatment related to a COVID-19 diagnosis. “During these challenging times, Anthem stands by our legacy and commitment to living our values and supporting those we serve,” said Anthem President and CEO Gail K. Boudreaux. “By applying our approach for innovation, compassion and inclusion, we are focused on the issues needed most in this time of crisis, including affordability and access to care for those dealing with treatment related to COVID-19. We are also proud to serve as a partner to frontline caregivers and community leaders to meet the evolving needs of our nation.” The expansion covers the waiver of cost share for COVID-19 treatment received through May 31, 2020. Anthem will reimburse health care providers at in-network rates or Medicare rates, as applicable, for Anthem's affiliated health plan fully insured, Individual, Medicaid and Medicare Advantage members. Anthem is strongly encouraging participation by our self-funded employers and will work with them to ensure their employees' needs are met. These employers will, however, still have the option to opt out of participation. Anthem will also provide post-discharge support to Medicare members with complex care needs who may need additional assistance as they transition back to home following hospitalization. Anthem's care managers can help provide coordination of medications and home health needs, scheduling follow up appointments and transportation, and arranging for post-discharge meal delivery. This action expands upon the proactive steps Anthem has already taken to support care providers and protect our members, associates and communities against COVID-19, which include: Waiving copays, coinsurance and deductibles for the diagnostic test related to COVID-19, as well as for visits associated with COVID-19 testing, whether the care is received in a physician's office, an urgent care center or an emergency department. Relaxing early prescription refill limits for members who wish to receive a 30-day supply of most maintenance medications, where permissible. Waiving any member cost share until June 14, 2020 for telehealth visits, including visits for mental health and select Physical, Occupational and Speech therapies, for our fully insured employer plans, Individual plans, Medicare plans and Medicaid plans, where permissible. Launching a COVID-19 symptom assessment tool available online and via the Sydney Care mobile app. Suspending select prior authorization requirements to allow care providers to focus on caring for patients diagnosed with COVID-19. This includes suspension of prior authorization requirements for patient transfers, prior authorization requirements for skilled nursing facilities, along with the suspension of prior authorization requirements for the use of medical equipment critical to COVID-19 treatment. Temporarily adjusting the approach to monitoring claims and audits. Supreme Court Tells U.S. Government to Pay Insurers $12 billion Under ACA (Reuters) - The federal government must “honor its obligations” and pay private insurers $12 billion owed to them under an Obamacare provision aimed at encouraging them to offer medical coverage to uninsured Americans, the U.S. Supreme Court ruled on Monday. [FN11] The 8-1 ruling authored by liberal Justice Sonia Sotomayor paves the way for a significant one-time cash infusion for major companies such as Humana Inc, Anthem Inc and Centene Corp. The justices reversed a lower court's ruling that Congress had suspended the government's obligation to make such payments under the Affordable Care Act, widely known as Obamacare. Unlike other litigation involving Obamacare - long targeted by Republicans for repeal in Congress or invalidation through the courts - this case concerned only payments to insurers and did not directly challenge the law itself. The Supreme Court in its next term, which starts in October, is set to hear a more politically freighted case concerning a bid by 20 Democratic-led states including California and New York to preserve Obamacare in the face of a challenge by Republican-led states backed by President Donald Trump's administration. In Monday's ruling, the court sided with insurers that had argued that the lower court ruling would have let the government pull a “bait- and-switch” and withhold money the companies were promised. “The government should honor its obligations,” Sotomayor wrote. Justice Samuel Alito, one of the five conservative justices, was the sole dissenter, saying the court's ruling “has the effect of providing a massive bailout for insurance companies that took a calculated risk and lost.” Moda Health Plan Inc and other insurers that sued to try to compel the U.S. Department of Health and Human Services (HHS) to make the payments have said the government was supposed to help them recover from early losses they suffered after the law was passed by Congress in 2010 and signed by Trump's Democratic predecessor Barack Obama. The law has enabled millions of Americans who previously had no medical coverage to obtain insurance, including those with pre- existing medical conditions. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -9- Other insurers involved in the case included Blue Cross and Blue Shield of North Carolina, Maine Community Health Options and Land of Lincoln Mutual Health Insurance Company. “We appreciate that today's Supreme Court 8-1 decision ensures that the federal government honors the obligations it made for services the private sector already delivered,” said Matt Eyles, president of America's Health Insurance Plans, an industry group representing insurers. An HHS spokeswoman said officials were “disappointed in the court's ruling.” Payments would have come through the law's so-called risk corridor program designed to mitigate insurers' risks from 2014 to 2016, when they sold coverage to previously uninsured people through exchanges established under Obamacare. Insurers that paid out significantly less in claims on policies sold through the exchanges than they took in from premiums provided some of their gains to the government. Insurers that paid out more were entitled to government compensation for part of their losses. From 2015 through 2017, Congress passed legislation barring HHS from using general funds to pay the government's risk corridor obligations. Health insurers turned to federal courts to obtain the payments. The U.S. Court of Appeals for the Federal Circuit ruled in 2018 that Congress effectively repealed its obligation to pay the insurers, prompting the insurers to appeal to the Supreme Court. In a case directly challenging Obamacare, the Supreme Court in 2012 upheld the bulk of the law. Three years later, it rejected another challenge to it. U.S. Healthcare Groups Call for More Aggressive Insurance Response in COVID-19 Relief (Regulatory Intelligence) - Representatives of health insurers, hospitals, and businesses are calling on Congress to take more aggressive steps in their next coronavirus relief bill to give the uninsured more access to comprehensive health coverage while ensuring people with insurance can afford to keep their benefits. They asked the federal government to temporarily subsidize self- insured employers to keep their employee's existing benefits and allow health savings accounts to be used for premium payments. [FN12] For the uninsured, they have sought an expansion of subsidies allowed by the Affordable Care Act (ACA) and the opening of a special enrollment period (SEP) on the federal insurance marketplace to bring more people without coverage into the cover of ACA health plans. The administration of President Donald Trump, which has consistently sought to repeal the ACA and weaken its provisions, has opposed resorting to the ACA to deal with the fallout of the global pandemic. Trump instead has offered to reimburse hospitals for treatment costs for the uninsured through the $100 billion relief package provided in the CARES Act. Loosening requirements for ACA subsidies and reopening enrollment in the federal health insurance marketplace for the duration of the public health emergency would be “far more effective,” a joint letter from America's Health Insurance Plans, the U.S. Chamber of Commerce and 30 other healthcare-related groups said to leaders of Congress. The letter said the administration's approach of allocating funds from the CARES Act will “quickly deplete” the emergency fund and not provide the benefits of better coverage such as protections against preexisting conditions to that section of the population. U.S. House Speaker Nancy Pelosi, who has supported a special enrollment period and other insurance relief through the ACA, said on Tuesday lawmakers were considering boosting funding for Medicaid. That would give states more scope to bring uninsured into ACA- compliant plans. The COVID-19 outbreak has led to about 26 million people losing jobs and in many cases, their health coverage as well, within the span of a few weeks. Those employed also run the risk of losing coverage as financial strain from the COVID-19 crisis is moving employers to reduce health benefits to their employees to manage expenses, the letter said. Government help is required to preserve workers' access to stable, secure health benefits, they added. “We know that the private sector and government working together can help overcome this crisis,” said Matt Eyles, AHIP's Chief Executive said. Health insurers are making efforts to ensure their consumers have continued access to care but their actions cannot help people who lose their coverage, he added. Trump to Continue Fight Against ACA as Supreme Court Weighs Contraceptive Case (Regulatory Intelligence) - U.S. President Donald Trump said on Wednesday his administration will not back down from the fight to strike down the entire Affordable Care Act amid a review at the U.S. Supreme Court of a portion of it. His comments drew an immediate rebuke from Democrats who said preserving the law is even more crucial during the current global pandemic. Trump's announcement came a day after U.S. Attorney General William Barr reportedly recommended the administration modify its position and seek to [FN13] preserve some parts of the law passed by former President Barack Obama in 2010. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -10- “We're staying with the group ? with Texas and the group,” Trump said. “It's very bad healthcare. What we want to do is terminate it and give great healthcare... including preexisting conditions.” The administration sided with Texas and 19 other Republican-led states in a lawsuit in February 2018 case challenging the ACA's validity without the individual mandate -- that required everyone to buy health insurance or pay a tax penalty -- based on a Supreme Court ruling in 2012 that allowed the law to prevail as part of Congress' power to tax. “We've already pretty much killed it because we got rid of the individual mandate,” Trump said, referring to the removal of the tax penalty associated with the individual mandate in 2017. The Department of Justice had first argued at a district court in Texas that some parts of the law, also known as Obamacare, are unconstitutional, but a year later changed its position to argue the law be struck down in its entirety. The Texas district court invalidated the entire law, while the Fifth Circuit Court of Appeals held part of the law was invalid and sent the case back to the lower court for a more detailed review on the standing of the entire law. The Supreme Court on Wednesday heard oral arguments in another case testing the act, at a time when the new coronavirus outbreak has forced federal and state government to route many of its relief measures through the provisions of the ACA, such as coverage enrollment through the healthcare marketplace and Medicaid. U.S. Supreme Court justices grappled on Wednesday with whether Trump's administration went too far in allowing employers to obtain broad religious and moral exemptions from an Obamacare requirement that health insurance that they provide employees covers women's birth control. At issue is a challenge by the states of Pennsylvania and New Jersey to the administration's 2018 rule that permits broad religious and moral exemptions to the contraception mandate of the 2010 Affordable Care Act, commonly called Obamacare, and expands accommodations already allowed. Conservative Chief Justice John Roberts, a potential pivotal vote, appeared frustrated that the long-running litigation, a version of which previously reached the Supreme Court in 2016, has not led to a compromise. 'Is it really the case that there is no way to resolve those differences?' Roberts asked. Roberts wondered if the administration's approach was too broad by providing exemptions even to entities that had not complained about the adequacy of previous accommodations devised under Trump's Democratic predecessor Barack Obama. A group of 20 states defending the law, led by California, said in a brief filed on Wednesday in the Texas case that the ACA has allowed tens of millions of Americans to obtain high-quality healthcare coverage, slowed the growth of healthcare costs, improved health outcomes, and funded responses to emerging public health crises. Many of its reforms have proven indispensable in the context of the current pandemic. “The president's insistence on doubling down on his senseless and cruel argument in court to destroy the ACA and every last one of its benefits and protections is unconscionable, particularly in the middle of a pandemic,” said Nancy Pelosi, Speaker of the House of Representatives. Without the protections of the ACA, 133 million Americans with pre-existing conditions could be denied health insurance, California's Attorney General Becerra said. “We can't afford to return to those days, so we're marching forward at the Supreme Court determined to save the ACA and American lives.” Trump has said he aims to replace the ACA with “great healthcare” at a “lesser price” and provide protections for pre-existing conditions, but Becerra the President's team has only shown efforts to repeal the existing law without a plan to replace. The Affordable Care Act has provided health coverage to about 20 million Americans. More Than 25 million in U.S. Could Lose Employer-based Insurance Due to Pandemic - Report (Regulatory Intelligence) - An estimated 25 million Americans could lose their employer-sponsored health insurance if unemployment [FN14] reaches 20%, according to a new report from the non-profit Robert Woods Johnson Foundation and the Urban Institute. If unemployment increases to 25%, as many as 43 million could lose their workplace insurance coverage. The Federal Reserve Bank of St. Louis has estimated that the unemployment rate could soar as high as 30% in the second quarter, according to the report. In March 2020, prior to the start of the COVID-19 pandemic, an estimated 160 million Americans under the age of 65 were insured through employer-sponsored health plans. Of the 25 million losing their employer-sponsored insurance with unemployment at 20%, the researchers approximate 12 million will be able to replace that insurance through the Medicaid low-income health program and 6 million will find insurance through marketplace or other private insurance plans. The remaining 7 million will become uninsured. Newly underemployed residents of states that have expanded Medicaid eligibility under the Affordable Care Act, or Obamacare, will have greater access to coverage than those in states that have not expanded their Medicaid programs. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -11- If unemployment reaches 25%, approximate 12 million people would gain coverage through Medicaid and 10 million would gain coverage through the Affordable Care Act marketplace or other private plans. The remaining 12 million would become uninsured, according to the report. Individuals who lose their employer-sponsored health insurance might not realize they could be eligible for Medicaid or marketplace- based subsidized health insurance, which could contribute to even higher numbers of uninsured. Additionally, the sudden influx of uninsured could also overwhelm Medicaid administrative systems and make it difficult for states to process applications for Medicaid benefits. When the report compared states that expanded Medicaid under the Affordable Care Act with those that did not, it found 3 times more adults would be eligible for Medicaid in expansion states than non-expansion states. With the unemployment rate at 20%, as many as 40% of adults losing their workplace insurance in non-expansion states could remain uninsured. Thirty-six state jurisdictions expanded Medicaid under the ACA and 15 states did not expand coverage. An increase in the number of uninsured during a national public health emergency could worsen the crisis as uninsured individuals fail to seek treatment for COVID-19 symptoms out of fear that they will be unable to afford the cost of treatment. The report recommends allowing ‘speedy’ Medicaid expansions in non-expansion states and expanding the income range for eligibility for premium subsidies in the ACA to help increase access to insurance for those who lose their employer-sponsored coverage. It also recommends enhancing federal Medicaid matching rates even more than the increases already included in the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act to offset the increased costs to state Medicaid programs. At least three states have already announced deep cuts to their Medicaid programs, citing the impact of the COVID-19 pandemic on their state budgets. Colorado is cutting $229 million and Ohio is cutting $210 million from their Medicaid budgets. Georgia has is cutting all state spending by 14%, including from its safety net programs such as Medicaid. U.S. States Expand on Federal Coronavirus Insurance Responses to Increase Access to COVID-19 Care - Study (Regulatory Intelligence) - Although the United States Congress has taken measures to ensure individuals are able to receive coronavirus testing and treatment, states are taking additional measures to further ensure their citizens can access healthcare during [FN15] the crisis, according to a new Kaiser Family Foundation (KFF) report. Under the Families First Coronavirus Response Act (FFCRA), Medicare, Medicaid, all group health plans and individual health insurance policies are required to cover COVID-19 diagnostic testing and visit costs without cost sharing. The FFCRA also prohibits prior authorization requirements on diagnostic testing during the public health emergency. It also allows states to provide Medicaid coverage of COVID-19 testing for their uninsured residents with 100% federal funding. In addition to these federal actions, Kaiser foundation report found that a number of states have taken executive actions to increase access to COVID-19 testing and treatment as well as requiring insurers to cover a COVID-19 vaccination without cost-sharing, if and when one becomes available. Among the states taking additional action to reduce barriers to COVID-19 testing and treatment, KFF found that 5 states, Kentucky, Louisiana, Maine, New Hampshire, Pennsylvania, require insurers to waive prior authorization requirements for COVID-19 testing. Six additional states, Delaware, District of Columbia, Massachusetts, Oklahoma, Rhode Island and Washington, require insurers to waive prior authorization requirements for COVID-19 testing and treatment. Ten states have taken action to require insurers to cover the cost of a vaccine, if one becomes available. Nine states, District of Columbia, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Nevada, New York and Rhode Island require cost-free vaccine coverage. Oregon has entered into an insurer agreement to cover the cost of a vaccine. Other states are requiring insurers to waive patient cost-sharing for COVID-19 treatment and related conditions. Three states, District of Columbia, Massachusetts and New Mexico, require insurers to waive cost sharing for COVID-19 treatment. Three other states, Idaho, Michigan and Minnesota, have reached an agreement with insurers to waive cost-sharing requirements. Twelve states have taken steps to extend their state health insurance marketplace special enrollment periods, including California, Colorado, Connecticut, District of Columbia, Maryland, Massachusetts, Minnesota, Nevada, New York, Rhode Island, Vermont and Washington, according to the report. Special enrollment periods allow individuals without insurance to enroll outside the normal enrollment period due to a significant change in their circumstances such as the loss of a job. Several states have also taken actions to relax prior authorization and utilization review requirements to increase access to treatment without the delays in treatment. 'Medicaid Best Price' Changes Aimed at Value-based Gene Therapy Contracts: U.S. Agency © 2021 Thomson Reuters. No claim to original U.S. Government Works. -12- (Reuters) - Proposed changes to requirements that state-run Medicaid programs are given the best drug prices would clear the way for commercial health insurers to enter into “value-based” payment schemes, the U.S. Centers for Medicare & Medicaid Services said on [FN16] Wednesday. Drug manufacturers by law must give Medicaid their “best price,” meaning the lowest price they negotiate with any other buyer. But health plans have expressed concerns that the requirement prevents them from linking drug prices to patient outcomes - a practice known as “value-based” pricing. “The problem has been that the Medicaid best price regulations are a barrier. ... Today we are announcing that we are updating them to allow for more value-based pricing,” CMS Administrator Seema Verma told Reuters in a telephone interview. The proposed changes are being driven by the increasing availability of very expensive, potentially curative, gene therapy treatments, she said. Spark Therapeutics Inc, now owned by Roche Holding AG, in 2018 launched its Luxturna treatment for an inherited genetic mutation that causes blindness at a price of $850,000. Novartis AG last year won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy, pricing the one-time treatment at a record $2.125 million. Commercial health insurers have considered linking reimbursement of such drugs to health outcomes, but have been stymied by the Medicaid best price rules, Verma said. “If a drug didn't work in 20% of cases, in those cases the payment might be zero, which could completely alter the Medicaid best price,” she explained. The changes proposed include calculating the best price based not just on one discount, but as a comprehensive blend of prices. They would also allow for price calculations outside of the current three-year window. CMS said the aim is to provide greater flexibility for payers and manufacturers to enter into value-based agreements while ensuring Medicaid always gets the best deal. The proposed changes will be open for a 30-day comment period. U.S. Health Insurers May Balk at Paying for Coronavirus Antibody Testing (Reuters) - U.S. health insurers may balk at covering tests that look for coronavirus antibodies in some cases, arguing that employers [FN17] or the government should foot a bill expected to run into billions of dollars. Health insurers have largely escaped the economic pain wrought by the pandemic. Their profits increased as many Americans delayed more routine and expensive medical care during the recent lockdown period, while the total cost of covering COVID-19 patients has been less than expected in many regions with low case numbers. Now the industry is tallying up the potential cost of expanding both diagnostic and antibody testing, seen as a critically important component of safely reopening businesses across the country. Diagnostic tests determine if someone is currently infected and contagious, while the antibody, or serology, tests show whether someone was previously infected and possibly immune. Wall Street firm Jefferies & Co estimates a need for hundreds of millions of antibody tests in the next 18 months, accounting for about one-quarter of an anticipated $15 billion in U.S. COVID-19 test spending through the end of 2021. In pushing back, health insurers draw lines between what they deem as medically necessary tests, and those done for research or return-to-work purposes. Businesses may require repeat testing of employees, and they note that private health insurance covers only about half of Americans. The government needs to provide guidance on the role of insurers, employers and public health officials, insurers say. 'It is also critical that these strategies consider related funding in that context,” Kristine Grow, spokeswoman for America's Health Insurance Plans said in a statement. AHIP estimates antibody testing will cost the United States as much as $19 billion a year. The biggest national insurers including UnitedHealth Group Inc, CVS Health Corp's Aetna unit and Cigna Corp have policies to cover the tests, which cost around $50, and related appointment fees, when doctors say they are medically necessary. Others, such as Blue Cross of Idaho, say they will not cover the tests to help determine the prevalence of the disease in a community, which officials see as necessary for controlling subsequent outbreaks. Doctors' groups and diagnostics makers say broad serology testing is an important component of understanding COVID-19 and the level and length of immunity prior infection confers. AdvaMedDX, a trade group that represents test makers including Roche Holding AG and Abbott Laboratories, expects about 94 million laboratory-based tests to be shipped by the end of June. It has sent letters to Blue Cross of Idaho and Blue Cross & Blue Shield of Mississippi telling them their policies do not align with the law. Neither company responded to a request for comment. “Clinicians really need at their disposal the full range of COVID-19 testing,” said Susan Van Meter, executive director of AdvaMedDX. The U.S. Congress passed legislation calling for health insurance coverage for COVID-19 testing to cope with a pandemic that has killed more than 115,000 people and infected over 2 million nationwide. The federal government set aside $26 billion at the beginning of May for coronavirus testing, much of which was earmarked for government health agencies, states and research and development. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -13- The U.S. Centers for Disease Control and Prevention has since instructed Americans not to assume a positive antibody test means they are immune from future infection, and to continue physical distancing and use of masks until there is more evidence around immunity. Limiting use Covering only tests insurers see as medically necessary could limit them to people who either have symptoms of COVID-19 or been in close contact with someone who has. They may also cover testing for recovered COVID-19 patients who want to donate antibody-rich plasma for treatment of others or for children with a rare coronavirus-related complication. The uncertainty around coverage of tests for other purposes is slowing a return to business for Andrew Matta, who runs the North American Dental Group. The group has 200 affiliated locations in about 15 states, including New York, Georgia and Texas, with more than 1 million patients. It is working with a physician's group that orders both a diagnostic and serology test ahead of dental procedures. The patient then has a blood draw at the dentist's office, and returns three days later for the procedure. Dental patients are starting to return with basic safety protocols in place, but Matta expects testing to help reassure customers more wary of coronavirus exposure. Insurers have been noncommittal about whether they will cover the cost of that testing, or whether patients will end up being billed by the testing lab, he said. “If we knew these would be covered for pre-procedures, we would be scaling it rapidly right now,” Matta said. Sabrina Corlette, a health policy professor at Georgetown University, had been advocating for private insurers to pay for these tests broadly. She now says there should be a separate government-run fund for testing to make sure patients ? insured or uninsured - can easily get the tests they need. “If people fear they are going to face hundreds of dollars in bills, they are not going to get tested,' Corlette said, ‘and it's a risk not just to them, but to everybody around them.” Loss of Coverage Insurance Enrollment Surges in 2020: U.S. Health Agency (Regulatory Intelligence) - More people have signed up through the special enrollment provision for 2020 health coverage on the federal healthcare exchange than in previous years, the Centers for Medicare and Medicaid Services said on Thursday. Over 892,000 people have signed up for health coverage through May via the special enrollment period (SEP) compared to the approximately [FN18] 704,000 people who used the same provision through May last year. The SEP allows consumers to obtain comprehensive health coverage under the Affordable Care Act outside the usual open enrollment period due to a “life-changing” qualifying event such as marriage, the birth of a child or “loss of coverage” as a result of a job loss The largest gain in loss of coverage SEP enrollments occurred in April 2020, with enrollments increasing by 139 percent to 159,000 from a year earlier, the CMS said. Loss of coverage enrollments in May declined to 103,000 people in May but still rose 43 percent from the previous year. Unemployment soared across the country as government stay-at-home orders were implemented in March, with almost 30 million people filing for jobless claims by the end of April 2020. The Trump Administration had been called on to open a separate COVID-19 special enrollment period to accommodate consumers suffering job losses. The CMS first began considering the option in late March but Vice President Mike Pence later said there would be no pandemic-related special enrollment period on the federal healthcare exchange. The CMS on Thursday used the April and May enrollment data to back the Administration's decision to not open a separate SEP during the public health emergency. “These enrollment numbers show that individuals who lost their jobs or experienced other qualifying life events due to the COVID-19 pandemic are using existing SEPs to enroll in coverage through HealthCare.gov.” the U.S. health agency said in its report. “CMS strongly encourages individuals to visit HealthCare.gov to explore their coverage options.” Health experts and consumer advocates had cautioned that uninsured people and their families who lost their job as a result of the pandemic would be excluded from the loss of coverage SEP and that a separate enrollment provision would need to be made available for them. The current loss of coverage SEP only allows those with prior coverage but newly unemployed to access an ACA plan. About 13 states in the country operate their own healthcare exchange but the consumers in the rest of the country rely on the federal healthcare exchange to buy healthcare coverage on the individual market. U.S. Supreme Court's Contraceptives Ruling on Religious Exemptions Sparks Insurance Gap Concerns (Regulatory Intelligence) - The U.S. Supreme Court on Wednesday upheld a Trump administration rule allowing religious organizations and companies to deny contraceptive coverage to their employees. The ruling has raised concerns of gaps in health insurance [FN19] coverage for women impacted by the rule. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -14- The court ruled 7-2 against a challenge brought by the states of Pennsylvania and New Jersey against a rule issued by the administration of President Donald Trump in 2018 which enabled employers with religious or moral objections to deny contraceptive coverage in insurance plans for their employees. Earlier government guidelines mandated that under the 2010 Affordable Care Act (ACA), employer-sponsored health plans had to provide contraceptive coverage. Advocates of religious liberties cheered the ruling while policy analysts and women's rights advocates alleged the court's ruling not only hampers some women from receiving contraceptive coverage but also promotes discrimination against women's reproductive rights. Women affected by the ruling might have to pay out of pocket for contraceptive services, as insurance companies do not currently offer contraceptive coverage separately. “It would be unfair for only women of childbearing age to have to purchase additional coverage, just as it would be unfair for only people with a given health condition to have to purchase policies that covered that condition,” said Cheryl Fish-Parcham, director at Families USA, a consumer healthcare advocacy organization. The administration's new rule allows any employer, including public companies, to seek an exemption from paying for coverage related to birth control on religious grounds. The exemption is also available to religiously-affiliated entities that provide health insurance, such as universities that provide coverage to students. The Little Sisters of the Poor, a Roman Catholic order of nuns, was one of the groups seeking the exemption to avoid paying penalties for not covering contraceptive and abortion care. “We are overjoyed that, once again, the Supreme Court has protected our right to serve the elderly without violating our faith,” said Mother Loraine Marie Maguire of the Little Sisters. Alex Azar, Secretary of the Department of Health and Human Services, whose department oversaw the exemptions, said the ruling showed that the government can enhance access to healthcare while simultaneously protecting religious beliefs and moral convictions. Some lawmakers and regulators worried the ruling would exacerbate existing gender inequalities, especially related to women of color who also face other barriers to care. The Trump administration has estimated that about 126,000 women may lose their employer-provided health coverage under the new rule. Many more women, however, could lose coverage as the ruling may make it easier for any employer or university to claim religious or moral objections to covering birth control for women, said Jamille Allsbrook, director of Women's Health and Rights at the Center for American Progress. Insurers have maintained that they oppose any discrimination in access to coverage. America's Health Insurance Plans, an association of health insurers, did not immediately respond to a request for comment on Wednesday's Supreme Court ruling. The Supreme Court held, in an opinion written by Justice Clarence Thomas, that the administration had the statutory authority under the ACA to create the exemptions and that the rulemaking followed the proper procedures. The ACA requires covered employers to offer health coverage that includes certain ‘minimum essential coverage’ provisions and imposes penalties on those employers who fail to comply. One of those provisions requires covered employers to provide women with preventive care and screenings without ‘any cost-sharing requirements.’ However, the ACA did not define what was included in preventive care and screenings. Instead, Congress said that coverage must include preventive care and screenings as provided for in Health Resources and Services Administration (HRSA) guidelines that had not yet been written when the ACA was passed. HRSA is an agency of the Department of Health and Human Services (HHS). The HRSA guidelines issued soon after the passage of the ACA in 2010 included all FDA approved contraceptive methods, which provided the basis for the so-called “contraceptive mandate.” Later, a religious exemption was created to allow qualifying religious organizations to opt out of the mandate under certain circumstances. However, in subsequent challenges, the Supreme Court held that under the Religious Freedom Restoration Act of 1993 (RFRA) the mandate substantially burdened closely held corporations with ‘sincerely held religious exceptions' by requiring them to provide their employees with certain methods of contraception. Subsequently, HHS and the Labor and Treasury departments issued two rules following a 2017 executive order from President Donald Trump directing them to consider expanded, “conscious based-objections” to the mandate. The first rule provided a broader religious exemption. The second rule created a similar ‘moral exemption’ for employers with a moral, but not necessarily religious objection, to providing contraceptive coverage. Pennsylvania and New Jersey's challenge argued that the departments lacked the statutory authority under the ACA or the religious freedom act to issue the exceptions and also that the rules failed to follow the requirements of the Administrative Procedure Act, which governs the federal rulemaking process. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -15- Thomas said in the court's opinion that the ‘virtually unbridled discretion’ of the HHS to determine what was meant by preventive care and screenings also left the agency's discretion ‘equally unchecked in other areas,’ included its ability to create exceptions to the guidelines. More litigation is certain on the matter, especially where the administration's new rule conflicts with state laws that preserve ACA protections or mandate contraceptive coverage. Calls are also being made to Congress to pass fresh legislation to ensure that women do not have to pay more for coverage of contraceptive services. Some states have begun trying to find ways to shield consumers from losing coverage for contraceptives. Washington state is working on rules to begin enforcing a new law to ensure that employees of organizations that claim a religious or moral exemption also have access to coverage options. Before the law passed, the state paid for any necessary services required by people covered by a religiously-sponsored health insurer that did not want to pay for abortion services. The fund was held in the state's Department of Health and may be utilized in the future for others impacted by the Supreme Court ruling. “A woman's right to contraception shouldn't depend on her employer's whims,” the Washington Office of the Insurance Commissioner said. “Religious employers can exercise the conscience clause but women still have the right to the benefit.” Rule Requiring Separate Billing for Abortion Coverage Struck Down by U.S. Judge (Regulatory Intelligence) - A federal judge in Baltimore has struck down a rule of the U.S. Department of Health and Human Services that required health insurers to send consumers a separate, additional bill for charges in their plan related to covering abortion services. [FN20] The rule was slated to go into effect in August and was applicable to plans receiving federal assistance on the Affordable Care Act's individual healthcare market. It was seen by women's rights advocates as an attack on reproductive rights, and health insurers worried two separate bills requiring two separate payment transactions for a single health plan could lead to confusion, additional compliance costs and result in lost coverage for many consumers even as a result of unintentional non-payment of premiums. U.S. District Court Judge Catherine Blake on Friday found the requirement was “arbitrary and capricious” and would create unreasonable barriers for patients. It also ignored the statutory aim of the Affordable Care Act, or ‘Obamacare’ to increase the number of Americans covered by healthcare and decrease the cost of healthcare, she added. The HHS had recognized that the rule would raise insurance premiums for consumers, and cost more than $1 billion by 2024. Insurers currently only need to give policyholders notice that abortion coverage is included and may or may not break down costs by coverage on their monthly bill. The Trump administration had proposed the rule in December 2019, citing federal law prohibitions on the use of federal public funding for abortions except those arising from rape or incest. HHS Secretary Alex Azar said requiring health plans in the individual care market to send consumers separate bills would help the administration prevent tax credits from going toward coverage of abortions. Clarke, however, said the rule did not explain how the government would ensure public funds are not used for unauthorized purposes. The HHS said it was reviewing the court's decision but did not comment further on whether an appeal was in the works. “Abortion care is health care, and it should not be separated, “carved out,' or treated differently from any other medical service,” Karen Nelson, CEO of Planned Parenthood of Maryland said. The rule required insurers to send consumers a separate bill of at least $1 per member per month related to coverage of abortion services. ”It would have created a logistical nightmare for health insurers and individual enrollees and pushed abortion even further out of reach in the midst of a global pandemic that has upended our economy, disproportionately harming people with low-incomes, people of color, and people with disabilities,” said Meagan Burrows, staff attorney with the American Civil Liberties Union. The ACLU joined Planned Parenthood of Maryland (PPM) and several individual consumers in suing the HHS and the Centers for Medicare and Medicaid Services for promulgating the rule. More than 3 million consumers would be affected by the rule's restrictions, and the requirement would be applicable to one-third of the individual-market exchange plans nationwide, the Maryland group said. Plans in states that permit but do not mandate abortion coverage could drop coverage of abortion altogether to avoid the rule's administrative burdens, the Maryland group said. Opponents argued that consumers would be at risk of losing coverage befits and facing surprise medical bills if they failed to make the additional premium payments under the rule. It was also feared the rule could lead consumers to opt-out of abortion coverage to avoid the task of making two premium transactions every month. Appeals Court Upholds Trump Administration Rule on Short-term Health Plans (Regulatory Intelligence) - The United States District Court of Appeals for the District of Columbia upheld the Trump administration's [FN21] 2018 rule allowing expanded access to short-term limit-duration insurance. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -16- “Junk insurance is an inferior and hazardous substitute for comprehensive coverage. The court's decision today protects these plans and their harmful practices, placing patients, families, and providers at increased risk amidst a global health emergency,' Association for Community Affiliated Plans (ACAP) CEO Margaret A. Murray said in a statement following the 2-to-1 panel decision issued Friday. The short-terms, or STLD, plans are not subject to many Affordable Care Act (ACA) provisions, including community-rating, guaranteed-issue and essential-health-benefits requirements. As a result, although short-term plans may have much lower premiums, they can also have higher deductibles and exclude coverage for preexisting conditions. Under prior rules, the plans were capped at 3-month terms and renewals were prohibited. However, the appeals court recognized the prohibitions were not enforced and insurers often marketed STLDI ‘policies in year-round blocks.’ When premiums in the individual health insurance market increased in 2016 and 2017, while enrollments also declined, the Department of Health and Human Services (HHS) issue a final rule defining STLDI as ‘coverage with an initial contract term of less than one year and a maximum duration of three years counting renewals.’ The short-term plan was intended to increase access to affordable care and provide more consumer choice. HHS also expanded disclosure requirements including that the policy might exclude coverage of preexisting conditions, might not provide certain health benefits and might not trigger a special enrollment period if coverage expired mid-year. However, critics of the rule change argued that the plans could still result in unexpected out-of-pocket consumer costs because of the higher deductibles and coverage exclusions. HHS said the new rule would increase access to affordable health insurance among the uninsured and would increase consumer choice. It estimated 100,000 uninsured people would enroll in STLDI plans in 2019 and as many as 500,000 would ‘swap their ACA- compliance plans for STLDI plans.’ ACAP, a coalition of nonprofit safety net health plans, challenged the 2018 short-term plans rule, alleging it was contrary to law and arbitrary and capricious. The DC district court granted HHS's motion for summary, holding the rule was a reasonable interpretation of the law and was not arbitrary and capricious. The court of appeals held that the government's definition of ‘short-term limited duration insurance’ was based on a permissible constructions of the Health Insurance Portability and Accountability Act (HIPAA) and ACA it was entitled to Chevron deference in its de novo review of the district court's summary judgment decision. ACAP's ‘core contention’ was that the rule contravened the spirit of the ACA because it allowed a separate ‘shadow’ market for health insurance that does not provide comprehensive insurance. However, the appeals court found that the exception for the plans was ‘baked’ into the ACA when Congress exempted short-term plans from providing certain benefits. The court also rejected the ACAP's arguments that Congress intended to amend the HIPAA definition of short term plans in the ACA or that ‘short-term’ required something ‘meaningfully’ shorter than the standard 365-day policy term. The court found even 364 days was enough to be short-term. The appeals court also rejected ACAP's argument that ‘limited duration’ should be read as ‘nonrenewable.’ The court found that because the plans ‘cannot be renewed beyond three years' they are ‘quite literally’ limited in duration. The appeals court also rejected ACAP's argument that the rule was arbitrary and capricious. The dissenting panel judge argued the expanded rule ‘flies in the face’ of the ACA's comprehensive statutory scheme ‘to address certain problems that had existed for decades in the health insurance market.’ Judge Judith W. Rogers pointed to the denial of basic benefits, price discrimination and preexisting conditions as contrary to the ACA. ACAP intends to seek review by the full panel of the DC District Court of Appeals. II. MERGERS & ACQUISITIONS MetLife to Buy Versant Health for $1.68 billion (Reuters) - Insurer MetLife Inc has agreed to buy vision-care benefits company Versant Health for $1.68 billion from an investor group [FN22] led by Centerbridge Partners and FFL Partners, it said on Thursday. The deal is expected to close in the fourth quarter of 2020, the company said in a statement. III. OTHER FINANCIAL REPORTS UnitedHealth Bets on Government Health Plan Growth in 2020 (Reuters) - UnitedHealth Group Inc, the largest U.S. health insurer, reported a better-than-expected fourth-quarter profit on Wednesday, [FN23] and said it expects strong sales of its government health plans this year. The company also reported solid sales growth in its pharmacy benefits business. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -17- UnitedHealth expects to enroll 700,000 more people in its Medicare Advantage plans in 2020, Chief Executive Officer David Wichmann said on a call to discuss the quarterly results. That was at the upper end of the Medicare Advantage forecast the company provided at its investor conference in December. The plans provide health benefits to older Americans and the disabled. Shares of UnitedHealth, the first major U.S. insurer to report earnings this season, were up more than 2% at $294.65, lifting shares of rivals Anthem Inc, Humana Inc and Cigna Corp by about 1%. Evercore ISI analyst Michael Newshel said the stock was likely reacting to the solid Medicare Advantage enrollment forecast. Newshel also cited the industry bellwether's comments regarding limited cost impact from the current flu season, which picked up pace in the last few weeks, according to the U.S. Centers for Disease Control and Prevention. Wednesday's share rise comes on the back of gains in insurer shares over the last two months as fears eased that the 2020 presidential election would lead to a major overhaul of the U.S. healthcare system. UnitedHealth affirmed its full-year forecast for 2020 adjusted earnings of $16.25 to $16.55 per share, with a midpoint a bit below analysts' average estimates of $16.46, according to Refinitiv data. Total revenue rose 4.3% to $60.90 billion, just shy of Wall Street expectations of $61.04 billion. Sales of the company's core business selling health insurance plans rose 4.4% to $48.25 billion. Revenue from the Optum unit, which manages drug benefits and offers healthcare data analytics services, rose about 8% to $29.8 billion. UnitedHealth has bolstered its Optum business with a string of small acquisitions, the latest a $300 million purchase of Diplomat Pharmacy. On an adjusted basis, the company earned $3.90 per share, exceeding analyst estimates of $3.78. Blues Health Insurers Put up $55 million to Take on Generic Drug Makers (Reuters) - A group of Blue Cross Blue Shield insurers is investing $55 million in a venture that aims to offer cheaper prices to their [FN24] members on generic drugs that currently have little or no competition, the companies said on Thursday. The Blue Cross Blue Shield Association (BCBSA) and 18 Blue Cross Blue Shield health insurers are working with Civica Rx, a non- profit formed two years ago to try to increase competition for hospital-based generic drugs. The new subsidiary will focus on drugs that members can purchase via mail order or in retail pharmacies. Starting in 2022, it plans to begin selling new rivals for about 7 to 10 expensive generic medicines that currently have just one manufacturer, Civica Chairman Dan Liljenquist said. An advisory board will select the drugs. Civica will be able to sell the drugs at a lower price than a current manufacturer by leveraging the volume of prescriptions among its Blues plans members to guarantee discounts, Liljenquist said. The company may also manufacture drugs itself. Members will benefit from those lower prices based on their plan design, BCBSA strategy head Maureen Sullivan said. The lower cost to the Blues plans could translate into lower out-of-pocket spending, savings on the overall premium or potentially a lower co-pay or a co-pay waiver for patients, she said. About 78% of the $335 billion in annual U.S. drug spending goes to generic versions of branded drugs that have lost patent protection, according to generic industry trade group, the Association for Accessible Medicines. Large generic drug manufacturers say price competition has severely crimped profits for many of their drugs, leading to industry consolidation. That has increased the number of drugs with only one manufacturer, which can result in significant price spikes on lifesaving medicines. Some particularly egregious recent examples of price gouging or drug shortages led the U.S. Food & Drug Administration to enact new policies to try to ease the process for approving new rival generic drugs where there are only one or two existing versions available. A Civica spokeswoman said that as of the beginning of this year, it was either supplying or producing a total of 18 hospital-based medicines including commonly used medicines like bacitracin, lidocaine and morphine. Generic manufacturers that currently produce them include Hikma Pharmaceuticals, Xellia Pharmaceuticals and Exela Pharma Sciences, she said. Participating Blues plans include Independence Blue Cross, Blue Shield of California and Highmark Blue Cross Blue Shield among others. Trump Admin to Try Letting States Limit Medicaid Benefits (Reuters) - The Trump administration on Thursday said it will test allowing state Medicaid programs to limit health benefits and [FN25] prescription drug coverage for some patients in return for changing how federal government contributions to the states are made. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -18- Medicaid plans currently pay for most prescription drugs. The new approach would align their coverage with that of many private health plans and Medicare prescription drug plans that typically use the threat of excluding a drug from coverage to seek lower prices from manufacturers. The Centers for Medicare & Medicaid Services (CMS), part of the U.S. Department of Health and Human Services, said states would have to opt into the Healthy Adult Opportunity program. It said patients eligible for the program would be limited to adult beneficiaries under age 65 who are not eligible on the basis of a disability or their need for long-term care. The program is primarily targeted at the roughly one-fifth of Medicaid patients who received health coverage through the Affordable Care Act's (ACA) Medicaid expansion program since 2014, CMS Administrator Seema Verma said. The program would require states to commit in advance to either a total Medicaid spending figure or a per capita spending amount in order to receive federal money, a change from the current method in which the federal government reimburses states for a percentage of actual spending, and one that could run into legal challenges. Much like private health insurers, participating states would be able to create a formulary of covered drugs, which allows them to give a drugmakers' medicine priority in exchange for lower prices. There are special protections for drugs that treat HIV and behavioral health conditions. ”This is an opportunity for states to have greater negotiating power with manufacturers,” Verma said on a conference call with reporters. States participating in the program will be required to report key quality metrics to CMS. There are more than 71 million people currently covered under Medicaid, an important social safety net program created five decades ago and expanded by Trump's predecessor Barack Obama through the ACA, popularly known as Obamacare. Evercore ISI analyst Michael Newshel said the program could be in violation of Federal law, which requires Medicaid funding to be open ended. “Any capped funding arrangement will most likely be overturned in court,” Newshel wrote in a research note. Americans' healthcare coverage has been a central issue in the 2020 presidential election. Democrats have been critical of programs like the one being proposed by the administration. U.S. Government Proposes Higher Payments to Medicare Insurers in 2021 (Reuters) - The U.S. government on Wednesday proposed an average 0.93% increase in its payments in 2021 to the health insurers [FN26] that manage Medicare Advantage insurance plans for about 22 million people aged 65 or older or disabled. The government will finalize the rate in April. UnitedHealth Group Inc, Humana Inc, Anthem Inc, CVS Health Corp and Centene Corp are among the largest players in the Medicare Advantage market, in which private insurers are paid a set rate by the government to manage member healthcare. The government payment rates affect how much insurers charge for monthly premiums, plan benefits and ultimately, how much they profit. Medicare Advantage covers about one-third of the people enrolled in the government's Medicare program. The Centers for Medicare and Medicaid Services, a division of the U.S. Department of Health and Human Resources, releases the proposed rate early each year and then opens a public comment period. The final rate adopted in April could be higher or lower than the proposed one. Evercore ISI analyst Michael Newshel said in a research note ahead of the report that he was expecting about a 2.5 percent increase, in line with the 2.53 percent increase the government put in place for 2020 plans. The government also proposed payment rates for advanced kidney disease. Humana Loses 550,000 Part D Members Health insurer Humana recently reported a loss of approximately 550,000 customers on its Medicare Part D prescription drug plans. This decrease, however, was not unexpected. In February 2019, Humana predicted that approximately 700,000 enrollees would leave its Part D plans in 2019. This prediction was based on increased competition from other insurers. According to the company's CFO, Brian Kane, “This business is exceedingly price-competitive, with a winner take all dynamic.' Kane further noted that, ‘We made important changes in 2020, re-positioning our [prescription drug plan] offerings have the lowest price offering in many markets.’ Humana's Medicare Advantage membership was approximately 3.5 million at the end of 2019, and Humana predicts that its 2020 individual Medicare Advantage membership will grow between 270,000 to 330,000 members. This number represents a 9.2% increase in growth compared to 2019. CEO Bruce Broussard noted in a statement that, “We are pleased with our 2019 performance, particularly our success in balancing and executing on multiple priorities as we grew membership, improved the quality and productivity of our operations, and continued to invest [FN27] in the long-term.' © 2021 Thomson Reuters. No claim to original U.S. Government Works. -19- Regulatory Push Needed to Ease U.S. Health Insurance Hurdles in Coronavirus Response - Policy Experts (Regulatory Intelligence) - A regulatory push from state and federal officials may be required to ease health insurance coverage restrictions that currently threaten to limit consumers' access to healthcare and potentially create a major hurdle in efforts to quickly [FN28] contain any outbreak of the novel coronavirus in the United States. State insurance departments are yet to issue any directive to insurers on their responsibilities in the event of a COVID-19 outbreak. Health insurers have said they are in talks with the U.S. Centers for Disease Control and Prevention about an emergency plan including the possibility of easing network requirements and cost-sharing. Health insurance experts say policymakers may need to act as soon as possible to smooth kinks in the system to ensure an outbreak is contained quickly. Fears of incurring unaffordable healthcare bills may prevent consumers from seeking treatment early could hasten the spread of the virus. Cost-sharing mechanisms need to be revisited The structure of the U.S health insurance system with cost-sharing mechanisms like deductibles and co-payments does not lend itself well to a pandemic, said John Graves, associate professor of health policy at Vanderbilt University School of Medicine. ”We have a system aligned around mechanisms keeping people from coming to the doctor for every sniffle and cough, and that's precisely what we're looking for now [in the COVID-19 infection]— We need to restructure these at least for the short term if not longer- term,” Graves said. Experts have raised concerns about health plans with high deductibles at a time when the potential for a pandemic has arrived at the start of the calendar year and consumers may be forced to pay a large sum for seeking medical attention for seemingly mild symptoms, in order to meet their deductible before their insurance coverage kicks in. State insurance departments may need to first issue directives to loosen requirements regarding deductibles and co-payments in instances of people seeking care related to the COVID-19 outbreak, before specifying other measures that insurers could take to make it easier for consumers to obtain care. Insurance companies themselves could choose to adopt such measures to avoid increasing the risk of person-to-person spread of COVID-19 or community spread, where the source of the infection is unknown. The CDC has already confirmed one possible case of community spread in California. Easing healthcare access through the Affordable Care Act Health insurers would have to cover COVID-19 infection treatment or preventive screenings and vaccines, if the disease is added to a list maintained by U.S. Preventive Services Task Force, an independent panel of experts who recommend clinical preventive services. The task force's recommendations -- like preventive flu shots, for instance -- must be covered by Affordable Care Act-compliant insurers without any requirement for patient cost-sharing. Concerns emerged over the potential costs of any vaccine to prevent COVID-19 infection, as the U.S. Health Secretary Alex Azar declined to give assurances over the affordability of a vaccine, and coverage for a vaccines by health plans remained uncertain. Health insurers would be required to cover the cost of a vaccine under the Affordable Care Act irrespective of its price if the USPSTF adds it to its list of recommended vaccines, the California Department of Insurance noted. Short-term health plans are exempt from providing such coverage, as they do not need to comply with the Affordable Care Act. All these efforts to contain the crisis also come at time the U.S. Supreme Court faces an appeal request by about 20 states, led by Texas, to declare the Affordable Care Act unconstitutional. The court has yet to take the case. Provide more funding to healthcare providers Government health officials have spent the last week urging healthcare providers to revisit their emergency manuals to begin preparing for the possibility of a widespread outbreak of the novel coronavirus, and the administration has asked Congress for $2.5 billion to respond to the threat. Healthcare providers, however, are now asking for the funding to be made available swiftly. The American Hospital Association and American Nurses Association issued a joint statement asking for $1 billion in immediate supplemental emergency funding to providers to prepare and respond to the outbreak. Funding is required to quickly train the health care workforce and support a wide range of activities, including implementing quarantine, conducting testing and monitoring of patients under investigation, ensuring laboratory capacity for rapid diagnosis, they said. Funds are also required to conduct public health surveillance activities to track the outbreak and inform response, they added. The request for funding comes as the number of COVID-19 infections grew rapidly in regions outside China where the virus originated. There were over 4,500 cases of individuals affected by COVID-19 in other parts of the world, as of February 28. U.S. States, Insurers Rush to Ease Restrictions on Access to Coronavirus Testing, Care © 2021 Thomson Reuters. No claim to original U.S. Government Works. -20- (Regulatory Intelligence) - U.S. health insurers voluntarily eased some restrictions related to coronavirus testing on Thursday as states insurance regulators raced to issue broad emergency orders removing more cost barriers preventing infected individuals with insurance [FN29] from seeking medical attention on time. Orders from Washington and California mandated that health insurers to waive all cost-sharing including copayments and deductibles associated with lab testing and visits to the doctors and hospitals for the purpose of COVID-19 testing. The order is wider in scope than that of New York, which required insurers to waive co-payments for coronavirus laboratory testing earlier this week. The state orders, however, are limited to state-regulated plans and Medicaid. Over 60 percent of the country's population, however, are self-insured through their employer and their insurance plans are regulated by the federal government. Both states on the West Coast have seen cases of the infection spread rapidly in recent days with Washington counting 70 individuals affected by the virus on Thursday, while California reported 60 cases of the nation's total of 230 cases. Both states declared an emergency over the crisis. Health insurers said they will voluntarily cover diagnostic testing and are looking at easing network, referral, prior authorization, and cost-sharing requirements, according to their representative group America's Health Insurance Plans. The group said it is encouraging the use of telehealth and at-home care to provide care while avoiding the spread of infection. Washington state's guidance Besides removing cost-barriers to seeking medical care, Washington's insurance commissioner Mike Kreidler also ordered insurers to suspend any prior authorization requirement for treatment or testing of COVID-19 and allow a one-time early refill for prescription drugs. If an insurer lacks enough medical providers in its network to provide testing and treatment for COVID-19, it must allow consumers to be treated by another provider at no additional cost, the Office of the Insurance Commissioner added. Most importantly, the order applies to short-term health plans as well those not recognized in the state as a “health plan” because they fail to comply with the Affordable Care Act. The order lasts 60 days until May 4 and can be extended by the commissioner for an additional 30 days, as long as state Governor Jay Inslee's emergency proclamation remains in effect. Those without health insurance have been urged to seek assistance through the state's health benefit exchange or see if they're eligible for special enrollment. California state's guidance The California Department of Insurance's order directs health insurers to immediately eliminate cost-sharing requirements to zero for all medically necessary screening and testing for the coronavirus. This includes waiving cost-sharing for the emergency room, urgent care or provider office visits for COVID-19. The order also directs health plans to increase resources to screen and treat patients as needed and to encourage the use of telehealth services to reduce the spread of the virus. Plans also must take steps to ensure patients receive necessary medication if there is a shortage of a particular drug. The CDI also said individuals who are unable to work as a result of quarantine can file a disability insurance claim with a physician's certification. Disability insurance benefit amounts are approximately 60-70 percent of wages (depending on income) and range from $50 - $1,300 a week, according to a statement. Individuals who care for an ill or quarantined family member with COVID-19 can file a paid family leave claim for similar benefits. Insurers easing restrictions Some health insurers have begun easing restrictions on seeking care in response to the situation and others are expected to follow. Cigna said on Thursday it will waive all co-pays, coinsurance, and deductibles for the laboratory testing of coronavirus in patients. The benefit will apply to all employer-sponsored plans in the United States, Medicare Advantage, Medicaid and the individual & family plans available through the Affordable Care Act. The cost-sharing waiver will be limited to COVID-19 laboratory tests administered upon the advice of a physician, a spokesperson said. Cigna encouraged the use of telehealth services for the treatment of symptoms and said it will set up a 24/7 resource center specifically dedicated to assisting customers with any administrative barriers related to coronavirus-related claims. Blue Cross Blue Shield of North Carolina said on Wednesday it will expand virtual access to doctors and expedite approvals for acute care relating to hospitalization and medical equipment at home for those suffering from COVID-19. Blue Cross NC will also waive early medication refill limits to have a 1-month supply of medication on hand, in line with the CDC's recommendation. Member cost-sharing is slated to apply as normal. The insurer said these measures will be effective March 6 and remain in effect for 30 days after which it will re-evaluate its plan. Anthem's Affiliated Health Plans Waive Member Costs for COVID-19 Testing © 2021 Thomson Reuters. No claim to original U.S. Government Works. -21- Anthem, Inc., announced on March 6 its efforts to eliminate the burden of additional costs for members in its affiliated health plans by providing coverage of the coronavirus screening test at no out-of-pocket-cost. The companies also confirm that prior authorization is not required for diagnostic services related to COVID-19 testing. ”We are committed to keeping healthcare affordable for the consumers we serve. While the CDC continues to advise that the risk for the virus remains low, we are mindful of our responsibility to our health plan consumers and communities to ensure access to care,” said Anthem President and CEO Gail K. Boudreaux. “These actions today should reduce barriers to seeing a doctor, getting tested and maintaining adherence to medications for long-term health issues.” Testing similar to what is offered now from the Centers for Disease Control will soon be offered more broadly. Anthem's waiver of copays, coinsurance and deductibles and prior authorization will extend to this focused test used to diagnose COVID-19 for all of Anthem's affiliated health plan fully-insured, individual, Medicaid and Medicare members when medically necessary. Anthem also recommends members use telehealth when possible, as it can help prevent them from spreading a virus further within a physical clinical setting. Anthem is also encouraging its health plan members who have a pharmacy plan that includes a 90-day benefit, to talk to their doctor about whether changing from a 30-day supply to a 90-day supply of any prescription medicines they take on a regular basis is appropriate. CMS Issues Guidance to help Medicare Advantage and Part D Plans Respond to COVID-19 On March 10, CMS announced further action to ensure patients have access to the critical healthcare services they need in the wake of the 2019 Novel Coronavirus (COVID-19) outbreak. Today, following a meeting with President Trump and Vice President Pence, many leading insurance companies and their industry associations announced they will be treating COVID-19 diagnostic tests as covered benefits and will be waiving cost sharing that would otherwise apply to the test. The President also directed CMS to provide more flexibility to Medicare Advantage and Part D plans to ensure they have the tools they need to provide seniors with the best coverage. As a result, CMS published a memorandum to Medicare Advantage (MA) and Part D health and prescription drug plans informing them of the flexibilities they have to provide healthcare coverage to Medicare beneficiaries for COVID-19 testing, treatments, and prevention. “The President directed CMS to make sure Medicare Advantage beneficiaries have access to the healthcare services they need during this time,” said CMS Administrator Seema Verma. “Today we announced guidance to Medicare Advantage and Part D plans to remove barriers that could prevent or delay beneficiaries from receiving care. Medicare beneficiaries are at the greatest risk of serious illness due to COVID-19 and CMS will continue doing everything in our power to protect them.” In the memorandum issued today, CMS outlines the flexibilities MA and Part D plans have to waive certain requirements to help prevent the spread of COVID-19. These flexibilities include: · Waiving cost-sharing for COVID-19 tests · Waiving cost-sharing for COVID-19 treatments in doctor's offices or emergency rooms and services delivered via telehealth · Removing prior authorizations requirements · Waiving prescription refill limits · Relaxing restrictions on home or mail delivery of prescription drugs · Expanding access to certain telehealth services These waivers break down barriers to beneficiaries accessing care and allow plans to work with pharmacies and providers to treat patients without burdensome requirements limiting their options during this outbreak. Coronavirus Treatment for Uninsured May Cost up to $42 bln: Estimate (Regulatory Intelligence) - The cost of covering COVID-19 treatment for the uninsured could touch $42 billion under the current plan by [FN30] the administration of President Donald Trump, according to a non-profit association that provides health policy data. The estimate assumes that 2% to 7% percent of uninsured people will require hospitalization for infections from the new coronavirus, ranging from about 670,000 to slightly more than 2 million hospital admissions, the data from Kaiser Family Foundation showed. The White House announced it would reimburse hospitals for the cost of the treatment provided to the uninsured in a bid to encourage more individuals to seek timely treatment of symptoms of the new coronavirus. The reimbursement would be made at Medicare rates, typically lower than what private insurers pay and hospitals will not be allowed to bill patients for the balance. The KFF estimate assumed a reimbursement rate of between $13,000 and $40,000 per patient, in line with the average 2017 Medicare payment for respiratory infections and inflammations with major complications of varying severity. The government has earmarked $100 for hospitals and healthcare entities providing care to COVID-19 patients. If the cost of treating the uninsured reaches the top of the estimate, it could consume over 40 percent of the amount budgeted to provide economic relief to facilities reeling from a loss of revenue from regular operations while incurring additional costs to prepare for cases of infections from the new coronavirus. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -22- Hospitals have already urged the federal government not to dip into the existing funding set aside for healthcare entities but instead find other means -- such as a special enrollment period on the federal healthcare exchange, Medicaid expansion or new funding in the next stimulus bill -- to absorb the treatment costs for the uninsured. Coronavirus Care Costs in U.S. May Cross $500 billion by 2021: Health Insurer Study (Regulatory Intelligence) - Covering healthcare related to COVID-19 could cost insurers in the United States anywhere between $56 billion to $556 billion through the next year, a study commissioned by a health insurance group showed on Wednesday. The report [FN31] comes at a time when health insurers are working on plans to determine their rates for the 2021 benefit year. The report includes the impact of testing and treatment costs of COVID-19 on the commercial market as well as Medicare Advantage and Medicaid managed care plans, said Wakely Consulting, which conducted the study. It assumes a 20 percent infection rate, or 50 million infections, with at least 5.5 million people requiring hospitalization and 1.3 million of those needing intensive care. Health insurers have said they are bracing for an unprecedented rise in claim costs from treating coronavirus patients while simultaneously working to ease burdens on individuals and businesses struggling to afford their current coverage through timely premium payments. America's Health Insurance Plans (AHIP), which commissioned the study, said insurers have not only waived testing and treatment costs for consumers but are also working with state, federal and local officials to support health care workers while assisting lawmakers and insurance commissioners with specific policy and regulatory changes to ease the response to the crisis. Insurers have waived lengthy procedural requirements and expedited claims processing to aid hospitals and healthcare workers in their work during the outbreak. They, however, turned down a request from the American Hospital Association to make periodic interim payments available to hospitals saying they needed to maintain “necessary resources” to cover these costs for the businesses and individuals. A different study last month from actuaries at Covered California, the state's health insurance marketplace, in late March estimated the cost of covering testing, treatment, and care for the 170 million Americans in the commercial market anywhere between $34 billion to $251 billion or more in the first year of the pandemic. Premiums in the individual and employer market could rise by 40 percent in 2021 as a result of COVID-19 alone, if the federal government did not intervene with assistance programs to limit the impact of these costs, Covered California's chief actuary, John Bertko said. “While there is a lot of uncertainty with anything related to COVID-19, one thing we can be certain of is that the impact will be significant.” Health Insurers See Enrollment Gains, Savings Cushioning COVID-19 Costs (Regulatory Intelligence) - U.S. health insurers have so far played down concerns of a major cost impact from COVID-19 testing and treatment, as gains from new customers in Medicaid and Medicare Advantage programs and postponement of elective procedures helped offset the pandemic-related costs. Nevertheless, firms said they had acted to strengthen liquidity by issuing hundreds of millions [FN32] of dollars in new debt and drawing on credit facilities. In addition to the public health emergency leading more people to seek insurance coverage, a rising level of unemployment is driving a consumer shift from commercial plans to the federal government-assisted Medicaid program for low-income families, assisted by states that have temporarily suspended re-verification efforts, they said. About 30 million people have sought unemployment claims in the last six weeks. About 30 million people were uninsured in 2019. Anthem's Chief Financial Officer John Gallina said the company expects the movement of consumers into the Medicaid and the Affordable Care Act marketplace to be a “significant shift.” Anthem currently operates Medicaid plans in 23 states and D.C. The company expects a diversification in its risk profile to help mitigate the effects of the economic disruption. Anthem which has been moving away from a risk-based contractual reimbursement system, to one based on pre-negotiated rates with providers, said it had less than 30 percent such risk-based contracts in the commercial and individual market now, Gallina said. Nevertheless, Anthem drew $600 million from credit facilities, and $900 million in the commercial paper market, he said. The firm has another $2.1 billion in undrawn borrowing capacity, he said. Humana said it expects current economic trends to be a tailwind to their Medicaid membership enrollment for the year. “States are not dis-enrolling individuals for Medicaid at this time and more individuals are beginning to qualify for coverage each day,” said Brian Kane, the company's Chief Financial Officer. Business in Medicare Advantage plans, or supplemental coverage for the federal government's health program for seniors, is also expanding, Gallina said. “We expect strong growth for the foreseeable future,” he added. Humana in March issued $1.1 billion in senior notes, and drew $1 billion under a one-year term loan bank commitment as liquidity strengthening measures. Cigna, a relatively smaller player in the Medicaid market, also said it expects to see “strong volume growth in its Medicare Advantage plans. The company said it was seeing employers stepping up in the marketplace and retaining benefits for their employees. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -23- ”I for one am just pleased to see how corporations have stepped up relative to coworker safety, coworker engagement protocols, even the number of employers that have stepped forward where they had employment dislocation by maintaining continuity of benefits,” Cigna's Chief Executive David Cordani said. Gains from deferred medical procedures Most health plans have waived cost-sharing requirements for COVID-19 testing and treatment and agreed to cover some related healthcare expenses at no cost to the consumer, either voluntarily or upon requests from lawmakers as the country rushed to curb the virus' spread. The relief could be short-lived, however, as the cost of antibody-testing, emerging treatment options, and upcoming vaccine costs remain unknown, they said. The insurers are also preparing for deferred elective procedures to see an uptick in the second half of the year with the health status of some patients in an aggravated condition from earlier. Humana's Kane said the company currently expects nonessential procedures to resume and ultimately ramp up in the coming weeks and months but that would depend greatly on consumer confidence in using the system, he added. “We are in uncharted territory, and the future may look markedly different from what anyone expects,” Anthem's Gallina said. UnitedHealth to Issue Premium Credits as Part of $1.5 billion Spending Plan (Reuters) - U.S. health insurer UnitedHealth Group Inc. said on Thursday it plans to spend $1.5 billion on its customers in part by [FN33] issuing credits against some commercial health insurance premiums in June due to the new coronavirus pandemic. Insurers have gained financially as Americans have cut back on medical appointments under stay-at-home orders designed to help slow the spread of the virus and allow hospitals and doctors to focus on COVID-19 patients. UnitedHealth said it would issue credits ranging from 5% to 20% of June monthly premiums to commercial fully-insured employer- based and individual insurance customers. As part of its plan, UnitedHealth will also waive cost-sharing for specialist and primary physician visits in Medicare Advantage, the government healthcare program for people 65 and older or with disabilities that is managed by private insurers. UnitedHealth will stabilize premiums in its supplementary Medicare plans and expand Medicaid coverage. It has nearly 16 million members in these government plans. UnitedHealth has 8.2 million members in at-risk insurance plans offered through employers and in individual plans created by the Affordable Care Act (ACA), also known as Obamacare. The rebates do not apply to its largest business in which it manages health benefits for large employers for a fee and the employer covers the medical costs. Under the 2010 health law, fully insured health plans are required to spend no less than 80% of the premiums they collect on medical care or must send rebates to customers. But the process to determine rebates takes place over several years, Chief Executive Officer David Wichmann told reporters. “As you know, people are hurting right now,” Wichmann said. He said only a portion of the credits are related to the ACA requirement. UnitedHealth has 8.2 million members in at-risk insurance plans offered through employers and in individual plans created by the Affordable Care Act (ACA), also known as Obamacare. The rebates do not apply to its largest business in which it manages health benefits for large employers for a fee and the employer covers the medical costs. Under the 2010 health law, fully insured health plans are required to spend no less than 80% of the premiums they collect on medical care or must send rebates to customers. But the process to determine rebates takes place over several years, Chief Executive Officer David Wichmann told reporters. “As you know, people are hurting right now,” Wichmann said. He said only a portion of the credits are related to the ACA requirement. Health Insurers Mull Return to ACA Marketplace as Enrollment Picks Up (Regulatory Intelligence ) - Health insurers are mulling a return to providing coverage through healthcare exchanges under the Affordable Care Act as the COVID-19 outbreak has not only increased the need for healthcare but also boosted enrollment in the [FN34] individual marketplace and Medicaid plans. A surge in pandemic-related job losses has largely contributed to the migration of customers from employment-based health plans to coverage options on the ACA exchanges. About 39 million people have filed for jobless claims since the start of March. An estimate from the Kaiser Family Foundation said nearly 23 million people could be newly eligible for ACA marketplace subsidies by January 2021, when unemployment insurance benefits end for those who lost jobs before May 2, this year. About 17 million of those would be eligible for Medicaid, the health policy data provider said last week. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -24- The loss of customers the market for employer-provided health insurance has insurers exploring their alternatives in the ACA markets which they avoided over the last four years, amid mounting losses from sicker-than-expected customer pool and new challenges to the stability of the healthcare law following the election of President Donald Trump. Insurer participation had peaked at six companies per state on average in 2016, but fell to 3.5 in 2018. Each state had an average of 4.5 insurers offering plans in 2020. The ACA continues to face threats to its survival, including a legal challenge before the U.S. Supreme Court, where the Trump administration and 18 states led by Texas have argued the entire law is invalid and must be struck down. Yet, insurers have shown interest in rejoining the ACA marketplace, citing new opportunities in a pandemic despite the uncertainty in an election year. UnitedHealthcare said last week it would join the ACA marketplace in Maryland in 2021 and may offer plans in other states as well. Cigna, a relatively small player in the Medicaid market, also said it is evaluating its participation in new markets. Centene, the largest provider of Medicaid and ACA plans in the country, said it expects rising unemployment to lead to a $4 billion increase in revenue this year as a result of higher enrollment. Anthem and Humana, also large players in the Medicaid market, said they expect to see strong gains in Medicaid enrollment and Medicare supplemental plans. The companies said efforts of state and federal lawmakers to further bolster Medicaid programs to include more consumers is an encouraging trend. Many also expect a declining trend in hospital visits to continue as social distancing measures and fears of contracting the novel coronavirus in a healthcare setting. STRETCH ON STATE BUDGETS Many state budgets, which are already in deficit, are struggling to meet the added expenses of increased enrollment in the Medicaid program. Michigan, for instance, which is projected to see a $1 billion to $3 billion deficit this year is now facing additional expenses of $500 million due to new enrollment in its Medicaid program. New York was already facing a $6 billion budget deficit and even contemplating a $2.5 billion cut in its Medicaid program before the pandemic broke out. States had mostly anticipated Medicaid enrollment to remain flat in 2020 as a result of a growing economy. Following the COVID-19 crisis, however, nearly all states with projections anticipate that total Medicaid spending rates will continue to increase in 2021 primarily due to the increase in enrollment, data from the KFF showed. A letter from the Congressional Budget Office said states will have to increase taxes or reduce expenditure to meet the budget shortfall being caused by increased enrollment at a time when revenue is expected to drop from the sudden reduction in economic activity in 2020. The U.S. House of Representatives has proposed increasing federal assistance to states on Medicaid, but it is unsure if that proposal will prevail in the Senate. Uncertainty Around Pandemic Larger Risk to Life, Health Insurers: Fitch (Regulatory Intelligence) - Life and health insurers are the insurance industry sectors most exposed to risks presented by the COVID-19 [FN35] pandemic, according to U.S. rating agency Fitch. “We are likely in the early stages of what could be a prolonged and severe economic downturn precipitated by this pandemic,” analysts led by Laura Kaster said in a note to clients on Wednesday. Life insurers -- more exposed to asset stress from capital-markets volatility and to higher mortality risk -- remain vulnerable to the uncertainty associated with the unprecedented and abrupt shutdown of the U.S. economy in response to the pandemic, according to Fitch. The sector, however, had a strong balance sheet with significant capital and good asset quality and favorable liquidity prior to the onset of the new coronavirus outbreak, it added. Health insurers, less exposed to a fallout in the capital market, still face “a lot of uncertainty” from the lack of clarity around the true infection rate, the potential for a second wave of infections, and the potential return of deferred care to the healthcare system. While national insurers are better prepared to absorb losses from this health crisis, a potential loss or shift of enrollment due to the rising unemployment and the threat of more acute-care claims from deferred diagnostic procedures present a risk to the entire health insurance sector. “We expect a very high level of uncertainty to continue for some time around how the pandemic will run its course, when or if an effective vaccine will be developed and widely administered or whether there will be a second wave of infections as states gradually begin to re-open the economy,” the analysts said. The uncertainty about the length of the pandemic also presents risk for property and casualty insurers underwriting travel and event cancellations and workers' compensation among others, they added. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -25- Insurers covering business interruption claims and currently facing pressure from lawmakers to reimburse losses from shutdown orders remain a “key area of contention,” the analysts said. “Successful efforts in any jurisdiction to change previously established business interruption coverage terms would not only lead to protracted litigation but also larger potential losses.” Fitch said it expects insured losses from the coronavirus outbreak to impact earnings in 2020 and 2021 but not lead to a “material deterioration” in capital for property and casualty insurers. This could change, however, as these insurers may be vulnerable to larger losses from natural disasters in the second half of 2020. U.S. Health Insurers Appear Unfazed by Coronavirus Costs in 2021 Rate Filings (Regulatory Intelligence) - Health insurers across the country are set to finalize rates for 2021 in the next few weeks while still dealing with the COVID-19 pandemic. Early filings, however, show that not all states are likely to see steep premium increases in the individual healthcare market next year. The rate filings made by insurers show the average rate increase in states like New York is about 11 percent, while states like Washington and Oregon are likely to see rates remain flat or rise by 1-2 percent. Consumers in states like [FN36] Maryland, on the other hand, may even see their premiums go down in 2021. The New York City area had quickly become the epicenter of the COVID-19 outbreak in the United States, accounting for nearly one- third of the cases in the entire country. The spread of the virus has since slowed after New York and New Jersey, the worst hit, imposed stay-at-home orders, and embarked on a slow recovery plan. New hotspots have now emerged across the country, especially in Texas, Florida, and California, taking the country's daily new case count above 50,000 several times in the last week. The daily count of new cases had dipped in May after peaking at about 35,000 cases each day in late March. Insurers have inserted disclaimers into their rate filings to accommodate a potential rate revisit should the coronavirus crisis widen in the coming months. Such requests are highly unusual in the health insurance sector, where rates are strictly fixed ahead of the calendar year of coverage. Insurers are likely to be conservative in their estimates of future costs, potentially driving rates up higher than in these preliminary filings, said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University. Regulators must demand transparency and a clear break-down of how much of insurers' 2021 premiums will be due to COVID-19-related costs, she added. “Although regulators are likely to give insurers some additional leeway in submission deadlines and the ability to make rate adjustments, an extra few weeks or months will likely be insufficient for anyone to have a clear picture of the course of the pandemic or its longer-term consequences before rates are finalized this fall,” Corlette added. Since the outbreak, insurers have been asked to bear the cost of COVID-19 testing at no cost to the consumer. In some cases, even treatment had to be provided at zero out-of-pocket costs. A study from Avelere Health estimated the total U.S. healthcare system costs for hospitalizations due to COVID-19 could range from $9.6 billion to $16.9 billion in 2020. These costs, however, were more than offset by the postponement of elective healthcare procedures March onward. With the new spike in COVID-19 cases seen across the country, it is unclear if and when non-coronavirus patients may begin to use the healthcare system for elective procedures again. Insurers are also now in talks to cover the cost of a potential vaccine for the new coronavirus in the future at zero cost to the consumer, the Department of Health and Human Services has said. Walmart Makes New Push into Healthcare with Insurance Business (Reuters) - Walmart Inc. is making its latest move into the healthcare space with its own insurance business, the company said on its [FN37] website. The world's largest retailer has created an insurance agency under the name “Walmart Insurance Services LLC” and is looking to hire agents in the Dallas area to sell Medicare insurance, starting in August, according to a post on its careers page. Walmart currently operates four health centers in the United States, which give low-priced medical healthcare services such as dental care and counseling for customers. U.S. Health Insurers, Wary of Telehealth Overuse, Urge More Planning in Policy Easing (Regulatory Intelligence) - U.S. healthcare providers and some lawmakers want to extend a regulatory accommodation for telehealth services granted during the COVID-19 pandemic. Health insurers, however, want policymakers to manage concerns regarding its [FN38] overutilization and to redefine healthcare-provider state licensing requirements. Growth in the use of telehealth services has skyrocketed during the pandemic as the Trump administration considerably relaxed regulations pertaining to the use and reimbursement for telehealth in the Medicare program. Patients and healthcare providers, forced to stay home and adhere to strict social distancing guidelines outdoors, quickly embraced telehealth when insurers widened the scope of reimbursements beyond that mandated by the government. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -26- Both Alex Azar, Secretary of the U.S. Department of Health and Human Services and Seema Verma, Administrator of the Centers for Medicare and Medicaid Services, have also expressed their support in making the regulatory relief longer lasting. However, Congressional action is required to revise legislation that impedes the use of telehealth more widely. Health insurers are supporting calls to extend this regulatory flexibility given to telehealth but urge caution in developing policies. To ensure the continued growth of telehealth, policymakers must allow insurance providers to be able to design their benefits and offerings in accordance with the needs of their members, according to Americas Health Insurance Plans, a group of health insurers. Insurers are also asking policymakers for flexibility in reimbursements and permission to use utilization management tools. Overutilization of telehealth has been one of the foremost concerns for insurers in the past. Private insurer claims from telehealth in the U.S. rose 4,347 percent to 7.52 percent in March 2020, from 0.17 percent the previous year, according to healthcare data provider FAIR Health. Insurers have been credited with being the game-changer in the astronomical growth in telehealth use since March, through their decision to reimburse almost all telehealth consultations at the same rate as face-to-face visits. Self-funded employers also are supportive of telehealth usage, seeing it as a convenience that means more productive hours for employees. eClinicalWorks, a telehealth service provider, said it saw usage minutes surge to more than 2 million minutes per day since May from an average of 50,000 minutes a month prior to the onset of the pandemic. “If they take away reimbursement for it, you won't find people using it — and you cannot have it fall because it is providing tremendous benefits to patients”, says Girish Navani CEO of eClinicalWorks. Consumers and healthcare providers have soaked up the convenience and accessibility associated with telemedicine, especially in rural areas, and the possibility of safe access to healthcare even during an infectious disease outbreak. Insurers, on the other hand, have shown “guarded enthusiasm” for this sudden explosion in telehealth usage, Navani said. While the concept of virtual care has been around for nearly two decades, few insurers covered telehealth services, and those that did applied varying criteria and reimbursement rates. At the start of 2020, only about half of U.S. states had rules mandating insurers to cover telehealth in some form. Federal agencies can address some of the policies around telehealth reimbursement on Medicare but state and federal legislators have to work on the bigger restrictions if momentum around the use of telehealth is to be sustained. For instance, legislators will have to solve a key issue of allowing healthcare professionals to practice across state boundaries. Currently, healthcare providers practicing in a state must be licensed to work in that state. These barriers were temporarily removed during the public health emergency when physicians and nurses were allowed to practice across state lines in some cases, to allow personnel to treat patients in COVID-19 hotspots. Policymakers must eliminate restrictions around geography, existing patient-provider relationships, and state licensure that prevent telehealth from growing organically, AHIP said. Insurers also want lawmakers to work on approving telehealth as “legitimate care” and allowing virtual healthcare providers to be counted toward network adequacy requirements. “As learned during the COVID crisis, telehealth can be clinically comparable to in-person care for many conditions and consumers. Policymakers must recognize this and allow for telehealth visits to be counted towards network adequacy requirements, risk adjustment calculations, and quality measurement,” AHIP said. In addition to healthcare-related changes, connectivity problems remain an additional concern that needs to be managed. Access to high-speed broadband internet continues to be a barrier for many rural telehealth programs especially where live video connections are required between providers and patients, according to Rural Health Information Hub. Dropped calls and delays in video feeds can interrupt care delivery hinder adaptation of telehealth programs. If widely adopted, up to $250 billion of the current U.S. healthcare expenditure could potentially be virtualized as a result of COVID-19, an estimate from McKinsey & Co shows. Divided 10th Circuit Revives Lawsuit Over Microsoft, Blue Cross ERISA Plan (Reuters) - A divided federal appeals court on Friday revived a New York family's lawsuit against Microsoft Corp. and its delegated ERISA plan administrator, Premera Blue Cross, for denying coverage for their teenage daughter's long-term psychiatric treatment at a [FN39] residential facility in Utah. In a 2-1 split, the 10th U.S. Circuit Court of Appeals said a federal judge in Salt Lake City gave too much deference to Premera's coverage determination based on a ‘discretionary authority’ clause in a plan document that the parents ‘had no way of knowing — even existed.’ The dissent accused the majority of creating a ‘back door’ mandate that all ERISA plan documents be distributed to participants, which the law itself does not require. Microsoft and Premera's attorneys at Kilpatrick Townsend & Stockton did not immediately respond to requests for comment on Friday. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -27- Brian King, whose Utah law firm represents David M., Lyn M. and their daughter, LM, said the opinion ‘moves this area of law in the right direction in terms of making sure employees know what benefits they are and are not getting from their employer's benefit plans.’ David M. participated in the Microsoft Corporation Welfare Plan, a self-funded benefit plan governed by ERISA. LM was a covered dependent. In 2015, the family placed LM in Eva Carlston Academy for residential psychiatric care and sought coverage for the $80,000 cost. Premera determined that a residential facility was not medically necessary and denied coverage, although it paid for the 10 days she had already spent there ‘as a courtesy.’ The M. family challenged the determination in its 2017 lawsuit. Premera and Microsoft argued that the governing Plan Instrument contained a ‘discretionary authority’ clause ? that is, a provision that vests the administrator with absolute discretion to make coverage determinations. The U.S. Supreme Court held in 1989 that if an ERISA plan includes a discretionary authority clause, the administrator's coverage determinations can be reversed only if they are arbitrary or capricious. Senior U.S. District Judge Bruce Jenkins ruled that Premera's determination was not arbitrary or capricious, and granted the defendants' motion for summary judgment in 2018. The 10th Circuit, however, said the discretionary authority clause was unenforceable in LM's case because Premera and Microsoft had never notified the M. family that it existed. David M. had received a copy of a Plan Summary, which said that members could ‘ask to examine or receive free copies of all pertinent plan documents, records, and other information relevant to your claim.’ Circuit Judge Allison Eid, in her dissent, said that was all ERISA required. However, the majority said the summary did not mention the Plan Instrument or otherwise indicate that there were limits on a federal court's ability to review the administrator's coverage decisions. Plan participants ‘cannot obtain notice from secret documents,’ Circuit Judge Robert Bacharach wrote. He joined by Circuit Judge Carlos Lucero. As an alternative, the majority said Premera's decision was arbitrary and capricious because it was based on the general criteria for ‘medical necessity’ listed in the Plan Summary, rather than the specific criteria in the plan's medical policy. Even so, the panel remanded the case to the district court for consideration under the non-deferential standard of de novo review. The case is Lyn M. and David M., as Legal Guardians of LM, a minor, v. Premera Blue Cross; Microsoft Corporation Welfare Plan, 10th U.S. Circuit Court of Appeals 18-4098. U.S. Insurance Regulators Form Committee to Focus on Race and Diversity (Regulatory Intelligence) - The National Association of Insurance Commissioners on Thursday formed a special “Race and Insurance' committee which will focus on analyzing the level of diversity within the U.S. insurance industry as well as determine whether current [FN40] practices in the industry may be hurting minority communities. The move comes as calls for racial equality grow in the United States, fueling widespread protests against police brutality and other forms of injustice against minorities. Many state government leaders and the corporate sector, in general, have been re-examining their own practices that might disadvantage or inadvertently hurt members of certain communities. 'It is the duty of the insurance sector to address racial inequality while promoting diversity in the insurance sector,” said Raymond Farmer, president of the NAIC, a group of state insurance regulators. “If not us, who? If not now, when?' The committee will be co-chaired by Farmer and David Altmaier, president-elect of the NAIC for 2021. The committee's first meeting will be held at a virtual gathering of the NAIC in the coming week. Farmer said the NAIC was seeing unprecedented discussions on race and its role in the design and pricing of insurance products. There is also discussion over the need to improve diversity in the insurance sector particularly in senior leadership roles, according to Farmer. The NAIC committee has been entrusted with the responsibility of making recommendations by year-end on steps to increase diversity and inclusion within the industry, identify and address practices that disadvantage minorities, and ensure continuous engagement of the NAIC on issues related to race. ”Our regulatory system and insurance in general is a reflection of the society it aims to protect, and while state insurance regulators have worked to eliminate overt discrimination and racism, we all have been increasingly aware that unconscious bias can be just as damaging to society,' NAIC's CEO Mike Consedine said. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -28- Last week, the NAIC also voted unanimously to create a task force focused on climate and resiliency. The group will coordinate all of the NAIC's domestic and international efforts on climate-related risk and resiliency issues, including dialogue among regulators and with the industry, consumers and other stakeholders. The task force will report to the Executive Committee. While states like Washington and California have previously taken the lead on conversations regarding climate risk within the NAIC, this is the first such large-scale effort by the group on the subject which has so far been met with polarized opinions across different states. Alphabet's Verily Targets Employer Health Insurance with Swiss Re Partnership (Reuters) - Alphabet Inc's life sciences division Verily is partnering with reinsurer Swiss Re to launch a unit to provide stop-loss [FN41] insurance, a financial product purchased by employers to cover unexpected and large employee healthcare costs. The subsidiary, Coefficient Insurance Company, will be backed by the commercial insurance arm of Swiss Re, which is also making a minority investment in the new company, Verily said on Tuesday. “Coefficient is aimed at reducing blind spots and providing greater cost control mechanisms for self-funded employers,” Verily Chief Executive Officer Andy Conrad said in a statement. Self-insurance arrangements are increasingly commonplace among larger employers, who typically pay health insurers to manage their healthcare benefits, but cover the costs of those claims themselves. Verily, which was previously part of Google's research and development unit, has tied up with several pharma companies on projects that range from research on surgical robots to developing the retina scan technology for early detection of some eye diseases. U.S. Health Insurers Cite Government-plan Enrollment Gains in Second Quarter (Regulatory Intelligence) - Higher enrollment in the government-funded Medicaid program buoyed health insurers in the second quarter [FN42] as regulatory relief and job losses made more consumers eligible for insurance coverage during the COVID-19 pandemic. Humana, Anthem and CVS Health, through its recent purchase of Aetna, recorded gains in Medicaid membership during the latest quarter largely due to states suspending their re-verification efforts and in some cases, widening eligibility criteria for sign-ups on the Medicaid program. “We continue to view Medicaid as a focus area with a strong pipeline of opportunities headed into 2021,” Eva Boratto, chief financial officer at CVS said on a conference call on Wednesday. The company's Medicaid membership grew 4.9 percent sequentially in the second quarter. Humana clocked a 47 percent increase in Medicaid membership, or about 220,000 additional customers, in the first half of this year as a result of new enrollments and new contracts in some states. The company also said it expects to grow its full-year Medicare Advantage membership to a range of between 330,000 to 360,000 this year from its previous range of 300,000 to 350,000 for the same period. Besides, health insurers are also benefiting from lower-than-expected loss of members in commercial plans as many employers chose to furlough their workers with continued health coverage instead of terminating their employment completely. Anthem, which operates in the commercial and government-aided health coverage segments, said its second-quarter Medicaid enrollment grew sequentially by nearly 10 times the decline it saw in its employer group enrollment. Cigna, which largely operates through commercial plans, saw its membership remain flat in the second quarter from a year ago, despite widespread unemployment in the United States since the start of the pandemic that has forced more than 50 million to file for jobless claims. CVS said its commercial membership declined approximately 0.5 percent sequentially, reflecting the impact of unemployment. DEFERRED CARE MAY RETURN SOON Health insurers largely reported care utilization reaching near-normal levels at the end of the second quarter, leading to expectations of a return of deferred care and higher claims costs in the second half of the year. The new spike in COVID-19 infections in the southern part of the country, however, has led to new uncertainty over the trend continuing to pick up at the same pace through the rest of the year. “There is another spike in COVID here in July. We're actually monitoring it very closely, trying to understand what the impact of the deferrals are and how the pent-up demand is impacting as well”, said John Gallina, Anthem's chief financial officer said on a conference call last week. “We have seen an increase in procedures, such as joint replacement surgeries and other procedures, some things can only be delayed so long until the pain or the severity is so significant that the person is going to go in and actually get the procedure”, he added. Stay-at-home orders in March and April and cancellations of elective medical procedures to free up hospitals and healthcare staff to tend to COVID-19 patients had led to lower claims cost for insurers through the first half of 2020. While insurers are preparing for © 2021 Thomson Reuters. No claim to original U.S. Government Works. -29- a higher-than-usual number of claims in the second half of the year from deferred care, uncertainty remains over the severity of the claims as care delays may have led to more chronic health conditions. More Regulation of Big Data Seen as a Key to Racial Equality in U.S. Insurance (Regulatory Intelligence) - U.S. insurance regulators must take more serious steps to regulate the use of big data in the industry and go beyond reliance on consumer complaints to better understand and prevent racial discrimination against customers, insurance experts [FN43] and consumer rights advocates said at a meeting of the National Association of Insurance Commissioners. Unregulated use of big data, irregularities in healthcare access due to insurer practices, and reduced access to insurance products and redress measures emerged as the most concerning issues that needed to be addressed to promote racial equality in the U.S. insurance industry. The group of insurance regulators had sought inputs from the industry on addressing problems that impact racial minorities in the insurance industry last week, in the NAIC's first-ever meeting aimed at solving the issue of systemic racism in the industry. The NAIC represents state insurance regulators. Large amounts of data, often collected from public and private sources through third parties but not verified for accuracy, are processed by data providers and then presented to insurers for use in rating practices. Insurance regulators have little control or jurisdiction over these data vendors and insurance filings often contain thousands of data points making it almost impossible for insurance regulators to review or question the data's validity, consumer advocates said. “There is no escaping that data is the foundation of the insurance industry. Data has been collected and used to predict long term losses, loss trends, and profitability,” said Sonja Larkin-Thorne, a retired insurance executive and consumer advocate. “But this new initiative - big data provided by unregulated third parties, extremely large data sets related to human behaviors, shopping habits, driving patterns, demographics — even Facebook friends - is raising major concerns,” she added. “Consumers often have to spend thousands of dollars to correct this data.” Insurance companies use data algorithms based on this alternate, unverified data for rating and underwriting purposes, which often leads to a disparate impact or unintentional discrimination on minority communities, Larkin-Thorne added. In addition to higher rates of uninsured people of color, insurer rating practices and reimbursement patterns on minority neighborhoods further perpetuate disparities in access to the insurance industry. Worst hit, as a result, is minorities' access to health insurance and healthcare in general. While the Affordable Care Act addressed the problem of eligibility discrimination, through its protections for consumers with pre-existing conditions, a larger problem that needs to be addressed is ‘coverage discrimination’ that prevents patients with chronic conditions from obtaining care, Dora Hughes, a professor of health policy at the George Washington University said. Data has shown that physicians whose practices have high numbers of minorities receive lower private insurance reimbursements, and that discourages health providers from working in these practices or neighborhoods, reducing access to care for minority groups who are already disproportionately likely to have chronic medical conditions, she added. Regulators need to go beyond consumer complaints to ensure equal access to insurance and among all communities. “Just because you are not receiving consumer complaints isn't always a key to what is really going in your communities. Many folks have just given up and don't even know how to reach out to insurance departments,” Larkin-Thorne said. Addressing Systemic Racism in Insurance The U.S. insurance industry has a history of imposing discriminatory rating practices on Black and other minority communities. George Nichols, the NAIC's first African American President in 2000 and Kentucky's first Black commissioner, said minority groups historically paid 30 to 40 percent higher premiums until the 1960s and received lower levels of reimbursement in claims. The NAIC adopted a non-discrimination stance in the 1980s but many insurers only revised their rating practices in the late “90s and early “00s. Some studies have found that race-based premiums were never adjusted, giving minorities fewer opportunities to rebuild or recover from previous losses in comparison to White communities, Nichols added. Birny Birnbaum, head of the Center for Economic Justice, a consumer rights organization, said the lack of adequate minority voices among regulators and in the industry has exacerbated a systemic racism entrenched in U.S. insurance industry. Consumers often lack access or knowledge to participate in critical regulatory processes, while insurers usually have the ability and funds to press for their interests in the lawmaking or rulemaking process. Trade associations have consistently fought against recognition of disparate impact as unfair discrimination in insurance and fought against disclosure of market-outcome data that would allow non-insurer stakeholders to analyze the issues related to systemic racism, he said. ”The result has been that insurers have largely not addressed issues of systemic racism because they have not had to,” he said. INSURERS PLEDGE EFFORTS Insurers have begun taking steps to address racism within their companies as well. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -30- Newark, New Jersey-based Prudential pledged $1 billion to the city, citing a “moral and business imperative” towards the cause. “We are prepared to be judged for our actions to support our colleagues, customers, and communities today and over the long term,” Charlie Lowrey, the life insurer's chief executive officer said. Health insurers said they are treating racism as a public health issue. Anthem said that it would commit resources to address racial injustice, food insecurity, and other concerns. The insurer said it had pledged $50 million over five years to impact racial injustice, strengthening communities, and address health inequities. Anthem added it has contributed to organizations addressing issues of inequality relating to the criminal justice system locally. Cigna announced the launching of a five-year program it said will provide local grants, scholarships, and employee volunteer hours to fight racism and health and economic disparities for people of color. The American Property Casualty Insurance Association said its member companies are committed to examining and providing “meaningful action” on, social equality and inclusion issues. “We look forward to hearing the perspective of regulators on these crucial topics,” it tweeted. Walmart to Sell Medicare Plans in Latest Healthcare Push (Reuters) - Walmart Inc. said on Tuesday it would sell Medicare insurance plans in 50 states and Washington D.C. through its broker, [FN44] marking the U.S. retailer's latest move into the healthcare space. Walmart Insurance Services LLC, which was launched in July, will offer policies from health insurers such as Humana Inc., UnitedHealth Group and Anthem Blue Cross Blue Shield from Oct. 15-Dec. 7, the company said. Medicare Advantage plans cater to Americans older than 65 and those with disabilities. The company already operates health centers across the United States, offering low-cost services such as dental care and counseling. Walmart's move comes at a time when health insurers face rising costs as Americans catch up on less urgent surgeries delayed by the COVID-19 pandemic. Hospitals rescheduled elective surgeries to reduce the burden on the healthcare system as coronavirus cases surged, while some patients canceled appointments to avoid potential contraction of the respiratory illness caused by the virus. U.S. Health Agency Acts to Ensure No-cost Access to Approved COVID-19 Vaccines (Regulatory Intelligence) - The Centers for Medicare & Medicaid Services (CMS) has issued a rule to ensure that Medicare and [FN45] Medicaid beneficiaries have access to a Food and Drug Administration (FDA) approved COVID-19 vaccine at no cost. 'CMS is acting now to remove bureaucratic barriers while ensuring that states, providers and health plans have the information and direction they need to ensure broad vaccine access and coverage for all Americans,” said CMS Administrator Seema Verma. The rules issued this week will ‘support the swift and successful distribution of a safe and effective vaccine for COVID-19,’ according to Verma. As soon as the FDA approves a COVID-19 vaccine, the vaccine and its administration will be added to the list of preventive vaccines that are covered under Medicare Part B without coinsurance or deductible pursuance to section 3713 of the Corona Aid, Relief, and Economic Security Act ( CARES Act). CMS will also announce coding and payment information as quickly as possible through program memoranda. Under section 6008 of the Families First Coronavirus Response Act ( FFCRA), state Medicaid programs can receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP), if the state provides COVID-19 vaccines and their administration for Medicaid enrollees without cost sharing. The interim final rule provides additional guidance on the implementation of section 6008 and requires states to cover COVID-19 vaccines for certain populations even after the section 6008 conditions are no longer in effect. Vaccine coverage requirements are the same for Children's Health Insurance Program (CHIP) remain the same even after the section 6008 condition lapse, according to the rule. The rule also provides increased reimbursement to hospitals when they treat patients with ‘innovative new products' approved to treat COVID-19. Additionally, the rule allows separate payments for outpatient hospital services for certain innovative treatments, including outpatient administration of a monoclonal antibody product if approved under an emergency use authorization. Requirements for private insurers The interim final rule also implements requirements that non-grandfathered health plans and health insurers provide coverage, without cost sharing, for qualifying coronavirus prevention services, including COVID-19 immunizations. The rule amends existing regulations to require coverage to be provided within 15 business days after the date on which the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) makes an applicable recommendation relating to a qualifying coronavirus preventive service. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -31- The rule also requires plans and issuers must cover without cost sharing qualifying coronavirus preventive services during the public health emergency for COVID-19, regardless of whether an in-network or out-of-network provider delivers such services. The interim final rule provides a 30-day comment period after its publication in the Federal Register. HHS, DOL, and Treasury Department Release Transparency in Coverage Final Rule, Which Also Addresses Prescription Drugs The Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury recently released the Transparency in Coverage final rule. This final rule is intended to help place health care price information in the hands of consumers and other stakeholders. The requirements in this rule are intended to provide consumers the tools needed to access pricing information through their health plans. This rule builds upon previous actions the Trump Administration has taken to increase price transparency by giving patients access to hospital pricing information. The requirements in the Transparency in Coverage final rule intend to reduce the secrecy behind health care pricing with the goal of bringing greater competition to the private health care industry. This rule will require most group health plans, and health insurance issuers in the group and individual market, to disclose price and cost-sharing information to participants, beneficiaries, and enrollees. The Departments are finalizing a requirement to give consumers real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability, through an internet based self-service tool. This requirement will empower consumers to shop and compare costs between specific providers before receiving care. Through this final rule, plans and issuers will also be required to disclose on a public website their in-network negotiated rates, billed charges and allowed amounts paid for out-of-network providers, and the negotiated rate and historical net price for prescription drugs. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the health care industry. This final rule includes two approaches to make health care price information accessible to consumers and other stakeholders, allowing for easy comparison-shopping. First, most non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to participants, beneficiaries and enrollees (or their authorized representative) personalized out-of-pocket cost information, and the underlying negotiated rates, for all covered health care items and services, including prescription drugs, through an internet-based self-service tool and in paper form upon request. Most consumers will be able to receive real-time and accurate estimates of their cost-sharing liability for health care items and services from different providers in real time, allowing them to both understand how costs for covered health care items and services are determined by their plan, and also shop and compare health care costs before receiving care. An initial list of 500 shoppable services as determined by the Departments will be required to be available via the internet based self-service tool for plan years that begin on or after January 1, 2023. The remainder of all items and services will be required for these self-service tools for plan years that begin on or after January 1, 2024. Furthermore, most non-grandfathered group health plans or health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to the public, including stakeholders such as consumers, researchers, employers, and third-party developers, three separate machine-readable files that include detailed pricing information. The first file will show negotiated rates for all covered items and services between the plan or issuer and in-network providers. The second file will show both the historical payments to, and billed charges from, out-of-network providers. Historical payments must have a minimum of twenty entries in order to protect consumer privacy. The third file will detail the in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level. Plans and issuers will display these data files in a standardized format and will provide monthly updates. This data will provide opportunities for detailed research studies, data analysis, and offer third party developers and innovators the ability to create private sector solutions to help drive additional price comparison and consumerism in the health care market. These files are required to be made public for plan years that begin on or after January 1, 2022. HHS will also allow issuers that empower and incentivize consumers through plans that include provisions encouraging consumers to shop for services from lower-cost, higher-value providers, and that share the resulting savings with consumers, to take credit for such “shared savings” payments in their medical loss ratio (MLR) calculations. HHS will allow this to ensure that issuers would not be required to pay MLR rebates based on a plan design that would provide a benefit to consumers that is not currently captured in any existing MLR revenue or expense category. HHS believes this change will preserve the statutorily-required value that consumers receive for coverage under the MLR program, while encouraging issuers to offer new or different value-based plan designs that support [FN46] competition and consumer engagement in the healthcare market. Trump Administration Finalizes Price Transparency Rule for Health Insurers Despite Objections (Regulatory Intelligence) - The Trump administration has finalized a rule requiring U.S. health insurers to disclose pricing agreements with health care providers and separately provide cost-sharing information to consumers. The move is aimed at promoting transparency © 2021 Thomson Reuters. No claim to original U.S. Government Works. -32- in pricing but insurers have warned that forcing them to disclose privately negotiated prices could end up raising costs for consumers. [FN47] The rule -- jointly issued by the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury which share jurisdiction over health insurance -- requires health insurers to provide cost-sharing information to patients before they use a service, on paper if required, as opposed to the current system where some patients are informed about their share of the cost after the service has been provided. The rule encourages the use of lower-cost, higher-value health care services, the agencies said, and would increase competition to keep service rates consistent. Insurers are encouraged to pass on savings to consumers and avail credit for doing so in their annual medical loss ratio calculations, starting in 2020. The Affordable Care Act currently requires health insurers to spend the bulk of the premiums collected on medical expenses for their insured. Many health insurers, however, have already made such information available to their patients through personalized tools on their websites and mobile apps but the rule expects them to go further by allowing consumers access to see the negotiated rate between their doctor and their plan or insurer as well. “The approach in the rule is flawed,” said Matt Eyles, CEO of America's Health Insurance Plans (AHIP), a group of health insurers. “We are disappointed that the final rule will work to reduce competition and push health care prices higher ? not lower.” Health insurers have particularly opposed the part of the rule that makes it mandatory for them to publicly disclose privately contracted rates that the insurers pay health care providers for the service. The CMS makes it mandatory for the information to be disclosed in a standardized, machine-readable format, starting 2022, opening up new avenues for research and price comparison tools using the newly available data. “Health insurance providers work hard to negotiate lower prices, which result in lower premiums and costs,” Eyles said, adding that disclosing privately negotiated rates will de-incentivize health care providers from offering lower rates for their products and services. Such a move could create a floor and not a ceiling for prices as the agencies expect, Eyles said. The AHIP pointed to a self-sponsored survey in which 3 out of 4 Americans said they would not support such federal regulations if it would eventually increase the cost of premiums. The rule finalized on Oct. 29 requires plans and issuers to make cost-sharing information available for 500 specified items and services for policy years beginning Jan. 1, 2023, and must make cost-sharing information available for all items and services for policy years beginning Jan. 1, 2024. CMS Proposes to Lower Fees for Issuers under ACA (Reuters) - The U.S. Centers for Medicare & Medicaid Services (CMS) on Wednesday proposed to lower the fee for healthcare exchange issuers under the Affordable Care Act as part of the Trump administration's efforts to reduce healthcare insurance premiums. [FN48] The agency proposed to reduce the user fee for Federally-Facilitated Exchange issuers from 3.0% to 2.25% of premium for the 2022 benefit year and for State-based Exchanges that use the federal platform to 1.75% of premium. The CMS runs enrollment for insurance plans created by the Affordable Care Act, often referred to as Obamacare, through online marketplace HealthCare.gov. A few states have separate state-based exchanges for enrollment with their own deadlines. IV. ENFORCEMENT & COMPLIANCE Unexpected Enrollment Growth Results in System Failures and CMS Sanctions Against Insurer CMS recently imposed immediate intermediate sanctions against Delaware Life Insurance Company (DLIC) for certain DLIC Medicare Advantage Prescription Drug (MA-PD) and Prescription Drug Plan (PDP) contracts. The intermediate sanctions include suspension of enrollment into the specified DLIC contracts and suspension of all marketing activities to Medicare beneficiaries effective January 31. Prior to 2020, DLIC provided benefits to approximately 5,300 beneficiaries under five MA-PD contracts. In 2020, DLIC added two MA- PD contracts and a new standalone PDP contract. As the same time, DLIC's enrollment processing vendor moved DLIC onto a new enrollment platform and understaffed its enrollment call center because it underestimated the increase in new members. When DLIC's enrollment increased by more than 1,000% in January, enrollment processing and call center issues began. In early January, CMS began receiving customer complaints from DLIC enrollees who complained that DLIC had no record of their enrollment and that the enrollees were unable to obtain their necessary prescription medications. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -33- On January 3, DLIC informed CMS that it had identified several issues with its MA-PD and PDP contracts, including: 1) failure to process enrollment transactions on time, 2) failing to send member ID cards and enrollment documents to enrollees and 3) call center wait times exceeding CMS standard timeframes. By the end of January, CMS had received more than 160 complaints. Separately, DLIC disclosed more than 400 grievances that customers had not reported to CMS and that had not yet been resolved. Although it offered several reasons for the failures, DLIC also had not provided CMS with comprehensive explanations for why some of the errors had occurred and whether the underlying issues had been resolved. CMS determined DLIC had substantially failed to comply with the terms of its contracts with CMS; Medicare enrollment requirements; Medicare information dissemination requirements; Part D benefit access requirements; and compliance program requirements. CMS determined that DLIC's deficiencies and the resulting denial of access to critical medications were sufficient for CMS to find a serious threat to beneficiaries' health and safety and impose the immediate sanctions. In addition to its enrollment issues, DLIC also informed CMS that its pharmacy benefit manager uploaded a file containing errors to it pharmacy network that was visible to DLIC enrollees and prospective enrollees. As a result, some individuals enrolled with DLIC because they believed their pharmacies were in network when they were not and the enrollees are now being turned away from their preferred pharmacies. The sanctions will remain in place until CMS is satisfied that DLIC has corrected the issues and that they are no likely to recur. California Orders ‘Healthcare Sharing’ Firms Aliera, Trinity to Stop Doing Business in State (Regulatory Intelligence) - The California Department of Insurance ordered Aliera Healthcare, Inc. and Trinity Healthshares, Inc., to stop doing business in the state, saying they deceived consumers into thinking they were buying traditional health insurance coverage while [FN49] representing themselves as alternative, unregulated, ‘healthcare sharing ministries.’ According to the order, they were misleading California consumers about their products and were transacting insurance business without a certificate of authority from the Insurance Commissioner. As many as 11,000 Californians may belong to unapproved plans offered by the Aliera and Trinity, the department said. Trinity is an affiliate of Aliera. According the department, the two companies offered ‘misleading lookalike health plans' that were marketed as healthcare sharing ministries. Health care sharing ministries sharing ministries require members to make fixed monthly contributions that are then either pooled or directly matched toward payment of the eligible healthcare bills of other members. They are nonprofit organizations with members who share similar religious or ethical beliefs. Offered as lower cost alternatives to traditional health insurance, healthcare sharing ministries are not insurance plans and are not regulated by state insurance commissioners. The plans are also not required to comply with Affordable Care Act requirements, which allows them to deny claims for pre-existing conditions, mental health services, preventative care, contraception or abortion services. Consumer confusion arises when members, believing they have healthcare insurance, find their claims for medical services denied. According to the department's cease and desist order, Aliera and Trinity provided misleading training to sales agents, promoted misleading advertisements to California consumers and sold products that did not comply with federal and state laws. Additionally, their deceptive marketing practices may have pressured some consumers to purchase a health sharing ministry plan by making them think they had missed the deadline to purchase coverage through Covered California. The department is encouraging consumers who purchased coverage through Aliera or Trinity to contact Covered California to determine if they have experienced a qualifying life event that would entitle them to a special enrollment opportunity. The companies have seven days to request a hearing on the order. California is just the latest state to take action against Aliera and Trinity. Texas Attorney General Ken Paxton filed suit in July 2019 to stop Aliera from selling health insurance and from engaging in the business of insurance without a state license. Washington Insurance Commissioner Mike Kreidler ordered the companies to immediately stop selling health insurance illegally in Washington state in May 2019. The Massachusetts Division of Insurance and New Hampshire Insurance Department both issued warnings to consumers about Aliera, pointing to Georgia court order from April 2019 finding that Aliera had misrepresented itself to members and the state as a healthcare sharing ministry when it was an unlicensed insurance company. U.S. Accuses Insurer Anthem of Medicare Advantage Fraud © 2021 Thomson Reuters. No claim to original U.S. Government Works. -34- (Reuters ) - The U.S. Justice Department on Friday announced a lawsuit accusing the insurer Anthem Inc of obtaining millions of dollars [FN50] by not correcting inaccurate information about the health status of patients enrolled in Medicare Advantage plans it operates. The lawsuit was filed in federal court in Manhattan and accused Anthem of submitting inaccurate diagnosis data to the government, allowing it to obtain inflated payments meant to compensate insurers for covering sicker patients. Indianapolis, Indiana-based Anthem in a statement said it planned to ‘vigorously defend’ its practices and the government was seeking to hold it to payment standards that are inconsistent with how Medicare operates. Anthem said it is being represented by the law firm O'Melveny & Myers. The case is one of a handful to result so far from long-running investigations by the Justice Department related to data that insurers who operate Medicare Advantage plans submit to receive ‘risk adjustment’ payments. The probes have led to a similar lawsuit against UnitedHealth Group Inc, and several other insurance companies, including Cigna Inc and Humana Inc, have disclosed requests for information from the department. More than one-third of Medicare recipients receive benefits through Medicare Advantage plans run by private insurers, who the government pays a predetermined monthly sum for each covered person based on individual diagnostic traits. Under this part of Medicare, the healthcare program for people aged 65 and older, the government makes ‘risk adjustment’ payments based on data it receives regarding the health status of a patient covered by a Medicare Advantage plan. The lawsuit said Anthem, one of the largest operators of Medicare Advantage plans, used a ‘retrospective chart review’ program to supplement its collection of diagnostic codes it already had collected from healthcare providers. That process involved reviewing patient records for all possible diagnostic codes to identify ones that it had not already submitted to the Centers for Medicare and Medicaid Services for risk-adjustment payments, the lawsuit said. But the complaint said when the record review did not validate diagnostic codes Anthem had already submitted to CMS, the company took no effort to delete them because it would hurt the insurer's revenue. The lawsuit said the chart review program is ‘one-sided’ as a result and viewed by Anthem as a ‘cash cow,’ helping it often generate more than $100 million in additional annual revenue. The lawsuit alleged Anthem's actions violated the False Claims Act, which prohibits submitting false claims for payment to the government. The lawsuit seeks civil penalties and treble damages. The case is United States v. Anthem Inc, U.S. District Court for the Southern District of New York, No. 20-2593. New York Charges Mallinckrodt with Insurance Fraud over Opioid Claims (Reuters Health) - Governor Andrew Cuomo said the charges brought by New York's Department of Financial Services are the first [FN51] against a major opioid manufacturer in the regulator's probe into entities that contributed to the nationwide opioid crisis. New York accused Mallinckrodt of overstating the benefits of long-term opioid treatment, downplaying the risks of addiction and abuse, and knowing its conduct would result in the payment of fraudulent insurance claims on unnecessary prescriptions. Mallinckrodt is the largest maker of generic opioids in the United States. According to New York, it supplied more than 1 billion pills to about 5 million policyholders in the state from 2009 to 2019. The company was charged with violating two New York insurance laws, with civil penalties of up to $5,000 per violation. Tuesday's charges follow Mallinckrodt's Feb. 25 agreement to pay $1.6 billion to settle thousands of lawsuits by state and local governments over its role in the U.S. opioid epidemic. As part of that agreement, Mallinckrodt agreed to put a U.S. generic drug business into Chapter 11 bankruptcy. Mallinckrodt in a statement said the New York charges were without merit and relied on ‘misperceptions' about the company, especially in light of state Attorney General Letitia James' support for the $1.6 billion settlement. Mallinckrodt also said it continues to manufacture ‘necessary, legitimate opioid medications' at an upstate plant. The company is headquartered in Staines-Upon-Thames in Britain, and has U.S. offices in Missouri and New Jersey. Opioids have contributed to more than 400,000 deaths since 1997, according to the U.S. Centers for Disease Control and Prevention. Cuomo has estimated that opioids caused about $2 billion of insurance rate increases to be passed on to New Yorkers. New York's financial services department formally notified about 23 opioid manufacturers and distributors last year that they might face civil enforcement charges for contributing to rising insurance premiums. It ordered Mallinckrodt to attend an Aug. 24 hearing at the regulator's offices in Albany, New York. The U.S. government on March 3 separately charged Mallinckrodt with defrauding Medicaid out of hundreds of millions of dollars on its top-selling Acthar Gel, which treats spasms in infants as well as multiple sclerosis. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -35- New York Charges Endo with Insurance Fraud Over Opioid Claims (Reuters) - New York state filed civil charges on Wednesday accusing Endo International Plc of insurance fraud for misrepresenting the [FN52] safety and efficacy of its opioid drugs. Governor Andrew Cuomo said the charges brought by New York's Department of Financial Services are the second in that regulator's probe into entities that contributed to the nation's opioid crisis. Endo shares were down 53 cents, or 11.8%, at $3.98 in late afternoon trading, with much of the decline coming after New York announced the charges. The company did not immediately respond to a request for comment. New York brought similar charges against Mallinckrodt Plc on April 21. AbbVie Agrees to Pay $24 million to Resolve Humira California Lawsuit (Reuters) - AbbVie Inc has agreed to pay $24 million to settle a lawsuit that alleged insurance fraud by the drugmaker in promoting its [FN53] blockbuster drug Humira, California's insurance regulator said on Thursday. AbbVie denied the allegations, but agreed to look into how Humira is marketed to health care providers in the state, the regulator said. The Insurance Commissioner of California said the company also agreed to disclose that AbbVie, and not a medical provider, paid the registered nurses who are employed as so-called AbbVie Ambassadors to interact with patients about Humira. Insurance Commissioner Ricardo Lara said AbbVie has paid $24 million to California and the whistleblower, a registered nurse who brought the case to the department's attention in October 2016. AbbVie said in a statement it was glad the settlement allows its nurse ambassador program to continue with no significant changes and noted that some parallel cases have been dismissed in other courts. Humira, the company's flagship arthritis treatment, brought in sales of $3.97 billion in the latest quarter. It has been the major driver of AbbVie's growth in recent years but faces expirations of its patents in U.S. in 2023. Among other things, the regulator had alleged AbbVie violated California's Insurance Frauds Prevention Act by unlawfully providing free and valuable professional goods and services to physicians to induce and reward Humira prescriptions. New York Charges Teva, Allergan with Insurance Fraud Over Opioid Claims (Reuters) - New York state filed civil charges on Tuesday accusing Teva Pharmaceutical Industries Ltd and Allergan Plc with insurance [FN54] fraud for downplaying the risks of their opioid painkillers to patients and doctors. Governor Andrew Cuomo said the charges by New York's Department of Financial Services are the third this year in that regulator's opioid industry probe, following charges against Endo International Plc and Mallinckrodt Plc. Teva denied the allegations. Abbvie Inc, which bought Allergan in May, did not immediately respond to requests for comment. New York said Teva, which made 20% of opioids distributed from 2006 to 2014 in the state, intentionally marketed opioids such as Actiq for off-label use, and drafted form ‘letters of medical necessity’ for doctors to boost prescriptions and insurer reimbursements. It said Allergan misrepresented the safety of its drugs in marketing materials, citing a 2010 U.S. Food and Drug Administration warning letter over its Kadian pain treatment. New York also accused Teva and Allergan of using ‘front groups' and doctors known as ‘key opinion leaders' to mislead people about the safety and effectiveness of opioids. It cited the 2012 annual meeting of the New York Pain Society in White Plains, New York, where Allergan was an exhibitor. The state said a key opinion leader present downplayed addiction signs by promoting the concept of ‘pseudoaddiction.’ Opioids have contributed to more than 400,000 deaths since 1997, according to the U.S. Centers for Disease Control and Prevention. Cuomo called the nation's opioid crisis ‘an American tragedy that has taken too many lives and caused irrevocable harm to communities,’ and he pledged to hold drugmakers accountable. New York charged Teva and Allergan with violating two state insurance laws, with civil penalties of up to $5,000 per violation. A hearing was scheduled for Oct. 26 at the financial services department's offices in Albany, New York. Pennsylvania Medicare Advantage Provider to Pay $2.25 million to Settle Inflated Bid Claims (Reuters) - A Pennsylvania Blue Cross affiliate that acts as an insurer under the federal Medicare Advantage program has agreed to pay $2.25 million to settle allegations that it incorrectly calculated anticipated plan costs, resulting in inflated bids to the federal [FN55] government. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -36- The settlement, announced Thursday by U.S. Attorney William McSwain in Philadelphia, resolves a whistleblower lawsuit against Keystone Health Plan East Inc and QCC Insurance Company Inc, two subsidiaries of Pennsylvania-based Independence Blue Cross LLC, under the federal False Claims Act. Independence Blue Cross did not immediately respond to a request for comment. In Medicare Advantage, private insurers contract with the federal government to provide hospital, medical and, in most cases, prescription drug insurance to Medicare beneficiaries. Insurers that take part in the program must submit bids each year that include their anticipated costs. Authorities alleged that Independence Blue Cross submitted improperly calculated, inflated plan costs, resulting in inflated reimbursement from the federal government, for the years 2009 and 2010. The lawsuit was originally filed by a whistleblower, Eric Johnson, in Philadelphia federal court in 2010. Johnson's relationship to Independence Blue Cross could not immediately be determined. Johnson will receive a share of about $500,000 from the settlement, according to the U.S. Attorney's office. The case is United States ex rel. Eric Johnson v. Independence Blue Cross, U.S. District Court, Eastern District of Pennsylvania, No. 10-cv-1520. Johnson & Johnson Charged by New York with Civil Insurance Fraud over Opioid Claims (Reuters) - J&J and its Janssen Pharmaceuticals affiliate were accused of targeting elderly patients for opioid treatment despite the [FN56] risks of side effects such as falls, fractures and neuropsychiatric symptoms. The company was also accused of employing marketing materials, ‘seemingly independent’ advocacy groups and ‘key opinion leaders' to dismiss opioid addiction as a myth. 'Misrepresentation of opioids to consumers for profit is inexcusable,' Governor Andrew Cuomo said in a statement. In a statement, J&J called its marketing and promotion of opioids ‘appropriate and responsible. Janssen provided these medicines for doctors treating patients suffering from pain and worked with regulators to provide appropriate information about their risks and benefits.’ The charges by New York's Department of Financial Services are the fourth in its opioid industry probe, following charges against Teva Pharmaceutical Industries Ltd and Allergan Plc, Endo International Plc and Mallinckrodt Plc. J&J, based in New Brunswick, New Jersey, has proposed paying $4 billion to settle opioid claims by U.S. states, cities and counties. It is separately appealing a $465 million judgment in Oklahoma from last November over its opioid marketing there. New York said J&J manufactured opioid products in the state including Nucynta and the fentanyl patch Duragesic, and received multiple U.S. Food and Drug Administration letters challenging its Duragesic marketing claims. The state also said J&J's ‘Norman Poppy,’ developed in 1994, once accounted for as much as 80% of the global supply for oxycodone raw materials. Oxycodone is the main ingredient in OxyContin, made by the now-bankrupt Purdue Pharma LP. The U.S. Centers for Disease Control and Prevention has said opioids have contributed to more than 400,000 deaths since 1997. J&J was charged with violating two New York insurance laws, with civil penalties of up to $5,000 per violation. UnitedHealth, Express Scripts Settle ERISA Claims Over EpiPen Pricing (Reuters) - UnitedHealth Group Inc and Express Scripts Holdings have settled lawsuits claiming that their pursuit of rebates and other discounts on the allergy injection EpiPen from Mylan NV drove up the medication's price, violating their fiduciary duties under the [FN57] federal Employee Retirement Income Security Act. The settlements came about two months after a St. Paul, Minnesota federal judge declined to certify classes against the companies and two other pharmacy benefit managers, meaning that UnitedHealth Group and Express Scripts each had to settle with only a single plaintiff to exit the litigation. The settlement between UnitedHealth and plaintiff Susan Illis was disclosed Thursday in a filing in the U.S. District Court for the District of Minnesota, while the settlement between Express Scripts and plaintiff Emil Jalonen was disclosed in a filing Monday. The filings did not reveal any details about the deals. Cari Campen Laufenberg of Keller Rohrback, a lawyer for the plaintiffs, did not immediately respond to a request for comment. Brian Boone of Alston & Bird, a lawyer for UnitedHealth, and Andrew Corkhill of Quinn Emanuel Urquhart & Sullivan, a lawyer for Express Scripts, also did not respond to requests for comment. Plaintiffs also said in a court filing Friday that they planned to drop their claims against CVS, though the filing did not mention a settlement. No settlement has been disclosed with the other defendant in the litigation, Prime Therapeutics. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -37- Pharmacy benefit managers negotiate drug prices for insurance plans and typically demand hefty discounts off list price from drugmakers in exchange for including the medicines on their lists of preferred drugs. The proposed class action began in 2017 after an outcry over Mylan's raising of the price for the EpiPen, a handheld device that treats life-threatening allergic reactions by allowing patients, often children, to inject themselves with a dose of epinephrine. Mylan, which acquired the right to market the EpiPen in 2007, recorded $1 billion in sales for the EpiPen in 2016, the year that the company raised the price of a pair of EpiPens to $600, up from $100 in 2008. The plaintiffs alleged that the price hikes were caused by the PBMs negotiating rebates, discounts and other fees with Mylan, forcing purchasers of EpiPens covered by various health plans to incur higher copays and deductibles. They claimed that the four PBMs' roles administering prescription drug benefits for health plans governed by ERISA made them fiduciaries for the plans. The companies denied wrongdoing and have argued the lawsuit was based on a false premise that PBMs rather than drug companies set the prices of their products. In denying class certification in August, U.S. District Judge Paul Magnuson said that whether the defendants were fiduciaries depended on the particular terms of each ERISA plan, and thus was ‘not susceptible of class-wide proof.’ The case is In re EpiPen ERISA Litigation, U.S. District Court for the District of Minnesota, No. 17-cv-01884. New York Files Charges Against Health-sharing Ministries (Regulatory Intelligence) - The New York State Department of Financial Services has charged ‘health care sharing ministries' Aliera [FN58] Companies (Aliera) and Trinity Healthshare (Trinity) on October 20 with illegally selling as health insurance. The department alleges that Aliera and Trinity have deceived consumers for years into ‘believing that they had purchased legitimate coverage responsible for legitimate medical expenses.’ Instead, the department charges that the companies were conducting an illegal insurance business in New York by selling health insurance, while overstating the coverage offered, and sometimes committing ‘outright fraud.’ “New Yorkers should not have to worry whether a trip to a medical professional could lead them to bankruptcy, a factor that has been compounded by this unprecedented global health crisis,” said Superintendent of Financial Services Linda A. Lacewell in a release. “DFS is committed to protecting consumers and the integrity of New York's healthcare marketplace, ensuring New Yorkers receive the care they expect and may need.” Since 2016, nearly 41,000 New York residents have enrolled in Aliera's products. The allegations against Aliera and Trinity include: Aliera refused to pay a consumer for her leukemia treatments, including thousands of dollars for emergency treatment in 2019. When the consumer attempt to resolve the claims, Aliera erroneously denied her claim due to a pre-existing condition. Aliera still has not paid her claim. In the summer of 2019, another consumer was denied coverage for surgery he needed for nerve damage in his hand. Aliera ‘stalled, delayed, and refused to respond,’ eventually telling the consumer it would not cover his surgery due to his ‘tobacco use.’ The consumer cancelled his policy with Aliera and has still not had the surgery. In 2020, a provider reported that Aliera denied a nearly $15,000 claim for a patient's breast cancer treatment. The department will conduct a hearing on the allegations on February 2, 2020. New York is just the latest state to take action against Aliera and Trinity for illegally selling health insurance and defrauding consumers. The attorneys general and departments of insurance in several states have alleged that the ministries mislead consumers by marketing themselves as insurance. Individual consumers have also filed lawsuits alleging that they were unfairly denied coverage for claims or that they were fraudulent sold products they understood provided health insurance coverage. Offered as lower cost alternatives to traditional health insurance, healthcare sharing ministries are not regulated by state insurance commissioners and are exempt from state insurance laws as long as they provide a written disclaimer explaining that they are not health insurance. The ministries are also not required to comply with Affordable Care Act requirements, allowing them to deny claims for pre-existing conditions, mental health services, preventative care, contraception or abortion services. The Department of Treasury and Internal Revenue Service recently proposed regulations, Certain Medical Care Arrangements, that would define healthcare sharing ministries as ‘medical insurance.’ As a result of the new definition, some healthcare sharing ministry members could deduct their monthly contributions under section 213 of the Internal Revenue Code as “payments for insurance.” © 2021 Thomson Reuters. No claim to original U.S. Government Works. -38- The attorneys general for 20 states filed a comment letter opposing the proposed regulatory change on the basis that healthcare sharing ministry create confusion for consumers and fail to cover medical claims, resulting in large out-of-pocket expenses for individuals. The Department of Treasury and IRS held a hearing on the proposed regulations on October 7. Kaiser Agrees to Pay $6.3 million to Resolve Medicare Advantage Allegations (Regulatory Intelligence) - Kaiser Foundation Health Plan of Washington, formerly known as Group Health Cooperative, agreed to pay more than $6.3 million to resolve allegations that it submitted false claims for its Medicare Advantage beneficiaries. According to the allegations, Kaiser submitted invalid diagnoses to Medicare for some beneficiaries and received ‘inflated payments from Medicare as a [FN59] result.’ “The United States relies on Medicare Advantage Organizations to submit accurate diagnosis data to Medicare to ensure that the compensation they receive is appropriate,” said Assistant Attorney General Jeffrey Bossert Clark of the Department of Justice's Civil Division said this week in a statement. Kaiser agreed to settle allegations that Group Health knowingly submitted diagnoses that were not supported by the beneficiaries' medical records to inflate the payments it received from Medicare. A former employee of Group Health brought the allegations as part of a whistleblower action under the False Claims Act. She will receive approximately $1.5 million as a result of the settlement. “When insurance providers take advantage of Medicare and falsely claim that they are entitled to repayment for unsupported diagnoses, American taxpayers suffer in the form of higher costs,” stated U.S. Attorney James Kennedy, Jr. of the Western District of New York in a statement. In the Medicare Advantage or Medicare Part C program, Medicare beneficiaries elect to obtain their healthcare coverage through private insurance plans that are owned and operated by private insurer. Medicare pays these Medicare Advantage Organizations (MAOs) a fixed, monthly amount to provide healthcare coverage to the Medicare beneficiaries who enroll in their plans. Medicare will adjust the monthly payments based on the health status of each beneficiary so it pays more for sicker beneficiaries than for healthier individuals in the plan. The MAOs reports on the health status of their beneficiaries to Medicare on an annual basis. Medicare then uses this information to adjust the payments. Kaiser acquired Group Health Cooperative in 2017. V. DATA BREACHES Health Insurer Agrees to Pay Second-largest Settlement to U.S. Federal Agency Over Data Breach (Regulatory Intelligence) - Premera Blue Cross has agreed to pay $6.85 million to the U.S. Department of Health and Human Services [FN60] to settle violations of patient privacy rules. The settlement with the HHS Office for Civil Rights represents the second-largest payment in its history to resolve a case involving the Health Insurance Portability and Accountability Act (HIPAA). Premera previously paid $74 million to settle a class action lawsuit arising from the data breach, including $32 million in direct benefits to class members and a commitment to spend $42 million to improve its information technology systems. Premera also paid $10 million to settled an action brought by a coalition of 30 state attorneys general, led by Washington State Attorney General Bob Ferguson. The states alleged Premera failed to protect consumer data. Premera operates in Washington and Alaska and is the largest health plan in the Pacific Northwest. It serves more than 2 million people. On March 17, 2015, Premera filed a breach report for itself and its network of affiliates stating cyber-attackers had gained unauthorized access to it information technology system. The hackers used an email phishing campaign to install malware that gave them access to Premera's system in May 2014, which was not detected for until January 2015, nearly nine months later. The hackers were believed to originate in China, according to the class action suit. Hackers allegedly took advantage of known weaknesses in the insurers data security systems. Cybersecurity experts and Premera's own auditors warned it of the risks but Premera failed to fix its practices. As a result of the undetected cyber attack, the protected health information (PHI) of more than 10.4 million people was disclosed, including their names, addresses, dates of birth, email addresses, Social Security numbers, bank account information and medical records. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -39- “If large health insurance entities don't invest the time and effort to identify their security vulnerabilities, be they technical or human, hackers surely will. This case vividly demonstrates the damage that results when hackers are allowed to roam undetected in a computer system for nearly nine months,” said Roger Severino, director of the HHS civil rights office, in a statement. An investigation by the civil rights office found systemic noncompliance with the HIPAA privacy and security rules. Premera also agreed to enter into a corrective action plan as part of the OCR settlement. Premera agreed to: Conduct a risk analysis. Develop and implement a risk management plan. Review, develop and/or revise written privacy and security policies and procedures to address the alleged conduct. Make those policies and procedures available to its workforce. Premera is also subject to two years of monitoring. Aetna Agrees to Pay $1 million to Settle Three HIPAA Breaches (Regulatory Intelligence) - Aetna Life Insurance Company has agreed to pay $1 million to the Office for Civil Rights at the U.S. Department of Health and Human Services (HHS) to settle potential violations of the Health Insurance Portability and Accountability Act [FN61] (HIPAA) Privacy and Security Rules. The settlement, which HHS announced last week, resolves allegations relating to three separate 2017 breaches that occurred within a 6-month period. In April 2017, Aetna discovered that two web services used to display plan-related documents to health plan members allowed documents to be accessed without login credentials. The services were also being indexed by various internet search engines. Aetna reported that nearly 5,000 individuals were affected by the breach. The breach disclosed the individuals' protected health information (PHI), including names, insurance identification numbers, claim payment amounts, medical procedure service codes and dates of services. In July 2017, benefit notices were mailed to Aetna members using window envelopes. Soon after the mailing, Aetna received complaints from members that ‘HIV medication’ was visible through the envelope's window below the member's name and address. Aetna reported nearly 12,000 were affected by this disclosure. In September 2017, a research study mailing sent to Aetna plan members contained the name and logo of the atrial fibrillation research study they were participating in on the envelope. Aetna reported 1,600 individuals were affected by this disclosure. 'When individuals contract for health insurance, they expect plans to keep their medical information safe from public exposure. Unfortunately, Aetna's failure to follow the HIPAA Rules resulted in three breaches in a six-month period, leading to this million dollar settlement,' said OCR Director Roger Severino in a release. The Office for Civil Right's investigation determined that, in addition to the impermissible disclosures, Aetna failed: to perform periodic technical and nontechnical evaluations of operational changes affecting the security of their electronic protected health information (ePHI);to implement procedures to verify the identities of individuals or entities seeking access to ePHI; to limit PHI disclosures to the minimum necessary to accomplish the purpose; and to have appropriate administrative, technical and physical safeguards in place to protect the privacy of PHI. In addition to the monetary settlement, Aetna will undertake a corrective action plan that includes two years of monitoring. Aetna has previously reached settlements with individual states on these breaches, including paying more than $900,000 to California and more than $1 million to New York to settle the HIV status breach allegations. The company also paid settlements to Connecticut, the District of Columbia, New Jersey and Washington to settle the HIV status and atrial fibrillation study breaches. Aetna also agreed to paid more than $17 million to settle class action allegations regarding the HIV status breach. Aetna is the third-largest U.S. health insurance company by revenue and sells traditional and consumer-directed health insurance and related services. It is now part of CVS Health. VI. PRESIDENTIAL CAMPAIGN: 2020 Why ‘Medicare for All’ Is a Prominent Issue in 2020 Election Campaign (Regulatory Intelligence) - Healthcare is once again a top issue for likely voters in the 2020 election campaign, according to polls. A majority of the Democratic candidates for the 2020 presidential nomination are proposing a “Medicare for All” or “Medicare for All who [FN62] want it” platform. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -40- The candidates hope this approach, building on the familiarity and popularity of the federal Medicare health program for older Americans, will get the United States to near-universal healthcare coverage after legal and administrative setbacks to the 2010 Affordable Care Act. Former President Barack Obama had hoped that his signature ‘Obamacare’ legislation would result in near universal healthcare coverage for Americans. Although it significantly reduced the number of uninsured, the results have not met expectations. When the act was adopted in 2010, there were more than 46.5 million nonelderly Americans without insurance. By 2016, the number of uninsured had dropped to less than 27 million, but then it rebounded to 28 million in 2018. What happened? Legal challenges to the ACA resulted the U.S. Supreme Court deciding that states were not required to expand the federal-state Medicaid low-income health program. Many states then opted not to expand Medicaid, leaving their poorest citizens without health insurance. Under the Trump administration, most supports for the program, such as advertising to encourage enrollment, and requirements, such as the tax penalty for not obtaining insurance, have been weakened. As a result, many individuals are again choosing not to purchase health insurance. In 2017 and 2018, about 500,000 people lost health insurance coverage each year. What is Medicare? Medicare now covers people 65 or older, or those under 65 with certain disabilities and people of all ages with end-stage renal disease. Traditional Medicare has three parts: · Medicare Part A covers inpatient care in hospitals and skilled nursing facilities (SNFs) and also helps cover hospice care and some home health care. Most people ? 99% -- do not have to pay a premium for Part A because they or a spouse paid for it through payroll taxes. · Medicare Part B covers physician services and outpatient care that Part A does not cover, including medically necessary physical and occupational therapists and supplies and some home health care. Most people have to pay a premium for Part B coverage. · Medicare Part D provides prescription drug coverage and is available to anyone with Medicare. Most people have to pay a premium for Part D prescription drug benefits. Medicare Advantage Plans (Part C) are Medicare managed care plans. They include all of the coverage in traditional Parts A and B but also provide Medicare beneficiaries with additional benefits such as vision, hearing, dental and health or wellness programs. Medicare Advantage Plans usually include Part D coverage too. Like HMOs or PPOs, Medicare Advantage plans control their costs by negotiating reduced in-network rates for services. This typically means that individuals will likely pay more if they choose to see a provider or receive services outside their network. Opponents of Medicare for All often point to the loss of individual choice, although traditional Medicare allows individuals to receive treatment from any provider participating in Medicare. And, most providers and facilities participate in Medicare. Health insurers who oppose Medicare for All or a public option are likely focusing on the lower profitability of Medicare Advantage plans compared to private insurance. However, nearly 29% or more than $200 billion of Medicare spending went to private insurers offering Medicare Advantage plans. Is Medicare the answer? In 2018, nearly 60 million Americans were enrolled in Medicare. Approximately two-thirds were enrolled in traditional Medicare and the remaining one-three were enrolled in Medicare Advantage plans. In FY 2018, the total federal Medicare expenditure was $740.6 billion. Although not universally loved, 88% of individuals 65 and older rated their healthcare coverage as excellent or good, according to a 2018 Gallup poll. Medicare satisfaction ranks higher than private insurance, employer-sponsored plans and Medicaid. Medicare also has a much lower overall cost of administration with most estimates showing less than 2% of spending going to program administration overall, although Medicare Advantage plans typically have higher administrative costs that traditional Medicare. But compared with estimates between 13% to 17% for private health plans, both Medicare options have lower administrative costs. Medicare also provides a clear pathway to enrollment. Currently, individuals already receiving Social Security benefits are automatically enrolled when they become eligible. If not, individuals can enroll three months before and up to three months after they turn 65. And, while enrollment is not necessarily a mandate, there are consequence for people who fail to enroll when they become eligible. If someone enrolls late and is not covered by an employer-sponsored plan, Medicare will charge a penalty of 10% of the monthly Part B premium for every year you they are eligible but don't enroll. The penalty applies for life. Because most people do not have to pay a separate premium for Part A coverage, the penalty doesn't usually have an impact on Part A costs. What is the result? © 2021 Thomson Reuters. No claim to original U.S. Government Works. -41- If President Donald Trump wins reelection, it is unlikely that insurance coverage will increase to cover more Americans. Although he ran on the promise of repealing the ACA and offering an improved healthcare plan, his administration has focused on reducing the cost of prescription drugs without offering plans to expand healthcare coverage. Instead, many of the administration's efforts have worked to reduce coverage. If either Senator Bernie Sanders or Senator Elizabeth Warren win the presidency, Medicare for All will be their plan. However, a plan that upends the segment representing 18% of the nation's GDP will face steep challenges on the path toward enactment. Medicare for All as a single-payer plan will meet significant resistance. Another alternative supported by some candidates is a ‘public option,’ which would allow people to retain employer-sponsored plans but offers a buy-in to Medicare or a Medicare-like plan. This may have greater chances. It would allow individuals to feel more empowered to make choices, while offering a more cost-effective option that could significantly expand coverage. It would also allow the insurance industry to retain their significant market share. No matter who wins, the public will likely continue to look for the government to ensure they have healthcare solutions. Pre-election roundup: Trump and Biden on Health Insurance Policy (Regulatory Intelligence) - As the COVID-19 pandemic response dominates the U.S. pre-election debate this year, it is casting a spotlight is on the fate of the Affordable Care Act and continued health insurance access during a public health emergency and [FN63] economic slowdown. Days away from the presidential elections, however, neither President Donald Trump and former Vice President Joe Biden have provided any extensive guidance on what their healthcare plan would be once elected. Here is a round-up of the positions taken by the two candidates on key issues pertaining to the ACA and health insurance: Affordable Care Act Trump has said he hopes the Supreme Court will strike down the ACA in a case now before it and give him a chance to replace the law with “a brand new, beautiful health care” plan of his own. He has made no proposals public despite making several assertions that a plan is ready. In the recent, much-publicized interview with CBS News reporter Lesley Stahl he made contradictory claims about a potential healthcare plan - once mentioning that it was ready and will be revealed once the Supreme Court decides on the ACA, but later saying his administration would come up with a replacement plan in the event that the law is struck down by the court. Meanwhile, Biden has vowed to protect the ACA from plans by Republicans and some Democrats to replace it. He has proposed to introduce a “public option” automatically available to any Americans who fail to qualify for Medicaid, the federal-government aided, subsidized coverage program in their state. These consumers currently need to buy private health coverage options on the ACA-regulated individual market, which that has been criticized for its lack of availability and affordability in many parts of the country. Some Democrats have called for universal ‘Medicare for All’ government funded health coverage -- a major debating point in the Democratic presidential primaries. Role of private insurance Biden has distanced himself from charges that he would eliminate private insurers. He has previously said his “public option” or “Bidencare” would be a federal-government provided insurance option available on the healthcare exchanges alongside private coverage options that already exist on the individual market. “I support private insurance,” he said at the second and final debate with Trump in Nashville, Tennessee, last week. Trump and other critics have alleged that Biden will be pressured by the progressive wing of the Democratic Party to support a “Medicare-for-all” type program. Trump's plan to replace the ACA would leave the role of private health insurers intact, he has said. Private health insurance is the primary source of health coverage in the United States, with more than 200 million people receiving coverage from private insurers, data from the Congressional Research Service shows. Pre-existing conditions Trump has said any ACA replacement plan will have to ensure coverage of pre-existing conditions in order to receive his approval. His administration, however, is in the Supreme Court fighting to invalidate the law which currently offers guaranteed coverage for consumers irrespective of pre-existing health conditions. Trump issued an executive order to protect patients with pre-existing conditions in September but experts have said he lacked the legal authority to do so and that such a sweeping provision could only come from Congressional action. Biden has criticized any effort to remove protections for pre-existing conditions, including the Trump administration's efforts to overturn the ACA in the Supreme Court. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -42- Although protections for individuals with pre-existing conditions has received much of the focus, allowing children to stay on parent's policies until age 26 and mandatory coverage for essential health benefits may also be lost if the Supreme Court rules the ACA is unconstitutional. Individual mandate Biden had said in 2019 he would bring back a mandate to purchase health insurance that was rendered ineffective when Congress removed a tax penalty associated with it in 2017. He has not, however, provided any recent comments on the matter. Meanwhile, Trump has repeatedly touted the scrapping of the individual mandate requirement of the ACA as a victory for those who had “to pay a fortune for the privilege of not having to pay for bad health insurance,” and made clear he would not bring back the provision. The lawsuit before the Supreme Court has sought to invalidate the individual mandate and the ACA in its entirety. Medicaid expansion While Trump has not addressed the topic of Medicaid expansion in his recent comments, he has previously called for the payment of “block grants” to states and advocated more stringent criteria for Medicaid eligibility, such as the introduction of work requirements. Critics have said any efforts to limit federal government funding to states to run their Medicaid programs would seriously strain the state budgets while restricting the number of patients the program can cover. Biden has repeatedly supported the Medicaid expansion provision of the ACA, under which states can choose to receive federal aid to provide health coverage to a wider group of people than the low-income people eligible for Medicaid. The Medicaid program is run by states and hence its eligibility criteria vary from state to state. His “public” insurance option may serve as an additional option for low-cost coverage for those living in states with stringent eligibility rules for their Medicaid program. Democrats have also called for increasing the federal match in state Medicaid programs during the public health emergency. Medicaid expansion has been a particularly important issue during the COVID-19 public health emergency as states that previously rejected expansion have moved to expand Medicaid in order to provide better access to care. © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] . Lawrence Hurley, U.S. appeals court sidesteps major Obamacare ruling, Reuters (Dec. 18, 2019). [FN3] . Jonathan Stempel, U.S. appeals court upholds risk payments to health insurers, Reuters (Dec. 31, 2019). [FN4] . Lawrence Hurley, Democrats ask U.S. Supreme Court to save Obamacare, Reuters (Jan. 3, 2020). [FN5] . Lawrence Hurley, Supreme Court to hear Trump appeal in Obamacare contraception fight, Reuters (Jan. 17, 2020). [FN6] . Michael Erman, Trump administration says California can't require insurers to cover abortion, Reuters (Jan. 24, 2020). [FN7] . Ollove, Michael, “The Youngest Children Are Falling Out of Health Insurance,” Pew Trusts Stateline, February 19, 2020, available at https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2020/02/19/the-youngest-children-are-falling-out-of-health- insurance. [FN8] . Lawrence Hurley, U.S. Supreme Court takes up Democratic bid to defend Obamacare, Reuters (March 2, 2020). [FN9] . Antonita Madonna, U.S. $2 trillion coronavirus relief package stops short of covering uninsured, Thomson Reuters Regulatory Intelligence (March 27, 2020). [FN10] . Antonita Madonna, U.S. working on blueprint for COVID-19 treatment costs for uninsured, Thomson Reuters Regulatory Intelligence (April 3, 2020) at http://go-ri.tr.com/N7ZCSU. © 2021 Thomson Reuters. No claim to original U.S. Government Works. -43- [FN11] . Lawrence Hurley, Supreme Court tells U.S. government to pay insurers $12 billion under Obamacare, Reuters (April 27, 2020). [FN12] . Antonita Madonna, U.S. healthcare groups call for more aggressive insurance response in COVID-19 relief, Thomson Reuters Regulatory Intelligence (April 29, 2020) at: http://go-ri.tr.com/unSHap. [FN13] . Antonita Madonna, Trump to continue fight against Affordable Care Act as Supreme Court weighs contraceptive case, Thomson Reuters Regulatory Intelligence (May 7, 2020) at http://go-ri.tr.com/f2nhY3. [FN14] . Melissa D. Berry, More than 25 million in U.S. could lose employer-based insurance due to pandemic ? report, Thomson Reuters Regulatory Intelligence (May 12, 2020) at: http://go-ri.tr.com/8gz730. [FN15] . Melissa D. Berry, U.S. states expand on federal coronavirus insurance responses to increase access to COVID-19 care -study, Thomson Reuters Regulatory Intelligence (May 20, 2020) at http://go-ri.tr.com/y1KRUl. [FN16] . Deena Beasley, ‘Medicaid best price’ changes aimed at value-based gene therapy contracts: U.S. agency, Reuters (June 17, 2020). [FN17] . Caroline Humer, U.S. health insurers may balk at paying for coronavirus antibody testing, Reuters (June 17, 2020) at: http://go- ri.tr.com/8jUMSo. [FN18] . Antonita Madonna, Loss of coverage insurance enrollment surges in 2020: U.S. health agency, Thomson Reuters Regulatory Intelligence (June 26, 2020) at: http://go-ri.tr.com/gXkBgf. [FN19] . Antonita Madonna and Melissa D. Berry, U.S. Supreme Court's contraceptives ruling on religious exemptions sparks insurance gap concerns, Thomson Reuters Regulatory Intelligence (July 9, 2020). [FN20] . Antonia Madonna, Rule requiring separate billing for abortion coverage struck down by U.S. judge, Thomson Reuters Regulatory Intelligence (July 14, 2020). [FN21] . Melissa D. Berry, US appeals court upholds Trump administration rule on short-term health plans, Thomson Reuters Regulatory Intelligence (July 20, 2020). [FN22] . Abhishek Manikandan, MetLife to buy Versant Health for $1.68 billion, Reuters (September 17, 2020). [FN23] . Manojna Maddipatla, UnitedHealth bets on government health plan growth in 2020, Reuters (Jan. 15, 2020). [FN24] . Caroline Humer, Blues health insurers put up $55 million to take on generic drug makers, Reuters (Jan. 23, 2020). [FN25] . Caroline Humer and Michael Erman, Trump admin to try letting states limit Medicaid benefits, Reuters (Jan. 30, 2020). [FN26] . Caroline Humer and Carl O'Donnell, U.S. government proposes higher payments to Medicare insurers in 2021, Reuters (Feb. 5, 2020). © 2021 Thomson Reuters. No claim to original U.S. Government Works. -44- [FN27] . “Humana bleeds 550K Part D members amid ‘winner take all’ market,” Robert King, FierceHealthcare, February 5, 2020, available at: https://www.fiercehealthcare.com/payer/humana-beats-4q-earnings-strong-medicare-advantage-growth. [FN28] . Antonita Madonna, Regulatory push needed to ease U.S. health insurance hurdles in coronavirus response - policy experts, Thomson Reuters Regulatory Intelligence (Feb. 28, 2020). [FN29] . Antonita Madonna, U.S. states, insurers rush to ease restrictions on access to coronavirus testing, care, Thomson Reuters Regulatory Intelligence (March 6, 2020). [FN30] . Antonita Madonna, Coronavirus treatment for uninsured may cost up to $42 bln: estimate, Thomson Reuters Regulatory Intelligence (April 8, 2020) at http://go-ri.tr.com/JuOe64. [FN31] . Antonita Madonna, Coronavirus care costs in U.S. may cross $500 billion by 2021: health insurer study, Thomson Reuters Regulatory Intelligence (April 9, 2020) at http://go-ri.tr.com/eScqle. [FN32] . Antonita Madonna, Health insurers see enrollment gains, savings cushioning COVID-19 costs, Thomson Reuters Regulatory Intelligence (May 5, 2020) at http://go-ri.tr.com/sM16Q4. [FN33] . Caroline Humer, UnitedHealth to issue premium credits as part of $1.5 bln spending plan, Reuters (May 7, 2020) at https:// www.reuters.com/article/us-unitedhealth-rebates/unitedhealth-to-issue-premium-credits-as-part-of-1-5-billion-spending-plan- idUSKBN22J1AB. [FN34] . Antonita Madonna, Health insurers mull return to ACA marketplace as enrollment picks up, Reuters (May 22, 2020) at http://go- ri.tr.com/MpqBZY. [FN35] . Antonita Madonna, Uncertainty around pandemic larger risk to life, health insurers : Fitch, Thomson Reuters Regulatory Intelligence (May 29, 2020) at http://go-ri.tr.com/cBKL0e. [FN36] . Antonita Madonna, U.S. health insurers appear unfazed by coronavirus costs in 2021 rate filings, Thomson Reuters Regulatory Intelligence (July 7, 2020) at: http://go-ri.tr.com/V49BWx. [FN37] . Aditi Sebstian, Walmart makes new push into healthcare with insurance business, Reuters (July 8, 2020). [FN38] . Antonita Madonna, U.S. health insurers, wary of telehealth overuse, urge more planning in policy easing, Thomson Reuters Regulatory Intelligence (July 21, 2020) at: http://go-ri.tr.com/WVNYgs. [FN39] . Barbara Grzincic, Divided 10th Circ. revives lawsuit over Microsoft, Blue Cross ERISA plan, Reuters (July 24, 2020). [FN40] . Antonita Madonna, U.S. insurance regulators form committee to focus on race and diversity, Thomson Reuters Regulatory Intelligence (July 24, 2020). [FN41] . Munsif Vegattil and Caroline Humer, Alphabet's Verily targets employer health insurance with Swiss Re partnership, Reuters (August 25, 2020). © 2021 Thomson Reuters. No claim to original U.S. Government Works. -45- [FN42] . Antonita Madonna, U.S. health insurers cite government-plan enrollment gains in second quarter, Thomson Reuters Regulatory Intelligence (August 6, 2020) at: http://go-ri.tr.com/nJkf1K. [FN43] . Antonita Madonna and Joe Passe, More regulation of big data seen as a key to racial equality in U.S. insurance, Thomson Reuters Regulatory Intelligence (August 17, 2020). [FN44] . Noor Zainab Hussain, Walmart to sell Medicare plans in latest healthcare push, Reuters (October 6, 2020). [FN45] . Melissa D. Berry, U.S. health agency acts to ensure no-cost access to approved COVID-19 vaccines, Thomson Reuters Regulatory Intelligence (October 30, 2020) at: http://go-ri.tr.com/ESc3eP. [FN46] . “Transparency in Coverage Final Rule Fact Sheet,” October 29, 2020, available at: https://www.cms.gov/newsroom/fact-sheets/ transparency-coverage-final-rule-fact-sheet-cms-9915-f. [FN47] . Antonita Madonna, Trump Administration finalizes price transparency rule for health insurers despite objections, Thomson Reuters Regulatory Intelligence (November 19, 2020). [FN48] . Dania Nadeem, U.S. CMS proposes to lower fees for issuers under Obamacare, Reuters (November 25, 2020). [FN49] . Melissa D. Berry, California orders ‘healthcare sharing’ firms Aliera, Trinity to stop doing business in state, Thomson Reuters Regulatory Intelligence (March 11, 2020). [FN50] . Nate Raymond, U.S. accuses insurer Anthem of Medicare Advantage fraud, Reuters (March 27, 2020). [FN51] . Jonathan Stempel, New York charges Mallinckrodt with insurance fraud over opioid claims, Reuters (April 21, 2020). [FN52] . Jonathan Stempel, New York charges Endo with insurance fraud over opioid claims, Reuters (June 10, 2020). [FN53] . AbbVie agrees to pay $24 million to resolve Humira California lawsuit, Reuters (August 6, 2020). [FN54] . Jonathan Stempel and Mrinalika Roy, New York charges Teva, Allergan with insurance fraud over opioid claims, Reuters (August 18, 2020). [FN55] . Brenda Pierson, Pa. Medicare Advantage provider to pay $2.25 mln to settle inflated bid claims, Reuters (September 3, 2020). [FN56] . Jonathan Stempel, Johnson & Johnson charged by New York with civil insurance fraud over opioid claims, Reuters (September 17, 2020). [FN57] . Brendan Pierson, UnitedHealth, Express Scripts settle ERISA claims over EpiPen pricing, Reuters (October 2, 2020). [FN58] © 2021 Thomson Reuters. No claim to original U.S. Government Works. -46- . Melissa D. Berry, New York files charges against health-sharing ministries, Thomson Reuters Regulatory Intelligence (October 21, 2020). [FN59] . Melissa D. Berry, Kaiser agrees to pay $6.3 million to resolve Medicare Advantage allegations, Thomson Reuters Regulatory Intelligence (November 19, 2020). [FN60] . Melissa D. Berry, Health insurer agrees to pay second-largest settlement to U.S. federal agency over data breach, Thomson Reuters Regulatory Intelligence (September 29, 2020). [FN61] . Melissa D. Berry, Aetna agrees to pay $1 million to settle three HIPAA breaches, Thomson Reuters Regulatory Intelligence (November 5, 2020). [FN62] . Melissa D. Berry, Explainer: Why ‘Medicare for All’ is a prominent issue in 2020 election campaign, Thomson Reuters Regulatory Intelligence (Feb. 14, 2020). [FN63] . Antonita Madonna and Melissa D. Berry, Pre-election roundup: Trump and Biden on health insurance policy, Thomson Reuters Regulatory Intelligence (October 29, 2020). Produced by Thomson Reuters Accelus Regulatory Intelligence 14-Mar-2021 © 2021 Thomson Reuters. No claim to original U.S. Government Works. -47-