REGULATORY INTELLIGENCE

YEAR-END REPORT - 2021

Health Policy Tracking Service - Issue Briefs
Healthcare Reform
Administrative Rulemaking

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.

12/20/2021
I. FINAL RULES, GUIDANCE AND EXECUTIVE ORDERS

U.S. Health Agency Mandates Review of Regulations Every 10 Years

(Regulatory Intelligence) - The outgoing Trump administration has finalized a rule that will require all new regulations by agencies
under the Department of Health and Human Services to be reviewed for relevance every 10 years or face automatic expiration. The

department, however, will now have five years to review all existing regulations, instead of the two-year timeline proposed earlier. [FN2]

The regulation was proposed on Nov. 4 and criticized for its timing on the day of the 2020 U.S. Presidential elections. With the 'sunset"
rule -- as it is called -- being finalized in the last few days of the current administration, almost all of this exercise will have to be
executed by the new HHS team in the administration of President-elect Joe Biden.

Biden's nominee to lead the HHS, Xavier Becerra, has already criticized the rule saying it would take time away from the agency's
efforts to focus on pandemic-related healthcare relief efforts. The rule could face a challenge in Congress under the Congressional
Review Act, a prospect increased by the Democratic party's capture of control in the Senate in last week's Georgia elections. It is
unclear, however, what priority Democratic President-elect Joe Biden will place on trying to overturn Trump administration regulations
issued in its final days.

Under the final rule, any regulation issued by HHS will cease to be effective after 10 years unless the HHS performs an assessment of
the regulation and verifies its necessity. A more detailed review will be required in cases of regulations that have a more 'significant"
economic impact upon a substantial number of small entities, the HHS said.

All existing regulations, since the agency's inception in 1953, would have to be reviewed within five years. The department had
extended the review horizon after facing criticism for proposing a two-year period to review over 70 years' worth of regulation, amid the
COVID-19 pandemic. 'The first reviews are not due until 2026, which is expected to be long after the pandemic has subsided,' the HHS
said about the revised timeline.

The rule will apply to regulations from all agencies governed by the HHS, excluding the Food and Drug Administration's (FDA) device-
specific, food standard, and over-the-counter drug-specific regulations. Regulations that cannot be legally rescinded and some
categories exempt from standard rulemaking requirements under the Administrative Procedure Act are also excluded from the rule. The
rule will not apply to guidance from HHS.

Rules issued in conjunction with other agencies will be reviewed jointly with those agencies. HHS-issued guidance over the years will
not be subject to the new rule.

Senior HHS officials on a call with the media said the purpose of the review is to terminate burdensome regulations unless their
necessity is publicly demonstrated.

Biden Orders Review of Regulations that Restrict Affordable Care Act, Reopens Enrollment

(Regulatory Intelligence) - President Joe Biden on Thursday ordered a review of all regulations that limit the scope of the Affordable
Care Act and re-opened enrollment on the federal healthcare marketplace for three months, as part of his first executive order aimed
at strengthening the law. In a separate order, Biden also rescinded the "Mexico City policy' that blocked federal funding to international

organizations providing abortion services. [FN3]

 
  

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'There's nothing new that we're doing here, other than restoring the Affordable Care Act and restoring the Medicaid to the way it was
before Trump became President," Biden said at the signing of two executive orders on healthcare - one to strengthen the ACA and
another directed at boosting healthcare protections for women in the U.S. and abroad.

The administration under former President Donald Trump opposed the healthcare law, also known as 'Obamacare,' saying it was
proving too expensive to the government while providing little benefit to consumers.

As part of the executive order on strengthening the ACA, Biden has also ordered the review of all waivers granted for state initiatives
to revamp their administration of the state-federal Medicaid low-income healthcare program. Some states had used these waivers to
impose work restrictions on the eligible population, while some others had sought to modify the shared funding arrangement with the
federal government to settle for a block grant instead of a cost-sharing agreement originally provided by the ACA. The ACA expanded
Medicaid coverage, but a subsequent Supreme Court decision enabled states to make their own determinations on whether to expand
the program. Twelve states had not expanded their Medicaid programs as of November.

Biden also ordered a review of policies that make it more difficult for consumers to enroll in the Medicaid or ACA, potentially targeting
strict verification criteria that made fewer eligible for coverage.

Agencies will consider whether to take additional actions to strengthen and protect access to health care, as part of the review, the
White House said.

Special enrollment period opened

A special COVID-19 enrollment period from February 15 to May 15 was announced on the federal healthcare exchange, within hours of
Biden's signing the executive order asking the Department of Health and Human Services to do so.

The announcement from the Biden administration prompted states like Colorado, California, and Washington with their own healthcare
exchanges to announce SEPs on Thursday to run alongside the newly announced federal SEP, which would impact about 30 states.

The Centers for Medicare and Medicaid Services said it will set aside $50 million for a public outreach campaign, including a paid
advertising campaign and direct outreach to consumers in English, Spanish, and other languages to spread awareness about the
additional enrollment opportunity.

The Trump administration had resisted calls to open a special enrollment period on the ACA exchange during the COVID-19 pandemic,
citing already existing provisions that allowed people to sign up for coverage in case of a job loss.

Some feared a special opening would risk "adverse selection', or sick people enrolling for coverage, hence opening up insurers to
larger-than-expected losses.

However, several states which had opened SEPs on their own healthcare exchanges at the start of the pandemic in 2020 only saw only
a modest uptick in enrollment and limited rate increases for 2021, indicating insurers did not suffer extraordinary losses as a result of
the additional enrollment opportunity.

America's Health Insurance Plans, a trade group of health insurers, said they supported the executive order and 'stand ready to
implement the guidance that will follow."

Health policy experts have suggested that ACA subsidies will need to be increased in order to encourage more people to sign up for
health plans. Biden has proposed an expansion of ACA subsidies and suggested capping premiums at 8 percent of an individual's
income as part of his $1.9 trillion COVID-19 relief package. That however, would require Congressional action to implement.

More healthcare protections for women in US, abroad

Biden also signed a separate executive order that would make it easier for women in the U.S. and outside to access complete medical
information, including abortion services, reversing the Mexico City policy that restricted federal funds to international organizations that
perform or promote abortions.

The order also requires the HHS to review domestic regulations that prohibit healthcare providers receiving funds from Title X -- a
federal program for low-income women -- from referring patients to abortion providers.

'Women should have access to the healthcare they need. For too many women today, both at home and abroad, that is not possible...
restrictions on the use of Federal funds have made it harder for women to obtain necessary healthcare," the executive order said.
Large Enrollment Gains on ACA Marketplace Ahead of Expected Boost from COVID Relief

(Regulatory Intelligence) - More than 200,000 people have signed up for health coverage on the federal marketplace in the first two
weeks of a special enrollment period. This spike in coverage could increase in the coming weeks as provisions in President Joe Biden's

$1.9 trillion COVID-19 relief package will lower the cost of health plans on the exchange for more consumers. [FINA]
The number of new consumers requesting coverage at the end of the two-week period stood at 386,000, about 12 percent more than

those who sought coverage at the same time during the open enrollment in November 2020, data from the Centers for Medicare and
Medicaid showed.

 
  

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'It's an encouraging sign, but we have further to go," Biden said on Wednesday urging more people to sign up before May 15 when the
enrollment is slated to end.

A special enrollment period, open to all, was considered a necessity when the pandemic had begun to take hold in parts of the U.S.
around March last year, but President Donald Trump had resisted the idea. The CMS said about 76,000 people signed up for coverage
during the same time last year when new enrollments were only open to those who had lost coverage on their job or had a change in
marital status.

When Biden took measures to open a three-month enrollment window through an executive order, some policy experts said it was
unlikely to gain much traction as consumers stranded without coverage may have signed up for it during the annual open enrollment
period at the end of 2020.

The Biden administration's plan to open the special enrollment period, however, came with an additional $50 million in funding
dedicated to outreach and information campaigns about the enrollment opportunity. The move also led many states to open a special
enrollment period to run alongside that of the federal government on their own exchanges.

The increase in enrollment comes at a time when the COVID-19 relief package backed by Biden and passed by the House of
Representatives would make subsidies more widely available for consumers signing up on the exchange. Democrats expect the bill to
be signed into law by March 14.

'Getting more Americans covered is an important part of the equation - but we also need to lower health costs," Biden said in a
statement, referring to the relief package.

The bill proposes to eliminate premiums through tax credits for consumers with income below 150 percent of the poverty line and widen
the group of people eligible for subsidies to lower their premium costs. Health policy experts believe more than 2.5 million people could
become newly eligible for subsidies on the exchange through this provision

The bill also caps the cost of premium at 8.5 percent of an individual's salary, irrespective of income level.

Besides making premiums more affordable, the relief package contains incentives for states to expand their Medicaid program to a
wider pool of recipients. About 4 million people could become newly eligible for coverage if the dozen states that do not currently have
Medicaid expansion programs implement the provision.

Affordable Care Act Gets Its Biggest Boost in a Decade from Biden's COVID Relief

(Regulatory Intelligence) - The $1.9 trillion COVID-19 relief package U.S. President Joe Biden signed into law on Thursday delivers
among its provisions the first major expansion of the Affordable Care Act since its inception in 2010. The new law is designed to
improve affordability, increase enrollment and spur expansion of the Medicaid low-income health program, but may fall short of being

fully embraced by states because of a two-year expiration date and political opposition. [FNS]

Biden rolled part of his healthcare agenda to fix and expand the ACA into the American Rescue Plan Act, making good on promises
to improve coverage affordability through subsidies, tax credits, and measures intended to lure states to increase enrollment in their
federally subsidized Medicaid programs. The plan omits the 'public option' government insurance coverage he had proposed - a tough
goal with the Democratic party's razor-thin majority in the Senate.

Proponents of the law said it would set the stage for a stronger, while critics accused Biden of steamrolling his own party's agenda
through Congress under the guise of pandemic relief with a very large price tag. The bill passed through the Senate on party lines and
Biden signed it a day earlier than expected, saying he wanted to move 'as fast as possible".

Under the new law, the ACA -- which has survived a decade-long attempt at repeal -- will now expand a tax credit for premiums to
middle-income people, closing gaps in coverage. Those who received extra credits in 2020 will not be required to return them. Tax
credits for the purchase of coverage on the federal insurance marketplace will continue through February 2022. Premiums will also be
capped at 8.5 percent of an individual's total income.

The Congressional Budget Office has estimated a 1.7 million spike in sign-ups for the program; as part of an earlier pandemic response
a special enrollment is now open on the federal exchange and some states until May 15.

The new law will also subsidize 100 percent of COBRA coverage, a stop-gap program for those who lose employer-based insurance,
until September 2021. This could result in a gap in affordable coverage after the subsidy ends and before open enrollment in
November. The gap could conceivably be addressed by a special enrollment in September for those who fall off COBRA coverage. The
administration has not yet addressed the possibility.

The law will also increase a federal match for costs in states that have recently adopted a Medicaid expansion program or plan to do so
in the next two years. Oklahoma and Missouri recently adopted the Medicaid expansion program through a ballot initiative but have not
yet implemented it. Twelve other states have so far resisted the ACA provision to expand Medicaid coverage with federal assistance.

About 4.5 million uninsured people in the 12 states could become eligible for the Medicaid expansion program, a study by KFF showed.

The 5 percentage point increase in federal aid for two years is considered unlikely to persuade conservative states like Texas to expand
Medicaid program, but it could potentially make the argument stronger in states such as Kansas and North Carolina where Democratic

 
  

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governors have tried to expand their Medicaid program but been prevented by Republican-controlled legislatures concerned about
rising costs.

Policy experts say the law's extension of postpartum care coverage for twelve months beyond the current 60 days under Medicaid and
the expansion in coverage for the Child Health Insurance Program (CHIP) would strengthen the people's support for state expansion of
healthcare in states that have not already done so.

Conservatives have typically opposed Medicaid expansion citing cost-related concerns.

Under an earlier budget law passed by Congress, the COVID bill would trigger a $36 billion Medicare spending cut for next year to help
pay for the large stimulus. Congress would have to pass a new measure to stall those cuts to Medicare spending and the House of
Representatives is slated to vote on the issue next week.

Policy experts believe that the measure will sail through Congress; citing previous bipartisan support for a similar waiver.
More changes to healthcare regulation is expected as Biden's pick for healthcare secretary, Xavier Becerra, a strong defender of the

ACA, inches closer to confirmation. He has vowed to reverse the changes made by the previous administration and bolster provisions
of the existing health law.

Biden Rescinds Trump-era Health Insurance Requirement for New Immigrants

(Reuters) - U.S. President Joe Biden on Friday revoked a 2019 proclamation by former President Donald Trump that sought to bar the
entry of immigrants who could not prove they had health insurance or could cover healthcare costs. [FN6]

In an announcement by the White House, the Democratic president said the suspension imposed by his Republican predecessor 'does
not advance the interests of the United States.'

Trump issued a proclamation in October 2019 requiring all prospective immigrants to show proof of U.S. health insurance within 30
days of their arrival in the United States or enough money to pay for 'reasonably foreseeable medical costs.'

A federal judge blocked the healthcare requirement before its effective date a month later. But in a December 2020 ruling, the 9th U.S.
Circuit Court of Appeals upheld the Trump proclamation, saying it fell within the president's executive power.

Biden took office weeks later, and advocates said the measure never went into effect. The White House and other U.S. agencies did
not immediately respond to requests for comment.

Biden has vowed to reverse many of Trump's restrictive immigration policies, rolling back a travel ban on 13 mostly Muslim-majority and
African countries and halting construction of the U.S.-Mexico border wall.

Trump's initial announcement of the health insurance requirement sent prospective immigrants scrambling to figure out how to get the
necessary coverage and navigate U.S. bureaucracy.

Immigrant advocates said the proclamation would have barred entry to as many as two-thirds of legal immigrants had it been allowed to
take effect.

Biden's proclamation came as part of a package of actions late on Friday reversing some largely symbolic policy statements by Trump.
Those included the former president's executive orders deriding online censorship, street protests attacking monuments and excessive
government regulation.

Another order reversed by Biden proposed building a sculpture garden of American 'heroes.'
Price Transparency Rules May Stay as Deadline Looms for U.S. Health Insurers

(Regulatory Intelligence) - U.S. health insurance price transparency rules adopted last year are unlikely to be rescinded by U.S.
President Joe Biden's administration, and insurers may need to re-think their consumer and pricing strategy as they prepare to comply,

industry experts said. FN7]

The rule -- jointly issued by the Department of Health and Human Services, the Department of Labor, and the Department of the
Treasury -- requires health insurers to provide cost-sharing information to patients before they use a service, 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 was issued last
October 29 and firms must comply by January 1, 2022.

Health insurers have opposed the rule as it requires them to publicly disclose negotiated rates with providers within and out of their
network. They have cited large costs of compliance and concerns over the management of sensitive and proprietary data. They also
say it would not provide any meaningful benefit to consumers.

Many insurers already have pricing tools that provide consumers with cost estimates. The new rule requires them to go a step further
and publicly post and update machine-readable files with detailed pricing information for all health services.

Some in the industry had expected the Biden administration to ease the rules or at least delay the compliance deadline. Regulatory
experts, however have warned that the new administration was unlikely to rescind or delay them and said insurers should continue to
expect more scrutiny on pricing.

 
  

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Generally, issues around value-based care or price transparency attract bipartisan support, said Anne Phelps, Health Care Regulatory
Leader at consultancy Deloitte. Health and Human Services Secretary Xavier Becerra has also supportive comments about
transparency, she added.

Experts suggest insurers should rethink their conversations with healthcare providers and find ways to show value to consumers
alongside raw pricing.

'Just being compliant is table stakes, it is bare-bones, and a lot of plans and providers and disruptors are starting to think beyond that,"
Phelps said.

Plans and providers need to figure out ways to generate revenue while providing services that consumers value enough to want to
'stick" to the same health plan or provider, she said. 'If the relationship between payer and provider is just transactional, you're missing
an opportunity," Phelps added. Insurers may also need to strategize how they communicate the pricing of services to consumers.
Research has shown that consumers prefer quality over price, so payers and providers could provide more information about quality
outcomes besides pricing, Christi Skalka, Managing Director at Deloitte said at a conference this month of the insurer's trade group
America's Health Insurance Plans. Patients currently rely on consumer-review websites such as Yelp for information on the quality of a
provider, and plans and providers could fill in an information gap, she added. Insurers will also need to rethink how they collect, manage
and store data and how they can address privacy concerns associated with sharing data with third-party technology companies that are
not subject to the same scrutiny as healthcare-related entities.

The cost of compliance also remains an unaddressed issue. The Blue Cross Blue Shield Association, a group of health insurers,
said the total cost of setting up a tool and remaining compliant with the rule could cost a single insurer nearly $14 million. The federal
Centers for Medicare and Medicaid Services estimates insurers that would need $5.3 million to set up a tool from scratch.

Insurers could also look to hospitals, facing similar price transparency rules, for insights on dealing with the new rule. Hospitals have,
however, come under fire after a media report showed they were publishing prices as required by the rule, but using technology to
block the data from web search results.

U.S. Regulations Now Require Increased Electronic Health Information Sharing

(Regulatory Intelligence) - Healthcare providers and others involved with health information technology in the United States must now
comply with federal regulations intended to provide patients and their providers with easier access to electronic health information.

These rules are part of the interoperability requirements outlined in the 21st Century Cures Act, and prohibit 'information blocking." [FN8]

'Information blocking' is interfering with patient or healthcare provider access, exchange or use of electronic health information,

or 'EHI.'The new requirements were enacted under Section 4004 of the 21st Century Cures Act and implemented in a final rule
released more than a year ago. Compliance with the rules was delayed until April 5, 2021 to allow more flexibility during the COVID-19
pandemic.

Healthcare providers, health IT developers of certified health IT, health information networks and health information exchanges must
comply with the information blocking rules. During the next 18 months, the information blocking rules apply to a smaller subset of
electronic health information as set out in the United States Core Data for Interoperability Version 1. This subset still includes most
common patient treatment and demographic information. Information not included in the first subset, such as diagnostic imaging and
some provider specific information, will be added in later versions.

However, the Office of the National Coordinator for Health Information Technology, which oversees implementation of the rules,
strongly encourages the 'regulated community to make all EHI available as if the scope of EHI were not currently limited.'

The Cures Act identifies practices that could be considered information blocking, including:

Practices that restrict authorized access, exchange or use under applicable law of information for treatment or other permitted
purposes.

Implementing health IT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging
or using electronic health information.

Implementing health IT in ways that would restrict sharing complete information sets between health IT systems.

Practices that could lead to fraud, waste or abuse or impede innovations and advancements in health information access, exchange
and use, including care delivery by health IT.

There are eight exceptions for reasonable and necessary activities that will not constitute information blocking when certain conditions
are met. These include situations such as when providing the information would cause harm or violate privacy. The exceptions also
allow some procedural limitations on fulfilling requests.

Although the Office of the National Coordinator will provide educational materials to stakeholder about the information blocking
regulations, it will also partner with the Department of Health and Human Services Office of Inspector General to investigate alleged
violations of the information blocking regulations. A final rule regarding the imposition of civil monetary penalties for violations is still
pending.

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CMS Reduces Maximum Out-of-Pocket Expenses

The Centers for Medicare & Medicaid Services (CMS) announced new provision to lower maximum out-of-pocket costs owed by
consumers by $400 for consumers who purchase health insurance through the Federal Health Insurance Marketplaces for plan year
2022.

According to CMS, 'These actions demonstrate a strong commitment by the Biden-Harris Administration to protect and build on the
Affordable Care Act (ACA), reduce health care costs, and make our health care system easier to navigate and more equitable."

The second 2022 Notice of Benefit and Payment Parameters final rule (the '2022 payment notice") also includes provisions to assist
consumers in choosing plan options and increase opportunities for consumers to qualify for future special enrollment periods (SEPs).

'Families deserve to have access to health care coverage that doesn't break the bank. That's why today we're acting to lower

consumers' maximum out-of-pocket costs by $400 and why President Biden has a plan to reduce families' health care costs for the long
run," said U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra. 'Health care access is personal to me as it
is for families across the country. The Department of Health and Human Services is committed to building on the ACA to make sure our

health care system is more accessible for every American." FN®!
CMS Publishes Guidance and FAQs on its Interoperability Final Rule

CMS released its final rule on interoperability and patient access on May 1, 2020, which is published at 85 F.R. 25510-0141 (May 1,
2020). The rule applies to multiple organizations and entities, including Medicare Advantage plans, Medicaid managed care plans, state
Medicaid agencies, CHIP agencies and managed care plans, and qualified health plans offered on the Marketplace. In an email update,

[FN10] CMS explained,

The Interoperability and Patient Access final rule (CMS-9115-F), published May 1, 2020, included revisions to the hospital Conditions
of Participation (CoPs) at 42 CFR 482.24(d) (and at 42 CFR 482.61(f) for psychiatric hospitals and at 42 CFR 485.638(d) for critical
access hospitals (CAHs). These revisions require hospitals, including psychiatric hospitals, and CAHSs that utilize an electronic

medical records system or other electronic administrative system, which is conformant with the content exchange standard at 45 CFR
170.205(d)(2), to send electronic patient event notifications of a patient's admission, discharge, and/or transfer to applicable post-acute
care services providers and suppliers or any practitioner(s) a patient considers primarily responsible for his or her care.

Today, The Centers for Clinical Standards and Quality released guidance for providers and state surveyors outlining the new
requirements for admission, discharge, and transfer electronic patient event notifications for surveyors assessing compliance with the
revised CoPs, /FN11

The guidance is in the form of a memo IFN12] and an FAQ sheet. FN"!
CMS to Raise Ceiling on Hospital Price Transparency Fine to $2 million

(Regulatory Intelligence) - The U.S. Centers for Medicare and Medicaid Services has proposed raising the penalty on hospitals that
fail to comply with newly introduced price transparency rules to a maximum of about $2 million from $109,500, and also plans to clamp

down on hospitals that have placed technological barriers to block access to the files published online. [FN14]

The new rule that went into effect on January 1 requires hospitals to publish prices of their services in a machine-readable format on
their website. The rule, part of a set of measures also applicable to health insurers from 2022, aimed to bring more transparency to
healthcare costs and was introduced by the administration of former President Donald Trump.

The penalty for non-compliance had however been capped at $300 per day, which critics said was surprisingly low and could weaken
enforcement. It would also encourage hospitals to delay compliance with the rule, even if they did not want to breach federal regulation
in the long term, critics said.

CMS has now proposed to set a minimum fine of $300 per day, with a maximum of $5,500 a day, with the amount varying on the size of
the hospital facility.

CMS' proposal to raise the penalty comes after President Joe Biden said in an executive order last week that he planned to enforce the
previous administration's price transparency rules.

Analyses by patient advocates and media found that hospitals that complied with the rule often buried the prices on their websites and
even used code to prevent the file from appearing in web searches and in third party software applications attempting to read the file.

'No medical entity should be able to throttle competition at the expense of patients - With today's proposed rule, we are simply
showing hospitals through stiffer penalties: concealing the costs of services and procedures will not be tolerated by this administration,"
Secretary of the U.S. Department of Health and Human Services, Xavier Becerra, said.

CMS has also proposed to update the list of activities that present barriers to access to the machine-readable file, specifically to require
that the published file is accessible to automated searches and direct downloads. The proposed rule is subject to a 60-day comment
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Hospitals lost a legal attempt in 2020 to delay the implementation of the transparency rules, which they criticized as being vague. They
said the effort would ultimately reduce affordability as hospitals offering services at lower rates would raise their prices to match higher-
priced peers.

The American Hospital Association on Monday said it will closely review the agency's proposed regulations related to price
transparency but said it was 'deeply concerned about the proposed increase in penalties for non-compliance, particularly in light of
substantial uncertainty in the interpretation of the rules."

Biden's Executive Order Moves to Improve Competition in U.S. Healthcare

(Regulatory Intelligence) - U.S. President Joe Biden issued an executive order to improve competition in the American economy on
July 9. In part, the order address concerns around hospital mergers, the use of non-compete agreements and the price of prescription

drugs. FN15

'Hospital consolidation has left many areas, particularly rural communities, with inadequate or more expensive healthcare options,'
according to the order. In response, the order calls on the Federal Trade Commission (FTC) and Department of Justice (DOJ) to
examine hospital mergers to ensure the mergers to not compromise patient choice and patient care.

The hospital industry is critical of the order.

'[Tloday's today's executive order falls short in several ways. For example, it does not recognize the exceptional value and essential
services health systems provide to their patients and communities each day,' said Rick Pollack, president and CEO of the American
Hospital Association in a press release about the order.

'Additionally, it is important to stress that hospital mergers and acquisitions undergo an enormous amount of rigorous scrutiny from the
federal antitrust agencies and state attorneys general,' Pollack said.

The executive order also calls on the FTC to 'curtail the unfair use of non-compete clauses and other clauses or agreements that may
unfairly limit worker mobility.' In healthcare, it is common for physicians to sign non-compete agreements to prevent them from leaving
a hospital or practice group and taking their patients with them. However, most states limit the scope of non-competes to a certain
length of time and/or a limited geographic area.

Last year, James L. Madara, MD, executive vice president and CEO of the American Medical Association, submitted comments to
an FTC workshop on non-competes in the workplace that identified several instances where non-competes might be necessary for
physicians.

'Physician employers, like hospitals and group practices, use non-competes to prohibit a physician from leaving and then establishing
a competing practice, or joining a competing practice or hospital, in the former employer's vicinity and benefitting from proprietary
information, training, patient contacts, and other resources provided by the former employer,' wrote Madara.

'Non-competes may give the employer the peace of mind necessary to invest significant resources in the employed physician's
success, without the employer having to worry that the physician will later leave the employer after the physician has developed a
significant patient base, taking those patients with him or her,' Madara continued.

The executive order also addresses ongoing concerns about the high costs of prescription drugs, '[T]oo often, patent and other laws
have been misused to inhibit or delay - for years and even decades - competition from generic drugs and biosimilars, denying
Americans access to lower-cost drugs.'

According to the order, the Biden administration will support aggressive legislative reforms to lower prescription drug prices, including
'allowing Medicare to negotiate drug prices, by imposing inflation caps' and other measures.

The order also calls on the Department of Health and Human Services (HHS) to submit a plan within 45 days to 'combat excessive
pricing of prescription drugs and enhance domestic pharmaceutical supply chains,' to reduce the pricing the federal government pays
for drugs and to address the problem of 'price gouging.'

The order also calls on the Commissioner of Food and Drugs to work with states and Indian tribes to develop the section 804
importation programs introduced during the Trump administration to all the importation of certain generic drugs for Canada.

CMS to Issue New Regulation Requiring Nursing Homes to Require All Staff to be Vaccinated Against COVID-19

CMS, in collaboration with the CDC, announced on August 18 that it is developing an emergency regulation requiring staff vaccinations
within the nation's more than 15,000 Medicare and Medicaid-participating nursing homes.

This new requirement is a key component of protecting the health and safety of nursing home residents and staff by ensuring that all
nursing home staff receive COVID-19 vaccinations. Over the past several months, millions of vaccinations have been administered to
nursing home residents and staff, and these vaccines have shown to help prevent COVID-19 and have proven to be effective against
the Delta variant.

'Keeping nursing home residents and staff safe is our priority. The data are clear that higher levels of staff vaccination are linked
to fewer outbreaks among residents, many of whom are at an increased risk of infection, hospitalization, or death," said CMS
Administrator Chiquita Brooks-LaSure. 'We will continue to work closely with our partners at the CDC, long-term care associations,

 
  

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unions, and other stakeholders to advance policies that keep residents and staff safe. As we advance these new requirements, we'll
work with nursing homes to address staff and resident concerns with compassion and by following the science."

The action is in keeping with CMS's authority to establish requirements to ensure the health and safety of individuals receiving care
from all providers and suppliers participating in the Medicare and Medicaid programs. About 62% of nursing home staff are currently
vaccinated as of August 8 nationally, and vaccination among staff at the state level ranges from a high of 88% to a low of 44%. The
emergence of the Delta variant in the United States has driven a rise in cases among nursing home residents from a low of 319 cases
on June 27, to 2,696 cases on August 8, with many of the recent outbreaks occurring in facilities located in areas of the United States
with the lowest staff vaccination rates.

In May, the agency issued new regulations that require Long-Term Care (LTC) facilities and Intermediate Care Facilities for Individuals
with Intellectual Disabilities (ICFs/IID) to educate residents, clients, and staff about COVID-19 vaccination and, when available, offer a
COVID-19 vaccine to these individuals. These regulations also mandate that LTC facilities report weekly COVID-19 vaccination data for
residents and staff to the CDC's National Healthcare Safety Network (NHSN).

CMS will continue to analyze vaccination data for residents and staff from the CDC's National Healthcare Safety Network (NHSN) data
as an additional method of compliance monitoring and in keeping with current practice, as well as deploy the Quality Improvement
Organizations (QlIOs)}-operated under the Medicare Quality Improvement Program-to educate and engage nursing homes with low
rates of vaccinations.

CMS strongly encourages nursing home residents and staff members to get vaccinated as the Agency undergoes the necessary steps
in the rule-making process over the course of the next several weeks. CMS expects nursing home operators to act in the best interest
of residents and their staff by complying with these new rules, which the Agency expects to issue in September. CMS also expects
nursing home operators to use all available resources to support employees in getting vaccinated, including employee education and
vaccination clinics, as they work to meet this staff vaccination requirement.

U.S. Government to Tackle Medicare Drug Payments to Try to Cut Costs

(Reuters) - President Joe Biden's administration on Thursday unveiled its promised initiative aimed at cutting drug prices, saying it
will test new ways to reduce such costs for the Medicare health insurance program including tying payments for medications to their

effectiveness. 'FN"6l
The U.S. Department of Health and Human Services (HHS), which oversees the federal medical insurance program for people age 65

and older and the disabled, announced the initiative, which will use models to gauge the clinical value of medicines to determine how
much Medicare pays for them.

The department also said it will test so-called bundled payment models for Medicare and gather data from insurers to improve
transparency.

The Biden administration is separately backing legislation in Congress that would seek to stem rising drug prices.

While the administration has lauded drugmakers for their efforts amid the COVID-19 pandemic, it also has highlighted the high costs
of medications in the United States compared to other nations. Pharmaceutical manufacturers have raised prices on more than 500
medicines, according to an analysis by healthcare research firm 46brooklyn in January.

Pharmaceutical manufacturers have opposed efforts to regulate drug prices, calling them 'misguided' and saying this would stifle
innovation.

'While large companies like Merck will survive, the hundreds of thousands of small biotechs that rely on venture capital ... will just
disappear," Kenneth Frazier, executive chairman of Merck & Co and its former chief executive, said during an industry panel on
Wednesday.

The pharmaceutical industry supports reforming federal drug payments to reduce patient costs, but the current proposal will damage
the industry more than it will help taxpayers, two other executives said on the panel.

Other drug pricing experts said the industry may be overstating the risk to drug development.

'The current model where we pay high prices without respect to value is also problematic for innovation," said Aaron Kesselheim, a
professor of medicine at Harvard Medical School.

'| think that (the proposed reforms) would actually provide incentives for the innovations that patients actually want."

HHS Secretary Xavier Becerra defended the administration's plan. He said letting Medicare negotiate for drug prices under Part B -
which, among other things, covers medications used in hospitals and other healthcare settings - would 'make those prices available to
other purchasers.' That could help patients pay less and reduce costs not only for the federal government but also other commercial
payers, he said.

The department also said it will test ways to reduce costs under Part D, which covers over-the-counter drugs, through biosimilars and
generic drugs.

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'By promoting negotiation, competition, and innovation in the healthcare industry, we will ensure cost fairness and protect access to
care,' Becerra said.

The White House's legislative agenda for reforming federal drug payments is likely to run into the same challenges that stymied similar
efforts in the past, said Michael Tanner, a senior fellow at the Cato Institute, a conservative think tank.

The U.S. House of Representatives and the Senate both proposed reforms under the Trump administration but none succeeded in
passing into law.

'The main reason that nothing can be done is that Medicare' cannot refuse coverage for a drug it deems too expensive, Tanner said.
'Until you are willing to tell seniors 'you can't have every drug you want,' you are not going to save money."
U.S. Agencies Release Second Surprise-billing Health Care Rule

(Regulatory Intelligence) - The U.S. Biden administration has issued a second interim final rule aimed at protecting consumers from
surprise medical bills under the No Surprises Act. [FN17]

The rule establishes new protections from surprise billing and excessive cost sharing for consumers receiving healthcare services.
These protections include provisions 'related to the independent dispute resolution process, good faith estimates for uninsured
individuals, the patient-provider dispute resolution process, and expanded rights to external review.'

The rule was issued last week by the federal departments of Health and Human Services (HHS), Labor and Treasury and the Office of
Personnel Management. It provides for a 60-day comment period.

'No one should have to go bankrupt over a surprise medical bill," HHS Secretary Xavier Becerra said in an announcement. 'With today's
rule, we continue to deliver on President Biden's Competition Executive Order by promoting price transparency and exposing inflated
health care costs. Our goal is simple: giving Americans a better deal from a more competitive health care system."

The dispute resolution process is intended to take consumers out of the middle of payment disagreements between providers and
health plans. It establishes an independent process applying to 'out-of-network providers, facilities, providers of air ambulance services,
plans and issuers in the group and individual markets.' They can use the process to determine the out-of-network rate for items or
services after 'an unsuccessful open negotiation.'The process applies 'only to those services for which balance billing was prohibited'
under the previously-issued ' Requirements Related to Surprised Billing; Part I' rule.

Health insurers have sought more clarity on the scope of that initial rule to implement legislation passed with bipartisan support late last
year. They have also requested until at least 2023 to comply with the regulations, which are slated to go into effect at the start of 2022.

'The administration's approach signals a strong commitment to consumer affordability and lower health care spending through an
independent dispute resolution process that should encourage more providers to join health plan networks,' said a spokesperson for
the industry group Association of Health Insurance Plans. 'We are particularly encouraged to see the rules conform to the intent of the
No Surprises Act and direct that arbitration awards must begin with a presumption that the appropriate out-of-network reimbursement is
the qualified payment amount. This is the right approach to encourage hospitals, health care providers, and health insurance providers
to work together and negotiate in good faith. It will also ensure that arbitration does not result in unnecessary premium increases for
businesses and hardworking American families.'

The qualified payment amount is usually the plan or issuer's 'median contracted rate for the same or similar service in the specific
geographic area." If the parties cannot agree to a payment amount during the 30-day open negotiation period, they can initiate

the federal independent dispute resolution process. Under the dispute resolution process, the parties may jointly select a certified
independent dispute resolution entity to resolve the dispute. The parties are to submit their 'offers for payment along with supporting
documentation.'The entity will then issue a binding determination 'selecting one of the parties' offers as the [out-of-network] payment
amount.' Both parties must pay an administrative fee and the non-prevailing party is responsible for a dispute-resolution fee.

Impact of Surprise Medical Bills on Consumers

The agencies cited research showing that surprise medical bills can be expensive for the patient, their employer and the healthcare
system. One study found that payments made by people who got a surprise bill for emergency care 'were more than ten times higher
than those made by other individuals for the same care.' Additionally, out-of-network cost-sharing and surprise bills usually 'do not
count toward a person's deductible and maximum out-of-pocket limit.' These means people end up paying more out-of-pocket even
when they have met their in-network deductible or out-of-pocket limits.

Although some states have enacted laws to 'reduce or eliminate balance billing,' the agencies say 'these efforts do not provide
comprehensive consumer protections.'

Additional Protections for Consumers

In order to provide consumers with advance information about healthcare costs, the rule requires a provider or facility 'to give an
uninsured (or self-pay) individual a good faith estimate of expected charges after an item or service is scheduled, or upon request.' The
estimate will include 'expected charges' for the primary item or service, as well as any other items or services that would 'reasonably be
expected' to be included as part of the scheduled or requested items or services.

 
  

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The rule's estimate requirements include:

A timeline for when the provider or facility must provide the estimate.

Itemized 'specific details and the expected charge' grouped by provider or facility.

Use of clear and understandable language. Estimates can be provided in paper or electronic form.

The rule also provides a new dispute resolution process for when an uninsured individual receives a bill that is 'substantially greater
than the expected charges' in the good faith estimate.

An uninsured individual has 120 calendar days to begin the dispute resolution process when the actual bill is at least $400 more than
the good-faith estimate. Individuals can request that a third-party dispute resolution organization review the estimate, the bill and
information submitted from the individual and provider or facility to determine if the additional charges are allowed or if the provider can
charge only what was on the estimate.

Although HHS will charge consumers a $25 administrative fee to initiate the process, it will be credited back to the consumer if the
dispute resolves in the consumer's favor.

For insured consumers, the rule also expands the scope of the external review processfor individuals with group or individual health
coverage. This process is used to appeal a payment for a 'health care item/service that was denied by their health plan due to an item/
service not being covered, restrictions on coverage, or the item/service not being considered medically necessary by the health plan.'

The rule specifically says that coverage decisions that involve whether a health plan is complying with the surprise billing and cost-
sharing protections under the No Surprises Act are eligible for external review.

The rule will apply to group health plans and health insurance issuers for plan and policy years beginning on or after January 1, 2022.
It is available for inspection on the Federal Register Public Inspection site and will publish in the Federal Register on October 7, 2021.
Comments on the rule must be received by 60 days after publication in the Federal Register.

CMS Approves Coverage of LGBTQ+ Care as an Essential Health Benefit in Colorado

For the first time, the Centers for Medicare & Medicaid Services (CMS) approved a request to provide gender-affirming care in
the individual and small group health insurance markets as part of Colorado's Essential Health Benefit (EHB) benchmark. Today's
landmark step is aligned with the Biden-Harris Administration's efforts to address health care disparities by removing longstanding
barriers and expanding access to care for transgender persons.

Colorado's new EHB-benchmark plan will enhance access to coverage for gender-affirming care that meets individual needs and
discourages the use of a 'one-size-fits-all' framework for transgender persons seeking medical care. Changes to the EHB-benchmark
plan will allow access to a wider range of services for transgender individuals in addition to benefits already covered. Such treatments
will include eye and lid modifications, face tightening, facial bone remodeling for facial ferninization, breast/chest construction and
reductions, and laser hair removal. The state is also adding EHBs in the benchmark plan to include mental wellness exams and
expanded coverage for 14 prescription drug classes. These changes will take effect beginning on January 1, 2023.

'Health care should be in reach for everyone; by guaranteeing transgender individuals can access recommended care, we're one step
closer to making this a reality," said HHS Secretary Xavier Becerra. 'Il am proud to stand with Colorado to remove barriers that have
historically made it difficult for transgender people to access health coverage and medical care.'

'Health care should be accessible, affordable and delivered equitably to all, regardless of your sexual orientation. To truly break down
barriers to care, we must expand access to the full scope of health care, including gender-affirming surgery and other treatments, for
people who rely on coverage through Medicare, Medicaid & CHIP and the Marketplaces,' said CMS Administrator Chiquita Brooks-
LaSure. 'Colorado's expansion of their essential health benefits to include gender-affirming surgery and other treatments is a model for
other states to follow and we invite other states to follow suit.'

Gender-affirming care is considered a standard level of care by the American Medical Association, the American Academy of Family
Physicians, and the American Psychiatric Association. Transgender patients often face discriminatory hurdles in accessing medically
necessary health care services that affirm gender identity.

The Affordable Care Act (ACA) requires non-grandfathered health plans in the individual and small group markets to provide coverage
in 10 categories of EHBs, including preventive and wellness services, chronic disease management, maternity and newborn care,
hospitalization, prescription drugs, mental health and substance use disorder services, behavioral health treatment, and lab services.
CMS regulations allow states the flexibility to develop state-specific 'benchmark' plans that detail the specific services covered among
these broad categories based on a typical employer plan offered in the state.

CMS recognizes that expanded, gender-affiming coverage vastly improves health care outcomes for the LGBTQ+ community, reduces
high rates of depression, anxiety, and suicide attempts as well as decreases substance use, improves HIV medication adherence, and
reduces rates of harmful self-prescribed hormone use.

U.S. Health Agency Releases Climate Adaptation and Resilience Plan

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(Regulatory Intelligence) - The U.S. Department of Health and Human Services (HHS) released its Climate Adaptation and Resilience
Plan this month. The plan will bolster resilience of department operations and assets from the 'accelerating impacts of climate change.'
With its plan, HHS joins 20 other federal agencies that have released plans in support of Executive Order 14008 on Tackling the

Climate Crisis at Home and Abroad, which President Biden signed on January 27, 2021. [FN18]

'On top of facing the historic health threat of the pandemic, now more than ever, vulnerable communities face the brunt of climate
change at the expense of their health," said HHS Secretary Xavier Becerra in a release. 'The investments we make today to protect
Americans' health from climate change will pay dividends for generations, in terms of reducing illness and health costs."

The department identifies 'record-breaking heat waves, hurricanes, floods, wildfires, droughts, and increasingly severe storms'
as consequences of climate change that 'affect people's health in different ways, from direct exposure to heat and floodwaters, to
increased risk of certain infections as the life cycles of ticks and mosquitoes change.' The department also states that severe and
repeated weather-related disasters 'contribute to anxiety, depression, and other mental health impacts.'

The plan provides a road map for assuring that all parts of the Department 'address the threats to health and well-being related to
climate change for all people in the United States, especially those most vulnerable.' It also provides for continuity of HHS operations
during extreme weather events, fosters healthy greenhouse gas reduction as well as resilience efforts in the public health sector and
community.

HHS identified 5 priority actions that it will implement throughout the department, including:
Expand existing climate change-related public health and biomedical research activities.
Improve HHS responses to the climate crisis.

Develop climate-resilient grant policies at HHS.

Workplace optimization and effective space management for climate resilience.

Promote sustainable and climate resilient operations at HHS facilities.

The list of 5 adaptation action is the 'first step in HHS's climate resilience efforts.' The department will identify and initiate additional
actions as the plan is implemented.

CMS Improves Home Health Services for Older Adults and People with Disabilities

CMS issued a final rule on November 2 that furthers CMS' strategic commitment to drive innovation that promotes comprehensive,
person-centered care for older adults and people with disabilities by accelerating the shift from paying for home health services based
on volume, to a system that incentivizes value and quality. The final rule will also strengthen CMS' data collection efforts to identify and
address health disparities and use of care among people who are dually eligible for Medicare and Medicaid, people with disabilities,
people who identify as LGBTQ+, religious minorities, people who live in rural areas, and people otherwise adversely affected by
persistent poverty or inequality.

The Calendar Year 2022 Home Health Prospective Payment System (PPS) Final Rule addresses challenges facing Medicare
beneficiaries who receive health care at home. The final rulefinalizes nationwide expansion of the successful Home Health Value-
Based Purchasing (HHVBP) Model to incentivize quality of care improvements.

'CMS is committed to helping people get the care they need, where they need it," said CMS Administrator Chiquita Brooks-LaSure.
'This final rule will improve the delivery of home health services for people with Medicare. It will also improve our data collection efforts,
helping us to identify health disparities and advance health equity."

The CMS Innovation Center (Innovation Center) launched the original HHVBP Model on January 1, 2016, to determine whether CMS
could improve the quality and delivery of home health care services to people with Medicare by offering financial incentives to providers
that offer better quality of care with greater efficiency. The original HHVBP Model comprised all Medicare-certified home health
agencies (HHAs) providing services across nine randomly selected states. The Third Annual Evaluation Report of the participants'
performance from 2016-2018 showed an average 4.6 percent improvement in HHAs' quality scores and an average annual savings of
$141 million toMedicare.

The final policies promulgated in this rule expand the HHVBP Model nationally, with the first performance year beginning January 1,
2023. The HHVBP Model is one of four Innovation Center models that have met the requirements to be expanded in duration and
scope since 2010. Starting in 2025, CMS will adjust fee-for-service payments to Medicare-certified HHAs based on the quality of care
provided to beneficiaries during the CY 2023 performance year. Throughout 2022, CMS will provide technical assistance to HHAs to
ensure they understand how performance will be assessed. Overall, these policies support the Agency's commitment to advancing
value-based care by providing incentives for HHAs to improve the beneficiary experience and quality of care.

Additionally, the final rule will advance CMS' coordination of care efforts through improvements to the Home Health Quality Reporting
Program, Long-Term Care Hospital Quality Reporting Program, and Inpatient Rehabilitation Facility Quality Reporting Program and
finalizes the mandatory COVID-19 reporting requirements for Long Term Care facilities (nursing homes) established as a part of the
May 2020 and May 2021 Interim Final Rules beyond the current COVID-19 public health emergency (PHE)until December 31, 2024.

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The ruleremoves or replaces several quality measures to reduce burden and increase focus on patient outcomes. CMS is also finalizing
its proposals to begin collecting data on two measures promoting coordination of care in the Home Health Quality Reporting Program
effective January 1, 2023 as well as measures under Long-Term Care Hospital Quality Reporting Program and Inpatient Rehabilitation
Quality Reporting Program effective October 1, 2022. The effective dates position the agency to support the recent Executive Order
13985 of January 20, 2021, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.

Finally, this rule implements provisions of the Consolidated Appropriations Act, 2021 that establish survey and enforcement
requirements for hospice programs serving Medicare beneficiaries. These provisions will require the use of multidisciplinary survey
teams, prohibition of surveyor conflicts of interest, and expansion ofsurveyor training to include accrediting organizations (AOs). The
provisions also establish a hospice program complaint hotline and create the authority for CMS to impose enforcement remedies
for noncompliant hospice programs. These changes will strengthen oversight, enhance enforcement, and establish consistent and
transparent survey requirements in hospice care.

Biden Administration Issue Emergency Regulation Requiring COVID-19 Vaccination for Healthcare Workers

The Biden Administration is requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and
Medicaid programs. The emergency regulation issued by the Centers for Medicare & Medicaid Services (CMS) on November 4 protects
those fighting this virus on the front lines while also delivering assurances to individuals and their families that they will be protected
when seeking care.

'Ensuring patient safety and protection from COVID-19 has been the focus of our efforts in combatting the pandemic and the constantly
evolving challenges we're seeing," said CMS Administrator Chiquita Brooks-LaSure. 'Today's action addresses the risk of unvaccinated
health care staff to patient safety and provides stability and uniformity across the nation's health care system to strengthen the health of
people and the providers who care for them."

The prevalence of COVID-19, in particular the Delta variant, within health care settings increases the risk of unvaccinated staff
contracting the virus and transmitting the virus to patients. When health care staff cannot work because of illness or exposure to
COVID-19, the strain on the health care system becomes more severe and further limits patient access to safe and essential care.
These requirements will apply to approximately 76,000 providers and cover over 17 million health care workers across the country. The
regulation will create a consistent standard within Medicare and Medicaid while giving patients assurance of the vaccination status of
those delivering care.

Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose of a two-dose
COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021.

All eligible staff must have received the necessary shots to be fully vaccinated ? either two doses of Pfizer or Moderna or one dose

of Johnson & Johnson ? by January 4, 2022. The regulation also provides for exemptions based on recognized medical conditions or
religious beliefs, observances, or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with
federal law.

CMS accelerated outreach and assistance efforts encouraging individuals working in health care to get vaccinated following

the Administration's announcement that it would expand the requirement for staff vaccination beyond nursing homes to include
additional providers and suppliers. Since the Administration's announcement, nursing home staff vaccination rates have increased by
approximately nine percentage points ? from 62 to 71 percent. This increase is encouraging, and this regulation will help to ensure even
greater improvement in the vaccination rate among health care workers.

CMS will ensure compliance with these requirements through established survey and enforcement processes. If a provider or supplier
does not meet the requirements, it will be cited by a surveyor as being non-compliant and have an opportunity to return to compliance
before additional actions occur. CMS's goal is to bring health care providers into compliance. However, the Agency will not hesitate to
use its full enforcement authority to protect the health and safety of patients.

The requirements apply to: Ambulatory Surgical Centers, Hospices, Programs of All-Inclusive Care for the Elderly, Hospitals, Long
Term Care facilities, Psychiatric Residential Treatment Facilities, Intermediate Care Facilities for Individuals with Intellectual Disabilities,
Home Health Agencies, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, Clinics (rehabilitation agencies,
and public health agencies as providers of outpatient physical therapy and speech-language pathology services), Community Mental
Health Centers, Home Infusion Therapy suppliers, Rural Health Clinics/Federally Qualified Health Centers, and End-Stage Renal
Disease Facilities.

CMS is taking necessary action to establish critical safeguards for the health of all people, their families, and the providers who care
for them. CMS knows that everyone working in health care wants to do what is best to keep their patients safe. Yet, unvaccinated
staff pose both a direct and indirect threat to the very patients that they serve. Vaccines are a crucial scientific tool in preserving and
restoring efficient operations across the nation's health care system while protecting individuals. This new requirement presents an
opportunity to continue driving down COVID-19 infections, stabilize the nation's health care system, and ensure safety for anyone
seeking care.

Il. CHALLENGES TO RULEMAKING

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Federal Judge Blocks Trump Administration Drug Pricing Rule
(Reuters) - A federal judge on Wednesday blocked a last-minute Trump administration rule aimed at lowering drug prices as of next
week, /FN19]

The rule, scheduled to take effect on Jan. 1, would have tied reimbursements for 50 drugs by Medicare, a U.S. government
insurance program, to the lowest prices paid by certain other countries. U.S. District Judge Catherine Blake in Maryland ruled that the
administration had rushed the rule without giving the public a chance to comment, in violation of federal law.

The decision is a victory for PhRMA, the nation's leading pharmaceutical industry trade group, which had filed a lawsuit challenging the
so-called 'most favored nation" rule, arguing it would result in Medicare patients losing access to vital care. The group said Wednesday
that it welcomed Blake's decision.

The Department of Health and Human Services, the federal agency that passed the rule, did not immediately respond to a request for
comment.

The administration has said that the rule, which was unveiled in November, could save taxpayers and patients $85 billion over seven
years.

Blake's order is temporary, and could be lifted later if the administration ultimately prevails in the lawsuit.
Biotechnology Innovation Organization (BIO), a trade group, is also challenging the rule in a separate lawsuit in California.

Efforts by the administration to keep down drug prices, such as a proposed rule to force drugmakers to reveal list prices in
advertisements, have been undermined by successful industry lawsuits in the past.

Since he lost the election, U.S. President Donald Trump has been issuing and finalizing a host of rule changes in areas ranging from
energy to healthcare to immigration in a bid to bolster key areas of his agenda prior to leaving the White House in January.

U.S. Appeals Court Upholds Trump Health Care Price Disclosure Rule
(Reuters) - A federal appeals court on Tuesday upheld a White House-backed rule to require hospitals to disclose the prices they
negotiate with insurers for an array of common tests and procedures. [FN20]

The 2-0 decision by the U.S. Court of Appeals for the District of Columbia Circuit is a victory for President Donald Trump's effort to
make health care pricing more transparent so patients can be better informed when deciding on treatment.

The American Hospital Association and other hospital groups had challenged the rule, which was issued in November 2019 and is
scheduled to take effect on Jan. 1, 2021.

They said it would require them to divert scarce resources, including to fight COVID-19, to the 'herculean" and costly task of compiling
health care costs, while reducing competition and causing confusion about patients' out-of-pocket expenses.

Circuit Judge David Tatel, however, said concerns about the burdens 'miss the mark," and pointed to Health and Human Services
Secretary Alex Azar's findings that greater disclosures would benefit the 'vast majority" of consumers and likely result in lower - not
higher - prices.

'The Secretary weighed the rule's costs and benefits and made a reasonable judgment that the benefits of easing the burden for
consumers justified the added burdens imposed on hospitals," Tatel wrote.

Melinda Hatton, the American Hospital Association's general counsel, said the group was disappointed, and hopes the incoming Biden
administration will revise the rule and exercise 'enforcement discretion" until the pandemic runs its course.

Azar praised the decision. 'Big win for American patients," he wrote on Twitter. 'Starting January 1, Americans will have access to the
actual prices paid for the most common hospital services."

Patients have long complained about getting surprise medical bills following treatment.
Tuesday's decision upheld a June 23 ruling by U.S. District Judge Carl Nichols in Washington.

The U.S. Chamber of Commerce supported the hospital groups, saying the rule could cause hospitals to demand higher prices for their
services if they saw other hospitals charging more.

The case is American Hospital Association et al v Azar, D.C. Circuit Court of Appeals, No. 20-5193.
Biden Administration Asks U.S. Supreme Court to Dump Medicaid Work Case

(Reuters) - President Joe Biden's administration on Monday asked the U.S. Supreme Court to cancel an upcoming oral argument on
a policy introduced under his predecessor Donald Trump backing work requirements for people who receive healthcare under the

Medicaid program for the poor. [FN21]

Acting Solicitor General Elizabeth Prelogar said the Biden administration has started the process of reversing the previous policy and
asked the justices to dump the scheduled March 29 arguments concerning pilot programs adopted by the states of Arkansas and New
Hampshire.

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Under Trump, the Department of Health and Human Services in 2018 approved the pilot projects in those two states as part of a push
to put a conservative stamp on Medicaid, a program that was expanded under the Affordable Care Act, also known as Obamacare, to
provide coverage to millions more Americans.

Prelogar asked the justices to consider throwing out the pending cases altogether.

Biden, a Democrat, succeeded Trump, a Republican, on Jan. 20. Under Biden, the same department made a preliminary finding that
work requirements would be inconsistent with the objectives of Medicaid, which provides medical insurance for the poor, Prelogar told
the court.

The justices in December agreed to hear Trump administration appeals of rulings by a lower court that deemed the work requirement
programs unlawful. The lower court noted that about a quarter of the people subject to the requirement lost their Medicaid coverage in
the first five months after the Arkansas work requirement was implemented.

The Supreme Court on Feb. 3 canceled oral arguments in two other cases after the Biden administration changed course from Trump
policies. Both were appeals by Trump's administration - one defending his funding of the U.S.-Mexico border wall and the other
defending his so-called 'remain in Mexico" asylum policy.

Trump in 2019 redirected $2.5 billion from military counter-narcotics programs for border wall construction in California, New Mexico
and Arizona. Biden issued a proclamation on his first day in office ordering a freeze on border wall projects and directing a review of the
legality of its funding and contracting methods.

The 'remain in Mexico" policy has forced tens of thousands of migrants to wait in Mexico, rather than entering the United States, while
their asylum claims are processed.

Texas Sues Biden Administration Over Loss of Medicaid Waiver

(Reuters) - Texas has sued President Joe Biden's administration over its decision to rescind the previous administration's approval of
changes to its Medicaid program, saying the move was meant to pressure the state into expanding Medicaid under the Affordable Care
Act, FN221

In a complaint filed Friday in federal court in Tyler, Texas, the state said that the loss of the approval could cost the state more than $30
billion and would have an 'almost incalculable effect on Texas' most vulnerable citizens.'

'The Biden administration cannot simply breach a contract and topple Texas' Medicaid system without waming,' Texas Attorney
General Ken Paxton said in a statement. 'This disgusting and unlawful abuse of power aimed at sovereign states must end.'

The U.S. Centers for Medicare and Medicaid Services (CMS), the agency within the Department of Health and Human Services that
administers Medicaid, had no immediate comment.

The dispute centers on a so-called Medicaid waiver first granted to Texas in 2011. CMS can provide waivers to states wishing to depart
from usual federal rules for administering Medicaid, a joint federal and state program meant to cover low-income and disabled people.

Texas' waiver, which has been modified several times, allows the state to require Medicaid recipients to enroll in managed care
organizations (MCOs), which are intended to reduce costs. Under a managed care model, Medicaid pays MCOs a fixed premium for
each beneficiary, rather than paying for services directly.

Texas also receives federal funding for a related incentive program through which bonuses are distributed to Medicaid providers or
regions based on improvement metrics. About $20 billion has been distributed through that program, according to the lawsuit, but
federal support for the program is set to expire this September.

In 2020, the state sought an extension of the waiver, set to expire in 2022, through 2030. It was allowed to bypass the normal notice
and comment period in light of the COVID-19 emergency.

The newly extended program included new federal funding to replace the expiring incentive program, according to the lawsuit. In April,
however, CMS informed Texas that the extension had been improperly granted because there had been no notice and comment
period.

The state said in the lawsuit that the sudden rescission violated federal law. 'Federal authorities may not topple a state's Medicaid
system as a child might a sandcastle,' it said.

The state also said that the decision had an 'ulterior motive,' noting that CMS had cited a letter from three advocacy groups - Children's
Defense Fund-Texas, Every Texan and Texans Care for Children - that criticized the state for relying on its waiver program rather than
expanding Medicaid under the ACA.

The organizations said in their letter that despite 'valuable contributions' of the waiver, 'Texans need and deserve more.'
The state is seeking a court order that the April rescission is invalid.

Texas is one several Republican-led states that have not taken advantage of expanded Medicaid funds through the ACA, the signature
achievement of Democratic former president Barack Obama.

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The case is State of Texas et al v. Richter et al, U.S. District Court, Eastern District of Texas, No. 21-cv-00191.
U.S. Supreme Court Rebuffs Insurers on ACA Reimbursements

(Reuters) - The U.S. Supreme Court on Monday declined to hear a bid by health insurance companies to seek a full reimbursement
from the federal government under a provision of the Obamacare law aimed at encouraging them to offer medical coverage to

uninsured Americans. '*N2*

The justices turned away appeals brought by private insurers Maine Community Health Options, Community Health Choice Inc and
Common Ground Healthcare Cooperative.

The insurers had said they were collectively owed millions of dollars for each year they did not receive payments the government had
pledged to make under the 2010 law, formally called the Affordable Care Act. Litigation will now continue in lower courts over how much
the insurers can claim.

The Supreme Court left in place an August 2020 ruling by the U.S. Court of Appeals for the Federal Circuit that the insurers'
reimbursement for money owed could be offset by other income they received from the government in the form of premium tax credits.

The Supreme Court in an 8-1 ruling in April 2020 in an earlier stage of the same litigation decided that the federal government must
'honor its obligations' and pay various private insurers up to $12 billion owed to them. But when the case returned to lower courts after
that ruling, the federal government continued to argue that it was not required to pay in full, setting up a new round in the legal fight.

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 court in a 7-2 ruling last Thursday rejected a Republican challenge to the law, the third time that the justices preserved Obamacare
over the past decade.

The insurers have said the government was supposed to help them recover from early losses they suffered after the law was passed by
Congress and signed by Democratic former President 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, though an expansion of the Medicaid program for the poor and though private insurers.

Payments to the insurers 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 the U.S. Department of Health and Human Services from using general
funds to pay the government's risk corridor obligations. Health insurers turned to federal courts to obtain the payments.

Ill. PROPOSED ACTIONS

Democrats Push for Public Option

U.S. Senator Patty Murray (D-WA), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced plans
to create legislation with Congressman Frank Pallone, Jr. (D-NJ), chair of the House Energy and Commerce Committee that would
establish a public option for health insurance coverage.

The plan focuses on decreasing health care costs and increasing access to quality, affordable health care.

Murray and Pallone issued a Request for Information (RFI) as they began working with legislators who support a public option. They
hope to craft new comprehensive legislation that would create a public option.

'This pandemic has underscored why it's so important to patients, families, and communities across the country that health care is truly
a right, not a privilege. No one should suffer or die because quality health care was too expensive or too hard to get. | believe we must
take bold steps to lower health care costs and move toward universal coverage by creating a federal public option available to everyone
-and a clear majority of Americans agree. A federal public option will help guarantee that no matter where you live, who you are,

or what your income-if you live in America, you can get the quality health care you need without worrying about cost," said Senator
Murray.

'I'm grateful to our colleagues who have already put forward thoughtful proposals on dramatically expanding coverage-and President
Biden who has always been clear that this is a priority for his Administration. | look forward to working with everyone in the weeks

and months ahead as we work to craft bold legislation and finally getting this done for families across the country," Senator Murray
indicated.

The RFI letter to the public requested input as the Committee leaders began drafting the legislation for the public option.
The Senator requested input by July 31, 2021.

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Murray indicated that a national public option would particularly affect families in Washington state.

'Even before COVID-19, | was hearing from people across Washington state about how hard it was to get, and afford, the health care
they needed-but this pandemic has made things so much worse. I'm proud Washington state has been a leader when it comes to
establishing a state public option and working to make sure everyone can get quality, affordable health coverage, and I've been in
touch with state officials about how bold action at the federal level can strengthen Washington's efforts," said Senator Murray.

'Establishing a strong, federal public option will force insurance companies to compete, bring drug companies and health care providers
to the table, provide every Washingtonian a new quality, affordable coverage option, and ultimately drive down health care costs for all

families regardless of how they are covered." IFN24]
The public option is one of President Biden's campaign promises that has faced significant opposition.

The RFI from Murray and Pallone asked for input on who should be eligible for the public option health insurance coverage, how the
benefits would work, and what health care providers and pharmaceutical companies should expect as payments under a public option
plan.

'We believe bold steps are necessary in order to achieve universal coverage and lower health care costs," Murray and Pallone indicated
in the letter. 'As we work to craft legislation, our priority is to establish a federally administered public option that provides quality,
affordable health coverage throughout the United States."

Democratic legislators attempted to include the public option in the Affordable Care Act, passed under President Obama. Biden brought
back the idea during his presidential campaign in 2020.

Insurers and health care providers are largely unsupportive of a public option. Others in the health care industry are unsure of the plan.

The American Hospital Association asserted that the public option plan would have 'inadequate reimbursement rates" and could reduce
quality of care.

According to a statement from the group's president, Rick Pollack, "We continue to urge Congress and the administration to work to
improve the programs that already exist in an effort to ensure that everyone is enrolled in some form of comprehensive coverage."

Larry Levitt of the nonpartisan Kaiser Family Foundation noted, 'There are a host of difficult issues to address ... but the biggest by far
is determining how much doctors, hospitals, and drug companies get paid. A public option has the potential to reduce prices and make

health care more affordable, but the further it goes in that direction, the bigger the blowback will be from the health care industry." [FN25]
U.S. Health Agency Proposes Rule to Restrict Surprise Billing

(Regulatory Intelligence) - The administration of U.S. President Joe Biden issued an interim final rule on Thursday aimed at restricting

surprise billing and balance billing for emergency and out-of-network services in employer-sponsored and commercial health plans.
[FN26]

The rule requires insurers to treat all emergency services on an in-network basis in terms of costs, without any pre-authorization
requirement. Insurers will also have to limit out-of-network cost-sharing requirements to the in-network maximum that can be charged
as per their plan.

The rule is open to a 60-day comment period and will go into effect on Jan. 1, 2022. The regulation aims to implement some of the
'No Surprises Act" that passed with bipartisan support late last year. The new regulation applies to surprise bills or unknowing costs
from providers outside the network of the insurer and balance bills that hold the patient liable for remaining costs after the insurer has
reimbursed a certain part. Balance billing is currently prohibited in both Medicare and Medicaid. 'No patient should forgo care for fear
of surprise billing," Secretary of the Department of Health and Human Services, Xavier Becerra, said. 'Two-thirds of all bankruptcies
filed in the United States are tied to medical expenses and researchers estimate that 1 of every 6 emergency room visits and inpatient
hospital stays involve surprise bills from care from at least one out-of-network provider, the department said. The rule also bans out-
of-network charges for any type of ancillary care, such as anesthesiology or an assistant surgeon for any treatment provided at an
in-network facility. Insurers will have to provide advance notice to the consumer on any out-of-network charges outside the scope of
this rule. Health care providers will also be required to provide patients with a 'plain-language consumer notice" explaining that patient
consent is required to receive care on an out-of-network basis before that provider can bill at the higher out-of-network rate, HHS said.

These provisions will provide patients with financial peace of mind while seeking emergency care as well as safeguard them from
unknowingly accepting out-of-network care and subsequently incurring surprise billing expenses. The HHS is working on surprise billing
regulations along with the Labor and Treasury Departments and the Office of Personnel Management.

Proposed Actions Address Health Care Inequities
The Centers for Medicare & Medicaid Services (CMS) is proposing actions to address health care inequities in the United States.

The actions aim to give consumers information needed for fully informed decisions about health care, improve emergency care access
in rural areas, and use lessons from the COVID-19 pandemic to improve care in the future.

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CMS is proposing these actions in response to President Biden's Competition Executive Order to move toward price transparency, hold
hospitals accountable, and give consumers important information regarding health care.

'As President Biden made clear in his executive order promoting competition, a key to price faimess is price transparency," said HHS
Secretary Xavier Becerra. 'No medical entity should be able to throttle competition at the expense of patients. | have fought anti-
competitive practices before, and strongly believe health care must be in reach for everyone. With today's proposed rule, we are simply
showing hospitals through stiffer penalties: concealing the costs of services and procedures will not be tolerated by this Administration."

'CMS is committed to addressing significant and persistent inequities in health outcomes in the United States and today's proposed rule
helps us achieve that by improving data collection to better measure and analyze disparities across programs and policies," said CMS
Administrator Chiquita Brooks-LaSure. 'We are committed to finding opportunities to meet the health needs of patients and consumers
where they are, whether it's by expanding access to onsite care in their communities, ensuring they have access to clear information
about health care costs, or enhancing patient safety."

The proposed rule spans the following areas:
Price Transparency

According to CMS, 'Hospital price transparency helps Americans know what a hospital charges for the items and services they provide.
CMS takes seriously concerns it has heard from consumers that hospitals are not making clear, accessible pricing information available
online, as they have been required to do since January 1, 2021."

The proposed rule would increase the penalty for hospitals that do not comply with Hospital Price Transparency final rule. A minimum
civil monetary penalty of $300/day would apply to smaller hospitals with a bed count of 30 or fewer. Larger hospitals would face
additional fines of $10/bed/day up to daily fines of $5,500.

CMS indicated, 'Based on information that hospitals have made public this year, there is wide variation in prices ? even within the same
hospital or the same system, depending on what each insurance plan has negotiated with that hospital. CMS is committed to ensuring
consumers have the information they need to make fully informed decisions regarding their health care, since health care prices can
cause significant financial burdens for consumers."

Health Equity

CMS asked for input on ways to make reporting of health disparities based on social risk factors, race, and ethnicity more
comprehensive and actionable.

The agency would like comments on potential collection of data, and analysis and reporting of quality measure results by a variety
of demographic data points including, but not limited to, race, Medicare/Medicaid dual eligible status, disability status, LGBTQ+, and
socioeconomic status.

Access to Emergency Care in Rural Areas

CMS noted that 138 rural hospitals have closed since 2010. The closures have especially affected communities with a higher
population of people of color and communities with higher poverty rates. People living in these areas have shorter life expectancies,
higher mortality, and have fewer local health care providers, resulting in poorer health outcomes in rural areas.

CMS indicated, 'Rural hospital closures deprive people living in rural areas of crucial services, including access to emergency care.
To address these concerns, Congress enacted Section 125 of the Consolidated Appropriations Act of 2021 (CAA), which establishes
a new provider type for Rural Emergency Hospitals (REHs). REHs will be required to furnish emergency department services and
observation care and may provide other outpatient medical and health services as specified by the Secretary through rulemaking. In
this proposed rule, CMS is requesting information to inform the development of requirements that would apply to Rural Emergency
Hospitals (REHs). This new provider designation will apply to items and services furnished on or after January 1, 2023."

The agency solicited feedback on issues relating to access to healthcare in rural areas, including the potential services to be provided
by REHs; health and safety standards and quality measures to be established for REHs; and payment provisions for this provider type.

COVID-19 Lessons

The agency also asked for comment on the extent to which hospitals are using flexibilities offered during the COVId-19 pandemic to
provide mental health services remotely. The agency is considering making information about vaccination status of healthcare workers
available to the public to consumers know how many workers in a health care setting are vaccinated against COVID-19.

CMS solicited comments on improving patient experiences and outcomes and improving patient safety. [FN27]

U.S. Government to Tackle Medicare Drug Payments to Try to Cut Costs

(Reuters) - President Joe Biden's administration on Thursday unveiled its promised initiative aimed at cutting drug prices, saying it
will test new ways to reduce such costs for the Medicare health insurance program including tying payments for medications to their

effectiveness, '*N2®l

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The U.S. Department of Health and Human Services (HHS), which oversees the federal medical insurance program for people age 65
and older and the disabled, announced the initiative, which will use models to gauge the clinical value of medicines to determine how
much Medicare pays for them.

The department also said it will test so-called bundled payment models for Medicare and gather data from insurers to improve
transparency.

The Biden administration is separately backing legislation in Congress that would seek to stem rising drug prices.

While the administration has lauded drugmakers for their efforts amid the COVID-19 pandemic, it also has highlighted the high costs
of medications in the United States compared to other nations. Pharmaceutical manufacturers have raised prices on more than 500
medicines, according to an analysis by healthcare research firm 46brooklyn in January.

Pharmaceutical manufacturers have opposed efforts to regulate drug prices, calling them 'misguided' and saying this would stifle
innovation.

'While large companies like Merck will survive, the hundreds of thousands of small biotechs that rely on venture capital ... will just
disappear," Kenneth Frazier, executive chairman of Merck & Co and its former chief executive, said during an industry panel on
Wednesday.

The pharmaceutical industry supports reforming federal drug payments to reduce patient costs, but the current proposal will damage
the industry more than it will help taxpayers, two other executives said on the panel.

Other drug pricing experts said the industry may be overstating the risk to drug development.

'The current model where we pay high prices without respect to value is also problematic for innovation," said Aaron Kesselheim, a
professor of medicine at Harvard Medical School.

'| think that (the proposed reforms) would actually provide incentives for the innovations that patients actually want."

HHS Secretary Xavier Becerra defended the administration's plan. He said letting Medicare negotiate for drug prices under Part B -
which, among other things, covers medications used in hospitals and other healthcare settings - would 'make those prices available to
other purchasers.' That could help patients pay less and reduce costs not only for the federal government but also other commercial
payers, he said.

The department also said it will test ways to reduce costs under Part D, which covers over-the-counter drugs, through biosimilars and
generic drugs.

'By promoting negotiation, competition, and innovation in the healthcare industry, we will ensure cost fairness and protect access to
care,' Becerra said.

The White House's legislative agenda for reforming federal drug payments is likely to run into the same challenges that stymied similar
efforts in the past, said Michael Tanner, a senior fellow at the Cato Institute, a conservative think tank.

The U.S. House of Representatives and the Senate both proposed reforms under the Trump administration but none succeeded in
passing into law.

'The main reason that nothing can be done is that Medicare' cannot refuse coverage for a drug it deems too expensive, Tanner said.
'Until you are willing to tell seniors 'you can't have every drug you want,' you are not going to save money."

HHS Proposes Rescinding Two Trump Administration Rules

The Department of Health and Human Services (HHS) is proposing IFN28] to rescind two final rules issued under the Trump

administration that the agency said 'create unnecessary hurdles that hinder the Department's ability to issue guidance, bring
enforcement actions, and take other appropriate actions that advance the Department's mission."

One of the final rules was issued in December 2020 and stated that 'significant guidance documents"-defined as those likely to have
an annual economic effect of $100 million or more-may not be issued without notice-and-comment.

The second final rule, which was published in January, set forth a series of procedural requirements for HHS civil enforcement actions,
including that the agency can only apply standards or practices that have been publicly stated in a manner that would not cause unfair
surprise and that the agency give parties written notice of its initial legal and factual determinations and an opportunity to respond
before taking a civil enforcement action.

According to HHS, both rules conflict with the new administration's polices 'to use available tools to confront the urgent challenges
facing the nation, including the coronavirus pandemic, economic recovery, racial justice, and climate change," through 'flexibility to use
robust regulatory action to address national priorities."

Both rules also 'have a disproportionate effect on marginalized and vulnerable historically underserved communities, because they
make it harder for agencies to take action to protect public health or remove bad actors from the market," HHS said.

Comments on the proposed rule are due November 19.

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IV. EFFORTS TO REPEAL AND REPLACE THE ACA

Major Rulings Including ACA Loom for U.S. Supreme Court

(Reuters) - The U.S. Supreme Court heads into the last month of its current term with several major cases yet to be decided including

a Republican bid to invalidate the Obamacare healthcare law, a dispute involving LGBT and religious rights and another focused on

voting restrictions. [FN3O]

The court, which has a 6-3 conservative majority, now has 24 cases in total left to decide after issuing two rulings on Tuesday. There
also is speculation about the potential retirement of its oldest justice, Stephen Breyer. Some liberal activists have urged Breyer, who is
82 and has served on the court since 1994, to step down so President Joe Biden can appoint a younger liberal jurist to a lifetime post
on the court.

In the most notable of Tuesday's decisions, the court unanimously endorsed the authority of Native American tribal police to stop and
detain non-Native Americans on tribal land.

The court's nine-month term starts in October and generally concludes by the end of June, though last year it continued into July
because of delays caused by the COVID-19 pandemic.

Speaking during an online event for students on Friday, Breyer hinted at the court's complex deliberations that go into deciding high-
stakes cases at this time of year.

'It's complicated by the fact that you are dealing with eight other colleagues. ... You'd better be willing to compromise,' Breyer said.

Republican-governed states have asked the court to strike down the Affordable Care Act, a law signed in 2010 by Democratic former
President Barack Obama that has helped expand healthcare access in the United States even as Republicans call it a government
overreach.

It appears unlikely based on November's oral arguments that the court would take such a drastic step. But if the Obamacare law were
to be struck down, up to 20 million Americans could lose their medical insurance and insurers could once again refuse to cover people
with pre-existing medical conditions. Obamacare expanded public healthcare programs and created marketplaces for private insurance.

Another major case yet to be decided is one that pits religious rights against LGBT rights as the justices weigh Philadelphia's refusal
to let a Catholic Church-affiliated group participate in the city's foster care program because it would not accept same-sex couples as
prospective foster parents.

The conservative justices appeared during the November arguments in the case to be sympathetic toward the Catholic group's claim
that its religious rights under the U.S. Constitution's First Amendment had been violated. The court's conservative majority has taken an
expansive view of religious rights and has spearheaded several rulings backing churches in challenges to COVID-19 pandemic-related
restrictions.

With various states enacting new Republican-backed voting restrictions in the aftermath of former President Donald Trump's false
claims that the 2020 election was stolen from him through widespread voting fraud, the court is preparing to rule in a case concerning
Arizona voting limits.

Republican proponents of Arizona's restrictions cite the need to combat voting fraud. A ruling upholding the restrictions could further
undermine the Voting Rights Act, a landmark 1965 federal law that prohibits racial discrimination in voting.

The court also is getting ready to decide a closely watched case involving the free speech rights of public school students. It involves
whether a high school that punished a cheerleader for a foul-mouthed social media post made off campus on a weekend violated her
free speech rights under the First Amendment.

The court has taken up major cases on gun and abortion rights for its next term, which begins in October.
U.S. Supreme Court Upholds Affordable Care Act for the Third Time

(Regulatory Intelligence) - The Supreme Court of the United States preserved the Affordable Care Act for the third time in more than
a decade on Thursday as it dismissed a lawsuit brought by a group of Republican-led states, saying the challengers lacked the legal
standing to attack the law and its provisions. The premise of the ruling could potentially lower the prospect of another legal challenge to

the landmark healthcare law, experts said. [FN31]

The 7-2 ruling from a largely conservative Supreme Court is being seen as a major vindication by proponents of the ACA even though
the Justices did not rule on the merits of the case or the constitutionality of the law. Justices Samuel Alito and Neil Gorsuch dissented in
the ruling, while Justice Amy Coney Barrett, seen as a major threat to the survival of the law, joined the majority in the verdict.

'With millions of people relying on the Affordable Care Act for coverage, it remains, as ever, a (big deal). And it's here to stay,"
President Joe Biden tweeted. 'It is time [to] move forward and keep building on this landmark law," he later said in a statement. House
Speaker Nancy Pelosi called the ruling a 'landmark victory for Democrats' work" and Senate Majority leader Chuck Schumer said
lawmakers were now 'going to try to make it bigger and better'.

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Former President Barack Obama, who signed the ACA into law in 2010, said the top court's ruling served to establish the principle of
universal coverage and advocated for efforts to build upon the ACA.

'The COVID-19 public health emergency has underscored the importance of safeguarding this life-saving law and it is only fitting that
the Supreme Court recognized its lawfulness," said Xavier Becerra, Secretary of the U.S. Department of Health and Human Services.
Becerra had led the defendants in the lawsuit, as California's Attorney General, along with 20 other Democrat-led states.

Texas led a group of 18 Republican states and two individual plaintiffs in arguing the entire law was invalid without the individual
mandate -- a provision that imposed a tax penalty on people without any form of health insurance. President Donald Trump reduced the
penalty to $0 in 2017, rendering the mandate ineffective.

Justice Stephen Breyer said in Thursday's ruling the plaintiffs failed to demonstrate they had sustained any harm or injury caused by
the individual mandate and therefore lacked the legal standing to attack it as unconstitutional.

'Unsurprisingly, the States have not demonstrated that an unenforceable mandate will cause their residents to enroll in valuable
benefits programs that they would otherwise forgo. It would require far stronger evidence than the States have offered here to support
their counterintuitive theory of standing, which rests on a highly attenuated chain of possibilities', Breyer wrote, on behalf of the
majority.

In doing so, the Supreme Court reversed a previous judgment by the Fifth Circuit Court of Appeals that ruled the individual mandate
unconstitutional but reserved judgment on the validity of the rest of the law.

Dissenting Justice Alito wrote the ruling was the latest in the Supreme Court's 'epic Affordable Care Act trilogy" in which the Court had
pulled off an improbable rescue when the ACA was under threat.

Justice Clarence Thomas addressed Alito's 'trilogy' statement and said the current lawsuit had to be assessed on its own terms,
irrespective of the law's history in the Supreme Court where its defendants had once argued the individual mandate was the law's
'linchpin". 'Here, there is a fundamental problem with the arguments advanced by the plaintiffs. . .Today's result is thus not the
consequence of the Court once again rescuing the Act," he wrote.

Future challenges unlikely even as court avoids ruling on main arguments

The latest ruling did not come as a surprise to many. Oral arguments in the Supreme Court hearing in November signaled the Justices
were less likely to throw out the entire law. The entire healthcare system could have been thrown into disarray had the court decided to
side with the challengers of the law.

More than 130 million people stand to benefit from the law's protections for people with pre-existing conditions and about 31 million
people have enrolled in the ACA's individual healthcare marketplace and Medicaid expansion provision.

'Even if it was an unlikely event, you need to care about tail events just because the implications would be huge," said Loren Adler,
Associate Director of the USC-Brookings Schaeffer Initiative for Health Policy. An unfavorable decision would have also derailed the
Biden administration's agenda for the near future, forcing them to devote all their energy into successfully passing a replacement for the
ACA, he added.

The latest ruling may have also been the result of a concerted effort by the Supreme Court to not strike down the law during a
pandemic.

'They didn't strike it but they didn't approve it, they sidestepped it. And in that sense, it was a very politique decision," said Wendy
Parmet, faculty director for the Center for Health Policy and Law at Northeastern University School of Law. 'The [severability] claim-
always seemed absurd and it would have been an extraordinary stretch for the majority to go there."

The Justices may have wanted to avoid taking an 'activist' stance in a decision that could have had dire consequences for the
healthcare of millions, she said. It could have also created enormous political problems for the Republican party, she added. Consumer
support for the ACA has been at an all-time high after the start of the pandemic.

Experts also believe the latest court decision on the legal standing of the plaintiffs could shut the door or at least fend off some legal
challenges to the ACA in the future. Given's the court's stance on the plaintiffs inability to prove harm as a result of the $0 penalty, it
would be hard for any other party to refile the lawsuit and prove injury as a result of the individual mandate, experts said.

'There will likely be no more cases challenging the broad constitutionality because it does seem like you're getting more and more far-
fetched each time," Adler said.

Lawsuits targeting parts of the law might be more likely, such as Kelley v. Becerra, currently brewing in a federal court in Texas and
being heard by Judge Reed O'Connor, who earlier struck down the ACA in 2018. The challengers have argued they must not be forced
to purchase health plans where insurers are mandated to cover preventive services that are in conflict with their religious beliefs.

Experts believe the lawsuit would not likely evolve into a major threat to the overall law, as it targets one of the most popular aspects of
the ACA - preventive coverage of certain services at no cost to the consumer.

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'| don't see the appetite among the majority for revisiting the ACA for the fourth time. It is probably here to stay but there are political
points to be made by constantly challenging it and for any law that is as complicated and wide-reaching as the ACA, a lawyer can find a
ground," Parmet said.

Healthcare insurers, providers welcome decision

Health insurers and healthcare providers welcomed the Supreme Court's decision that largely represents the status quo for the
industry, and alleviates concerns about uncertainty in the individual healthcare market in the coming years.

"We believe the Supreme Court rightly concluded this case does not belong in court, as the challengers have not suffered any injury.
After a year filled with unprecedented loss when reliable comprehensive health coverage has never been more important,' Matt Eyles,
president and CEO of AHIP, a group of health insurers, said. 'It is clear that Americans agree we should continue to build on the ACA to
improve coverage and care for everyone."

The American Hospital Association called for redoubling efforts to close coverage gaps and make care more affordable and accessible.
'The AHA is eager to partner with Congress and the Biden administration to make sure all Americans can achieve their highest potential
for health," Rick Pollack, chief executive of the American Hospital Association, said.

The Centers for Medicare and Medicaid said it was focused on building on the successes of ACA to further expand access to health
coverage. 'Our work is far from finished," Administrator Chiquita Brooks-LaSure said.

The ACA could still face a legislative challenge from Republicans but they would likely need to win the Presidency and Congress before
that.

V. BIDEN ADMINISTRATION

Biden, Congress Initiatives Would Bolster Affordable Care Act

(Regulatory Intelligence) - President Joe Biden has prepared a shot in the arm for the Affordable Care Act and Medicaid program with
multiple initiatives to increase subsidies, cap premiums, and implement other measures to make insurance coverage under the act
more affordable. The administration, however, will need to convince a dozen states to adopt the Medicaid expansion program in order

to realize the full benefit of its actions nationwide. "N32!

Congressional Democrats are rolling some Medicaid-related incentives into a COVID-19 relief package promoted by the Biden
administration in a bid to push these 12 states to expand the federal-state program within their jurisdictions. The House Committee on
Energy and Commerce said earlier this week it was considering a two-year funding increase to states that newly expand their Medicaid
programs to cover more low and middle-income Americans.

States that expand Medicaid would for two years receive 95 percent of all Medicaid expenses from the federal government, compared
to the current 90 percent subsidy, according to the legislative proposal from the House committee. The benefit would also apply to
Missouri and Oklahoma which have recently adopted the Medicaid expansion program.

The proposal also would give states the option to cover vaccines through the Medicaid program up to one year after the COVID-19
public health emergency and to extend postpartum coverage for women up to 12 months from the 60 days currently provided. The
maternity coverage benefit has been proposed for a period of five years.

Data suggests about 4 million Americans could become eligible for Medicaid coverage if the remaining 12 states yet to expand their
programs were to do so. Opposition from Republican state leadership or state budget constraints have often impeded the adoption of
the expansion program. The 2010 Affordable Care Act, or Obamacare, provided for the expansion of Medicaid eligibility to cover more
low-income Americans by raising income eligibility thresholds. But the U.S. Supreme Court in 2012 ruled that states could not be forced
to expand their Medicaid programs, leaving it up to each state to determine whether to participate

Health policy experts say the limited, two-year, tenure of the incentives in the House proposal, including the increased funding match,
may not be enough to get more states to adopt an expansion program.

It could, however, strengthen the argument for those advocating an expansion in coverage, given states would now have to pay only 5
percent of their total Medicaid bill as opposed to 10 percent if they were to adopt the expansion program.

In addition, the Biden administration has already proposed other incentives to make the ACA healthcare market more affordable.

The U.S. Department of Health and Human Services has opened a special enrollment period on the federal healthcare exchange and
set aside $50 million in funds for a public outreach program to steer newly unemployed or uninsured people towards coverage.

The relief package has also proposed raising eligibility for ACA premium subsidies for those buying coverage on the exchange to
include those earning up to 150 percent of the federal poverty line. Biden has already proposed capping premium spending at 8.5
percent of total income for everyone buying on the exchange, irrespective of their income level.

Biden's administration has also supported suspending verification criteria for the duration of the public health emergency.

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Health insurers, usually opposed to such measures for fear of more sign-ups from a sick population than healthy individuals, have
also supported the administration's moves to increase coverage at a time when utilization of medical services has dropped across the
country.

HHS Announces Biden-Harris Administration Staff Appointments

On February 16, the Department of Health and Human Services announced Biden-Harris Administration appointments. The
appointments represent both an experienced and diverse team committed to President Biden's mission to end the COVID-19 pandemic,
expand affordable health care and reduce costs, and advance equity.

'As our country navigates an unprecedented public health crisis, President Biden is building a strong, experienced, and diverse team
at the U.S. Department of Health and Human Services," said HHS Chief of Staff Sean McCluskie. "Together, in the Biden-Harris
Administration, we will tackle the COVID-19 pandemic, protect and strengthen the Affordable Care Act, expand access to quality,
affordable health care, and advance health equity in communities across the country."

These new appointees join tens of thousands of talented, dedicated career officials throughout the agency, whose expertise is critical
for tackling the ongoing public health crisis, ensuring Americans have access to quality, affordable health care, strengthening support
for seniors and other vulnerable populations, conducting groundbreaking research, and more. The Biden-Harris Administration is
committed to restoring public trust in our health agencies and leading with science and facts.

A full list of the new appointees and their roles is available here: https:/Avww.hhs.gov/about/news/202 1/02/16/us-department-health-
and-human-services-announces-biden-harris-administration-staff-appointments.html.

Senate Confirms Becerra to Cabinet Role as U.S. Health Secretary

(Regulatory Intelligence) - Xavier Becerra won confirmation by the U.S. Senate on Thursday as Health and Human Services Secretary
in President Joe Biden's cabinet. Coming from his position as California attorney general, Becerra will be faced with the task of leading
the federal response to the COVID-19 pandemic, managing the Affordable Care Act through a pending U.S. Supreme Court decision,

and taking care of unaccompanied minors at the southern border. [FN33]

A narrow Senate vote of 50-49 confirmed Becerra's nomination. His new department which oversees the Centers for Medicare and
Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), among
others. He stepped down as attorney general on Thursday evening to become the first Latino to assume the new role.

The new HHS chief would have had his agenda full even without the pandemic, ACA threat, or border crisis. The Biden administration
wants to reverse several health coverage policy decisions of the past administration, expand the ACA's protections, end disparities

in healthcare protections, tackle the opioid crisis, and cushion the impact of skyrocketing healthcare costs. The Supreme Court is
expected to rule by June on a case seeking to invalidate the Affordable Care Act. The case argues that the earlier repeal of a tax
penalty for people who do not obtain insurance renders the whole program unconstitutional. Most analysts interpreted the court's

oral arguments on the case in November as indicating it would not invalidate the entire act. Becerra led a group of Democratic state
attorneys general in supporting the act in that case.

Becerra's nomination met criticisms, led by conservatives, over his relative lack of experience in public health, advocacy of abortion
rights, and support for universal healthcare. Some conservatives labeled him as an opponent of religious rights and accused him of
suing the Roman Catholic charity Little Sisters of the Poor in a case he filed against former President Donald Trump's administration
over employers' healthcare obligations. The group of nuns had joined the case on the administration's side after the original filing, his
supporters have repeatedly sought to clarify.

Becerra has also been accused of excessive partisanship by Senate Minority Leader Mitch McConnell and other Republicans for suing
the Trump administration more than 100 times during its term in the White House. He later won the support of Republican Senator
Susan Collins and some Republican state attorneys general who described Becerra as respectful of all viewpoints, accessible, and
collaborative at work.

Becerra will be closely watched for the smooth roll out of the vaccination drive, ability to make ACA provisions more accessible,
equitable and affordable, expansion of Medicaid in states, and ability to secure equitable healthcare protections for women and LGBTQ
members. He will also be responsible for implementing Biden's proposed public option, an unlikely target in the next two years.

The healthcare industry has supported Becerra's nomination. 'His leadership will be tested early as he arrives amid a pandemic and
challenges to the Affordable Care Act," the American Medical Association said. 'The AMA believes he is the right person for the job."

America's Health Insurance Plans, a group of health insurers said, Becerra has exhibited 'unceasing dedication to protecting the health
and wellbeing of all Americans" and that he 'will provide the strong leadership" the country needs to overcome the COVID-19 crisis.

Biden Administration Again Extends Healthcare Special Enrollment Period

(Regulatory Intelligence) - The administration of U.S. President Joe Biden has extended the special enrollment period on the federal
healthcare exchange to mid-August, saying it aims to give consumers more access to subsidies on the latest stimulus package - the

American Rescue Plan Act. [FNS4]

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The COVIC-19 relief measure, championed by Biden and enacted earlier this month, delivered the first big boost to the Affordable
Care Act (ACA) passed 11 years ago. It aimed to close gaps by widening eligibility criteria for the purchase of health insurance in
the individual coverage market and made coverage more accessible by increasing subsidies through tax credits and capping overall
premium spend to 8.5 percent of total income.

"We have a duty not just to protect it [the ACA], but to make it better and keep becoming a nation where healthcare is a right for all,"
Biden said when announcing the decision to extend the enrollment period to August 15 from May 15.

The announcement will result in a total six-month leeway to sign up for health coverage this year. Under former President Donald
Trump's administration, consumers were allowed to sign up only during the annual open enrollment period of about six weeks from
November 1 each year, unless they qualified under a change in circumstances during the year.

Some insurers, like United Healthcare and CVS Health's Aetna which earlier complained about a worsening risk pool in the ACA
market, have now returned to the individual healthcare market this year as the pandemic and increasing assistance from the
government, has steered many consumers into the state and federal healthcare exchange

More than 200,000 consumers had signed up for coverage in the first two weeks of a special enrollment started February 15 this year.
Those numbers are expected to climb after the newly-allowed subsidies kick in on April 1.

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety
Review

Following a thorough safety review, including two meetings of the CDC's Advisory Committee on Immunization Practices, the U.S.
Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause
regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should
resume, the agencies announced on April 23.

The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration
of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to
assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the
body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or
low blood platelet counts. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they
were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique
treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

The two agencies have determined the following:
Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.

The FDA has determined that the available data show that the vaccine's known and potential benefits outweigh its known and potential
risks in individuals 18 years of age and older.

At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in
continuing to investigate this risk.

Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine
Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers,
which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people
who have received the Janssen COVID-19 Vaccine.

CDC's independent Advisory Committee on Immunization Practices met today to discuss the latest data on TTS, hearing from the
vaccine manufacturer Janssen and the COVID-19 Vaccine Safety Technical (VaST) Subgroup, as well as a risk benefit analysis. ACIP
is committed to be vigilant and responsive to additional information that could impact the risk benefit analysis of any of these vaccines.
Vaccine safety monitoring will continue and any new information about TTS will be brought to ACIP as needed.

'Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work-
identifying even these small number of cases. We've lifted the pause based on the FDA and CDC's review of all available data and in
consultation with medical experts and based on recommendations from the CDC's Advisory Committee on Immunization Practices.
We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks
in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness
and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care
provider," said Janet Woodcock, M.D., Acting FDA Commissioner.

'Above all else, health and safety are at the forefront of our decisions," said CDC Director Dr. Rochelle P. Walensky. 'Our vaccine safety
systems are working. We identified exceptionally rare events ? out of millions of doses of the Janssen COVID-19 administered ? and
we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are
vaccinated. | continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe

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and effective, and they protect people from disease, hospitalization, and death. | urge anyone with questions about the COVID-19
vaccines to speak with their healthcare provider or local public health department."

Biden Administration Reinstates Healthcare Protections for Gay, Transgender People

(Regulatory Intelligence) - The U.S. Department of Health and Human Services said on Monday it will reinstate healthcare protections
for LGBT people, on the basis of a Supreme Court decision that prevents discrimination on the basis of sex or gender-identity at the

workplace. [FN35]

The new policy will reverse the previous administration's stance on the definition of sex being restricted to apply to 'male or female and
as determined by biology" in Section 1557 of the Affordable Care Act. The section also prohibits discrimination on the basis of race,
color, national origin, age, or disability in covered health programs or activities.

The Trump administration rule finalized in June 2020 enabled healthcare providers and insurers to refuse service or reimbursement
to a patient whose biological gender differed from the one they identified with. A previous regulation in 2016 had clarified that the
guaranteed protection from 'sex discrimination" under the ACA would include an individual's gender identity.

Under the latest policy, the HHS' Office for Civil Rights will interpret and enforce Section 1557 and Title IX's prohibitions on
discrimination based on sex to include discrimination on the basis of sexual orientation and gender identity, a statement from the
Department said.

'Fear of discrimination can lead individuals to forgo care, which can have serious negative health consequences- LGBTQ people
should be able to access health care, free from discrimination or interference, period," HHS Secretary Xavier Becerra said. A quarter of
LGBT people who faced discrimination postponed or avoided receiving medical care for fear of further discrimination, the HHS said.

The department said it made the decision to expand the protections under the law on the basis of a Supreme Court decision in an
employment-related case where the top court ruled that the protection from discrimination based on sex at a workplace would include
discrimination based on gender identity and sexual orientation.

Health insurers applauded the HHS' move and said they will continue to work with other health care leaders to eliminate barriers
that stand between those who identify as a member of the LGBT+ community and their access to better health. 'Discrimination and
inequality are wrong in any form," Matt Eyles, CEO of trade group America's Health Insurance Plans said in a statement.

It's unfortunate that such an obvious step had to be taken; the AMA welcomes this common-sense understanding of the law,' added
American Medical Association President Susan Bailey.

Lambda Legal, a gay rights association, which took the administration of President Donald Trump to court after it finalized the rule
limiting the scope of Section 1557 said the new policy is 'just one step in what is a long road to undo the undermining of health
care protections for all people under the Trump administration." The June 2020 rule had also removed ACA protections laid down
by thePlanned Parenthood, a women's healthcare and abortion provider, said nearly one in three transgender people have faced
discrimination with a health care provider and the rate is even higher for Black transgender people and other transgender people of
color.

ACA Healthcare Special-enrollment Signups Hit 1 million, Biden Seeks Permanent Cost Relief

(Regulatory Intelligence) - One million people have signed up for health insurance in the individual healthcare market through a
continuing special enrollment period (SEP) on the U.S. federal healthcare exchange, President Joe Biden said on Tuesday. He also
called on Congress to recognize the appetite for health insurance and make the temporary financial relief permanent through legislative

action. [FN36]

The Biden administration had created a pandemic-related enrollment opportunity that allowed people to sign up for health plans
compliant with the Affordable Care Act from February 15. The period will end on August 15. The popularity of the enrollment period
has been boosted by new subsidies and tax credits introduced by the new administration to make health coverage more affordable to
consumers during the pandemic.

The financial relief, part of the March $1.9 trillion COVID-19 bill, is also the latest in the administration's efforts to bolster the existing
healthcare law that has been criticized for being unaffordable to many. Nearly 2 million current enrollees have seen their monthly
premiums fall by over 40 percent on average, and new consumers selecting plans during the SEP saw monthly premium drop over

25 percent after the increased tax credits went into effect in April, the HHS said. Out-of-pocket costs are also expected to drop as the
median deductible for Americans signing up for new coverage on the exchange has fallen by nearly 90 percent, to $50, Biden said in a
statement.

'The Affordable Care Act has been a lifeline for millions of Americans. The pandemic has demonstrated how badly it is needed, and
how critical it is that we continue to improve upon it," Biden said.

Demand for health coverage has risen since the start of the pandemic in 2020 but President Donald Trump had resisted calls to open
a special enrollment period citing opportunities for consumers to gain coverage through existing provisions relating to extraordinary life
circumstances such as a job loss

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Biden has proposed making this temporary financial relief to purchase insurance permanent through the proposed American Families
Plan. It is currently scheduled to expire in two years.

'Today's milestone demonstrates that there is a need and a demand for high quality, affordable health insurance across this country. It
is up to Congress to hear them, and act quickly to pass the American Families Plan," Biden said.

U.S. to Bolster Public Health Workforce to Fight COVID-19, Future Pandemics

(Reuters) - The Biden administration is releasing $7.4 billion to bolster the nation's healthcare workforce amid the ongoing COVID-19

pandemic and to prepare for future epidemics and health challenges, the White House said in a statement on Thursday. [FN37]

The funds, allocated as part of the $1.9 trillion aid package pushed by President Joe Biden and passed by Congress in March, will be
used to recruit and hire a range of healthcare workers to help with vaccinations, testing and contact tracing, it said.

Of the $7.4 billion, $4.4 billion will go to states and local public health departments to address disease outbreaks and hire school
nurses. It will also be used to expand the U.S. Centers for Disease Control and Prevention's ability to track outbreaks and to create a
service corps dedicated to public health. The remaining $3 billion will boost local public health workforces ahead of future challenges,
with an emphasis on recruiting diverse candidates, the White House said.

The United States is making progress in its efforts to emerge from the coronavirus pandemic, which shut down much of the country last
year and roiled the economy, with more than 582,000 deaths to date.

After a winter spike in COVID-19 infections, new cases have fallen for four straight weeks and deaths have also dropped as more than
one-third of the country has been vaccinated. Warmer weather has also helped to curtain the spread of the virus.

Nearly 154 million people in the United States had received at least one dose of a COVID-19 vaccine as of Wednesday, U.S. officials
said. [NL4N2MZ4B5] The pace of vaccinations, however, has slowed and U.S. health officials have said variants such as the one
emerging from India could still pose a threat.

Public health experts for years have decried a lack of funding for the CDC and other areas and have warned about the potential
devastating impact from epidemics of SARS, Ebola, swine flu and other diseases.

HHS Reminds Health Providers and Insurers that COVID Testing, Vaccines Must Be Free

(Regulatory Intelligence) - U.S. Department of Health and Human Services Secretary Xavier Becerra this week reminded COVID-19
vaccination and testing providers that they are to administer COVID-19 vaccines free of charge to patients. The letter also reminded

group health plans and health insurers of their 'legal requirement' to provide coverage of COVID-19 vaccinations and diagnostic testing

without any cost to patients, and that failures to comply can lead to enforcement actions. [FN38]

Becerra, in a letter to providers, said COVID-19 vaccines and their administration are 'free for any individual living in the United States,
regardless of their insurance or immigration status.'According to the terms of Centers for Disease Control and Prevention (CDC)
COVID-19 Vaccination Program Provider Agreement, providers must administer COVID-19 vaccines at 'no out-of-pocket cost to
patients' and cannot require patients to have additional medical services to receive the COVID-19 vaccination. Providers cannot 'charge
any type of fee if COVID-19 vaccination is the sole medical service provided.'

Becerra acknowledged that providers incur costs when administering COVID-19 vaccines. The letter encouraged providers to 'see
reimbursement through Medicare, Medicaid, private insurance, or other applicable coverage.'

Most group health plans and health insurers are statutorily required to cover COVID-19 vaccines recommended by the Advisory
Committee on Immunization Practices of the CDC without cost-sharing by patients.

If providers administer vaccines to uninsured or underinsured patients, they may bill the Health Resources and Services Administration
COVID-19 Uninsured and COVID-19 Coverage Assistance Fund programs for vaccine-related fees.

If providers accidentally billed and received payments from patients for COVID-19 vaccine-related fees, those payments should
immediately be returned to their patients.

Becerra further said that providers who fail to follow the CDC vaccine program requirements may be reported to the HHS Office of
Inspector General for possible enforcement action. Health plans and health insurers that fail to comply with the legal requirements
many be reported to appropriate state insurance departments or to the Centers for Medicare & Medicaid Services for possible
enforcement action.

The United States had administered nearly 305 million doses of COVID-19 vaccines as of June 10, with approximately 52% of the
population receiving at least one dose, according to Reuters.

CMS Announces $80 Million Available for ACA Navigators

The Centers for Medicare & Medicaid Services (CMS) issued the 2021 Navigator Notice of Funding Opportunity (NOFO) on June 4,
which will make $80 million in grant funding available to Navigators in states with a Federally-Facilitated Marketplace (FFM) for the
2022 plan year. This is the largest funding allocation CMS has made available for Navigator grants to date. With the additional funding,

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CMS encourages current and past Navigators to apply, especially those that focus on education, outreach and enrollment efforts to
underserved and diverse communities.

'This eight-fold increase in funding is the largest investment ever made in the Navigator program and reflects the Biden-Harris
Administration's commitment to ensuring Americans can find the right health care coverage, access financial assistance, complete
their applications, and enroll in coverage through the Marketplaces, Medicaid, or the Children's Health Insurance Program," said CMS
Administrator Chiquita Brooks-LaSure. 'We know that Navigators are uniquely positioned to get the word out about the coverage and
financial assistance that can help underserved Americans who need to purchase health care coverage."

A Navigator's mission is to increase awareness among the uninsured about affordable health care coverage options available and
assist consumers through and beyond the Marketplace enrollment process. The increased grant funding is available to applicants
seeking to serve as Navigators in states with an FFM. The application details the eligibility requirements, required duties and the
available funding amountto applicants for this Navigator grant cycle.

Also, as part of the application, 2021 Navigator NOFO applicants will be asked to outline their outreach and enrollment efforts to the
underserved or vulnerable population they plan to target, while still being prepared to assist any consumer seeking assistance.

State Marketplaces that leverage the federal eligibility and enrollment platform are responsible for facilitating their own Navigator
funding and awards to ensure consumers in their states have access to the assistance they need when enrolling in Marketplace
coverage through HealthCare.gov.

To view the Notice of Funding Opportunity, visit: https:/Awww.grants.gov, and search for CFDA # 93.332.

CMS Announces $20 Million in American Rescue Plan Funding Available to Improve Access to State-based Marketplace
Coverage

The Centers for Medicare & Medicaid Services (CMS) announced $20 million in American Rescue Plan (ARP) funding to support State-
based Marketplaces (SBMs) to improve access to affordable, comprehensive health insurance coverage for consumers in their states.
The announcement was made on June 21.

States can apply for funding to help modernize or update their systems, programs, or technology to comply with federal Marketplace
requirements, including the recent provisions of the American Rescue Plan (ARP) that increased the financial assistance available to
certain consumers.

SBMs that operate their own eligibility platforms collectively enrolled over 3.8 million consumers in Marketplace coverage thus far for
the 2021 plan year. Most consumers are now eligible for increased savings to reduce monthly premium payments and many may

be eligible for lower out-of-pocket costs, such as lower deductibles, due to changes made through the ARP. This means states with
Marketplaces will be enrolling more consumers and reassessing current enrollees' eligibility for financial assistance as consumers seek
to access this broader financial help.

'Our State-based Marketplaces are the gateway to quality, affordable health care for millions of consumers and these investments will
make it even easier to sign up for coverage," said CMS Administrator Chiquita Brooks-LaSure. 'This funding available to states will help
them to provide consumers with swift eligibility determinations and enrollment into comprehensive health care plans. We applaud State-
based Marketplaces ? many of which have provided opportunities for special enrollment periods during the COVID-19 Public Health
Emergency ? for their hard work."

Under this funding opportunity, up to 21 cooperative agreement grants can be awarded to currently-approved SBMs that meet the
application requirements, including those that use the HealthCare.gov for eligibility and enrollment. SBMs can prioritize funding to make
modifications to systems or technology infrastructure related to the implementation of applicable federal requirements. This includes
changes needed to ensure consumers can quickly receive a new eligibility determination in order to access the increased premium tax
credits and cost-sharing reductions available through the ARP.

States may also use the funds for program policies or procedures required for implementation of applicable federal requirements. This
includes consumer notifications, consumer education or other assistance activities, stakeholder education or training, state and federal
reporting, call center or appeal supports, staff training, and oversight and monitoring activities.

Applications from eligible SBM applicants will be due on July 20, 2021. CMS anticipates issuing grant awards in early September 2021.
The period of performance for this grant will be from the date of the award through September 30, 2022. The NOFO provides additional
details regarding eligibility and program requirements, as well as key deadline and application submission information.

To view the Notice of Funding Opportunity, visit https:/Avww.grants.gov, and search for CFDA # 93.525.
HHS Announces Record Enrollment in Medicaid and CHIP and a Large Increase in Enrollment During the Pandemic

HHS announced in a press release that, according to the latest Medicaid and CHIP enrollment trend snapshot, 80 million individuals
are now enrolled in Medicaid and CHIP, all all-time high. Of that number, 9.9 million enrolled during the COVID-19 public health
emergency, an increase of 13.9%. Data from January 2021 revealed that 50% of the 80 million enrolled in Medicaid and CHIP are
children. Secretary Xavier Becerra remarked,

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'The Biden-Harris administration is using every lever to ensure any American needing access to quality health coverage receives it.
Now more than ever, people need the peace of mind of knowing that they have health coverage . . . . This report reminds us what a
critical program and rock Medicaid continues to be in giving tens of millions of children and adults access to care. This pandemic taught

us that now more than ever, we must work to strengthen Medicaid and make it available whenever and wherever it's needed using the

unprecedented investments Congress provided." [FN39}

HHS attributes much of the increase during the public health emergency to the temporary 6.2 percentage point increase in state FMAPs
if states adhered to a maintenance-of-effort provision that required states to keep Medicaid participants enrolled in coverage. CMS
Administrator Chiquita Brooks-LaSure wrote that the increase in enrollment during the pandemic demonstrates that the program worked
exactly as it should have:

'Medicaid and CHIP serve as a much-needed lifeline for millions of people throughout this country. The increase we are seeing is
exactly how Medicaid works: the program steps in to support people and their families when times are tough . . . . For the parents
that may have lost a job or had another life change during the pandemic, having access to coverage for themselves and their kids is
lifechanging. CMS is committed to ensuring our nation's marginalized communities and low-income families have the coverage they
need,' FN40]

ACA Special Enrollment Sees 2 million New Signups Across Country

(Regulatory Intelligence) - New health coverage enrollment on the Affordable Care Act's U.S. federal and state exchanges passed
2 million by the end of June, during the special sign-up period which began earlier this year, data from the Centers for Medicare &

Medicaid Services showed. N41!

U.S. health agencies are open to the possibility of extending the special enrollment period (SEP) beyond the August 15 deadline and
are looking for guidance from President Joe Biden on the potential extension, Xavier Becerra, Secretary of the U.S. Department of
Health and Human Services said on a call with journalists Wednesday. The current enrollment period began on February 15.

Data from June shows 1.5 million consumers signed up on the federal exchange since the start of the special enrollment period, a
rise of 300,000 from last month. An additional 600,000 enrolled in coverage by the end of June through 15 state-based marketplaces
that opened for special enrollments after the announcement from the Biden administration. The CMS has released consolidated state
enrollment data for the first time this month. Enrollment in ACA plans has continued to climb a month after a landmark ruling from the
U.S. Supreme Court dismissed a challenge to the constitutionality of the health law.

The Biden administration has used the ACA as a vehicle to route healthcare relief to people seeking coverage during the pandemic and
introduced multiple subsidies and tax credits to make coverage affordable to more people.

'The American Rescue Plan has made health coverage more affordable and accessible than ever ? and people are signing up,' CMS
Administrator Chiquita Brooks-LaSure said.

The administration also directed about $80 million in funding to outreach efforts to promote sign ups on the healthcare exchanges.
Biden also increased funding for Medicaid to states at a time when states' suspension of stringent enrollment criteria also made more
people eligible for federal government-subsidized coverage.

Biden Administration to Invest More Than $1.6 Billion to Support COVID-19 Testing and Mitigation in Vulnerable Communities

As part of the Biden-Harris Administration's ongoing COVID-19 response efforts, the U.S. Department of Health and Human Services
(HHS) will invest more than $1.6 billion from the American Rescue Plan to support testing and mitigation measures in high-risk
congregate settings to prevent the spread of COVID-19 and detect and stem potential outbreaks, HHS announced on July 22.

As COVID-19 cases rise among unvaccinated people and where the more transmissible Delta virus variant is surging, this funding
will expand activities to detect, diagnose, trace, and monitor infections and mitigate the spread of COVID-19 in homeless shelters,
treatment and recovery facilities, domestic violence shelters and federal, state and local correctional facilities? some of the hardest hit
and highest risk communities across the country.

'As we continue the vaccination program to get more Americans protected, it is important that we double down on our efforts to increase
testing especially in vulnerable communities," said HHS Secretary Xavier Becerra. 'Thanks to the American Rescue Plan, we can make
sure high-risk environments like correctional facilities and shelters for those experiencing homelessness have greater capacity for
testing to prevent potential outbreaks and continue our nation's progress in moving out of the pandemic."

This funding will support expanded COVID-19 testing and mitigation measures for:

Mental Health and Substance Use Providers: HHS, through the Substance Abuse and Mental Health Services Administration
(SAMHSA), will invest $100 million to expand dedicated testing and mitigation resources for people with mental health and substance
use disorders. This funding provides supplemental funding to both the substance abuse prevention and treatment and community
mental health services block grant state grantees for rapid onsite COVID-19 testing and for facilitating access to testing services.
Funds are available to provide behavioral health services to staff working as contact tracers and other members of the COVID-related
workforce, training and technical assistance on implementing rapid onsite COVID-19 testing and facilitating access to behavioral
health services, including the development of onsite testing confidentiality policies personal protective equipment (PPE), supporting

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mobile health units, particularly in medically underserved areas, and expanding local or tribal programs workforce to implement COVID
-response services for those connected to the behavioral health system.

Shelters for People Experiencing Homelessness, Group Homes and other Congregate Settings: HHS, in partnership with the
Department of Housing and Urban Development (HUD) and the Centers for Disease Control and Prevention (CDC), will invest $80
million to support state and local COVID-19 testing and mitigation measures among people experiencing homelessness, residents
of congregate settings including group homes, and encampments. State health departments will use this funding to hire workers

to coordinate resources, develop strategies and support existing community partners to prevent infectious disease transmission in
these settings. State health departments will also use this funding to procure COVID-19 tests and other mitigation supplies such as
handwashing stations, hand sanitizer and masks for people experiencing homelessness and for those living in congregate settings.

Federal, State and Local Prison Populations: HHS, in partnership with the Department of Justice's (DOJ) Federal Bureau of Prisons,
will invest $169 million to advance testing and mitigation efforts in federal congregate settings. This will include funding to support
routine testing and surveillance for outbreak and non-outbreak situations in accord with public health recommendations. This funding
will also be used to support ongoing vaccination efforts and the necessary hospital costs associated with this pandemic. HHS also
announced that CDC, in partnership with DOJ's Office of Justice Programs, is distributing $700 million to 64 state and local jurisdictions
to help prevent the spread of COVID-19 in confinement facilities, including prisons, jails, and juvenile confinement facilities. These
funds will allow facilities to implement COVID-19 diagnostic and screening programs for people who are incarcerated, staff, and
visitors. Funds also may be used to support other activities, including COVID-19 contact tracing, isolation and quarantine strategies,
infection control practices, and education and training on ways to minimize the spread of COVID-19 for facility staff and people who are
incarcerated/detained.

Local Domestic Violence Shelters and Tribal Shelters Supportive Services for Survivors of Domestic and Dating Violence:
HHS, through the Administration for Children and Families (ACF), will invest $550 million in the Family Violence Prevention and
Services Program to support state and tribal programs for detecting, diagnosing, and mitigating infections for adults, children, and
youth experiencing domestic violence and dating violence. This funding will also support cultural competency training and technical
assistance for implementing rapid onsite COVID-19 testing and facilitating access to mobile health unit services for adult and youth
victims of family violence, domestic violence, or dating violence, and their dependents, including the development of onsite testing
confidentiality policies, procurement of PPE, enhancing information technology, data modernization, and to coordinate confidential
reporting with local health departments.

ACA Special Enrollment Hits 2.5 million Ahead of Signup Deadline

(Regulatory Intelligence) - More than 2.5 million people have signed up for health insurance coverage on the federal and state
marketplaces during the special enrollment period slated to close on August 15, buoyed in part by large premium subsidies and more

outreach efforts by the federal government. [FNA2]

Signups soared 64 percent in the last week of July, taking enrollment on the federal healthcare exchange to 1.8 million since the
administration of President Joe Biden announced the opening of a special enrollment period, orSEP, from February 15, data from the
U.S. Centers for Medicare and Medicaid showed.

CMS data showed about 723,000 others enrolled for coverage through the 15 state-based marketplaces that opened their own
exchanges to new enrollments after the federal government's announcement.

'That is 2.5 million people who can rest easier knowing that they can go to the doctor without taking on debt,' Vice President Kamala
Harris said. 'This is especially important now, while we are in the middle of a major public health crisis.

Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, has shown a willingness to extend the duration of the
SEP beyond its August 15 deadline if Biden supports the idea, but the president has yet to publicly signal his interest in delaying the
closure of the SEP.

Biden and his administration have used the Affordable Care Act as one of their crucial vehicles to provide health protections during the
COVID-19 pandemic. His predecessor Donald Trump, a fierce critic of the ACA, had refused to open a special enrollment period when
the pandemic first spread through the United States in 2020.

The American Rescue Plan passed in March this year gave large premium subsidies and tax credits to a wider section of the population
buying insurance in the individual healthcare marketplace. CMS data showed over a third of the customers on the federal healthcare
exchange found coverage for $10 or less per month, while families saved $40 per person per month on premiums from the newly
available premium credits.

Deductibles also dropped, with the median plan deductible falling by nearly 90 percent to $50 from $450. Biden has proposed to extend
these lower premiums as part of his broader healthcare and pandemic relief agenda.

Medicaid and Children's Health Insurance Program (CHIP) enrollment also touched a record high of nearly 81.7 million now receiving
coverage, as of March 2021.

Biden Urges U.S. Congress to Take Steps to Lower Prescription Drug Costs

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(Reuters) - President Joe Biden on Thursday called on U.S. lawmakers to enact legislation aimed at lowering drug prices, including
allowing Medicare to negotiate drug prices and imposing penalties on drugmakers that hike prices faster than inflation. [FN43]

The Democratic president's remarks laid out his vision to help reduce the costs for prescription medications as part of the Build Back
Better agenda he is seeking to push through Congress as the nation continues to grapple with the COVID-19 pandemic.

Pharmaceutical manufacturers have earned high praise for quickly developing vaccines against the novel coronavirus. But the outbreak
of the highly contagious disease, which upended the economy and has so far killed more than 617,000 people in the United States,
also drew renewed attention to healthcare costs.

Biden on Thursday lauded drugmakers for their life-saving work developing the COVID-19 vaccines.

'But we can make a distinction between developing these breakthroughs and jacking up prices on a range of medications for a range of
everyday diseases and conditions,' he said in remarks at the White House.

Biden said U.S. prescription drug costs were higher than any other nation in the world by two to three times.

Drugmakers, reeling from a reduction in doctor visits and demand for some drugs amid the pandemic, raised prices on more than 500
medicines, an analysis released in January showed.

After passing a $1.9 trillion coronavirus-related bill in March, Democrats adopted a two-pronged strategy - a $1 trillion hard
infrastructure plan that passed the Senate this week and a forthcoming $3.5 trillion spending measure for so-called human
infrastructure.

That spending plan would expand Medicare to include dental, vision and hearing benefits as well as lower the eligibility age, among
other healthcare, climate and childcare provisions. More than 61.2 million people have coverage under the Medicare health insurance
program for the elderly and disabled, according to the Centers for Medicare and Medicaid Services (CMS).

'MISGUIDED APPROACH'
Biden wants CMS to be able to negotiate for a subset of the highest-cost drugs that have no competitors.

'We're going to provide that competition through Medicare. Medicare is going to negotiate a fair price,' he said. 'Drug companies would
have to sell their drugs to all distributors at the Medicare price or face up to a 95 percent excise tax. The savings for employers and
employees would be billions of dollars a year.'

Biden's proposal is not well-liked by companies. The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade
association, called it a 'misguided approach.'

'The price controls proposed by the Biden administration are nothing more than a tax on the research investments that have made
break-throughs, like the COVID vaccines, possible,' U.S. Chamber of Commerce Vice President Neil Bradley said in a statement on
behalf of the business lobby group.

'Price controls will result in less research investment and fewer U.S. jobs, leaving America unprepared for the next public health crisis
and delaying the development of treatments for cancer, Alzheimer's and many other diseases,' he said.

About 1.6 million More Americans Had Health Insurance in 2020 - CDC
(Reuters) - About 1.6 million more Americans had some form of health insurance coverage despite the COVID-19 crisis last year,
helped mainly by enrollment growth in government-sponsored health plans, early data from a U.S. government office showed. IFN44]

Estimates based on a household survey by the statistics division of the U.S. Centers for Disease Control and Prevention showed on
Tuesday that a total of 31.6 million, or 9.7% of Americans of all ages, were uninsured last year, down from 33.2 million in 2019.

Among Americans of all age groups, the number of people with public health plan coverage grew by 2.1 million to 123.5 million in 2020,
while those that had private health insurance grew by 1.9 million to 200.6 million.

The United States last year saw a steep rise in job cuts compared to 2019, as companies were forced to lay off employees to cope with
the COVID-19 pandemic.

About 14% of Americans between the ages of 18 and 64 were uninsured last year, compared to 14.7% in 2019.

Hispanic adults were the most likely to lack health insurance coverage, followed by non-Hispanic black adults, the National Center for
Health Statistics survey showed.

Americans with a family income of less than 100% of the federal poverty level, had the highest percentage of coverage from public
health plans such as those of Medicaid, Medicare or children's health insurance program, the survey showed.

Officials said the estimates for last year could be impacted by lower response rates, as lockdowns due to the pandemic forced data
collection to switch to a telephone-only mode beginning March 2020.

Biden Administration to Require COVID-19 Vaccinations in CMS-certified Facilities

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The Biden administration will require COVID-19 vaccination of staff within all Medicare and Medicaid-certified facilities to protect both
them and patients from the virus and its more contagious Delta variant.

The Centers for Medicare & Medicaid Services (CMS), in collaboration with the Centers for Disease Control and Prevention (CDC),
announced on September 9 that emergency regulations requiring vaccinations for nursing home workers will be expanded to include
hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in
the Medicare and Medicaid programs. The decision was based on the continued and growing spread of the virus in health care settings,
especially in parts of the U.S. with higher incidence of COVID-19.

'There is no higher priority for us than patient health and safety. As the Delta variant strengthens, the Biden-Harris Administration is
committed to doing everything we can to keep patients, and those who care for them, safe," said U.S. Department of Health and Human
Services (HHS) Secretary Xavier Becerra. 'There is no question that staff, across any health care setting, who remain unvaccinated
pose both direct and indirect threats to patient safety and population health. Ensuring safety and access to all patients, regardless of
their entry point into the health care system, is essential."

Nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In
CMS's review of available data, the agency is seeing lower staff vaccination rates among hospital and End Stage Renal Disease
(ESRD) facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all providers and suppliers
that participate in the Medicare and Medicaid programs. Vaccinations have proven to reduce the risk of severe illness and death
from COVID-19 and are effective against the Delta variant. CMS will continue to work closely with all Medicare and Medicaid certified
facilities to ensure these new requirements are met.

'We know that those working in health care want to do what is best for their patients in order to keep them safe," said CMS
Administrator Chiquita Brooks-LaSure. 'As the Delta variant continues to spread, we know the best defense against it lies with the
COVID-19 vaccine. Data show that the higher the level of vaccination rates among providers and staff, the lower the infection rate is
among patients who are dependent upon them for care. Now is the time to act. I'm urging everyone, but especially those fighting this
virus on the front lines, to get vaccinated and protect themselves, their families, and their patients from COVID-19."

CMS is developing an Interim Final Rule with Comment Period that will be issued in October. CMS expects certified Medicare and
Medicaid facilities to act in the best interest of patients and staff by complying with new COVID-19 vaccination requirements. Health
care workers employed in these facilities who are not currently vaccinated are urged to begin the process immediately. Facilities are
urged to use all available resources to support employee vaccinations, including employee education and clinics, as they work to meet
new federal requirements.

U.S. Health Agency Establishes Climate Change and Health Equity Office

(Regulatory Intelligence) - The U.S. Department of Health and Human Services (HHS) is establishing an Office of Climate Change and

Health Equity (OCCHE) in response to President Joe Biden's executive order for a government wide effort to tackle climate change.
[FN45]

The office announced on Monday is the first to address to address the disparate effects of climate change on the health of
disadvantaged people at the national level. Its mission is 'to protect vulnerable communities who disproportionately bear the brunt of
pollution and climate-driven disasters, such as drought and wildfires, at the expense of public health.'

'History will judge us for the actions we take today to protect our world and our health from climate change. The consequences for our
inaction are real and worsening. We've always known that health is at the center of climate change, and now we're going to double-
down on a necessity: fighting climate change in order to help protect public health in our communities," HHS Secretary Xavier Becerra
said in a release.

'COVID-19 highlighted the inequities faced throughout our nation. Unfortunately, some of the same groups disproportionately impacted
by COVID-19 will be the same groups struggling the most with the effects of climate change on our health. We will use the lessons
learned from COVID-19 to address these disparities, prioritizing and protecting the nation's health," said HHS Assistant Secretary for
Health Dr. Rachel L. Levine.

Many disadvantaged communities currently bear the brunt of climate-induced risks from extreme heat, poor air quality, flooding,
extreme weather events, and vector borne diseases, according to HHS. Although the impacts of climate change will be felt by all
Americans, HHS said they will be deeper and longer lasting among the poor, people of color and other populations.

HHS also cited World Health Organization (WHO) estimates that at least 250,000 deaths will occur every year between 2030 and 2050
due climate change. WHO also estimates that direct damage costs to health will be between $2 billion to $4 billion by 2030.

The Office of Climate Change and Health Equity will prioritize:

Identifying communities with disproportionate exposures to climate hazards and vulnerable populations.
Addressing health disparities exacerbated by climate impacts to enhance community health resilience.
Promoting and translating research on public health benefits of multi-sectoral climate actions.

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Assisting with regulatory efforts to reduce greenhouse gas emissions and criteria air pollution throughout the health care sector,
including participating suppliers and providers.

Fostering innovation in climate adaptation and resilience for disadvantaged communities and vulnerable populations.

Providing expertise and coordination to the White House, Secretary of Health and Human Services and federal agencies related
to climate change and health equity deliverables and activities, including Executive Order implementation, and reporting on health
adaptation actions under the United Nations Framework Convention on Climate Change.

Promoting training opportunities to build the climate and health workforce and empower communities.

Exploring opportunities to partner with the philanthropic and private sectors to support innovative programming to address disparities
and health sector transformation.

The office will also facilitate the use of regulatory and statutory powers of HHS to address matters affecting 'disadvantaged
communities and people on the front lines of the climate crisis."

Nearly 3 million Americans Sign up for Healthcare During Special Enrollment Period
(Reuters) - Nearly three million Americans have signed up for health insurance on the U.S. government website Healthcare.gov during
a special enrollment period that began on Feb. 15, President Joe Biden said in a statement on Wednesday. [FN46]

Biden, a Democrat, re-opened the online health insurance marketplace to give more Americans a chance to take advantage of benefits
provided under the Affordable Care Act, also known as Obamacare.

The special enrollment period was open through Aug. 15.

'The peace of mind that comes from having affordable, quality health coverage should be a right - not a privilege - for every
American,' Biden said.

Biden said altogether 12.2 million Americans are enrolled in coverage under the Affordable Care Act, which is an all-time high.

More than four in 10 Americans who gained coverage during the special enrollment period found a plan for $10 or less a month, he
said.

Twenty states and the District of Columbia saw premiums decrease by more than $75 a month. Out-of-pocket spending also declined
with the median deductible for new enrollees dropping by more than 90%, from $750 to $50, Biden said.

Safety Nets Kept U.S. Uninsured Rate Steady During Pandemic, HHS Says
(Reuters) - Enrollment in U.S. government-run health insurance program Medicaid during the COVID-19 pandemic grew 16%, with
more than 11 million additional Americans signing up, the Department of Health and Human Services said on Friday. [FN47]

Safety nets like Medicaid and re-opening enrollment through the Affordable Care Act helped stabilize uninsured rates even while
millions lost employer-related health insurance coverage as the pandemic rattled the U.S. economy, the department said.

'The COVID-19 pandemic has disrupted our lives in many ways, yet today's report shows we made significant strides to protect
Americans' health,' said HHS Secretary Xavier Becerra.

The pandemic disrupted the federal surveys that the HHS relies on for coverage estimates, the agency said in a report tracking health
insurance coverage. It added lower response rates, especially among lower income and younger respondents, may have affected the
accuracy of its estimates.

The data showed a stable uninsured rate in 2020, with estimates ranging from 8.6% to 9.7% of the population, about 28-31.6 million
people. Around 30 million U.S. residents were uninsured in 2019, before the pandemic, federal surveys show.

The uninsured rate was significantly higher in Hispanic populations at 18.3%, residents of states that did not expand Medicaid coverage
at 17.6%, people below the poverty line at 17.2%, and Black populations at 10.4%, Friday's report showed.

Addressing these disparities is a top priority for the President Joe Biden's administration, the department said.

The data comes ahead of the enrollment period for the online health insurance marketplace created by the ACA, also known as
Obamacare, for 2022, set to open on Monday and close on Jan. 15.

Around 2.8 million people signed up for health insurance on government website Healthcare.gov after Biden re-opened enrollment for a
special period from Feb. 15 to Aug. 15 in part because of the pandemic.

The Democrat ran in 2020 on a promise to curb growing inequality, including expanding access to healthcare and affordable drugs
amid a pandemic that has killed over 745,000 people so far.

Biden presented a negotiated social spending plan on Thursday to Congress and voters.

It expands ACA premium tax credits through 2025 and adds coverage of hearing costs for people 65 and older, but notably lacked
significant Medicare and Medicaid coverage expansions as well as drug price reform.

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HHS Report Highlights How the No Surprises Act Will Prevent Surprise Medical Bills

A new report from the U.S. Department of Health and Human Services (HHS) highlights that millions of Americans with private health
insurance experience some kind of surprise medical billing. The report, which was written by researchers in HHS's Office of the
Assistant Secretary for Planning and Evaluation (ASPE), found that surprise medical bills are relatively common among privately-
insured patients and can average more than $1,200 for services provided by anesthesiologists, $2,600 for surgical assistants, and $750
for childbirth-related care. While many states have taken steps to try to address surprise billing, state laws have left critical consumer
protection gaps that will be addressed when the No Surprises Act takes effect in 2022.

'No one should have to worry about going bankrupt after falling ill or seeking critical care," said Health and Human Services Secretary
Xavier Becerra. 'Today's report shows that despite some state efforts to tackle surprise medical bills, patients continue to experience
exorbitant medical expenses due to lack of transparency and rules. The Biden-Harris Administration will continue implementing federal
regulations from the No Surprises Act to not only protect the patients but also curb rising costs in health care."

Consumers often expect their employer-sponsored insurance will shield them from high out-of-pocket costs for emergency services.
Unfortunately, the ASPE report reveals that an estimated 18 percent of emergency room visits by individuals with large employer
coverage resulted in one or more out-of-network charges, and this percentage varies greatly by state, ranging from a low of 3 percent
in Minnesota to a high of 38 percent in Texas. These costs can be quite alarming to consumers. Another finding in the report is that
patients receiving a surprise bill for emergency care paid physicians more than 10 times as much as patients without a surprise bill for
emergency care.

In the absence of prior congressional action, several states have enacted laws aimed at combatting surprise medical billing. The

ASPE report describes how 18 states have comprehensive approaches to address surprise medical billing, while an additional 15
states have taken partial steps. These efforts include establishing standard payment rates to restrict high variation for out-of-network
charges and dispute resolution processes to resolve additional payments for which patients may no longer be held responsible.
Unfortunately, despite their best efforts, state laws have significant limitations in protecting many patients from surprise medical billing.
Most importantly, state insurance rules do not apply to self insured employee benefit plans, which cover 67 percent of workers with
employer sponsored health coverage. Additionally, research has found that some state efforts to resolve surprise billing payment
disputes have resulted in increased health care costs. The Administration's implementation of NSA are designed to address these gaps
in state policies and apply protections against surprise billing nationwide.

Accordingly, in implementing the bipartisan NSA, the Biden-Harris Administration issued a series of regulations that, starting January
1, 2022, will finally provide patients with individual or employer health coverage relief from surprise medical billing and reduce health
care costs. Individuals with most individual and employer insurance can no longer be balance-billed for emergency and certain non-
emergency services in most circumstances. Patients will be removed from payment disputes that must be settled between providers
and insurers. Further, the Congressional Budget Office predicted that the No Surprises Act will reduce health insurance premiums for
consumers.

The Administration recently released an interim final rule with comment period detailing the process for resolving disputed claims that
takes consumers out of the dispute and ensures they do not end up with surprise bills. The Administration is still welcoming comments
on this rule and will carefully review all that it receives.

While the Administration will be collecting more information in the future to further bolster consumer protections and reduce health care
costs, today's ASPE report underscores the critical need for immediate nationwide protections to ban surprise medical billing.

© Copyright Thomson/West - NETSCAN's Health Policy Tracking Service

 

[FN2]

. Antonita Madonna, U.S. health agency mandates review of regulations every 10 years, Thomson Reuters Regulatory Intelligence
(January 11, 2021).

[FN3]

. Antonita Madonna, Biden orders review of regulations that restrict Affordable Care Act, reopens enrollment, Thomson Reuters
Regulatory Intelligence (January 29, 2021).

[FN4]

. Antonita Madonna, Large enrollment gains on ACA marketplace ahead of expected boost from COVID relief, Thomson Reuters
Regulatory Intelligence (March 5, 2021) at http://go-ri.tr.com/JIIQfF.

[FN5]

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. Antonita Madonna, Affordable Care Act gets its biggest boost in a decade from Biden's COVID relief, Thomson Reuters Regulatory
Intelligence (March 12, 2021) at http://go-ri.tr.com/deMXLb.

[FN6]

. Ted Hesson, Kristina Cooke, Trevor Hunnicutt and Mohammad Zargham, Biden rescinds Trump-era health insurance requirement for
new immigrants, Reuters (May 14, 2021).

[FN7]

. Antonita Madonna, Price transparency rules may stay as deadline looms for U.S. health insurers, Thomson Reuters Regulatory
Intelligence (March 26, 2021).

[FN8]

. Melissa D. Berry, U.S. regulations now require increased electronic health information sharing, Thomson Reuters Regulatory
Intelligence (April 8, 2021).

[FN9]

. Press release, "CMS to Adopt Rules to Lower Health Care Costs in 2022 Federal Health Insurance Marketplace Plans," CMS
Newsroom, April 30, 2021, available at https:/Avww.cms.gov/newsroom/press-releases/cms-adopt-rules-lower-health-care-costs-2022-
federal-health-insurance-marketplace-plans.

[FN10]
. To receive email updates from CMS, visit cms.gov and complete the "Receive Email Updates" bar on the bottom right of the opening
page.

[FN11]

. CMS email update, "Interoperability and Patient Access final rule (CMS-9115-F) Guidance and FAQs," May 10, 2021.

[FN12]

. 'Advance Copy- Interoperability and Patient Access Rule- Admission, Discharge, and Transfer Notifications for Hospitals, Psychiatric
Hospitals, and Critical Access Hospitals (CAHs) Interpretive Guidance," QSO-21-18 Hospitals/CAHs, CMS, May 7, 2021, available at:
https:/Avww.cms.gov/files/document/qso-21-18-hospitals-cahs. pdf.

[FN13]

. 'Interoperability and Patient Access Final Rule (CMS-9115-F) Frequently Asked Questions (FAQs)," CMS, available at: https://
www.cms.gov/files/document/faqs-interoperability-patient-access-and-cop-event-notifications-may-2021.pdf.

[FN14]

. Antonita Madonna, U.S. health agency to raise ceiling on hospital price transparency fine to $2 million, Thomson Reuters Regulatory
Intelligence (July 21, 2021).

[FN15]

. Melissa D. Berry, Biden's executive order moves to improve competition in U.S. healthcare, Thomson Reuters Regulatory Intelligence
(July 19, 2021).

[FN16]

. Susan Heavey and Carl O'Donnell, U.S. government to tackle Medicare drug payments to try to cut costs, Reuters (September 9,
2021).

[FN17]

. Melissa D. Berry and Antonita Madonna, U.S. agencies release second surprise-billing health care rule, Thomson Reuters Regulatory
Intelligence (October 5, 2021).

[FN18]

. Melissa D. Berry, U.S. health agency releases climate adaptation and resilience plan, Thomson Reuters Regulatory Intelligence
(October 19, 2021).

[FN19]
. Brendan Pierson, Federal judge blocks Trump administration drug pricing rule, Reuters (December 23, 2020).

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[FN20]
. Jonathan Stempel, U.S. appeals court upholds Trump health care price disclosure rule, Reuters (December 29, 2020).

[FN21]
. Lawrence Hurley, Biden administration asks U.S. Supreme Court to dump Medicaid work case, Reuters (February 22, 2021).

[FN22]
. Brendan Pierson, Texas sues Biden administration over loss of Medicaid waiver, Reuters (May 14, 2021).

[FN23]
. Lawrence Hurley, U.S. Supreme Court rebuffs insurers on Obamacare reimbursements, Reuters (June 22, 2021).

[FN24]

. Press release, "Senator Murray Announces Plans to Develop a Public Option Proposal to Lower Health Care Costs," United Sfates
Senator Patty Murray Working for Washington State Newsroom, May 26, 2021, available at https:/Avwww.murray.senate.gov/public/
index.cfm/newsreleases?ID=8FF 12431 -5247-4677-95D3-68AFFA4E5491.

[FN25]

. Alonso-Zaldivar, Ricardo, "Leading Dems seek input on ?public option' health care plan," AP, May 26, 2021, available at https://
apnews.com/article/donald-trump-health-care-reform-business-health-government-and-politics-bbc45a9528f5852f0726ddf3cbe45ee5.

[FN26]

. Antonita Madonna, U.S. health agency proposes rule to restrict surprise billing, Thomson Reuters Regulatory Intelligence (July 6,
2021).

[FN27]

. Press release, "CMS Proposes Rule to Increase Price Transparency, Access to Care, Safety & Health Equity," CMS.gov, July 19,
2021, available at https:/Awww.cms.gov/newsroom/press-releases/cms-proposes-rule-increase-price-transparency-access-care-safety-
health-equity.

[FN28]

. Susan Heavey and Carl O'Donnell, U.S. government to tackle Medicare drug payments to try to cut costs, Reuters (September 9,
2021).

[FN29]
. See 86 Fed. Reg. 58042.

[FN30]
. Lawrence Hurley, Major rulings including Obamacare loom for U.S. Supreme Court, Reuters (June 1, 2021).

[FN31]

. Antonita Madonna, U.S. Supreme Court upholds Affordable Care Act for the third time, Thomson Reuters Regulatory Intelligence
(June 18, 2021).

[FN32]

. Antonita Madonna, Biden, Congress initiatives would bolster Affordable Care Act, Thomson Reuters Regulatory Intelligence (February
11, 2021).

[FN33]

. Antonita Madonna, Senate confirms Becerra to cabinet role as U.S. health secretary, Thomson Reuters Regulatory Intelligence
(March 19, 2021) at http://go-ri.tr.com/nZTMFk.

[FN34]

. Antonita Madonna, Biden administration again extends healthcare special enrollment period, Thomson Reuters Regulatory
Intelligence (March 24, 2021) at http://go-ri.tr.com/60Ng7M.

[FN35]

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. Antonita Madonna, Biden administration reinstates healthcare protections for gay, transgender people, Thomson Reuters Regulatory
Intelligence (May 11, 2021).

[FN36]

. Antonita Madonna, U.S. ACA healthcare special-enrollment signups hit 1 million, Biden seeks permanent cost relief, Thomson Reuters
Regulatory Intelligence (May 12, 2021) at http://go-ri.tr.com/o16As9.

[FN37]

. Steve Holland and Susan Heavey, U.S. to bolster public health workforce to fight COVID-19, future pandemics, Reuters (May 13,
2021) at https:/Avww.reuters.com/business/healthcare-pharmaceuticals/us-bolster-public-health-workforce-fight-covid-19-future-
pandemics-2021-05-13/.

[FN38]

. Melissa D. Berry, U.S. HHS reminds health providers and insurers that COVID testing, vaccines must be free, Thomson Reuters
Regulatory Intelligence (June 11, 2021) at http://go-ri.tr.com/IvdDd3.

[FN39]

. News Release, "New Medicaid and CHIP Enrollment Snapshot Shows Almost 10 million Americans Enrolled in Coverage During the
COVID-19 Public Health Emergency," HHS, July 1, 2021, available at: https://www.hhs.gov/about/news/2021/06/21/new-medicaid-and-
chip-enrollment-snapshot-shows-almost-10-million-americans-enrolled.html.

[FN40]

. News Release, "New Medicaid and CHIP Enrollment Snapshot Shows Almost 10 million Americans Enrolled in Coverage During the
COVID-19 Public Health Emergency," HHS, July 1, 2021, available at: https:/Awww.hhs.gov/about/news/2021/06/21/new-medicaid-and-
chip-enrollment-snapshot-shows-almost-10-million-americans-enrolled.html.

[FN41]

. Antonita Madonna, ACA special enrollment sees 2 million new signups across country, Thomson Reuters Regulatory Intelligence (July
16, 2021).

[FN42]

. Antonita Madonna, ACA special enrollment hits 2.5 million ahead of signup deadline, Thomson Reuters Regulatory Intelligence
(August 11, 2021).

[FN43]

. Susan Heavey, Jeff Mason and Michael Erman, Biden urges U.S. Congress to take steps to lower prescription drug costs, Reuters
(August 13, 2021).

[FN44]

. Amy Caren Daniel, Manojna Maddipatla and Caroline Humer, About 1.6 million more Americans had health insurance in 2020 - CDC,
Reuters (August 31, 2021).

[FN45]

. Melissa D. Berry, U.S. health agency establishes climate change and health equity office, Thomson Reuters Regulatory Intelligence
(September 1, 2021).

[FN46]

. Nandita Bose, Nearly 3 min Americans sign up for healthcare during special enrollment period, Reuters (September 15, 2021).

[FN47]
. Ahmed Aboulenein, Safety nets kept U.S. uninsured rate steady during pandemic, HHS says, Reuters (October 29, 2021).

Produced by Thomson Reuters Accelus Regulatory Intelligence 24-Jan-2022

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