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Find our analysis on legislation, regulations, MedPAC meetings, and more. 

Following Lawsuit, HHS Delays SUNSET Rule

Delays in your online shopping deliveries?  Yeah that’s annoying, and increasingly common even a year into COVID-10.  Delays in federal government rules?  Yeah that’s welcome news for health care stakeholders.  On March 18, the Department of Health and Human Services (HHS) delayed the effective date until 2022 of a controversial rule that requires HHS to review over 17,000 regulations.  The rule’s delay comes as a relief to health care providers, who worried the potentially herculean regulatory review process would create uncertainty across the health care industry and serve as a distraction from HHS’s efforts to address the pandemic.

Finalized on January 8, the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule calls for HHS to review any regulations over 10 years old to ensure they are up to date.  Any rules that are not reviewed or approved by 2026 will automatically expire.  However, the Biden Administration issued a regulatory freeze shortly after the President’s inauguration on January 20 that applied to all rules and regulations that had yet to be implemented.   With the regulatory freeze set to expire on March 21, the Biden Administration moved to delay the rule’s implementation until March 22, 2022.

In the announcement, HHS joined stakeholders in their concern over the lack of bandwidth to review properly hundreds of thousands of pages of rulemaking. Specifically, HHS noted the rule’s impact on the Food and Drug Administration’s ability to review medical product applications as well as higher uncertainty and compliance costs for Medicare providers and suppliers.

The rule, while delayed, is wrapped up in legal proceedings.  The American Lung Association and the National Association of Pediatric Nurse Practitioners filed a lawsuit in March against HHS to strike down the rule.  While not commenting on the litigation, the Biden Administration did note that delaying the SUNSET rule for one year is to allow the courts to conduct a “judicial review of its legality.”  If the courts fail to issue a ruling by March 2022, it is possible HHS will once again delay the SUNSET rule’s implementation. (Diazepam)

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PAYGO Cuts Face Uncertainty in Congress

While members of both parties agree the pending Medicare sequester needs to be extended, Republicans don’t seem favorable to waiving PAYGO budget rules to allow additional cuts to be averted.  The result is continued uncertainty for health care providers and a likely sign of spending fights to come in Congress.

Medicare is currently facing two automatic budget cuts.  Under the first cut, Congress was initially set to reduce 2% of the Medicare budget, or $18 billion, in Fiscal Year 2020 due to a process known as sequestration that provides an automatic spending reduction to enforce certain budgetary goals.  However, Congress opted to delay the 2% cut to April 1, 2021 due to the pandemic’s financial impact on health care providers.  The American Rescue Plan Act of 2021 (H.R. 1318) is scheduled to trigger a second cut to Medicare to the tune of 4%, or $36 billion.  This second cut is a requirement of the Pay-As-You-Go (PAYGO) budget rule, which says legislation that fails to offset spending increases must be offset by cuts to mandatory programs such as Medicare.  Unlike the sequester, PAYGO cuts would not go into effect until the beginning of 2022.

Health care stakeholders are adamantly opposed to the cuts.  In letters sent to congressional leadership on March 11 and March 17 respectively, the American Hospital Association and American Medical Association (AMA) requested lawmakers find a bipartisan solution to avoid the both the sequester and PAYGO-triggered spending reductions.   In particular, AMA urged Congress to avoid legislation that would again induce PAYGO cuts to avoid creating further uncertainty in the health care system.

The House is set to take up a bill on March 19 that would waive PAYGO for the American Rescue Plan and delay Medicare sequestration through the end of the 2021(H.R. 1868). While both Democrats and Republicans agree the sequester needs to be delayed again, Republicans do not seem favorable to waiving PAYGO.  In a March 16 hearing on H.R. 1868 by the House Rules Committee, Ranking Member Tom Cole (R-OK) implied the American Rescue Plan was too large due to lack of bipartisan cooperation, and that a smaller COVID-19 relief bill could have passed Congress without triggering PAYGO cuts.  Additionally, many Republicans may be unwilling to waive a budgetary rule that was directly triggered by a massive bill that passed without a single GOP vote.

Likewise, it is unclear what the Senate will do with the measure once it is sent over from the House.  Introduced by Jeanne Shaheen (D-NH) and Susan Collins (R-ME), S. 748 would extend the sequester moratorium through the end of the COVID-19 health emergency but did not address the broader PAYGO issue.  The bill pays for the limited extension by extending the time period for sequestration by one year, through Fiscal Year 2031.

Given the political dynamics of the overall PAYGO issue and with Democrats controlling the Senate by just one vote, it is unclear at this time whether the Senate would take up the House measure or the Shaheen/Collins bill.  Adding to the uncertainty is the upcoming congressional recess period where both chambers will be out of session starting March 29 until April 13.  At this point, there hasn’t been any signal yet that the Senate will take action next week to avoid the current March 31 sequestration relief expiration from taking effect.  However, we would anticipate action at some point, even if it would have to be made retroactive, given the overall bipartisanship that remains generally for giving providers relief from the projected cuts.

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Despite Reintroduction, Medicare for All, Medicare-X Proposals Face Limited Odds

With control of the White House and both chambers of Congress, Democrats are newly emboldened to expand access to health care coverage.  A group of progressives in the House are making another attempt at Medicare for All, while moderates in the House and Senate want to expand coverage via a public option.  However, lack of Republican support for either proposal means both are likely doomed.

Medicare for All

On March 17, Reps. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI) introduced the Medicare for All Act of 2021 (H.R. 1976).  The bill has so far attracted 109 co-sponsors, indicating the highest-ever level support in Congress for a national health insurance program.  While a Medicare for All bill has never advanced out of a congressional committee, advocates for single-payer feel the COVID-19 pandemic has laid bare the inefficiencies of the current health care system and made their case even stronger.  In a press release, Rep. Jayapal touted Medicare for All as a solution for the millions of Americans who lost employer-sponsored coverage because of the pandemic.

In addition to being a total non-starter with Republicans, Medicare for All faces two major obstacles.  One is resistance from health care stakeholders, who have long thrown cold water on single-payer proposals.  The Partnership for America’s Health Care Future, a coalition of insurer and provider organizations, issued a recent statement saying Medicare for All is unaffordable and would lead to lower quality.  Additionally, the US Chamber of Commerce said in press release that Medicare for All would reduce access to providers and hospitals.

The second major obstacle comes from within the Democratic party itself.  President Biden has clearly stated his preference for expanding access to coverage through a public health insurance option, one that moderate and centrist members of the party share.  While Biden has gradually moved leftward over the course of his political career, it is extremely unlikely he would champion a health care proposal that remains divisive among members of his own party.

Medicare X

Closer to the President’s ideological preferences for expanding coverage is the Medicare X Choice Act of 2021 (S. 386/H.R. 1227).  First introduced by Sens. Michael Bennet (D-CO) and Tim Kaine (D-VA) in 2017, this proposal would allow all Americans to purchase a public health insurance plan based on the Medicare program that would reimburse providers at the same rate Medicare currently does and allows patients to access providers that accept Medicare.  Supporters of Medicare X tout it as a more realistic proposal to achieve universal coverage that would be less disruptive to the health care system.  Additionally, a January 2020 poll from the Kaiser Family Foundation found a public option-based proposal is more favorable to a greater number of Democrats and Independents than Medicare for All.

The fact that Medicare X/a public option enjoys higher favorability than Medicare for All does not necessarily improve its odds of passage.  Medicare X is similarly unpopular with Republicans and given the party’s razor-thin control of the Senate, Democrats would likely have to use budget reconciliation to advance any kind of public option proposal.  While reconciliation was used to pass the Affordable Care Act (ACA) in 2010, it remains unclear if a proposal like Medicare X would meet the strict budgetary criteria required to be considered under budget reconciliation.  Furthermore, Congress is limited to the number of times it can use budget reconciliation in any given year, and Democratic leadership have yet to make any prognostications about what proposals it could consider under budget reconciliation in the future.

Implications

While Medicare for All and Medicare X are unlikely to become law anytime soon, a key implication of both proposals is their potential to hasten divisions between progressive and moderate Democrats.  Since the start of the Biden Administration, both wings of the party have largely set aside their differences to advance key components of the President’s agenda, including cabinet nominations and a sweeping $1.9 trillion COVID-19 relief package.  While the House, and some argue the Democratic Party, have moved more to the left – it remains clear that moderate Democrats in the Senate maintain a high level of power over the fate of any legislation in the upper chamber.  Disagreements over health care proposals have the potential to disrupt broader legislative goals from the White House, such as immigration, infrastructure, or tax reform.

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Looking to the Future of Telehealth

Telehealth is here to stay, said participants of a March 12 Axios forum on how technology is impacting the health care system.  However, that doesn’t mean telehealth is without its problems, and the participants separately warned of concerns related to privacy, health disparities, and connectivity going forward.

1)  Patient Data.  Sen. Bill Cassidy (R-LA) explained how increased use of telehealth has the potential to allow for misuse of patient data.  He warned an insurer could hypothetically pull data from a smartwatch belonging to a person in the early stages of Parkinson’s disease and increase premiums based on what the data reveals about the person’s movement.  Alternatively, the Senator theorized a health care provider could use the same smartwatch data to stage an early medical intervention.  Thus, Cassidy emphasized a need to ensure health data is being used to help patients and not for nefarious reasons.

2)  Health Disparities.  Additionally, Deneen Vojta, MD (UnitedHealth Group) pointed out how telehealth has laid bare the extent of health disparities in America.  Moving forward, she predicted providers will “focus relentlessly” on addressing disparities by analyzing health data and encouraging more training on data science.  On a side note, Vojta also suggested policymakers standardize quality reporting for telehealth encounters.

3)  Fragmentation.  While telehealth has made strides over the past year, Ryan Panchadsaram (US Digital Response) said there is still room for improvement.  Much of the telehealth ecosystem remains fragmented, and Panchadsaram stressed a need to ensure more systems can work with each other by promoting interoperability and transparency.  To break the logjam on flow of health data, Panchadsaram recommended implementing a unique patient identifier, which could be made voluntarily to preemptively address privacy concerns.

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CMS Puts Geo Model on Hold

On March 1, the Center for Medicare and Medicaid Services (CMS) announced its Geographic Direct Contracting Model is “currently under review” until further notice.   While CMS has yet to provide a reason for the pause, criticism from industry stakeholders and the new Center for Medicare and Medicaid Innovation (CMM) Director may explain the pause.

Announced in December 2020, the Geographic Direct Contracting Model, or the “Geo Model,” envisions using direct contracting entities (DCEs) to build integrated relationships with health care providers and coordinate care for Medicare beneficiaries in designated geographic regions.  The model, which had been under development for two years, builds on lessons learned from the Next Generation ACO model, Medicare Advantage, and other initiatives.

However, the Geo Model is the only CMMI model that has been paused by the new Administration so far.   In the absence of an official justification from CMS, one of the reasons why the model may have been put on hold was criticism from health care stakeholders.  In a December 2020 letter to then-CMMI Director Brad Smith, the National Association of ACOs warned the model could generate confusion among beneficiaries over who is compelled to participate.  Additionally, the Center for Medicare Advocacy urged the then-Biden Transition Team in a December 2020 letter to halt the Geo Model due to uncertainty over how the model would work with other forms of insurance such as Medigap.

The move to suspend the Geo Model is not entirely without precedent.  The Biden Administration paused or withdrew numerous actions by the previous Administration since assuming power, which is typical for new presidential administrations.  For instance, CMS has withdrawn proposed rules on oversight for accrediting organizations, revisions to dialysis coverage requirements, and changes to Medicare Part A enrollment requirements since January 20.

It should be noted that not all stakeholders oppose the Geo Model.  In a March 4 letter, America’s Physician Groups urged CMMI to restart the model as soon as possible due to “extensive financial investments” participating providers have already made in preparation for the model’s launch, as well as a genuine belief that the model represents a meaningful shift away from the fee-for-service model.

In addition to external criticism, pressure to put the Geo Model on hold may have come from within CMMI itself.  Recently, the Biden Administration tapped Liz Fowler to serve as CMMI Director.  Prior to her new leadership role at CMS, Fowler served as Executive Vice President for Programs at the Commonwealth Fund, where she co-authored a December 2020 blog post about the Geo Model.  While the blog post largely served as an explainer for the model, it raised several questions, including how CMS would be able to produce savings CMS had projected and whether CMS is adequately tracking beneficiaries’ use of services under the model.

Thus, pressures from both inside and outside CMS have likely led to the Administration’s decision to suspend the model for the time being.  That said, while not knowing yet where CMMI may take the geographic-based care and payment model, it certainly seems possible that the Administration could choose to pause other CMMI models in the future.

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