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Law360 (March 11, 2021, 5:13 PM EST) --
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| Miranda Franco |
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| Suzanne Joy |
All were key architects behind the drafting and implementation of the Affordable Care Act, Becerra as a congressman serving on the U.S. House of Representatives' Ways and Means Committee, Brooks-LaSure as a staffer on the committee, and Fowler at the U.S. Senate Finance Committee under former Chairman Max Baucus, D-Mont.
Brooks-LaSure and Fowler have extended health care resumes, both previously serving in various capacities at CMS and Brooks-LaSure at the Office of Management and Budget, while as attorney general for California, Becerra led 20 states and the Washington, D.C., in defending the ACA.
If confirmed, Becerra would be the first Latino and Brooks-LaSure the first African American woman to hold both posts. The picks shed additional light on what are already gearing up to be top priorities of the new Biden administration.
Health Equity
Addressing health inequities will be a key focus for the Biden administration and is expected to have bipartisan support from Congress. In an executive order,[1] Biden ordered a review of the public charge rule, issued by the Trump administration's U.S. Department of Homeland Security in 2019.
The rule allows federal officials to consider whether immigrants are receiving or are likely to receive Medicaid or other public benefits when reviewing their residency applications.
The rule remains in effect, but it is likely to either be rescinded by the Biden administration or enjoined by a court. Notably, Becerra, in his role as California's attorney general, denounced[2] the rule warning it would have "dire consequences for the vitality of California and undermine our State's investment in our communities and our commitment to supporting working families."
Both Brooks-LaSure and Fowler are known for their work to expand health care access and improve equity. They have both raised concerns about the lack of available data regarding disparities in health care treatments and outcomes.
The CMS Innovation Center is seen as a critical vehicle through which CMS can collect more data on health care disparities and rollout targeted interventions to reach underserved patient populations, particularly with Fowler at the helm.
Brooks-LaSure has also demonstrated a strong personal interest in reducing maternal mortality disparities, and has authored[3] articles noting the crucial role Medicaid can play in combating the crisis. Notably, the American Rescue Plan would[4] expand Medicaid benefits for pregnant and postpartum women.
COVID-19 Recovery and Vaccine Rollout
After the Johnson & Johnson vaccine received emergency FDA approval[5] in late February, the Biden administration announced it is on track for the entire U.S. adult population to have vaccines available by the end of May.
During his confirmation hearing, Becerra noted that the ongoing pandemic response would be HHS' top priority and emphasized collecting more comprehensive data, mapping DNA to track mutations, enhancing vaccine efforts, particularly for disadvantaged populations and expediting the FDA approval process.
The Biden administration announced[6] it would start providing vaccines directly to community health centers to ensure access for underserved communities.
The American Rescue Plan Act would[7] double down on COVID-19 testing and vaccine efforts, allocating $14 billion for vaccine distribution, $49 billion for COVID-19 testing and tracing, and $50 billion for the Federal Emergency Management Agency disaster relief fund. It also includes a provision to cover 100% of Medicaid vaccine costs and boost federal funding for community health centers.
Telehealth
Telehealth services have exploded during the pandemic amidst relaxation of payment and regulatory requirements across public and private payers. In December, CMS permanently added more than 60 new services to the approved Medicare telehealth services list.
Many of the temporary flexibilities afforded during the public health emergency, such as allowing telehealth services to be administered in patients' homes and outside rural geographic areas, will require a statutory change.
However, the issue has been getting quite a bit of attention on Capitol Hill, so action is reasonably likely, in which case Brooks-LaSure and CMS will be charged with the implementation.
Expect equitable access to telehealth services to be a priority of Brooks-LaSure when it comes to telehealth expansion, particularly around the issues of broadband access and reimbursement for audio-only services, which is seen by many as a critical way to expand telehealth access to rural, elderly and low-income communities.
Notably, several recent spending bills have included funding to expand federal telehealth programs and broadband expansion efforts.
Strengthening the ACA and Expanding Access
On Biden's third day in office, his administration issued executive orders[8] establishing an ACA special enrollment period due to the COVID-19 pandemic and ordering a formal review of many of the Trump-era policies designed to weaken the ACA, including broadening association health plans, slashing the marketing budget for the healthcare.gov website, and state waivers for essential benefit design and work requirements.
In late February, CMS asked 10 states with previously approved Medicaid work requirements to submit the information that would support leaving the programs in place.
Both Brooks-LaSure and Fowler have been vocal proponents for enhancing ACA coverage affordability. The American Rescue Plan Act would[9] increase exchange subsidies and encourage non-expansion states to expand their Medicaid programs by increasing the federal medical assistance percentage for such expansion by 5% for two years.
Brooks-LaSure has been a vocal proponent of incentivizing holdout states to expand Medicaid. If the above proposals stay in the final bill, Brooks-LaSure would be tasked with overseeing implementation.
Both Becerra and Brooks-LaSure have shown support in the past for a public option. However, during his confirmation hearing, Becerra threw cold water on the idea, reassuring Republicans that he would build upon existing private sector insurance rather than pursuing Medicare for All.
Meanwhile, the Supreme Court is expected to rule sometime this summer on California v. Texas, which concerns the individual mandate and whether the remainder of the law can stand without it. In February, the U.S. Department of Justice formally changed its position[10] in the case.
Value-Based Reimbursement
Most predict that under Fowler's charge, the CMS Innovation Center will shift its strategic focus away from ramping up financial risk towards expanding participation in alternative payment models.
One strategic decision that's less clear is whether the Innovation Center will continue its "test and see" strategy of rolling out multiple concurrent demonstrations at once or hone in its overall scope to focus on a few key strategic priority areas and roll out fewer larger, more scalable models, particularly in light of a recent Medicare Payment Advisory Commission draft recommendation[11] calling for it to do just that.
Fowler's previous comments shed some light on her priorities about Innovation Center priorities. For example, last year, Fowler questioned[12] whether the new Medicare geographic contracting model would adequately evaluate the quality of care. In any case, it will likely take a few months, if not years, for the Biden team to get acclimated and begin issuing new models.
Another question hanging in the balance is the extent to which the new HHS under Becerra will embrace the Physician-Focused Payment Model Technical Advisory Committee, or PTAC, the advisory panel of industry experts charged with the screening of private sector models for possible implementation by HHS.
To date, no PTAC-recommended models have been implemented by HHS,[13] which has led to widespread criticism and frustration from stakeholders[14] and the resignation[15] of a handful of PTAC members.
Another challenge facing the Innovation Center will be the various technical adjustments needed to value-based models and programs to account for the downstream impact of COVID-19 related service disruptions/patterns on risk adjustment, patient attribution, quality benchmarks and pricing targets.
Finally, stakeholders anxiously await to see how the Biden administration will address the final rules that were promulgated in the final days of the Trump administration to modernize the Physician Self-Referral Law, also known as the Stark Law, and Anti-Kickback Statute, which are both currently frozen for review and include new exceptions for value-based arrangements.
Many expect the Biden administration will allow the changes to go into effect in some capacity because they address longstanding stakeholder concerns and are considered by many to be long overdue. Still, it is unclear if Becerra will look to put his stamp on the previously finalized regulations.
Prescription Drug Spending
During his confirmation hearing, Becerra stated that the Trump administration took sides with its last-minute rule banning drug rebates, which is currently frozen for review, and that he would build on the nonbinding Section 340B advisory opinion that would require drug manufacturers to offer discounts to contract pharmacies acting on behalf of covered entities.
Eyes will also be on Fowler and the CMS Innovation Center to see how they handle the most-favored-nation drug pricing model, which was scheduled to go into effect Jan. 1, 2021, but was issued two injunctions which prevent CMS from implementing it until a public notice and comment period is completed.
The injunctions will also require a response from the Biden administration. Biden's health plan has called for some similar policies, including enabling consumers to import drugs from other countries, so it is unclear whether Fowler and the Biden administration will keep and build on the most-favored-nation model or abandon it to possibly pursue its own strategy.
Biden's health plan also included a number of other policies, including allowing Medicare to negotiate lower prices with drug manufacturers, penalizing price increases over the general inflation rate, limiting launch prices for drugs that do not face market competition accelerating the development of generics.
A recent Buy American executive order[16] would establish a new position at the Office of Management and Budget to review and approve waivers to medical products and components produced abroad and encourages review of potential supply chain issues, including over-reliance on foreign products.
Antitrust
While antitrust enforcement is not statutorily within the HHS secretary's purview, Becerra will still play an important role. Becerra has made battling health care consolidation a signature issue since he took office as California attorney general in 2017. It is anticipated that the DOJ and the Federal Trade Commission will be more aggressive in scrutinizing consolidation and mergers.
Next Steps
The Senate Finance Committee split along party lines on whether to advance Becerra on March 3, leaving it to Majority Leader Chuck Schumer, D-N.Y., to bring his nomination up for a full Senate vote. Despite the partisan divide around Becerra, it is expected he will be confirmed. Hearing dates for Brooks-LaSure's confirmation are yet to be set. The CMS Innovation Center position does not require Senate confirmation.
Miranda Franco is a senior policy adviser and Suzanne Joy is a senior public affairs adviser at Holland & Knight LLP.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] www.whitehouse.gov/briefing-room/statements-releases/2021/02/02/fact-sheet-president-biden-outlines-steps-to-reform-our-immigration-system-by-keeping-families-together-addressing-the-root-causes-of-irregular-migration-and-streamlining-the-legal-immigration-syst/.
[2] calmatters.org/wp-content/uploads/2018/12/Ltr-to-Sec.-Nielsen-and-Chief-Deshommes-re-Proposed-Rule-Inadmissibilit....pdf.
[3] www.shvs.org/resource/medicaids-crucial-role-in-combating-the-maternal-mortality-and-morbidity-crisis-2/.
[4] www.budget.senate.gov/imo/media/doc/TheAmericanRescuePlanActSummaryFINAL.pdf.
[5] www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine.
[6] https://www.whitehouse.gov/briefing-room/statements-releases/2021/02/09/fact-sheet-president-biden-announces-community-health-centers-vaccination-program-to-launch-next-week-and-another-increase-in-states-tribes-territories-vaccine-supply/.
[7] www.budget.senate.gov/imo/media/doc/TheAmericanRescuePlanActSummaryFINAL.pdf.
[8] www.whitehouse.gov/briefing-room/statements-releases/2021/01/28/fact-sheet-president-biden-to-sign-executive-orders-strengthening-americans-access-to-quality-affordable-health-care/.
[9] www.budget.senate.gov/imo/media/doc/TheAmericanRescuePlanActSummaryFINAL.pdf.
[10] www.supremecourt.gov/DocketPDF/19/19-840/168649/20210210151147983_19-840%2019-1019%20CA%20v%20TX.pdf.
[11] insidehealthpolicy.com/daily-news/medpac-weighs-recommending-cms-cut-back-its-portfolio-demos.
[12] insidehealthpolicy.com/daily-news/medpac-weighs-recommending-cms-cut-back-its-portfolio-demos.
[13] aspe.hhs.gov/ptac-physician-focused-payment-model-technical-advisory-committee.
[14] www.healthaffairs.org/do/10.1377/hblog20181001.929573/full/.
[15] www.chqpr.org/downloads/Miller_Resignation_from_PTAC.pdf.
[16] www.whitehouse.gov/briefing-room/statements-releases/2021/01/25/president-biden-to-sign-executive-order-strengthening-buy-american-provisions-ensuring-future-of-america-is-made-in-america-by-all-of-americas-workers.
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