June 24, 2022

Volume XII, Number 175

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McDermottPlus Check-Up: April 8, 2022

This Week’s Dose

The Senate confirmed Ketanji Brown Jackson as the first African American woman to serve on the Supreme Court. A bipartisan agreement on a $10 billion fully paid-for COVID-relief package was reached by the Senate, but the deal was sidelined by concerns over border control policies; the Biden Administration finalized payment updates for Medicare Advantage plans for 2023 and proposed regulations to eliminate the “family glitch” under the Affordable Care Act extending coverage options for up to 5 million people.

Congress

Supreme Court Judge Confirmed. On April 7, the Senate voted 53-47 to confirm Joe Biden’s Supreme Court nominee Judge Ketanji Brown Jackson to the Supreme Court. Republican Sens. Susan Collins (R-MA), Mitt Romney (R-UT) and Lisa Murkowski (R-AK) joined with Democrats in the confirmation vote. She will be sworn in this summer after Justice Stephen Breyer officially retires at the end of this Supreme Court term.

COVID-19 Relief Hits Another Snag. On April 4, Majority Leader Chuck Schumer (D-NY) announced the Senate had reached a bipartisan deal for COVID relief. The agreement would provide $10 billion for domestic pandemic relief, smaller than the $15.6 billion package that Speaker Pelosi tried to advance last month, but then pulled from the omnibus fiscal year 2022 package after support for the COVID aid jeopardized the larger bill. Under the agreement, $9.25 billion would be allocated to the Biomedical Advanced Research and Development Authority for vaccines, therapeutics, and testing capacity; the remaining $750 million would be directed to the Public Health and Social Services Emergency Fund for research and development of vaccines for emerging variants. The spending would be fully offset through rescissions of certain unspent federal COVID funds. It leaves out funding for global COVID-19 aid and the uninsured fund which reimbursed providers for COVID care for patients who were uninsured.

Senate action on the bill was thwarted because Republicans and some Democrats insisted on an amendment to maintain Title 42 border restrictions, a pandemic-related policy that has allowed the Administration to restrict immigration from the southern border during the Public Health Emergency (PHE) based on perceived public health needs. The Biden Administration recently announced that the Title 42 restrictions will be lifted in May, which had Republicans and Democrats nervous about an influx of migrants that could result. As a result of this controversy, the package failed to move forward in a procedural vote (47-52) on April 5. The Senate is now on recess, so Congress will not return to this bill until Congress returns from their two-week recess.

Administration

Medicare Advantage Plans See Pay Increase. On April 4, the Centers for Medicare & Medicaid Services announced in the 2023 Medicare Advantage (MA) and Part D rate notice that MA plans will see an estimated 8.5% total average increase in payments next year. The final rate is higher than the 7.98% increase originally proposed in January. We believe an apples-to-apples comparison to last year’s rate announcement is a 5% average update (as compared to the 2022 proposed update of 2.82% and final update of 4.08%).

Medicare Covers COVID At-Home Testing. CMS announced on April 4 that Medicare beneficiaries, including those in MA plans, can obtain up to eight over-the-counter at-home COVID-19 tests per calendar month with zero cost-sharing from participating pharmacies and other enrolled providers. To be eligible, Medicare beneficiaries must be enrolled in Medicare Part B; according to HHS data, as of 2019, of the 62.5 million total Medicare beneficiaries, only 4.7 million (7.5%) are enrolled in Part A only. While the coverage of at-home tests under Medicare was first announced in February, CMS officially launched the coverage through a demonstration program, allowing providers to submit claims immediately. The benefit for Medicare beneficiaries will remain available until the end of the PHE.

Proposal to Fix Family Glitch. On April 5, President Biden was joined by former President Obama and Vice-President Harris for a White House event promoting ongoing efforts to improve the Affordable Care Act (ACA), which included the announcement of a fix to the long-standing “family glitch,” a shortcoming of the ACA that measures affordability for employer-sponsored coverage for a family solely on the cost of the employee’s coverage, rather than on the cost of family coverage. As a result, low- and moderate-income families must pay for expensive employer plans or forgo coverage all together, if they are not eligible for reduced price premiums through ACA plans.

The Department of Treasury issued a proposed rule “Affordability of Employer Coverage for Family Members of Employee,” to address the glitch. View the fact sheet here. The rule has a 60-day comment period, and a public hearing scheduled for Monday, June 27 at 10 am EDT. If finalized, it is expected to become effective for 2023.

Delay of Oncology Demo. On April 6, CMS released a proposed rule to indefinitely delay the start of the Radiation Oncology (RO) Model, a mandatory payment model that faced significant criticism from oncology providers over concern that it would negatively impact reimbursement. Congress had already intervened once with legislation to delay the start date from January 1, 2022 to 2023. The reasons cited by CMS for further beyond the legislative delays include the financial costs to CMS and RO model participants for continued preparation for this model and feedback from a subset of stakeholders that specific changes related to the methodology need to be made before they will support the model. CMS indicates that they will propose a start date and performance period at least six months prior to the proposed RO model in future rulemaking. Additionally, should this delay not be finalized, CMS notes that the model will start on January 1, 2023, without any adjustments to the geographic areas previously selected to participate. Public comments are due by June 7, 2022.

CMS Updates Certain Emergency Declaration Waivers. CMS announced on April 7 that they will phase out some emergency waivers and flexibilities that have been in effect throughout the Public Health Emergency. Additionally, a memo was sent to state regulators to outline the waivers that will end in 30 or 60 days. It is important to note that the announcement will not affect waivers used by critical access hospitals or hospitals and is specifically focused on skilled nursing facilities/nursing facilities, inpatient hospices, intermediate care facilities for individuals with intellectual disabilities, and end-stage renal disease (ESRD) facilities. Affected providers and state agencies will be given notice to adjust operations to the reinstituted operations. The notice is relevant for all stakeholders, however, as it indicates that CMS may take action on select flexibilities regardless of how long the PHE remains in effect.

CMS Finalizes Coverage for Alzheimer’s Treatment. CMS on April 7 released the National Coverage Determination (NCD) on coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease, specifically for aducanumab or brand name Aduhelm™ and any future FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s. The final rule is consistent with the proposed rule released in January, with some modifications. Originally, CMS proposed to cover the qualifying treatment through coverage with evidence development (CED), limiting the population of patients for coverage of the drug to Medicare patients enrolled in qualifying clinical trials. In the final NCD, Medicare will move forward with coverage with evidence development qualification for Aduhelm, but other FDA-approved drugs will be eligible for different pathways for coverage based on strength of evidence, and monoclonal antibodies that have clinical evidence that demonstrate a direct measure of clinical benefits can obtain CMS-approved prospective studies. For drugs that await studies for direct clinical trials, including the FDA accelerated approval pathway, Medicare will provide coverage when the beneficiary is enrolled in FDA or National Institutes of Health approved trials. Additionally, CMS will not explicitly require patients to be treated at hospital-based outpatient centers, set forth in the initial proposal, and any new drugs in this class with full FDA approval to be made available in additional care settings. Lastly, it is noted that Medicaid cannot cover any drug non-covered according to the terms of this NCD, and this determination “would not shift coverage of these drugs from Medicare to Medicaid for full-benefit dually-eligible individuals.” CMS will hold a stakeholder call to discuss the coverage policy on April 11, 2022, at 11:00 am ET (register here).

Quick Hits

  • HHS released the full President’s Fiscal Year 2022 Budget in Brief.

  • The House Ways & Means Committee expanded their Request for Information on climate change by extending the inquiry to ten health care trade associations and two large dialysis companies.

  • On April 7, Reps. Sewell (D-AL) and Wenstrup (R-OH) introduced  H.R. 7487, the Employees Access to Worksite Health Services Act, a bipartisan bill to protect employees’ access to health care at their workplace health center by correcting a provision of the tax code that currently disincentivizes employers from offering worksite health clinics.

  • CMS published on April 8 updated materials for the ACO Realizing Equity, Access and Community Health Model to align key dates for PY2023 with the Medicare Shared Savings Program.

  • The House Committee on Energy & Commerce held a hearing on April 5th, entitled “Communities in Need: Legislation to Support Mental Health and Well-Being,” where the Committee examined 19 bills that provide resources for mental health and substance abuse prevention, care and coverage, treatment, and recovery support services.

  • The Senate Health, Education, Labor & Pensions Committee held a hearing on April 5, entitled “FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients,” where the Committee discussed reauthorization of User Fee agreements and improvements to accelerate development and introduction of new medical products to the market.

  • The Department of Health and Human Services (HHS) Secretary Xavier Becerra served as a witness for two Committee hearings this week, including the Senate Finance Committee and the House Committee on the Budget, to examine President Biden’s Fiscal Year 2023 budgetary requests for HHS.

Health Policy Breakroom Podcast

The "family glitch" is a loophole in the Affordable Care Act that has prevented about five million Americans from subsidized health plans. At a White House event on Tuesday, the Biden Administration announced their program to fix the glitch. Debbie Curtis and Rodney Whitlock return to review the proposed change that could affect households seeking to qualify for financial assistance.

 

 

Next Week’s Diagnosis

The House and Senate will both be in recess and will not return until the week of April 25.

© 2022 McDermott Will & EmeryNational Law Review, Volume XII, Number 100
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