Regulatory policy

April 8, 2022 Washington DC Health Care Policy Update

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

COVID-19 Relief hits another snag. On April 4, Majority Leader Chuck Schumer (D-NY) announced that the Senate had reached a bipartisan agreement for COVID relief. The deal would provide $10 billion for national pandemic relief, less than the $15.6 billion package that President Pelosi tried to advance last month but then withdrew from the omnibus package of fiscal 2022 after COVID aid support jeopardized the larger bill. Under the agreement, $9.25 billion would be allocated to the Biomedical Advanced Research and Development Authority for vaccines, therapies and testing capacity; the remaining $750 million would be directed to the Public Health and Human Services Emergency Fund for research and development of vaccines against emerging variants. Spending would be fully offset by write-offs of some unspent federal COVID funds. It leaves out funding for global COVID-19 relief and the uninsured fund that reimbursed COVID care providers for uninsured patients.

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 need. The Biden administration recently announced that Title 42 restrictions will be lifted in May, making Republicans and Democrats nervous about an influx of migrants that could result. As a result of this controversy, the package did not advance in a procedural vote (47-52) on April 5. The Senate is now in recess, so Congress will not revisit this bill until Congress returns from its two-week suspension. .

Medicare Advantage Plans See Salary 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 total average increase of 8.5% in payments next year. The final rate is higher than the 7.98% increase originally proposed in January. We believe that an apples-to-apples comparison with last year’s rate announcement is an average 5% update (compared to the proposed 2022 update of 2.82% and the final update of 4.08%).

Medicare covers home COVID testing. CMS announced April 4 that Medicare beneficiaries, including those in MA plans, can obtain up to eight over-the-counter COVID-19 home tests per calendar month without cost-sharing with participating pharmacies and other enrolled providers. . To be eligible, Medicare beneficiaries must be enrolled in Medicare Part B; according to HHS data, in 2019, of the 62.5 million total Medicare beneficiaries, only 4.7 million (7.5%) are enrolled in Part A only. While Medicare home testing coverage was first announced in February, CMS officially launched coverage through a demo program, allowing providers to submit claims immediately. The benefit for Medicare beneficiaries will remain available until the end of PHE.

Proposal to fix Family Glitch. On April 5, President Biden was joined by former President Obama and Vice President Harris for an event at the White House promoting ongoing efforts to improve the Affordable Care Act (ACA), which included the announcement of a solution to the long-standing “family problem”. a shortcoming of the ACA that measures the affordability of employer-sponsored coverage for a family solely on the cost of employee coverage, rather than the cost of family coverage. As a result, low- and middle-income families have to pay for expensive employer-sponsored plans or forgo coverage altogether, if they don’t qualify for discounted premiums under ACA plans.

The Department of the Treasury released a proposed “Affordability of Employer Coverage for Employee’s Family Members” rule to address the issue. View the fact sheet here. The rule provides for a 60-day comment period and a public hearing scheduled for Monday, June 27 at 10 a.m. EDT. If finalized, it should enter into force for 2023.

Oncology demo delayed. On April 6, CMS released a proposed rule to indefinitely delay the launch of the radiation oncology (RO) model, a mandatory payment model that has come under heavy criticism from oncology providers, fearing that it will have a negative impact on reimbursement. Congress had already intervened once with legislation to delay the start date from January 1, 2022 to 2023. Reasons cited by CMS for going beyond the legislative delays include financial costs to CMS and RO model participants for the further preparation of this model and feedback from a subset of stakeholders that specific changes related to the methodology need to be made before they support the model. CMS says it will propose a start date and performance period at least six months ahead of the proposed RO model in future rulemaking. Additionally, if this delay is not finalized, CMS notes that the model will start on January 1, 2023, without any adjustments to the geographies previously selected to participate. Public comments are expected by June 7, 2022.

CMS is updating certain emergency declaration waivers. CMS announced on April 7 that it would be phasing out certain emergency waivers and flexibilities that had been in place throughout the public health emergency. Additionally, a memo has been sent to state regulators outlining waivers that will expire in 30 or 60 days. It is important to note that the announcement will not affect waivers used by hospitals or critical access hospitals and focuses specifically on skilled nursing facilities/nursing facilities, inpatient hospices, intermediate care facilities for people with developmental disabilities and end-stage renal disease (ESRD). Suppliers and affected state agencies will be notified to adjust operations to restored operations. The advice is, however, relevant to all stakeholders, as it indicates that CMS may take action on certain flexibilities, regardless of how long the PHE remains in force.

CMS finalizes coverage for the treatment of Alzheimer’s disease. On April 7, CMS published the National Coverage Determination (NCD) on the coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, in particular for aducanumab or the brand name Aduhelm™ and any future FDA-approved monoclonal antibody directed against amyloid for the treatment of Alzheimer’s. The final rule is consistent with the proposed rule published in January, with some modifications. Originally, CMS proposed to cover eligible treatment through evidence-based coverage (EDC), limiting the patient population covered by the drug to Medicare patients enrolled in eligible 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 coverage pathways based on strength of evidence and antibodies. monoclonals that have clinical evidence that demonstrates a direct measure of clinical benefit may obtain CMS-approved prospective studies. For drugs awaiting studies for direct clinical trials, including the FDA’s accelerated approval pathway, Medicare will provide coverage when the beneficiary is enrolled in trials approved by the FDA or the National Institutes of Health. Additionally, CMS will not explicitly require that patients be treated in hospital-based ambulatory care centers, as stated in the original proposal, and that any new drug in this class with full FDA approval be released. disposal in additional care facilities. Finally, it should be noted that Medicaid cannot cover any drugs not covered under the terms of this NCD, and this decision “would not move coverage for these drugs from Medicare to Medicaid for those with dual eligibility for full benefits”. CMS will host a stakeholder call to discuss the hedging policy on April 11, 2022 at 11:00 a.m. ET (register here).

  • HHS has released the president’s full budget for fiscal year 2022 in a nutshell.

  • The House Ways & Means Committee has broadened its demand for information on climate change by extending the survey to ten professional health care associations and two major dialysis companies.

  • On April 7, Reps. Sewell (D-AL) and Wenstrup (R-OH) introduced HR 7487, the Employee Access to Health Services in the Workplace Act, a bipartisan bill aimed at protecting employee access to health care at their workplace health center by fixing a tax code provision that currently discourages employers from offering workplace health clinics.

  • CMS released updated documents for the ACO model of achieving equity, access and community health on April 8 to align key dates in the year 2023 with the savings program shared Medicare.

  • The House Committee on Energy and Commerce held a hearing on April 5, titled “Communities in Need: Legislation to Support Mental Health and Wellness,” during which the committee considered 19 bills providing resources for mental health and addictions prevention, care and treatment. coverage, treatment and recovery support services.

  • The Senate Committee on Health, Education, Labor and Pensions held a hearing on April 5, titled “FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation in the benefit of patients,” during which the committee discussed the reauthorization of user-fee agreements and enhancements to accelerate the development and introduction of new medical products to market.

  • Department of Health and Human Services (HHS) Secretary Xavier Becerra testified this week at two committee hearings, including the Senate Finance Committee and the House Budget Committee, to consider the requests President Biden’s fiscal year 2023 budgets for HHS.

Health Policy Break Room Podcast

The “family problem” is a loophole in the Affordable Care Act that has kept about five million Americans out of subsidized health plans. At a White House event on Tuesday, the Biden administration announced its agenda to address the issue. Debbie Curtis and Rodney Whitlock return to review the proposed change that could affect households seeking to qualify for financial assistance.

Diagnosis next week

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