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This Week (January 17-21)

Monday is a federal holiday. The House and Senate will reconvene on Tuesday, January 18.

Last Week (January 10-14)

Health Care Highlights

Biden administration issues FAQs on OTC tests. On Monday (Jan. 10), the Biden Administration issued highly anticipated guidance in the form of Frequently Asked Questions (FAQs) aimed at clarifying a requirement announced late last year that insurance companies and group health plans cover the cost of over-the-counter (OTC) at-home COVID-19 tests throughout the duration of the public health emergency (PHE), beginning on January 15, 2022. Among the FAQs are those aimed at clarifying the circumstances under which OTC tests must be covered, along with various limits and safe harbors for plans and issuers. This includes clarifying that plans and issuers:

• Must provide coverage without cost-sharing requirements, prior authorization, or other medical management requirements with respect to OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider purchased on or after January 15, 2022, and during the PHE. Coverage may, but is not required to, be provided for OTC COVID-19 tests purchased before January 15, 2022.
• May not limit coverage to tests that are provided through preferred pharmacies or other retailers unless a plan or issuer arranges for direct coverage through both its pharmacy network and a direct-to-consumer shipping program if various access and costs stipulations are met. In that case, they may limit reimbursement from non-preferred pharmacies or other retailers to no less than the actual price, or $12 per test (whichever is lower).
• May set limits on the number or frequency of OTC COVID-19 tests covered without cost sharing to no less than 8 tests per 30-day period (or per calendar month) per participant, beneficiary, or enrollee, for those tests administered without a provider’s involvement or prescription.
• Are permitted and may act to prevent, detect, and address fraud and abuse.
• May provide education and information resources to support consumers seeking OTC COVID-19 testing, as long as such resources make clear that the plan or issuer provides coverage and reimbursement of all eligible OTC COVID-19 tests and such information is consistent with the test’s emergency use authorization (EUA).

Biden administration officials also announced Friday (Jan. 14) that the administration will begin mailing COVID-19 tests directly to Americans starting next Wednesday (Jan. 19), despite not yet having formally acquired the full 500 million tests it has promised. Americans will be able to order four COVID-19 tests per household through COVIDTests.gov, a website set up by the administration and the United States Postal Service. The officials said the government currently has over 420 million tests under contract and they are confident the government will be able to procure the remaining 80 million by next Wednesday.

Supreme Court upholds CMS vaccine mandate, strikes down OSHA rule. The Supreme Court on Thursday (Jan. 13) ruled 5-4 that the Biden administration’s vaccine requirement for most health care workers could stay in place while declining to let their vaccination-or-testing mandate for large private employers continue in a separate 6-3 opinion, with the court's conservative majority saying that Congress has only given the Occupational Safety and Health Administration (OSHA) the ability to “set workplace safety standards, not broad public health measures.” The mandate for health care workers covers about 10 million people, while the rule for private employers would have applied to 84 million. “As a result of the Court’s decision, it is now up to States and individual employers to determine whether to make their workplaces as safe as possible for employees, and whether their businesses will be safe for consumers during this pandemic by requiring employees to take the simple and effective step of getting vaccinated,” President Biden said in a statement following the ruling. Also in response, CMS administrator Chiquita Brooks-LaSure said the agency “is extremely pleased the Supreme Court recognized CMS’ authority to set a consistent COVID-19 vaccination standard for workers in facilities that participate in Medicare and Medicaid… Giving patients assurance on the safety of their care is a critical responsibility of CMS and a key to combatting the pandemic.”

HELP committee advances Biden FDA pick to full Senate. On Thursday (Jan. 13), the Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-8 to advance Robert Califf's nomination to head the Food and Drug Administration (FDA). Two senators who caucus with Democrats — Bernie Sanders (I-VT) and Maggie Hassan (D-NH) — opposed the nomination due to concerns over Califf’s drug industry ties and his potential strategy to address the opioid epidemic. Sanders’ and Hassan’s opposition, along with that expressed by Sens. Joe Manchin (D-WV), Richard Blumenthal (D-CT) and Ed Markey (D-MA), means Democratic leaders need at least five Republicans to vote for Califf’s nomination on the floor, allowing Vice President Kamala Harris to cast the tiebreaker. Ranking Republican Richard Burr (R-NC) strongly backs Califf’s bid to lead FDA and will likely work his side of the aisle to ensure sufficient support.

HHS extends public health emergency. Friday (Jan. 14),Health and Human Services (HHS) Secretary Xavier Becerra renewed the PHE declaration, which was set to expire on Saturday (Jan. 16), for another 90 days. The PHE has been in effect for nearly two years and the Biden administration promised to provide at least 60-days notice before letting the PHE and its related regulatory flexibilities lapse. Of particular concern for provider groups are the continuation of waivers that loosened restrictions around telehealth services, nursing home staff training, three-day hospital stays and Medicaid eligibility, among others tied to the PHE. The Biden administration said this week they are sending 1,000 military medical personnel to six states to help hospitals overwhelmed by COVID-19, aimed at helping triage patients arriving at hospitals in an effort to ease the burden on emergency rooms.

HHS sends user fee agreements to Congress. On Wednesday (Jan. 12), HHS transmitted to Congress three user fee packages — negotiated agreements between FDA and industry — for the Prescription Drug User Fee Act VII, Generic Drug User Fee Amendments III and Biosimilar User Fee Amendments III, according to press reports. The action represents the latest step toward a potential five-year reauthorization of the must-pass legislation, which dictates programs where industry pays fees to FDA in exchange for commitments to conduct timely reviews of medical products. The current user fee agreements expire on September 30, and the legislation could serve as a vehicle for other FDA-related programmatic and policy changes, such as setting targets for the number of FDA approvals for each industry and other modifications to agency policy. One large piece of legislation which could be added is Cures 2.0 (H.R. 6000) – or proposals contained within – and specifically a proposal to authorize the Advanced Research Projects Agency for Health (ARPA-H), a Biden administration initiative with bipartisan support that is aimed at funding especially innovative medical research that prioritize longshot curative diseases.

CMS releases coverage determination for Alzheimer’s treatment. On Tuesday (Jan. 11), CMS released  a proposed National Coverage Determination on the coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease. Under the proposal, CMS would only cover the treatment through coverage with evidence development (CED), limiting the population of patients eligible for coverage under Medicare enrolled in qualifying clinical trials. The NCD applies to Biogen Inc.’s drug Aduhelm, which was controversially approved by the FDA in June 2021 through the accelerated approval pathway. The drug was also under scrutiny due to its initial price tag of $56,000 per patient, although the price was later cut in half and Biogen CEO acknowledged Monday that the company was “wrong” in its initial pricing. In response to the price cut, HHS Secretary Xavier Becerra told Medicare officials to reconsider the largest-ever hike on premiums under Medicare Part B due to the drug’s projected impact on the premium calculations. A final decision on the NCD will be announced by April 11 following a 30-day comment period.

Hearings

Senate HELP Committee hearing on COVID-19 response. On Tuesday (Jan. 11), The Senate HELP Committee held a hearing entitled, “Addressing New Variants: A Federal Perspective on the COVID-19 Response.” The hearing focused on the federal government’s response to the ongoing pandemic and how to address new variants, with testimony from Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci, FDA Acting Commissioner Janet Woodcock, and HHS Assistant Secretary for Preparedness and Response (ASPR) Dawn O’Connell. The witnesses faced scrutiny over the administration’s recent CDC guidance, as well as concerns over access to testing and increased hospitalization rates among children, among other issues. Ranking Member Richard Burr (R-NC) said conflicting guidance on issues such as boosters and testing have left the public confused about how best to protect themselves, calling the recent update to the quarantine and isolation guidance a “mess” and a “disaster,” adding that “I’m not questioning the science… but I’m questioning your communication strategies.” Dr. Fauci said that the appearance of new variants shows the importance of developing new vaccines that remain effective in the face of new mutations and Ms. O’Connell said it might be a good time to reassess the federal approach to the pandemic when Omicron passes. Administration officials also said they are working to drive up domestic production of high-quality masks in the coming weeks and that fulfilling the promise to deliver 500 million free COVID-19 tests to Americans will involve manufacturing additional tests.

Reports, Studies, and Journals

CMS Office of Minority Health:  Trends in Racial, Ethnic, Sex, and Rural-Urban Inequities in Health Care in Medicare Advantage: 2009-2018. Since 2015, CMS OMH has published annual reports to highlight inequities in the quality of care delivered to Medicare beneficiaries nationwide based. This report presents an analysis of historical trends in inequities by race, ethnicity, sex, and geography among Medicare beneficiaries enrolled in Medicare Advantage (MA) plans nationwide.

Health Affairs: Building On The CMS Strategic Vision: Working Together For A Stronger Medicare. In this piece, CMS officials discuss how they are advancing their goals to advance health equity; expand access to affordable coverage and care; drive high quality, person-centered care; and promote affordability and the sustainability of the Medicare trust funds. They also discuss available opportunities to align and partner across the health care system.

The Commonwealth Fund:  State Trends in Employer Premiums and Deductibles, 2010-2020. Premium contributions and deductibles in employer health plans accounted for 11.6 percent of median household income in 2020, up from 9.1 percent a decade earlier.

CIDRAP: Pfizer Booster Tied To Fewer COVID Cases In Health Workers. Israeli healthcare workers who received a third dose of the Pfizer/BioNTech mRNA COVID-19 vaccine had significantly lower rates of infection in the next 39 days, according to a single-center study yesterday in JAMA.

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