Washington Healthcare Update

September 12, 2022

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This Week in Washington: The House and Senate return to face funding the government and other issues; the administration reverses for good the Trump-era “public charge” rule.





Proposed Rules

Final Rules

Upcoming Hearings

House Ways and Means Committee, Preparing America’s Health Care Infrastructure for the Climate Crisis, Sept. 15, 11 a.m.

Senate Health, Education, Labor and Pensions Committee, Stopping the Spread of Monkeypox: Examining the Federal Response, Sept. 14, 10 a.m.



Funding the Government

Current funding for the federal government runs out on Oct. 1; Congress will need to do a short-term Continuing Resolution (CR). Currently being discussed in the House is a CR to run through Dec. 16. What is unclear is whether the CR will have anything attached to it.

The White House has asked that COVID and monkeypox funding be attached. They have requested $22.4 billion in COVID money and $4.5 billion for monkeypox funding. Republican senators state that there is already unspent money that could be used for these purposes. The administration also released a list of programs that should be included or programs they would not object to being included on the CR.

Meanwhile, Senate Budget Committee Chairman Bernie Sanders (I-VT) announced that he will vote against the CR if it includes a package of energy provisions meant to satisfy Sen. Joe Manchin (D-WVA). Sanders says that “at least” 59 House Democrats will be releasing a letter opposing the energy provisions as well.

Bipartisan Group of Members Ask for Input on How to Revamp the Medicare Access and CHIP Reauthorization Act (MACRA)

Eight House members led by Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN) are asking stakeholders for feedback concerning how to fix MACRA without dramatically increasing Medicare spending.

Members Push for Audio-Only Telehealth Coverage

Reps. Ann McLane Kuster (D-NH), Lori Trahan (D-MA) and Peter Welch (D-VT) wrote CMS Administrator Chiquita Brooks-LaSure to urge Medicare coverage of audio-only telehealth continue beyond the pandemic, raising concerns that ending reimbursement would add to health disparities. However, CMS has said it cannot do so without congressional action. CMS proposed to extend audio-only coverage for mental healthcare but said legislative restrictions prevent it from doing so for other telehealth services. 

The letter asks CMS to answer several questions, including how the agency is measuring the effectiveness of audio-only telehealth and what data it has about the factors that impact audio-only usage as opposed to other kinds of telehealth. It also asks what CMS believes the impact of ending audio-only telehealth coverage would be on rural beneficiaries and on other groups that are more likely to use the modality, including Black patients.


FDA User Fee Bill Drama Continues

Congress has until Sept. 29 to reauthorize the FDA User Fee program. FDA Commissioner Robert Califf has said the agency could fund the programs into early November using carryover user fees. Some believe that reauthorization should be added to the short-term CR in order to give more time for members to negotiate an agreement.

Senators Ask AHIP about HIV Prevention Medication Coverage

On Sept. 8, a letter lead by Sens. Jeff Merkley (D-OR) and Tina Smith (D-MN) asked the America’s Health Insurance Plans (AHIP) about reports that some insurers are not providing cost-free coverage of HIV prevention medication and related services as required under the Affordable Care Act. 

The letter comes after a federal district judge ruled that the pre-exposure prophylaxis (PrEP) mandate violates rights of a Texas employer under the Religious Freedom Restoration Act (RFRA) and that the ACA violates the appointments clause of the Constitution by deferring decisions on coverage requirements to the U.S. Preventive Services Task Force (USPSTF). 

Under the ACA, insurers must cover all preventive services rated “A” or “B” by the USPSTF without cost-sharing. In June 2019, the task force gave PrEP an “A” rating, and plans were required to cover the drug as of Jan. 1, 2021. CMS issued additional guidance to clarify that ancillary services, like testing fees and adherence consultations, must also be covered without cost-sharing.

The judge has yet to issue any remedies related to the decision, so it’s unclear whether it will apply only to the plaintiffs, or nationwide.

In their letter, the senators stressed it is an insurer’s responsibility to ensure the cost-free coverage is provided. 


Sec. Becerra Declares Section 564 Emergency for Monkeypox

On Sept. 7, Secretary for Health and Human Services Xavier Becerra signed a declaration under Section 564 of the Federal Food, Drug, and Cosmetic Act to allow FDA to issue emergency use authorizations for in vitro diagnostics for monkeypox tests in order to increase supply. The FDA guidance states that the agency will prioritize which tests will receive an EUA based on how necessary the test is to protecting public health. 

Biomedical Advanced Research and Development Authority Seeks Private-Sector Partners

A new program through the Biomedical Advanced Research and Development Authority (BARDA) is seeking private-sector partners to work on the development of medical countermeasures for fighting future pandemics and public health threats.

BARDA’s “Rapid Response Partnership Vehicle” will focus on the development of medical countermeasures for future health threats and potential pandemics, including development of manufacturing infrastructure.

The effort ties into BARDA’s strategic plan and is one of the new programs BARDA is implementing under the American Pandemic Preparedness Plan.

In the strategic plan, BARDA says it learned from the COVID-19 pandemic that it must “be ready to rapidly establish or expand partnerships when a public health emergency occurs by having contracting vehicles pre-established.”

FDA Approves New ALS Drug

On Sept. 7 an FDA advisory panel voted 7-2 in favor of approving Amylyx’s ALS drug six months after the same panel said the company’s data did not provide enough evidence that the drug is effective. Members of the panel said they were swayed by the latest analyses provided by Amylyx as well as the company’s promise that if the drug is approved but later shown to be ineffective in the company’s ongoing phase 3 trial, it will voluntarily withdraw the drug from the market. 

FDA Approves New Botox Alternative

On Sept. 7, the FDA approved a new anti-wrinkle injection from Revance. Like Botox, Daxxify uses a botulinum toxin to freeze facial muscles, but Revance is hoping Daxxify’s longer-lasting effects will be more popular.

Proposed Rules

HHS Announces Proposed Rule to Implement Section 1557 of the ACA

On July 25, the Department of Health and Human Services (HHS) released a proposed rule to implement Section 1557 of the Affordable Care Act (ACA) that bans discrimination based on race, color, national origin, sex, age and disability in certain health programs and activities. The proposed rule expands civil rights protections for patients in certain federally funded programs by clarifying the scope and application of Section 1557. An HHS press release on the proposed rule can be found here.

FDA Releases Proposed Rule to Standardize the National Drug Code Format

On July 25, the Food and Drug Administration (FDA) issued a proposed rule titled “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The proposed rule would amend the National Drug Code (NDC) to require one standardized format for all NDCs.

Public comments will be accepted until Nov. 22, 2022.

Final Rules

Homeland Security Issues Final Rule Reversing Trump “Public Charge” Rule

On Sept. 8 the administration issued final rules making it clear that the Department of Homeland Security will not refuse entry to non-citizens seeking admission to the U.S. or a green card due to their likelihood to receive Medicaid/CHIP or other health benefits except for long-term institutionalized care. The rule reverses the Trump administration’s public charge rules issued in 2019.  

CMS Publishes Final Rule to Update FY 2023 Hospice Payment Rate

On July 27, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Medicare Program; FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” The final rule makes updates to Medicare hospice payments and the aggregate cap amount for Fiscal Year (FY) 2023. The FY 2023 hospice payment update will be increased to 3.8% and a permanent budget-neutral 5% cap will be established on any decrease to an area’s wage index. The final rule also discusses the Hospice Outcomes and Patient Evaluation tool and provides an update on FY 2023 Quality Measures, the Consumer Assessment of Healthcare Providers and Systems, and Hospice Survey Mode Experiment. A press release on the final rule with additional information can be found here.

The final rule will go into effect on Oct. 1, 2022.

CMS Publishes FY 2023 Inpatient Psychiatric Facilities Prospective Payment System Final Rule

On July 27, the Centers for Medicare & Medicaid Services published a final rule titled “Medicare Program: FY 2023 Inpatient Psychiatric Facilities Prospective Payment System; Rate Update and Quality Reporting; Request for Information.” The final rule will update Medicare payment rates for the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) for Fiscal Year (FY) 2023 and sets a permanent 5 percent cap. The rule does not make any changes to the IPF Quality Reporting Program. A press release with additional information can be found here.

The final rule will go into effect on Oct. 1, 2022.

Final Rule to Change Qualifications for Products to be Considered “Made in America” Released

On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that would increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.

The White House Fact Sheet on the final rule can be found here.