Washington Healthcare Update

November 16, 2020

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This week in Washington: House Minority Leader Kevin McCarthy announced he is waiting to see who will become the next House speaker before working on another COVID-19 stimulus package; Senate Appropriations Committee releases Republican draft proposals for FY 2021.





Proposed Regulations/Guidance

Final Regulations/Guidance




Minority Leader McCarthy Will Wait for Next House Speaker to Negotiate COVID-19 Relief

On Nov. 12, House Minority Leader Kevin McCarthy (R-CA) announced he is waiting to see who will become the next House speaker before working on another COVID-19 stimulus package. Last week, Senate Majority Leader Mitch McConnell (R-KY) called for passing a fourth stimulus package during Congress’s lame-duck session.

Ways and Means Chairman Neal: CMS Needs to Reinstate Nursing Home Staff Trainings

On Oct. 30, House Ways & Means Chairman Richard Neal (D-MA) wrote a letter to the Centers for Medicare and Medicaid Services (CMS) stating that CMS should reinstate its 75-hour nursing home staff training requirements and publicly report how many current staff have not met that requirement. Neal and eight other members want CMS to reinstate the staff training and physician oversight requirements that CMS waived due to the COVID-19 pandemic, arguing facilities are better able to prevent or contain COVID-19 when they have higher staff ratios and highly trained staff.


Senate Appropriations Committee Releases Republican Draft Proposals for Fiscal Year 2021

On Nov. 10, the Senate Appropriations Committee majority (Republican) released their draft appropriations bills. These bills have not yet gone through the regular committee process. The current continuing resolution funds the government through Dec. 11. It is unclear whether Congress will fund the government for the full year or do a continuing resolution into next year and the new Congress.

Find more information here.

Sen. Murray Tells Secretaries of Education, Labor and HHS to Preserve All Records

On Nov. 10, Sen. Patty Murray (D-WA) sent letters to Secretary of Education Betsy DeVos, Secretary of Labor Eugene Scalia and Secretary of Health and Human Services (HHS) Alex Azar reminding them to comply with the Federal Records Act (FRA) and preserve all records as the end of the Trump administration approaches. Sen. Murray stressed to the Secretaries that violating the FRA can disqualify them from future federal office and reminded them that they have an obligation to inform the Archivist of any actual, impending or threatened unlawful action against records at their agency.

Find the letter here.


Trump Administration Partners with Chain and Independent Community Pharmacies to Increase Access to Future COVID-19 Vaccines

On Nov. 12, the Department of Health and Human Services (HHS) announced partnerships with large chain pharmacies and networks that represent independent pharmacies and regional chains. Through the partnership with pharmacy chains, this program covers approximately 60 percent of pharmacies throughout the 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. Through the partnerships with network administrators, independent pharmacies and regional chains will also be part of the federal pharmacy program. The goal is to further increase access to vaccine across the country. Vaccine will be administered at partners’ pharmacy locations at no cost to patients. Pharmacies that do not participate in the federal allocation program are able to join and can coordinate with their jurisdiction’s health department to become COVID-19 vaccine providers.

Find more information here.

Update CMS to Delay January on Hospitals’ Overall Star Ratings

On Nov. 12, the Centers for Medicare and Medicaid Services (CMS) announced that it will not update its overall hospital star ratings in January of next year as earlier planned. This delay is required to review public comments and finalize proposed changes to the star ratings calculations laid out in the proposed 2021 hospital outpatient pay rule.

Seniors Without Supplemental Plans to Pay $60 for COVID-19 Antibody

On Nov. 10, the Department of Health and Human Services (HHS) Deputy Chief of Staff Paul Mango said that seniors in fee-for-service Medicare Part B without supplemental plans will pay about $60 for infusions of Eli Lilly’s monoclonal antibody therapy for coronavirus. The federal government committed to paying Lilly $375 million for 300,000 vials of Lilly’s monoclonal antibody therapy, bamlanivimab, and has the option of buying 650,000 more vials. The government will provide those supplies free. However, it takes an hour to infuse the antibody, and Medicare pays doctors about $300 for that infusion service. Beneficiaries with fee-for-service Medicare Part B pay 20 percent of that cost, or $60, unless they have supplemental insurance.

FDA Grants EUA to Eli Lilly’s COVID-19 Investigational Antibody Therapy

On Nov. 9, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) for Eli Lilly’s investigational monoclonal antibody therapy, bamlanivimab. The antibody therapy is used for treatment of mild-to-moderate COVID-19 in adults and pediatric patients who have not been hospitalized, coming as the company’s trial of the drug in hospitalized patients remains on hold. FDA makes clear the therapy is not authorized for COVID-19 patients who have been hospitalized or who require oxygen, as bamlanivimab has not shown a benefit in hospitalized COVID-19 patients.

Proposed Regulations/Guidance

HHS Seeks Department Review of Every Rule, Every Decade

On Nov. 4, the Department of Health and Human Services (HHS) proposed a rule that would require HHS to review all its rules every 10 years to determine whether they are still necessary and eliminate those deemed burdensome and no longer necessary. HHS estimates approximately 2,480 rules would be revisited if the rule were implemented. Rules that are not reviewed in a timely manner would also be eliminated. A review of a rule will look at whether the rule has had a significant economic impact on a substantial number of small entities. The review will also look at the continued need for the rule; complaints about it; the rule’s complexity; the extent to which a rule duplicates or conflicts with other rules; and whether technological, economic and legal changes favor amending or rescinding the rule.

Find the proposed rule here. Public comments are due by Jan. 4, 2021.

CMS: Fourth COVID-19 Interim Final Rule with Comment Period

On Oct. 28, the Centers for Medicare and Medicaid Services (CMS) released another interim final rule in anticipation of the COVID-19 vaccine. The interim final rule announces that states must maintain enrollment only of validly enrolled beneficiaries in one of three tiers of coverage, with coverage maintained through the end of the month in which the COVID-19 public health emergency ends. The rule also allows that states seeking a 1332 waiver during the COVID-19 pandemic could request an expedited review of their application, and a shortened public comment period.

The Section 1332 waivers allow states to request exemptions from various Affordable Care Act (ACA) requirements and implement their own reforms. The interim final rule lays out CMS’s plan to provide free coverage of COVID-19 vaccines and therapeutics, and also lets the Department of Health and Human Services (HHS), the Department of Treasury and states modify the requirement to hold public comment periods to discuss the progress of a 1332 waiver. This rule is meant to prevent the spread of COVID-19 by limiting the need for the states to hold the public hearings required as part of the waiver application. The policy is effective immediately, although the Trump administration will be taking comments for 60 days.

Find the interim final rule here.

Medicare CY 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Policy Issues and Healthcare Common Procedure Coding System (HCPCS) Level II Proposed Rule

On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) proposed a durable medical equipment (DME) pay rule that would permanently increase pay for rural areas, expand coverage of continuous glucose monitors (CGMs), codify procedures for determining pay for new DME and expand coverage of external infusion pumps for certain drugs. The proposed rule asks for feedback on whether CMS should continue its current pay method for DME equipment that has essentially been removed from the bid program until that equipment goes back into bidding. If finalized, the rule would classify all CGMs as DME and establish payment amounts for the items and related supplies.

Find the proposed rule here. Public comments are due by Jan. 4, 2021.

Final Regulations/Guidance

FDA Final Compounding Guide Excludes Physicians from Enforcement Action

On Nov. 6, the Food and Drug Administration (FDA) released a final compounding guidance that FDA will not take regulatory action against physicians who compound products in a physician’s office for in-office administration. The guidance, Insanitary Conditions at Compounding Facilities, describes the types of insanitary conditions FDA has found at compounding facilities so that compounding facilities and state regulators understand what FDA considers to be an insanitary condition and can identify and remediate such conditions when they exist.

Find the final guidance here.


Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

Appeals Court Rejects Request for Full Panel Review of CSR Case

On Nov. 10, a federal appeals court rejected insurers’ request for a full court review of the August decision that found that the Centers for Medicare and Medicaid Services (CMS) must reimburse insurers for Affordable Care Act (ACA) subsidies. The subsidies were not paid in 2017 yet had limited the damages in later years to account for the “silver-loading” work-around that resulted in larger tax credits. Insurers, who are set to get about $1.7 billion for the 2017 plan year, say that they should also get the full payments for 2018 and beyond. However, the Department of Justice (DOJ) said if the court agreed to rehear the case based on insurers’ arguments, silver-loading should not factor into the post-2017 payments due. The DOJ added that the court should also revisit its ruling that the government owes insurers the full payments for 2017. The U.S. Court of Appeals for the Federal Circuit denied all the requests.


GAO: Medicaid Program Integrity – Action Needed to Ensure CMS Completes Financial Management Reviews in a Timely Manner

On Nov. 13, the Government Accountability Office (GAO) released a report on the length of time it is taking the Centers for Medicare & Medicaid Services (CMS) to conduct financial management reviews to verify states’ appropriate spending of federal Medicaid funds. Since FY2016, CMS started 49 financial management reviews, usually focused on one state. As of June 2020, most reviews were still ongoing. Some states will not address the problems identified until the reviews are done, leaving federal and state dollars at risk for misspending.

CMS officials cite competing priorities, less staff and the multi-step review process as contributing to the delay. GAO recommended setting time frames to ensure timely financial management reviews.

Find GAO’s recommendations here, and the full report here.

GAO: Private Health Insurance – Markets Remained Concentrated Through 2018, with Increases in the Individual and Small Group Markets

On Nov. 13, the Government Accountability Office (GAO) released a report on how several companies may be selling health insurance in a given market, but as GAO previously reported, most people usually enroll with one of a small number of insurers. Known as market concentration, this can result in higher premiums due to less competition in the market.

GAO found this pattern continued through 2018, with the markets for individuals and for small employers seeing an increase in concentration over the last two years. Specifically, three or fewer health insurers held at least 80 percent of the market in 46 states for both of these markets, marking an increase of market concentration in at least 10 states since 2011.

Find the full report here.

If you have any questions, contact the following individuals atMcGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate

Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.

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