Washington Healthcare Update

January 18, 2022

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This week in Washington: Supreme Court Rules on Biden Administration Vaccine Mandates

Congress 

Upcoming Hearings/Markups

House

Senate

Administration

Other Activity

Proposed Rules

Final Rules

Courts

Reports

Upcoming Hearings/Markups

House Veterans’ Affairs Committee Hearing: “The True Cost of Our Promise to Toxic-Exposed Veterans”
2:00 p.m.

For more information, click here.

Congress 

House

House Democrats Introduce Bill to Increase Access to At-Home COVID-19 Tests

On Jan. 12, Reps. Don Beyer (D-VA), Dina Titus (D-NV), Joe Morelle (D-NY) and Kaiali’i Kahele (D-HI) introduced the Free At-Home Tests for All Act. The bill would require the Department of Health and Human Services (HHS) to purchase enough rapid COVID-19 tests to give two tests a week to every U.S. resident, free of charge.

The bill text can be found here.

Senate

Senate HELP Committee Advances Nomination of Robert Califf for FDA Commissioner

On Jan. 13, the Senate Health, Education, Labor and Pensions Committee voted to advance Robert Califf’s nomination for Food and Drug Administration (FDA) Commissioner with a vote of 13-8. Two Democrats, Sens. Bernie Sanders (I-VT) and Maggie Hassan (D-NH), opposed the nomination along with six Republicans. Sen. Rand Paul (R-KY) did not vote. Califf’s nomination will now go before the full Senate for a vote.

Sen. Sanders Introduces Bill to Provide N95 Masks to Everyone in the U.S.  

On Jan. 12, Sen. Bernie Sanders (I-VT) introduced the Masks for All Act, which would provide three N95 respirator masks to every person in the U.S. The bill, which was first introduced in 2020 and developed in consultation with former COVID-19 Adviser Andy Slavitt, has 15 cosponsors. The House version of the bill is led by Reps. Ro Khanna (D-CA), Lori Trahan (D-MA) and Bonnie Watson Coleman (D-NJ), with 30 additional cosponsors.

The bill text can be found here.

Sens. Cardin and Collins Introduce Bill to Extend Shelf Life of Some Prescription Drugs

On Jan. 12, Sens. Ben Cardin (D-MD) and Susan Collins (R-ME) introduced the Drug Shortages Shelf Life Extension Act. The bill would update the Food and Drug Administration (FDA) guidance regarding the shelf life of prescription drugs that are in scarce supply. In addition, the bill would require the FDA to submit a report to the Senate Health, Education, Labor and Pensions (HELP) and Energy and Commerce Committees with information regarding requests from the Secretary of the Health and Human Services Department (HHS) to change prescription drug labels.

The bill text can be found here.

Sens. Luján, Collins and Casey Introduce Bill That Aims to Improve Behavioral Health Services Following Disasters and Emergencies

On Jan. 11, Sens. Ben Ray Luján (D-NM), Susan Collins (R-ME) and Bob Casey (D-PA) introduced the Securing Uninterrupted Pandemic Preparation of Resources and Therapies (SUPPORT) Act. The SUPPORT Act aims to improve preparedness for the behavioral health needs that follow disasters, public health emergencies and other emergency events. The bill would require the Substance Abuse and Mental Health Services Administration (SAMHSA) to provide access to mental health and substance abuse disorder treatment in response to public health emergencies and would direct the Government Accountability Office (GAO) to evaluate SAMSHA’s programming during the COVID-19 pandemic.

The bill text can be found here.

Administration

President Biden Commits to Ordering 500 Million More At-Home COVID-19 Tests

On Jan. 13, President Biden announced that the federal government would order 500 million at-home COVID-19 tests, bringing the total to 1 billion. He also said that the federal government will work to make medical masks free and available for Americans.

HHS Secretary Becerra Extends Public Health Emergency Declaration

On Jan. 14, the Secretary of the Health and Human Services (HHS) Department Xavier Becerra renewed the public health emergency (PHE) declaration for another 90 days. The declaration was set to expire on Jan. 16. The PHE declaration extension means that COVID-19 waivers that extended telehealth flexibility and Medicaid eligibility will remain in place.

HHS, Labor and Treasury Departments Issue Guidance Requiring Private Health Insurers to Reimburse Up to Eight Over-the-Counter COVID-19 Tests Per Month

On Jan. 10, the Departments of Health and Human Services (HHS), Labor and Treasury issued guidance requiring private health insurers to reimburse up to eight over-the-counter COVID-19 tests per person per month, starting on Jan. 15, 2022. The new coverage requirement makes it so individuals with private health insurance can go to a pharmacy or store and have at-home COVID-19 tests paid for up-front or have the cost reimbursed by their health plan. The initiative aims to decrease the financial burden of at-home COVID-19 testing for Americans.

Additional information on the requirements can be found here.

A CMS Frequently Asked Questions document on the guidance can be found here.

HHS Announces 14.2 Million Enrolled in Affordable Care Act Coverage During Open Enrollment

On Jan. 13, the Department of Health and Human Services (HHS) announced that 14.2 million Americans signed up for health coverage with the Affordable Care Act (ACA) Health Insurance Marketplaces during the open enrollment period that began on Nov. 1, 2021. The open enrollment period ended on Jan. 15, 2022.

HRSA Updates Preventive Health Care Guidelines for Women and Children

On Jan. 11, the Health Resources and Services Administration (HRSA) updated its preventive care and screening guidelines for women, infants, children and adolescents under the Affordable Care Act, with the additional services resulting in no out-of-pocket cost. The changes include expanded coverage for electric breast pumps and adolescent suicide risk screening.

The updated guidance can be found here.

CMS Moves to Limit Access to Monoclonal Antibodies Used to Target Amyloid to Treat Alzheimer’s Disease

On Jan. 11, the Centers for Medicare and Medicaid Services (CMS) published a proposed National Coverage Determination (NCD) decision memorandum titled “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease.”  CMS has been considering how to cover Aduhelm, Biogen’s controversial Alzheimer’s disease drug.  The Food and Drug Administration-approved drug will only be covered under Medicare if the beneficiary is enrolled in qualifying clinical trials. CMS’s final coverage policy will be announced by April 11. In light of this draft determination, Health and Human Services (HHS) Secretary Xavier Becerra has called for CMS to review the Medicare Part B premium increase, since that increase was in part anticipating the cost of coverage of Anduhelm.

A CMS press release on the proposed policy can be found here.

CMMI Announces Participants for the 2022 Kidney Care Choices Model

On Jan. 10, the Center for Medicare and Medicaid Innovation (CMMI) announced the 30 Centers for Medicare and Medicaid Services (CMS) Kidney Care First (KCF) practices and the 55 Kidney Contracting Entities (KCEs) that will participate in the Kidney Care Choices Model for performance year 2022.

The list of participants can be found here.

Other Activity

MedPAC Recommends Some Medicare Cuts for 2023

In Medicare Payment Advisory Commission’s (MedPAC) January public meeting, the Commission voted to recommend that Medicare cut payments to nursing homes, home health agencies and inpatient rehabilitation facilities by 5 percent next year. MedPAC recommendations are not binding but are considered by Congress.

Proposed Rules

CMS Issues CY 2023 Medicare Advantage and Part D Proposed Rule

On Jan. 12, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare Program: Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs.” The proposed rule makes a number of revisions to the following topics: MA and Part D regulations on marketing and communications, new or expanded MA and Part D plan criteria, MA and Part D plan quality ratings, provider network adequacy requirements, disaster or public emergency special requirements, medical loss ratio reporting, D-SNPs regulations and pharmacy price concessions. The proposed rule aims to lower out-of-pocket Medicare Part D prescription drug costs and improve health equity in MA and Part D.

Public comments are accepted until March 7, 2022.

The proposed rule can be found here.

FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages

On Jan. 11, the Food and Drug Administration (FDA) issued a draft guidance to explain how device makers should notify the agency of potential shortages during or before public health emergencies. The guidance requests that manufacturers inform the FDA of meaningful supply disruptions at least six months in advance, and if this is not possible, to notify the FDA as soon as is “practicable,” and no later than seven days after a disruption happens. The guidance is almost identical to a May 2020 guidance, and its recommendations are nonbinding.

Public comments will be accepted until March 12, 2022.

The draft guidance can be found here.

CMS Publishes Proposed Rule on Benefit and Payment Parameters for 2023

On Jan. 5, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023.” The proposed rule aims to provide a more stable regulatory framework and includes proposed payment parameters related to the risk adjustment data validation programs. In addition, the proposed rule includes 2023 user fee rates for issuers providing qualified health plans through the federal or state-based exchanges, among other things.

Comments will be accepted until Jan. 27, 2022.

The proposed rule can be found here.

FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic

On Dec. 23, the Food and Drug Administration (FDA) issued two draft guidance documents related to medical devices that received Emergency Use Authorization (EUA) during the COVID-19 pandemic. The guidance documents, titled “Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency (PHE)” and “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 PHE,” are intended to help manufacturers and stakeholders adapt to the eventual resumption of normal operations upon the end of the PHE.

Public comments will be accepted until March 23, 2022.

The guidance document titled “Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency” can be found here.

The guidance document titled “Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” can be found here.

CMS Publishes Draft Guidance for Antisense Oligonucleotide Drug Products for Severe Diseases

On Dec. 8, the Food and Drug Administration (FDA) published a draft guidance document for industry titled “Investigational New Drug (IND) Submissions for Individualized Antisense Oligonucleotide (ASO) Drug Products for Severely Debilitating or Life-Threatening (SDLT) Diseases: Clinical Recommendations.” The guidance is intended to help sponsor-investigators interested in developing ASO products for rapidly progressive SDLT genetic diseases with clinical recommendations for IND applications.

Comments will be accepted until Feb. 4, 2022.

The guidance can be found here.

FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions

On Nov. 3, the Food and Drug Administration (FDA) published new draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The guidance provides information on documentation sponsors need to submit for FDA’s evaluation of the safety and effectiveness of device software functions. When final, the guidance will replace prior guidance issued in 2005.

Public comments will be accepted until Feb. 2, 2022.

The draft guidance can be found here.

Final Rules

CMS Issues Final Rule to Revise Procedures for Announcing Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications

On Jan. 13, the Food and Drug Administration (FDA) published a final rule titled “Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications.” The final rule amends medical device regulations regarding the procedures for announcing approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs).

The rule will be effective on Feb. 14, 2022.

The final rule can be found here.

FDA Issues Final Rule to Revoke Regulations for Human Tissue Intended for Transplantation Recovered Prior to 2005

On Jan. 13, the Food and Drug Administration (FDA) published a final rule titled “Revocation of the Regulations for Human Transplantation and Human Dura Mater.” The final rule revokes regulations for human tissue products intended for transplantation that were recovered before May 25, 2005, saying these regulations are outdated as no human tissue products remain in inventory from that time.

The final rule goes into effect on Feb. 14, 2022.

The rule can be found here.

CMS Issues Durable Medical Equipment Final Rule

On Dec. 28, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Medicare Program; Durable Medical Equipment (DME), Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas.” The final rule aims to increase access to certain DME by establishing methodologies to adjust the Medicare DMEPOS fee schedule amounts. In addition, the final rule sets procedures for creating benefit categories and payment determinations for new DMEPOS.

The final rule will go into effect on Feb. 28, 2022.

The final rule can be found here.

FDA Issues Final Rule to Amend Laboratory Food Testing Requirements

On Dec. 1, the Food and Drug Administration (FDA) issued a final rule titled “Laboratory Accreditation for Analyses of Foods.” The rule amends FDA regulations to establish a program for accredited laboratories to test food under certain circumstances.

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

The final rule can be found here.

Courts

Supreme Court Upholds Vaccine Mandate for Medicare and Medicaid Facilities But Not for Large Companies

On Jan. 13, the Supreme Court issued a 5-4 ruling upholding the Centers for Medicare and Medicaid Services’s (CMS) vaccine mandate, saying it is aligned with the Health and Human Services’s (HHS) mission to protect patient health and safety. This ruling means that unvaccinated healthcare employees in facilities that participate in Medicare and Medicaid have until Jan. 27 to receive their first dose of the COVID-19 vaccine. However, the Supreme Court ruled 6-3 against the Occupational Safety and Health Administration (OSHA) regulation that required employees to be vaccinated or tested weekly, stating that OSHA had exceeded its authority.  

More information on the Supreme Court ruling’s implication for employers can be found here. Implications for healthcare providers can be found here.

Reports

GAO Report on the Veterans Community Care Program

On Jan. 13, the Government Accountability Office (GAO) released a report titled “Veterans Community Care Program: VA Should Strengthen Its Ability to Identify Ineligible Health Care Providers.” The report notes that the Veterans Affairs Department (VA) mistakenly allowed 1,600 potentially ineligible community providers to participate in the Community Care Program. The GAO recommended that the VA improve its controls and standard operating procedures going forward.

The full report can be found here.

GAO Report on VA Mental Health Care Partnerships  

On Jan. 13, the Government Accountability Office (GAO) published a report titled “VA Mental Health Care: Improvements Needed in Tracking and Overseeing Partnerships with Nongovernmental Entities.” The report notes that the Department of Veterans Affairs (VA) partners with nongovernmental groups to make veterans aware of mental health services available. The GAO observed that the VA cannot easily track these agreements since they are not stored in a single database. The GAO made three recommendations to the VA, including that the VA require the use of the Strategic Relationships Application and document annual reviews as significant activity.

The full report can be found here.

GAO Report on Assessments of State Opioid Response Grant Program

On Jan. 10, the Government Accountability Office (GAO) released a report titled “Opioid Use Disorder: Opportunities to Improve Assessments of State Opioid Response (SOR) Grant Program.” The report notes that the SOR grant program, run by the Substance Abuse and Mental Health Services Administration (SAMHSA), provides grants to address the negative impacts of the opioid crisis. SAMHSA assesses the grant program through its annual program profile and congressional report. However, the GAO notes that neither the program profile nor the report to Congress have information on limitations in these assessments, including data limitations. The GAO recommends that SAMHSA identify potential limitations to SOR grant program assessments and explain how these limitations could impact conclusions drawn. The GAO also recommends that SAMHSA further analyze existing program information to provide a more accurate assessment of the program.

The full report can be found here.

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

Stephanie Kennan, Senior Vice President
Alexandra Gale, 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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