Washington Healthcare Update

January 10, 2022

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This week in Washington: Build Back Better Negotiations on Hold

Congress 

Upcoming Hearings/Markups

House

Senate

Administration

Proposed Rules

Final Rules

Courts

Reports

 

Upcoming Hearings/Markups

January 11

Senate Health, Education and Labor Committee Hearing: “Addressing New Variants: A Federal Perspective on the COVID-19 Response”
10:00 a.m.

For more information, click here.

January 12

Senate Health, Education and Labor Committee Executive Session to consider the nomination of Dr. Robert Califf, to be Commissioner of the Food and Drug Administration at the Department of Health and Human Services
10:00 a.m.

For more information, click here.

Congress 

House

Reps. DelBene and Bucshon Call for Investment in KidneyX Initiative

On Dec. 20, Reps. Suzan DelBene (D-WA) and Larry Bucshon (R-IN), co-chairs of the Congressional Kidney Caucus, led a group of 18 members of Congress in a letter requesting that the Biden administration invest $25 million in the KidneyX initiative. KidneyX is a public-private partnership between the Health and Human Services (HHS) Department and the American Society of Nephrology that aims to accelerate research into chronic kidney disease and improve kidney care.

The letter can be found linked here.

Senate

Sens. Blunt and Burr Ask How HHS Will Address the COVID-19 Test Shortage

On Jan. 3, Sens. Roy Blunt (R-MO) and Richard Burr (R-NC) wrote to Health and Human Services (HHS) Department Secretary Xavier Becerra requesting information on the Biden administration’s plan to address the shortage of COVID-19 tests. The senators note that this shortage has occurred despite federal investments of $80 billion over two years to improve testing capabilities.

Administration

President Biden Pledges PPE and Military to Hospitals

During a Jan. 4 briefing, President Biden stated that the federal government will take action to provide hospitals with personal protective equipment (PPE) and reinforce hospital staff with military personnel in areas that are “overrun” with COVID-19.

HHS Announces 13.6 Million Enrolled in Affordable Care Act Marketplaces in 2022

On Dec. 22, the Health and Human Services Department (HHS) announced that 13.6 million people enrolled in health insurance coverage through healthcare.gov and state-based marketplaces during 2021. The special enrollment period deadline will end on Jan. 15, 2022.

HHS OCR Issues Guidance on HIPAA Information Disclosures for Extreme Risk Protection Orders

On Dec. 20, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued guidance to clarify how the 1996 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule allows covered providers to disclose protected health information to support extreme risk protection order applications without the individual’s permission. Risk protection orders temporarily prevent a person in crisis from accessing firearms. HHS stated that this guidance could help improve public safety by reducing firearm deaths.

The guidance can be found here.  

HRSA Announces $48 Million to Improve the Rural Public Health Workforce

On Dec. 23, the Department of Health and Human Services’ (HHS) Health Resources and Services Administration’s (HRSA) Federal Office of Rural Health Policy announced $48 million in American Rescue Plan funding for the Rural Public Health Workforce Training Network Program. The funding will be directed to community-based organizations expanding rural and tribal public health capacity through job development and training.

Grant applications are due on March 18, 2022.

SAHMSA Announces Funding to Transition National Suicide Prevention Lifeline to 988 Dialing Code

On Dec. 20, the Substance Abuse and Mental Health Services Administration (SAHMSA) announced $282 million would be invested to transition the National Suicide Prevention Lifeline from its current 10-digit number to a 3-digit dialing code 988.

CMS Extends California Advancing and Innovating Medi-Cal Waivers

n Dec. 29, the Centers for Medicare and Medicaid Services (CMS) approved a request from California’s Department of Health Care Services to extend its Medicaid Section 1115 and Sections 1915(b) waivers for five years. Both waivers, referred to collectively as California Advancing and Innovating Medi-Cal (CalAIM), had been set to expire on Dec. 31, 2021.

CMS Issues Guidance on Scope and Payment for Mobile Crisis Intervention Services

On Dec. 28, the Centers for Medicare and Medicaid Services (CMS) issued a guidance document titled “Medicaid Guidance on the Scope of and Payments for Qualifying Community-Based Mobile Crisis Intervention Services.” The guidance details a new option states have to support community-based mobile crisis intervention services for people with Medicaid.

The guidance can be found here.

CMS Rescinds Georgia’s Work Requirement Waiver

On Dec. 23, the Centers for Medicare and Medicaid Services (CMS) rescinded Georgia’s Trump-era work requirement waiver. CMS had informed states with work requirements in February that it planned to rescind the waivers after the Department of Health and Human Services (HHS) found that Medicare beneficiaries in work requirement waiver states experienced coverage losses and negative health effects. Georgia’s work waiver was originally set to go into effect in July 2021, but the start was delayed twice as the state worked to address CMS’s concerns with the program.

FDA Announces EUA for Two At-Home COVID-19 Tests Evaluated by New Accelerated Pathway

On Dec. 29, the Food and Drug Administration (FDA) announced that two new over-the-counter at-home COVID-19 tests received emergency use authorization (EUA) through a new accelerated pathway. The accelerated pathway operates via collaboration between the FDA and the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics Technology (RADx) program.

FDA Issues EUA for COVID-19 Oral Antiviral Treatment

On Dec. 22, the Food and Drug Administration (FDA) issued its first emergency use authorization (EUA) for an oral antiviral treatment of COVID-19. Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) is authorized to treat mild-to-moderate COVID-19 in adults and adolescents above 12 years of age who are at high risk for progression to severe COVID-19.

FDA Amends Pfizer’s EUA to Expand the Use of the COVID-19 Vaccine in Children

On Jan. 3, the Food and Drug Administration (FDA) amended Pfizer’s emergency use authorization (EUA) for its COVID-19 vaccine in an effort to expand its use among children. The changes include authorizing Pfizer’s COVID-19 booster for people aged 12 and older, shortening the booster interval to five months for people aged 12 and older, and authorizing a third primary series dose for immunocompromised children aged 5-11.

FDA Delays Some On-site Facility Inspections Due to Omicron Variant

On Dec. 29, the Food and Drug Administration (FDA) made the decision to postpone some on-site inspections amid the Omicron variant surge of the COVID-19 virus. The FDA will suspend non-critical on-site facility inspections temporarily in order to focus on in-person mission-critical work and will monitor non-critical facilities using remote tools through Jan. 19.

CDC Adds Rural Considerations Addendum to COVID-19 Vaccination Field Guide

On Jan. 7, the Centers for Disease Control and Prevention (CDC) added an addendum titled “Rural Considerations” to its COVID-19 Vaccination Field Guide for carrying out a rapid community assessment (RCA). An RCA is a process used to gather community insights on public health to inform program design. The COVID-19 Vaccination Field Guide details 12 strategies in use to increase COVID-19 vaccine confidence. The updated field guide now contains strategies tailored to help rural communities’ vaccine confidence.

The Rural Considerations Addendum to the COVID-19 Vaccination Field Guide can be found here.

CDC Updates Guidance for Pfizer Booster

On Jan. 4, the Centers for Disease Control and Prevention (CDC) updated its guidance regarding booster COVID-19 vaccines, shortening the interval of wait time between the Pfizer vaccine and the booster from six months to five months. The booster timeline recommendation for Moderna and Johnson & Johnson remains unchanged.

On Jan. 5, the CDC’s Advisory Committee on Immunization Practices voted 13-1 in favor of recommending Pfizer’s COVID-19 booster for adolescents aged 12-17. Following the vote, the CDC recommendation was changed to say that adolescents “should” get a booster dose of Pfizer’s vaccine.

Proposed Rules

CMS Issues CY 2023 Medicare Advantage and Part D Proposed Rule

On Jan. 6, 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.

The proposed rule 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.

FDA Issues Proposed Rule on Over-the-Counter Hearing Aids

On Oct. 20, the Food and Drug Administration (FDA) issued a proposed rule titled “Medical Devices: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.” The proposed rule would establish a new category of over-the-counter (OTC) hearing aids that could be sold to consumers directly without a medical exam or audiologic hearing. The proposed rule comes after President Biden’s July Executive Order aimed at promoting competition in the economy directed the FDA to increase access to OTC hearing aids.

Public comments will be accepted until Jan. 18, 2022.

The proposed rule can be found here.

Final Rules

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 Hears Cases on CMS Vaccine Mandate

On Jan. 7, the Supreme Court heard oral arguments in the cases of Becerra v. Louisiana and Biden v. Missouri, which both focus on the Centers for Medicare and Medicaid Services’ (CMS) interim final rule that required employees of facilities funded by Medicare or Medicaid to be fully vaccinated against COVID-19 by Jan. 4, 2022. Missouri and Louisiana federal courts have issued injunctions that stop the rule from being implemented in a total of 24 states.

On Dec. 28, CMS said that it would require compliance with the interim final rule in states not impacted by lawsuits. This is a shift from CMS’s earlier position that it would not enforce the vaccine requirement while the legal cases were ongoing.

Reports

GAO Report on VA Community Living Center Resident Complaints

On Dec. 30, the Government Accountability Office (GAO) released a report titled “Community Living Centers: VA Needs to Strengthen Its Approach for Addressing Resident Complaints.” The report examined how the Department of Veterans Affairs (VA) addresses complaints regarding quality of care in VA nursing homes, referred to as community living centers (CLCs). The GAO found that the VA has insufficient policies in place and limited monitoring abilities to address complaints about the care provided in CLCs. In addition, the GAO noted that VA guidance on this topic is unclear, which has resulted in CLC residents’ receiving incomplete or inaccurate information on how to file complaints. The GAO recommended that the VA better monitor and document CLC complaints and communicate this process.

The full report can be found here.

HHS OIG Releases Report on Medicare Part B Spending in 2020

On Dec. 30, the Health and Human Services (HHS) Office of the Inspector General (OIG) published a report titled “COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly.” The report notes that Medicare Part B spending increased from $7.7 billion in 2019 to $8.0 billion in 2020, an increase that was driven by new spending on COVID-19 tests. Spending for all other tests decreased by $1.2 billion in 2020, driven by reduction in non-COVID-19 tests during the pandemic.

The full report can be found here.

NIH Publishes Study on U.S. Oral Health

On Dec. 21, the National Institutes of Health (NIH) released a study titled “Oral Health in America: Advances and Challenges,” the culmination of two years of research. The study examines U.S. oral health over the last two decades.

The full report can be found here.

The executive summary 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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