This week in Washington: CMS Administrator confirmed, President releases budget.

Congress

Senate

• Brooks-LaSure Confirmed as CMS Administrator
• Senate HELP Committee Advances Bipartisan Bills
• Senate Republicans Propose Alternative Infrastructure Plan

Administration

• President Biden Releases Budget
• HHS Commits $4.6 Billion to HRSA Fund for Testing the Uninsured
• HHS Reinstates the Unapproved Drugs Initiative
• FDA Releases Draft Guidances on Medical Devices
• FDA Issues Updated COVID-19 Vaccine EUA Guidance
• FDA Grants Emergency Use Authorization to GlaxoSmithKline’s Monoclonal Antibody
• FDA Finalizes Guidance on Pediatric Cancer Drugs
• CMS Joins Online Platforms to Encourage Gig Workers to Enroll in ACA Plans
• CMS Proposes Delay of Medicaid Multiple Best Price Policy

Proposed Rules

• CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals
• CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities
• CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase
• CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System
• CMS Interim Final Rule Requires LTC Providers to Report Vaccination Rates and Educate Staff and Residents

Reports

• GAO Report on Employee Benefits Security Administration

Congress

House and Senate are in recess for two weeks.

Senate

Brooks-LaSure Confirmed as CMS Administrator

On May 25, the Senate voted 55-44 to confirm Chiquita Brooks-LaSure as the Centers for Medicare and Medicaid Services (CMS) administrator. Brooks-LaSure’s nomination process had been delayed after Sen. John Cornyn (R-TX) expressed his opposition to CMS’s decision last month to revoke a 10-year extension of a Texas 1115 Medicaid waiver.

Brooks-LaSure will be the first Black woman to lead CMS, and previously worked at CMS under the Obama administration.

Senate HELP Committee Advances Bipartisan Bills

On May 25, the Senate Health, Education, Labor and Pensions (HELP) Committee voted unanimously to pass six health bills out of committee. The bills are listed below.

• S. 1675, Maternal Health Quality Improvement Act
• S. 1491, Rural Maternal and Obstetric Modernization of Services Act
• S. 1662, Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act
• S. 1301, Promoting Physical Activity for Americans Act
• S. 610, Dr. Lorna Breen Health Care Provider Protection Act
• S. 1658, Providing Urgent Maternal Protections for Nursing Mothers Act

Senate Republicans Propose Alternative Infrastructure Plan

On May 27, Sens. Shelley Moore Capito (R-WV), Pat Toomey (R-PA), Roy Blunt (R-MO) and John Barrasso (R-WY) proposed a $928 billion infrastructure plan as an alternative to President Biden’s $1.7 trillion American Jobs Plan. The Republican plan does not include funds for caregiving infrastructure investments, as Republican senators have stated they want a plan that solely addresses physical infrastructure.

Administration

President Biden Releases Budget

On May 28, President Biden proposed a $6 trillion budget that incorporates the $2.3 trillion infrastructure proposal and the $1.8 trillion American Families Plan. The budget proposal requires congressional approval.

The budget can be found here.

A factsheet on the budget can be found here.

HHS Commits $4.6 Billion to HRSA Fund for Testing the Uninsured

On May 25, the Department of Health and Human Services (HHS) announced that it would designate $4.8 billion from the American Rescue Plan to the COVID-19 Uninsured Program, which reimburses providers for testing people who are uninsured. The COVID-19 Uninsured Testing Program is run by the Health Resources and Services Administration (HRSA) and was initially funded by the Family First Coronavirus Response Act (FFCRA).

HHS Reinstates the Unapproved Drugs Initiative

On May 26, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced they would reverse a Trump-era directive to eliminate FDA’s Unapproved Drugs Initiative.

The Unapproved Drugs Initiative was initially launched in 2006 and revised in 2011. The program is used to remove unapproved drugs from the market.

FDA Releases Draft Guidances on Medical Devices

On May 26, the Food and Drug Administration (FDA) released two draft guidances related to the continuous surveillance of certain medical devices. The first guidance, titled “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act,” includes information to assist manufacturers complete their postmarket surveillance plan in a timely manner, as well as FDA’s policy of posting information about postmarket surveillance. The guidance can be found here.

The second guidance is titled “Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order” and provides additional information to help stakeholders understand the post-approval study requirements conditioned by premarket approval. The guidance can be found here.

FDA Issues Updated COVID-19 Vaccine EUA Guidance

On May 25, the Food and Drug Administration (FDA) issued an updated guidance titled “Emergency Use Authorization (EUA) for Vaccines to Prevent COVID-19.” The guidance provides sponsors of EUA requests for COVID-19 vaccines with recommendations about the data and information needed.

The guidance can be found here.

DA Grants Emergency Use Authorization to GlaxoSmithKline’s Monoclonal Antibody

On May 26, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to GlaxoSmithKline’s investigational monoclonal antibody for use in patients with mild to moderate COVID-19. The monoclonal antibody, sotrovimab, is one of three antibody therapies that have EUA for COVID-19.

Under the EUA, health care workers can administer sotrovimab as a 500-milligram single dose to COVID-19 patients 12 years and older who are at high risk for progression to severe COVID-19 but have not yet been hospitalized.

FDA Finalizes Guidance on Pediatric Cancer Drugs

On May 24, the Food and Drug Administration (FDA) finalized guidance that explains how sponsors of molecularly targeted adult cancer drugs can show the FDA how these drugs can also be used in pediatric populations. The guidance clarifies the pediatric study requirements stated in the 2017 FDA Reauthorization Act (FDARA). Prior to the 2017 FDARA, the FDA only allowed new pediatric cancer drugs to be studied if the cancer type occurs in children, which slowed the development of pediatric cancer drugs.

The guidance, which is titled “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendment 505B of the FD&C Act,” can be found here.

CMS Joins Online Platforms to Encourage Gig Workers to Enroll in ACA Plans

The Centers for Medicare and Medicaid Services (CMS) has joined with several online platforms for the Gig Workers’ Week of Action to encourage employees to sign up for Affordable Care Act coverage and access the subsidies currently available under the American Rescue Plan.

Online platforms collaborating with CMS for the Gig Workers’ Week of Action include Uber, DoorDash and Lyft, among others.

CMS Proposes Delay of Medicaid Multiple Best Price Policy

On May 26, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would delay the Medicaid Multiple Best Price Policy implementation for six months. The Medicaid Multiple Best Price Policy would require manufacturers to report multiple best prices for a drug under Medicaid if the drug manufacturer is participating in a value-based purchasing arrangement.

The original rule, which was finalized on Dec. 31, 2020, would have implemented the requirements on Jan. 21, 2022, but the Biden administration’s proposed rule would delay the implementation until July 1, 2022.

The most recent proposed rule, titled “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements: Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States,” can be found here.

Proposed Rules

CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals

On April 27, the Centers for Medicare and Medicaid Service (CMS) issued a proposed rule titled “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program.”

The proposed rule would update Medicare fee-for-service payment rates and policies for inpatient hospitals and long-term care hospitals for fiscal year (FY) 2022. CMS is publishing this proposed rule to meet the legal requirements to update Medicare payment policies for IPPS hospitals and LTCHs on an annual basis. A fact sheet that discusses major provisions of the proposed rule can be downloaded from the Federal Register here.

The public comment period closes on June 28.

The rule can be found here.

CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities

On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year (FY) 2022.” In the rule, CMS proposes increasing skilled nursing facilities’ (SNF) pay a net 1.3 percent, or $444 million, in FY 2022 and adding two new quality reporting measures in FY 2021: vaccination rates among health care workers and health care–acquired infections.

The proposed rule also asks for public comments on potential ways to readjust the Patient Driven Payment Model (PDPM), a patient payment classification system created in 2019 to be budget-neutral but that data shows caused an unintended $1.7 billion increase in payments in fiscal year 2020. It is possible that the data was affected by the COVID-19 pandemic.

CMS proposes to add a new claims-based measure, health care–associated infections (HAI), to the quality reporting, which would use Medicare fee-for-service claims data to estimate the rate of health care–associated infections acquired during nursing home care that result in hospitalization. The goal is to assess which nursing homes have higher rates of infections acquired during care. The proposed rule also suggests several changes to the SNF Quality Reporting Program and seeks feedback on plans to define digital quality measures for the program. The proposed rule would also alter the SNF Value-Based Purchasing Program, which offers incentive payments to nursing homes based on the quality of care.

Public comments on the proposed rule will be accepted until June 7.

The rule can be found here.

CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase

On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program: FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements.” The proposed rule would increase payments in FY 2022 by 2.3 percent, or $530 million. Providers that do not meet the quality reporting requirements will receive a 2 percentage point reduction to their annual market basket update. The proposed rule also would increase the aggregate payment cap from $30,683.93 in 2021 to $31,389.66 for fiscal year 2022, a 2.3 percent increase.

The proposed rule would also revise the labor shares based on the compensation cost weights for each level of care, with labor share at 74.6 percent for continuous home care, 64.7 percent for routine home care, 60.1 percent for inpatient respite care and 62.8 percent for general inpatient care. In addition, the proposed rule would make the pseudo-patient waiver for hospice aide competency testing permanent and let pseudo-patients be used for hospice aide competency training. It would also have hospices conduct a competency evaluation related to whatever deficiencies and related skills a hospice aide supervisor noted. Also, the rule would allow CMS to modify the Hospice Quality Reporting Program by adding measures meant to promote health equity measures.

Comments are accepted until June 7.

The proposed rule can be found here.

CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System

On April 7, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program.” The proposed rule would update Medicare payment policies and rates for facilities under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program (QRP) for fiscal year (FY) 2022. CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for IRFs on an annual basis.

For FY 2022, CMS proposes to update the IRF PPS payment rates by 2.2 percent based on the proposed IRF market basket update of 2.4 percent, less a 0.2 percentage point multi-factor productivity (MFP) adjustment. IRFs that do not meet reporting requirements are subject to a 2 percentage point (2.0 percent) reduction in their annual increase factor. With the objective of advancing racial equity, CMS plans to utilize several social determinants of health measures and is seeking feedback. In addition, the rule proposes using COVID-19 vaccination coverage measures and updating transfer of health (TOH) information to determine quality of care.

Comments are accepted until June 7.

The proposed rule can be found here.

CMS Interim Final Rule Requires LTC Providers to Report Vaccination Rates and Educate Staff and Residents

On May 11, the Centers for Medicare and Medicaid Services released an interim final rule titled “COVID-19 Vaccine Requirements for Long-Term Care Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities Residents, Clients, and Staff.”

The rule requires long-term care (LTC) facilities and intermediate care facilities treating individuals with intellectual disabilities to submit weekly reports on the COVID-19 vaccination status of residents and staff. In addition, the interim final rule requires LTC and intermediate care facilities to educate residents and staff about the vaccine and offer shots when supplies are available.

There is a 60-day comment period.

The rule can be found here.

Courts

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

Reports

GAO Report on Employee Benefits Security Administration

On May 27, the Government Accountability Office (GAO) released a study on the Department of Labor’s (DOL) Employee Benefits Security Administration (EBSA), which is tasked with protecting the benefits of 154 participants in employer-sponsored retirement and health benefit plans. The study found that a 2013 decision to prioritize cases with the potential to affect many participants and recover significant assets led EBSA to recover more money, although the number of closed cases decreased.

The full report can be found here.

If you have any questions, contact the following individuals at McGuireWoods 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 and economic development, strategic communications & grassroots, and government relations services. McGuireWoods Consulting is a subsidiary of the McGuireWoods LLP law firm and has been named in The National Law Journal's special annual report, "The Influence 50," for the past several years. In the most recent report, McGuireWoods Consulting was ranked 15th of the 1,900 government relations firms in Washington, D.C.

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