Washington Healthcare Update - September 2021 #2

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This week in Washington: Reconciliation markup passes out of House Energy and Commerce and Ways and Means Committees.

Congress

Upcoming Hearings/Markups

House

  • House Energy and Commerce Committee Marks Up Build Back Better Act
  • House Ways and Means Committee Marks Up Build Back Better Act
  • House Rules Committee to Consider Continuing Resolution
  • Reps. Scalise and Comer Write to FDA Commissioner with Concerns Regarding White House Booster Shot Position

Senate

  • The Senate and Reconciliation

Administration

  • White House Announces National Cancer Advisory Board Nominees
  • HHS Announces 2.8 Million Registered for ACA Coverage During the Special Enrollment Period
  • FDA to Launch Pilot Program with EMA to Advise Generic Drug Manufacturers
  • CDC Vaccine Advisory Committee to Meet to Discuss COVID-19 Boosters
  • FTC Issues Statement Saying That Health Apps Must Follow the Health Breach Notification Rule
  • FTC Votes to Rescind Trump-administration Merger Guidance

Proposed Rules

  • CMS Issues Proposed Rule to Repeal Trump-Era Medicare Breakthrough Device Coverage Rule
  • CMS Issues Proposed Rule to Reassign Medicaid Provider Claims

Final Rules

  • CMS Issues Final Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities
  • CMS Issues Final Rule on Inpatient Rehabilitation Facility Prospective Payment System
  • CMS Issues Final Rule on Inpatient Psychiatric Facilities Prospective Payment System
  • CMS Issues Final Rule on Hospice Wage Index and Payment Rate Update
  • CMS Issues Final Rule for Long-Term Care Hospital Quality Reporting Program

Reports

  • Commonwealth Fund Survey on the Impact of COVID-19 on Older Adults
  • GAO Report on Chronic Health Conditions
  • GAO Report on Veterans’ Access to Services

Upcoming Hearings/Markups

September 20

House Rules Committee Meeting to discuss: H.R. 3755— Women’s Health Protection Act of 2021; H.R. _____— An act making continuing appropriations for the fiscal year ending September 30, 2022, and for providing emergency assistance, and for other purposes; and H.R. 4350— National Defense Authorization Act for Fiscal Year 2022
12:00 p.m.
For more information, click here.

September 21

House Veterans’ Affairs Committee Legislative Hearing
9:30 a.m.
For more information, click here.

September 22

House Veterans’ Affairs Committee Hearing: “Veteran Suicide Prevention: Innovative Research and Expanded Public Health Efforts”
10:00 a.m.
For more information, click here.

Senate Health Education, Labor and Pensions Committee, Subcommittee on Employment and Workplace Safety Hearing: “Getting America Ready to Work — Successful on the Job, Apprenticeship Training Programs to Help Workers and Businesses Get Ready to Work”
10:00 a.m.
For more information, click here.

House Energy and Commerce Committee, Subcommittee on Oversight and Investigations Hearing: “Putting Kids First: Addressing COVID-19’s Impacts on Children
10:30 a.m.
For more information, click here.

Congress

House

House Energy and Commerce Committee Marks Up Build Back Better Act

From Sept. 13-15, the House Energy and Commerce Committee held a markup of the Build Back Better Act provisions. The committee approved measures to permanently extend the Children’s Health Insurance Program (CHIP), expand maternal health coverage, fund ARPA-H, invest in home- and community-based services and expand Medicare coverage of dental, vision and hearing, among other things.

The committee did not pass the Medicare drug price negotiation bill (H.R. 3) due to resistance from three centrist Democrats. However, H.R. 3 will be included in the budget reconciliation bill since it was passed by the Ways and Means Committee. The next step is for the proposals of the different committees to be packaged together and considered by the full House.

For more information, find Chairman Pallone’s press release on the markup here.

House Ways and Means Committee Marks Up Build Back Better Act

On Sept. 15, the House Ways and Means Committee finished their markup of the Build Back Better Act provisions. Health care measures approved included making the Affordable Care Act tax credit permanent. The previous week, the committee had approved other health care measures including expanding Medicare hearing, vision and dental benefits and improving data collection in nursing homes. The next step is for the proposals of the different committees to be packaged together and considered by the full House.

For more information, find Chairman Neal’s press release on the markup here.

House Rules Committee to Consider Continuing Resolution

On Sept. 20, the House Rules Committee will meet to consider a continuing resolution to ensure that funding continues for the government past Sept. 30, 2021.

Reps. Scalise and Comer Write to FDA Commissioner with Concerns Regarding White House Booster Shot Position

On Sept. 14, ranking member of the Select Subcommittee on the Coronavirus Crisis Steve Scalise (R-LA) and ranking member of the Committee on Oversight and Reform James Comer (R-KY) wrote to the Food and Drug Administration’s (FDA) Acting Commissioner Janet Woodcock expressing their concern that the Biden administration is promoting COVID-19 vaccine booster shots despite a recent FDA publication stating that the current evidence does not support the need for a booster vaccine. President Biden previously stated that booster doses of the mRNA vaccine would be available to Americans starting on Sept. 20. The Republicans expressed concern that the White House is pressuring the FDA to authorize the booster shots and requested documents of communications with the White House on this topic.

The letter can be found here.

Senate

The Senate and Reconciliation

On Sept. 15, President Biden met with Sens. Kyrsten Sinema (D-AZ) and Joe Manchin (D-WV) to discuss their concerns with the Build Back Better reconciliation bill. Democrats need every Democratic senator to vote for the reconciliation package in order for it to pass.

While the Senate committees have not formally acted on the reconciliation, members are discussing legislation and will differ from the House in several ways.

Administration

White House Announces National Cancer Advisory Board Nominees

On Sept. 15, the White House announced seven appointees to the National Cancer Advisory Board, which provides guidance to the director of the National Cancer Institute. The appointees include Dr. John Carpten, Dr. Nilofer S. Azad, Dr. Luiz Alberto Diaz, Jr., Dr. Christopher Ryan Friese, Dr. Amy Heimberger, Dr. Ashani Weeraratna and Dr. Karen Winkfield. Dr. Carpten will serve as Chair of the Advisory Board.

The press release with additional information on the appointees can be found here.

HHS Announces 2.8 Million Registered for ACA Coverage During the Special Enrollment Period

On Sept. 15, the Health and Human Services (HHS) Department announced that 2.8 million people signed up for Affordable Care Act (ACA) coverage during the special enrollment period from Feb. 15 to Aug. 15.

FDA to Launch Pilot Program with EMA to Advise Generic Drug Manufacturers

On Sept. 15, the Food and Drug Administration (FDA) launched a pilot program with the European Medicines Agency (EMA) that would provide parallel scientific advice from both agencies to generic drug manufacturers seeking FDA or EMA approval. The program aims to help applicants better understand regulatory decisions and avoid unnecessary replication of studies or testing.

The press release can be found here.

CDC Vaccine Advisory Committee to Meet to Discuss COVID-19 Boosters

The Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee will meet on Sept. 22 and 23 to discuss how booster doses of the Pfizer COVID-19 vaccine will be administered.

FTC Issues Statement Saying That Health Apps Must Follow the Health Breach Notification Rule

On Sept. 15, the Federal Trade Commission (FTC) issued a policy statement clarifying that health apps and connected devices that use consumers’ health information need to comply with the Health Breach Notification Rule. This means that health apps and connected devices will need to notify consumers when their health data is breached. The FTC noted that health apps collect sensitive and personal data from consumers and have a responsibly to ensure the data collected is secure.

The official statement can be found here.

FTC Votes to Rescind Trump-administration Merger Guidance

On Sept. 15, the Federal Trade Commission (FTC) voted 3-2 to rescind the Vertical Merger Guidelines. The guidelines were issued in 2020 and set out enforcement policies for non-horizontal mergers.

The FTC stated that the 2020 guidance contained unsound economic theories that were not supported by the law or market realities. The agency said it will work with the Department of Justice (DOJ) to update merger guidance. The upcoming guidance would impact mergers that are increasingly common in health care.

Proposed Rules

CMS Issues Proposed Rule to Repeal Trump-Era Medicare Breakthrough Device Coverage Rule

On Sept. 15, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule that would repeal Medicare Coverage of Innovative Technology (MCIT) and the “Reasonable and Necessary” final rule published Jan. 14, 2021. CMS stated that the rule would be repealed due to patient safety risks posed by requiring CMS to immediately cover devices going through the FDA approval path.

The Trump administration rule automatically granted four years of Medicare coverage to breakthrough devices awarded FDA market authorization. In addition, the rule codified the Medicare definition of “reasonable and necessary.”

Public comments on the proposed rule will be accepted for 30 days.

The proposed rule can be found here.

CMS Issues Proposed Rule to Reassign Medicaid Provider Claims

On July 30, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicaid Program; Reassignment of Medicaid Provider Claims.” The proposed rule would explicitly authorize states to make payments to third parties to benefit individual practitioners by ensuring health and welfare benefits, training, and other benefits customary for employees, if the practitioner consents to such payments to third parties on the practitioner’s behalf.

Comments will be accepted until Sept. 28.

The proposed rule can be found here.

Final Rules

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

On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final 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 2022; and Technical Correction to Long-Term Care Facilities Physical Environment Requirements.” The final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the final rule includes a forecast error adjustment for FY 2022, updates the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), rebases and revises the SNF market basket, implements a recently enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates and includes a discussion of a PDPM parity adjustment. The regulations are effective Oct. 1, 2021.

The final rule can be found here.

CMS Issues Final Rule on Inpatient Rehabilitation Facility Prospective Payment System

On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program; Payment for Complex Rehabilitative Wheelchairs and Related Accessories (Including Seating Systems) and Seat and Back Cushions Furnished in Connection with Such Wheelchairs.” The final rule provides updates to and finalized proposals for the fiscal year (FY) 2022 Inpatient Rehabilitation Facilities Quality Reporting Program (IRF QRP). This rule includes one new finalized measure, the COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) Measure, as well as an update to the specifications for the Transfer of Health (TOH) Information to the Patient-Post-Acute Care Quality Measure. The rule will go into effect on Oct. 1, 2021.

The final rule can be found here.

CMS Issues Final Rule on Inpatient Psychiatric Facilities Prospective Payment System

On July 29, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022).” The rule updates the prospective payment rates, the outlier threshold and the wage index for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital.

The final rule can be found here.

CMS Issues Final Rule on Hospice Wage Index and Payment Rate Update

On July 29, the Centers for Medicare and Medicaid Services (CMS) released a rule titled “FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements.” The final rule updates the hospice wage index, payment rates and aggregate cap amount for fiscal year 2022. In addition, this rule makes changes to the labor shares of the hospice payment rates and finalizes clarifying regulations text changes to the election statement addendum that was implemented on Oct. 1, 2020. The regulations are effective on Oct. 1, 2021.

The final rule can be found here.

CMS Issues Final Rule for Long-Term Care Hospital Quality Reporting Program

On Aug. 2, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program.” The rule will update and finalize proposals for the FY 2022 Long Term Care Hospital Quality Reporting Program and includes the new COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) measure, among other things. The rule will go into effect Oct. 1, 2021.

The final rule can be found here.

Courts

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

Reports

Commonwealth Fund Survey on the Impact of COVID-19 on Older Adults

On Sept. 15, The Commonwealth Fund published a report titled “The Impact of COVID-19 on Older Adults: Findings from the 2021 International Health Policy Survey of Older Adults.” The survey stated that beyond older age being a risk factor for severe COVID-19 infection, older individuals were more likely to face social and economic hardships as a result of the pandemic. In addition, the survey found that older adults in the U.S. were more likely to lose their job or use up all or most of their savings than compared to their peers in other countries. Also, Latino/Hispanic and Black older adults were more likely than their white peers to experience significant negative economic consequences due to the COVID-19 pandemic.

The survey results in greater detail can be found here.

GAO Report on Chronic Health Conditions

On Sept. 16, the GAO publicly released a report titled “Chronic Health Conditions: Federal Strategy Needed to Coordinate Diet-Related Efforts.” The report stated that selected chronic health conditions linked to diet are prevalent, deadly and costly. These health conditions include cardiovascular disease, cancer, diabetes and obesity. The report notes that government spending to treat cardiovascular disease, cancer and diabetes was 54 percent of total spending to treat these conditions. In addition, cardiovascular disease, cancer and diabetes accounted for half of all annual deaths in the U.S. The GAO stated that there are 200 federal efforts related to diet across 21 agencies, however, agencies have not effectively managed fragmentation or duplication of diet-related efforts. The GAO recommended that Congress consider directing a federal entity to lead a federal strategy for diet-related efforts to reduce Americans’ risk of chronic health conditions.

The full report can be found here.

GAO Report on Veterans’ Access to Services

On Sept. 14, the Government Accountability Office (GAO) published a report titled “Veterans Justice Outreach Program: Further Actions to Identify and Address Barriers to Participation Would Promote Access to Services.” The Department of Veterans’ Affairs (VA) created the Veterans Justice Outreach Program to address the higher rates of homelessness and mental health conditions among veterans. The report made recommendations to the VA to improve the program, which included improving Veterans Justice Outreach (VJO) specialists’ training to increase awareness of services available for veterans with other-than-honorable discharges and increased research on the use of VA services for veterans in the criminal justice system.

The full report can be found here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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