Washington Healthcare Update - March 2021 #4

McGuireWoods Consulting
Contact

This week in Washington: Becerra confirmed 50-49 to be Secretary of Health and Human Services

Upcoming Hearings/Markups

Congress

House

  • House passes Medicare Sequester Moratorium
  • Democrats Prepare for Health Care and Drug Pricing Bills for Potential Second Reconciliation Package

Senate

  • Becerra Confirmed as HHS Secretary
  • Senators Ask for DOJ Investigation of McKinsey’s Opioid Work
  • Democratic Senators Sponsor Bill to Eliminate Trump Administration’s Section 1332 Guidance

Administration

  • White House to Launch Campaign to Target Vaccine Hesitancy
  • White House Advisor Opposes a Government-Issued Vaccine Passport
  • Biden Administration Increases Medicare Payment for COVID-19 Vaccine
  • HHS Postpones SUNSET Rule
  • HHS to Survey Providers on Use of Social Determinants of Health Data
  • CMS Reverses Trump Administration Plan to Weaken Part D Protections
  • CMS to Hold Session on Open Payments
  • FDA Emergency Use Authorization Adverse Events Dashboard
  • FDA to Hold Meeting on Drug Container Labels
  • FDA Will Expedite EUA for Asymptomatic COVID-19 Screening
  • HHS Report Finds Work Requirements and Other 1115 Demos Linked to Coverage Loss
  • FTC Working Group to Review Drug Industry Merger Strategy

Proposed Rules

  • CMS to Delay Breakthrough Device Coverage Rule

Courts

  • Injunction Denied in AdventHealth Lawsuit
  • Federal Court Sides with Eli Lilly on 340B Administrative Dispute Resolution Rule

Reports

  • MACPAC March Report to Congress
  • GAO Report on COVID-19 Housing Protections
  • GAO Testimony on Nursing Homes and COVID-19

Upcoming Hearings/Markups

March 23

Senate Health, Education, Labor and Pensions Committee, Subcommittee on Primary Health and Retirement Security: “Why does the U.S. Pay the Highest Prices in the World for Prescription Drugs?
10 a.m.

Witnesses:
Aaron Kesselheim, M.D., J.D., M.P.H., Professor of Medicine, Brigham and Women’s Hospital and Harvard Medical School
Nav Persaud, M.D., M.A., Canada Research Chair in Health Justice, University of Toronto
Elia Spates, Derby, VT
Alex Brill, Resident Fellow, American Enterprise Institute

For more information, click here.

House Energy and Commerce Hearing, Subcommittee on Health: “Building on the ACA: Legislation to Expand Health Coverage and Lower Costs”
11 a.m.
For more information, click here.

House Financial Services Committee: “Oversight of the Treasury Department’s and Federal Reserve’s Pandemic Response”
12 p.m.
For more information, click here.

March 24

House Committee on Veterans’ Affairs, Subcommittee on Oversight and Investigations: “The Pandemic and VA’s Medical Supply Chain: Evaluating the Year-Long Response and Modernization”
2 p.m.
For more information, click here.

March 25

Senate Health, Education, Labor and Pensions Committee: Examining Our COVID-19 Response: Improving Health Equity and Outcomes by Addressing Health Disparities”
10 a.m.
For more information click here.

Congress

House

House passes Medicare Sequester Moratorium

On March 19, the House of Representatives passed legislation to extend the Medicare sequester moratorium through the end of the year. The vote was 246-175. However, the bill is not certain to pass the Senate. This legislation was necessary to keep the cost of the American Rescue Plan, the COVID-19 relief package from triggering further cuts in spending.

Rep. Steny Hoyer (D-MD) was not available to vote for the bill, but released a statement in favor of the moratorium. A group of 29 Republicans voted in favor of the legislation, while seven did not vote, and the rest opposed the bill. Republican critics of the bill said Democrats should have thought about the pandemic relief package’s effect on Medicare before passing that legislation.

Democrats Prepare for Health Care and Drug Pricing Bills for Potential Second Reconciliation Package

On March 16, House Energy and Commerce Chair Frank Pallone (D-NJ) expressed support for legislation that would allow drug pricing negotiations, impose inflation caps and address launch prices. The legislation could be included in a second reconciliation package, and Pallone expressed hope that the bills could be passed with GOP support. These bills will be discussed at the Subcommittee on Health hearing, March 23. The bills included in the hearing are:

  • H.R. 1790, the Fair Indexing for Health Care Affordability Act
  • H.R. 1796, the Health Care Enrollment Innovation Act
  • H.R. 1872, the Marketing and Outreach Restoration to Empower (MORE) Health Education Act of 2021
  • H.R. 1874, the Expand Navigators’ Resources for Outreach, Learning, and Longevity (ENROLL) Act of 2021
  • H.R. 1875, a bill to amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage
  • H.R. 1878, the State Health Care Premium Reduction Act of 2021
  • H.R. 1890, the Health Care Consumer Protection Act
  • H.R. 1896, the State Allowance for Variety of Exchanges (SAVE) Act of 2021
  • H.R. 340, the Incentivizing Medicaid Expansion Act of 2021
  • H.R. 1738, the Stabilize Medicaid and CHIP Coverage Act
  • H.R. 1784, the Medicaid Report on Expansion of Access to Coverage for Health Care (REACH) Act
  • H.R. 1025, the Kids’ Access to Primary Care Act of 2021
  • H.R. 66, the Comprehensive Access to Robust Insurance Now Guaranteed for Kids Act, or the CARING for Kids Act
  • H.R. 1791, the Children’s Health Insurance Program Permanency (CHIPP) Act
  • H.R. 1888, the Improving Access to Indian Health Services Act
  • H.R. 1717, a bill to amend Title XIX of the Social Security Act to make permanent the protections under Medicaid for recipients of home and community-based services against spousal impoverishment
  • H.R. 1880, a bill to amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person Rebalancing Demonstration
  • H.R. 1390, the Children’s Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act

More information can be found here.

Senate

Becerra Confirmed as HHS Secretary

On March 18, the Senate voted 50-49 to confirm Xavier Becerra as HHS Secretary. The vote was mostly by party line but Sen. Susan Collins (R-ME) supported Becerra’s nomination and Sen. Mazie Hirono (D-HI) did not vote.

Senators Ask for DOJ Investigation of McKinsey’s Opioid Work

In a March 15 letter, Sens. Brian Schatz (D-HI) and Richard Blumenthal (D-CT) asked Attorney General Merrick Garland to investigate consulting firm McKinsey & Co.’s work with Purdue Pharma and other manufacturers to increase sales of opioids, including OxyContin. Last month, McKinsey reached an approximately $600 million settlement with states over its role in the opioid epidemic.

The letter can be found here.

Democratic Senators Sponsor Bill to Eliminate Trump Administration’s Section 1332 Guidance

On March 16, Sens. Mark Warner (D-VA), Ben Cardin (D-MD), Jeanne Shaheen (D-NH) and Tammy Baldwin (D-WI) introduced the “Protecting Americans with Preexisting Conditions Act of 2021,” which would reverse the Trump administration’s revised guidance on Section 1332 waivers which were codified as part of the 2022 exchange rule. The rule would allow policies to be sold that exclude pre-existing conditions. Over 40 Democratic senators are supporting the legislation.

Administration

White House to Launch Campaign to Target Vaccine Hesitancy

The White House announced a new campaign to reduce vaccine hesitancy. The campaign will involve $1.5 billion in television, radio and digital ads aimed at promoting public confidence in the vaccine and combating misinformation, with a focus on young people, people of color and conservatives. A majority of the funding for the vaccine campaign comes from the American Rescue Plan.

White House Advisor Opposes a Government-Issued Vaccine Passport

On March 15, Senior White House Adviser for COVID-19 Response Andy Slavitt told reporters that it is not the role of the government to issue vaccine passports or similar documents, and called for nonprofits and the private sector to take the lead. He stressed that health data should be kept private, but individuals should be able to access their own data.

Biden Administration Increases Medicare Payment for COVID-19 Vaccine

On March 15, the Centers for Medicare & Medicaid Services (CMS) increased the Medicare payment amount for administering the COVID-19 vaccine. This change is designed to increase the rate at which vaccines are administered, including hiring additional staff and increasing vaccination sites.

The payment rate for physicians, hospitals and pharmacies will be $40 to administer each dose of a COVID-19 vaccine given on or after March 15, 2021. This represents an increase from $28 for single-dose vaccines. COVID-19 vaccines requiring two doses will rise from approximately $45 to $80.

Additional information can be found in Medicaid’s toolkit, located here. More information on Medicare payment for COVID-19 vaccine administration can be found here. The CDC’s COVID-19 Vaccination Program Provider Requirements can be found here. Information on the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program can be found here.

HHS Postpones SUNSET Rule

On March 19, HHS announced that it is a Trump administration final rule that, if allowed to go into effect, would have required agency regulations to be reviewed every 10 years or be automatically tossed out. In the Federal Register notice, the department says it is looking at the rule in light of complaints cited in a lawsuit. The department believes the court could find the complaints have merit. In addition, there are concerns that the regulatory review required y the rule could pose a burden for the Food and Drug Administration (FDA). The rule would require the FDA review or lose more than 95% of its current regulations.

The Trump administration’s Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule was finalized Jan. 8. The Biden administration put the rule on hold as part of a regulatory freeze on all pending regulations that had not yet taken effect.

In its announcement, HHS says the lawsuit, filed March 9 in the U.S. District Court for the Northern District of California, raises questions about whether the rule is consistent with the policies and goals of the Biden administration both in terms of the appropriate role of regulatory oversight of the health care industry and necessary engagement with the public.

The suit alleges that SUNSET violates the Administrative Procedure Act and the Regulatory Flexibility Act because the Trump-HHS failed to name which regulations will expire under SUNSET, provided an insufficient 30-day notice-and-comment period, and unlawfully refused to consult with Indian tribes even though the proposal will affect tribal programs and tribal funding.

In addition to the FDA, HHS believes CMS may also face a burden to assess thousands of regulations within a short time and would increase CMS’ workload. In addition, the department says the rule also likely would result in significant uncertainty and compliance costs to Medicare providers and suppliers.

HHS to Survey Providers on Use of Social Determinants of Health Data

In a March 11 Paperwork Reduction Act Notice, HHS stated that it will survey providers on how they collect and utilize social determinants of health (SDOH) data to address non-clinical factors like food, housing and transportation insecurities that impact overall health. HHS’s SDOH project, located in the Office of the National Coordinator for Health Information Technology, was announced in August. Some stakeholders have noted that including SDOH data in an electronic health record could integrate public benefit programs and improve health outcomes, and other stakeholders have expressed concern about what SDOH data is reasonable to include.

CMS Reverses Trump Administration Plan to Weaken Part D Protections

On March 16, CMS announced it would eliminate the Trump administration’s plan to test waivers that would allow Medicare Part D plans to ignore patient safeguards related to the six protected drug classes and the requirement that formularies cover at least two drugs in other classes. In addition, CMS will now require plans risk penalties for missing spending targets.

CMS had planned to use a demonstration to test the policy changes, but because CMS had released the plan on President Trump’s last day in office, it was easy for the Biden administration to reverse it.

CMS to Hold Session on Open Payments

On March 25, CMS will hold an informative session on the Open Payments Program, its upcoming review and correction processes.

Register for the informative session here.

FDA Emergency Use Authorization Adverse Events Dashboard

On March 15, the Food and Drug Administration (FDA) launched a public dashboard that lists adverse event reports for COVID-19 drugs and biologics that are approved via the emergency use authorization (EUA).

The dashboard can be found here.

FDA to Hold Meeting on Drug Container Labels

The Food and Drug Administration and the Reagan-Udall Foundation will host a virtual public meeting titled “Potential Medication Error Risks with Investigational Drug Container Labels” on May 18 and May 19. The meeting will gather stakeholder input on the risks related to the content and information on investigational drug container labels, the occurrence of medication errors and practices that minimize such errors.

FDA Will Expedite EUA for Asymptomatic COVID-19 Screening

On March 16, the FDA announced that it is open to authorizing COVID-19 tests that can be used to regularly screen asymptomatic individuals, even if the tests have not been validated for use in asymptomatic patients. The FDA says it hopes this change will expand availability of screening tests and strengthen testing programs.

HHS Report Finds Work Requirements and Other 1115 Demos Linked to Coverage Loss

A HHS report found that a number of state Medicaid waivers correlate to coverage losses and negative health outcomes. The report states this is partly because beneficiaries do not understand the new conditions of the waivers related to work requirements, health savings accounts, premiums and more. HHS carried out the report in response to President Biden’s executive order that directed the agency to review demonstrations that could reduce Medicaid coverage.

The Supreme Court canceled oral arguments in the Medicaid work requirements lawsuit March 11, but briefs are still due later this month. The recent HHS report demonstrates to the Supreme Court that the Biden administration likely will not continue the work requirement.

On Feb. 12, CMS told states it does not believe that Medicaid work requirements promote Medicaid objectives. States have 30 days to provide CMS with information on why they disagree.

FTC Working Group to Review Drug Industry Merger Strategy

On March 16, the Federal Trade Commission (FTC) announced it would create a working group to explore strategies for antitrust reviews of drug industry mergers. The working group will include antitrust regulators from Canada, Britain and Europe, as well as state attorneys general and the Justice Department.

Proposed Rules

CMS to Delay Breakthrough Device Coverage Rule

On March 12, CMS announced it would delay the implementation of a Trump administration regulation that would give four years of Medicare coverage to designated breakthrough devices with marketing authorization from the FDA. CMS is holding a 30-day public comment period on the Trump-era rule and is requesting public feedback.

The official announcement can be found here.

Courts

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

Injunction Denied in AdventHealth Lawsuit

On March 12, the U.S. District Court for the Southern District of Iowa denied AdventHealth’s motion for a temporary restraining order and preliminary injunction in the case of AdventHealth vs. the Department of Health and Human Services. The lawsuit was brought under the Administrative Procedure Act (APA) and challenges the existing policy for the allocation of transplant kidneys. AdventHealth had hoped that an injunction would stay the policy’s March 14 implementation. This permitted the new allocation policy for kidneys to be implemented.

Federal Court Sides with Eli Lilly on 340B Administrative Dispute Resolution Rule

On March 16, the U.S. District Court for the Southern District of Indiana granted drug manufacturer Eli Lilly’s request to put the 340B Administrative Dispute Resolution (ADR) rule on hold while the manufacturer’s lawsuit on the regulation proceeds. Judge Sarah Evans Barker said HHS likely did not go through the proper notice and comment procedure on the ADR rule, given there were years between the proposed and final rule and when the Trump administration had announced that the proposal was withdrawn. The Trump administration had said the proposed rule had not been officially withdrawn through the Federal Register, regardless of the amount of time that passed between the proposed and final rule and the fact the rule appeared to be withdrawn from the unified agenda.

The judge pointed to earlier statements from Trump HRSA officials that the agency would not institute an ADR process until it received additional authority from Congress to enforce guidance, which the judge said could have also led stakeholders to believe the ADR rulemaking was not in progress.

Reports

MACPAC March Report to Congress

On March 15, Medicaid and CHIP Payment and Access Commission (MACPAC) released its report to Congress. In the report MACPAC recommended that Congress (1) adopt measures to improve Medicaid’s responsiveness during economic downturns; (2) address high rates of maternal morbidity and morality; and (3) reexamine Medicaid’s estate recovery policies. The report also discusses integrating care for people dually eligible for Medicaid and Medicare, and improving hospital payment policy for safety net hospitals.

The complete report can be found here.

GAO Report on COVID-19 Housing Protections

A March 15 GAO report found that although eviction moratoriums at the federal, state and local levels reduced eviction filings during the COVID-19 pandemic, some eligible renters may not have benefitted from a recent federal moratorium. In the report, the GAO recommends that the CDC and other relevant federal entities implement a communication and outreach plan to increase awareness of the CDC’s decision to extend its moratorium through March 31, 2021, and notes that HHS disagrees with this recommendation.

The report can be found here.

GAO Testimony on Nursing Homes and COVID-19

In a March 17 hearing, John Dicken, Director of Health Care at the GAO testified that HHS has not implemented several relevant GAO recommendations, including developing an implementation plan for recommendations found in CMS’s Nursing Home Commission Report and implementing a strategy to improve COVID-19 data in nursing homes.

The 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.

To sign up for the Weekly Washington Healthcare Update, use our online subscription form.

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.

© McGuireWoods Consulting | Attorney Advertising

Written by:

McGuireWoods Consulting
Contact
more
less

McGuireWoods Consulting on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.