Washington Healthcare Update - March 2021 #3

McGuireWoods Consulting
Contact

This week in Washington: Budget reconciliation package passes and is signed into law; Becerra’s nomination for HHS secretary advances in the Senate.

Upcoming Hearings/Markups

Congress

House

  • House Passes Final Budget Reconciliation Bill
  • Medicare Sequester Moratorium
  • Energy and Commerce Holds a Hearing on the Future of Telehealth
  • Representatives Request Information on Companies’ Plans for CARES Act Funding

Senate

  • Becerra’s Nomination for HHS Secretary to Advance

Administration

  • Gender Policy Council Established
  • Administration Purchases More Vaccine Doses
  • HHS Delays Rule Related to 340B Discounts and Community Health Centers
  • U.S. Preventative Services Task Force Makes Lung Cancer Screening Recommendations
  • HHS Nominee Becerra to Address Mifepristone Restrictions
  • CDC Recommendations for Vaccinated Individuals
  • CDC Faces Criticism for COVID-19 Data Collection
  • CMS and CDC Releases Guidelines for Expanded Nursing Home Visitation
  • CMS Sets Deadline for CHART Model Application
  • CMS Announces Final Participants in ET3 Model
  • Part D Senior Savings Model 2022 Part D Sponsor RFA Is Now Available
  • Department of Homeland Security Pulls the Public Charge

Proposed Rules

  • Public Comment Period for Proposed HIPAA Privacy Rule Changes Extended

Courts

  • Sunset Rule Lawsuit

Reports

  • Commonwealth Fund’s Prediction for Healthcare Industry Post COVID-19
  • Women Facing Higher Impact of COVID-19’s Mental Health Toll

Upcoming Hearings/Markups

March 17

House Energy and Commerce Committee Subcommittee Hearing: "Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations"
10:00 a.m.
For more information, click here.

Senate Finance Committee Hearing: "A National Tragedy: COVID-19 in the Nation’s Nursing Homes"
10:00 a.m.
Witnesses include:
John Dicken, Director of Health Care, Government Accountability Office
R. Tamara Konetzka, Professor of Public Health Sciences, University of Chicago
David Gifford, Chief Medical Officer, the American Health Care Association
For more information, click here.

March 18

Senate Committee on Health, Education, Labor and Pensions Hearing: "Examining Our COVID-19 Response: An Update from Federal Officials"
10:00 a.m.
Witnesses include:
Anthony Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases
David Kessler, M.D., Chief Science Officer for COVID Response at the Department of Health and Human Services
Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, Food and Drug Administration
Rochelle Walensky, M.D., M.P.H., Director of the Centers for Disease Control and Prevention (CDC)
For more information, click here.

House Appropriations Committee Subcommittee on Commerce, Justice, Science, and Related Agencies Hearing: "COVID Outbreaks and Management Challenges: Evaluating the Federal Bureau of Prisons’ Pandemic Response and the Way Forward"
2:00 p.m.
Witness: Michael Carvajal, Director, Federal Bureau of Prisons
For more information, click here.

House Veterans’ Affairs Committee Subcommittee on Health Hearing: "Beyond Deborah Sampson: Improving Healthcare for America’s Women Veterans"
2:00 p.m.
For more information, click here.

March 23

House Financial Services Committee Hearing: "Oversight of the Treasury Department’s and Federal Reserve’s Pandemic Response"
12:00 p.m.
For more information, click here.

March 24

House Committee on Veterans’ Affairs Subcommittee Hearing: "The Pandemic and VA’s Medical Supply Chain: Evaluating the Year-Long Response and Modernization"
2:00 p.m.
For more information, click here.

Congress

House

House Passes Final Budget Reconciliation Bill

On March 10, the House passed the final version of the Senate budget reconciliation bill. One Democrat voted with the Republicans, who were united against the bill. President Biden signed the bill into law on March 11.

Medicare Sequester Moratorium

The House of Representatives will take up an extension of the Medicare sequester moratorium next week. The House Rules Committee will meet Tuesday to consider the Rule for H.R. 1868, legislation to prevent across-the-board direct spending cuts. Providers had attempted to include the extension in the final version of the American Rescue Plan but were ultimately unsuccessful. The sequester moratorium extension had been included in previous pandemic relief packages that were not subject to reconciliation requirements. According to the Congressional Budget Office, the American Rescue Plan could result in increased sequester cuts due to its high cost. It is not clear how House Republicans stand on this issue.

Energy and Commerce Holds a Hearing on the Future of Telehealth

In a March 2 hearing of the Energy and Commerce’s Subcommittee on Health titled “The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care,” several representatives recommended that the panel not focus on telehealth’s potential shortcomings, as telehealth has been beneficial to supporting health care services during the pandemic. Last month, the Department of Justice named telehealth as one of its False Claims Act enforcement priorities.

The COVID-19 pandemic led to an expansion of Medicaid and Medicare telehealth use, and former HHS Secretary Alex Azar and HHS Secretary-nominee Xavier Becerra have stated that this will continue. Some representatives and stakeholders have expressed concern for potential fraud and overuse if telehealth continues to be widely utilized after the pandemic ends.

The Energy and Commerce hearing can be found here.

Representatives Request Information on Companies’ Plans for CARES Act Funding

On March 5, the House Committee on Oversight Reform Chairwoman Carolyn Maloney, Vice Chair Jimmy Gomez and member Mark DeSaulnier sent letters to Cardinal Health, McKesson Corporation, AmerisourceBergen and Johnson & Johnson.

In the letters, members requested information about the four companies’ plans to use their CARES Act tax provision to increase tax deductions for litigation costs related to opioid crisis settlements. The members expressed that this was not the intended purpose of the CARES Act, and also requested information about punitive actions taken within the companies.

Senate

Becerra’s Nomination for HHS Secretary to Advance

On March 11, the full Senate voted 51-48 to advance Xavier Becerra’s nomination to head the Department of Health and Human Services (HHS) after the Senate Finance Committee deadlocked 14-14 due to Republican opposition. This is the first time that Majority Leader Chuck Schumer (D-NY) used his powers to force a nomination out of a tied committee.

Administration

Gender Policy Council Established

On March 8, President Biden signed an executive order establishing the Gender Policy Council. The council will work to advance gender equity by ensuring access to health care and addressing the impact the COVID-19 pandemic has had on women and girls.

The Gender Policy Council will be composed of HHS staff and other agencies, and will collaborate with the White House COVID-19 Response Team and Equity Task Force.

The council, co-led by Jen Klein and Julissa Reynosa, will develop and submit a strategy to President Biden within 200 days recommending policies to advance gender equity and equality. The council will also evaluate the impact of existing programs and propose improvements.

The executive order can be found here.

Administration Purchases More Vaccine Doses

On March 10, the Biden administration announced its plans to secure an additional 100 million doses of the Johnson & Johnson COVID-19 vaccine by the end of 2021. The supply will be used to vaccinate children and administer as booster shots if needed.

HHS Delays Rule Related to 340B Discounts and Community Health Centers

HHS will delay for another four months the Trump administration’s rule to make health clinics pass 340B discounts on insulin and epinephrine to patients, stating that it needs more time to review the rule. The Biden administration froze the final rule, along with many other last-minute Trump administration regulations, but the original freeze expires this month. The rule comes from one of the drug pricing executive orders by former President Donald Trump in September, who stated the policy would lower insulin costs for low-income patients. Health clinics warned the policy could backfire for some patients.

U.S. Preventative Services Task Force Makes Lung Cancer Screening Recommendations

On March 9, the Preventive Services Task Force expanded recommendations for lung cancer screening, resulting in twice as many U.S. adults being eligible for lung cancer screening. Changes include starting annual screenings at 50 and reducing smoking intensity to a 20 pack-year history.

HHS Nominee Becerra to Address Mifepristone Restrictions

In a March 2 letter, nominee for HHS Secretary Xavier Becerra told Sen. Elizabeth Warren (D-MA) that, if confirmed, he will provide senators with more information about the FDA’s prescribing and dispensing restrictions for the abortion pill mifepristone. Becerra expressed support for making mifepristone available via telehealth.

CDC Recommendations for Vaccinated Individuals

On March 8, the Centers for Disease Control and Prevention (CDC) issued recommendations for individuals fully vaccinated against COVID-19.The guidance states that fully vaccinated people can gather indoors with other vaccinated people without wearing masks, visit with unvaccinated people from a single household without wearing masks and refrain from quarantine following exposure if they do not demonstrate any symptoms. The CDC recommends that fully vaccinated people continue to wear a mask and social distance when in public and meeting with people from multiple households. The report states that vaccinated people should also avoid medium and large in-person gatherings as well as travel.

The recommendation can be found here.

CDC Faces Criticism for COVID-19 Data Collection

The Office of the Inspector General for Health and Human Services is examining if the agency can improve data collection on how COVID-19 is impacting communities of color. The CDC has faced criticism for its incomplete data on race and ethnicity, which has serious implications as this data is utilized to allocate federal resources and vaccines. The Government Accountability Office (GAO) is also studying CDC’s data collection and will likely recommend the CDC and HHS condense their data in an upcoming report.

CMS and CDC Releases Guidelines for Expanded Nursing Home Visitation

On March 10, the CDC and the Centers for Medicare & Medicaid Services (CMS) issued updated guidance for nursing homes to expand visitation options. The guidance states that facilities should allow safe indoor visitation for all residents, regardless of vaccination status of the resident or their visitor. The guidance includes certain circumstances where visitation can be limited when risk may be higher.

The guidance emphasizes that “compassionate care” visits should be allowed at all times, regardless of vaccination status, the county’s COVID-19 positivity rate or the occurrence of an outbreak.

CMS continues to recommend facilities, residents and families adhere to the core principles of COVID-19 infection control, including maintaining physical distancing and conducting visits outdoors whenever possible.

Details on the updated nursing home visitation guidance released today can be found here.

A fact sheet can be found here.

CMS Sets Deadline for CHART Model Application

The Community Health Access and Rural Transformation (CHART) Model Community Transformation Track application deadline is May 11, 2021. The CHART Model will test whether financial incentives, operational flexibilities and technical support benefit rural providers. The Community Transformation Track provides funding through a Capitated Payment Amount (CPA).

The CHART Model website can be found here.

CMS Announces Final Participants in ET3 Model

On March 12, the Centers for Medicare & Medicaid Services (CMS) announced the final list of participants chosen to take part in CMS’s Emergency Triage, Treat, and Transport (ET3) Model, a payment model created to provide greater flexibility to ambulance care teams in addressing the health care needs of Medicare Fee-for-Service beneficiaries following a 911 call. Final participants include 184 public and private ambulance providers and suppliers from 36 states. CMS also issued a Notice of Funding Opportunity (NOFO) of up to $34 million over two years for local and state governments to expand emergency and non-emergency medical triage services.

More information on the ET3 Model can be found here.

Part D Senior Savings Model 2022 Part D Sponsor RFA Is Now Available

On March 11, CMS published the Calendar Year 2022 Part D Sponsor Request for Applications (RFA) and accompanying application for the Part D Senior Savings (PDSS) Model. Both are available online here and applications are due by April 12, 2021.

Department of Homeland Security Pulls the Public Charge Rule

On March 11, the Department of Homeland Security officially withdrew the Trump administration’s Public Charge Rule. The department filed this withdrawal with the Federal Register to be published March 15. The Public Charge Rule was the subject of a lawsuit, and because the Biden administration chose not to defend the rule in court, the Supreme Court dismissed the case.

Proposed Rules

Public Comment Period for Proposed HIPAA Privacy Rule Changes Extended

On March 9, the Office for Civil Rights (OCR) at HHS announced that the public comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule would be extended for 45 days, making the deadline for public comments May 6.

The proposed rule would strengthen individuals’ rights to access their own health information and improve information sharing for case management and care coordination. It would also add disclosure flexibility in emergency circumstances.

The NPRM is available for review and comment here.

Courts

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

Sunset Rule Lawsuit

On March 9, a coalition of health and consumer advocacy organizations filed a suit against HHS in an effort to eliminate the Trump administration rule requiring health agency regulations to be reviewed every ten years or be automatically scrapped, known as the “Sunset Rule,” which was set to take effect on March 22.

The coalition, which includes the County of Santa Clara, the California Tribal Families Coalition (CTFC), the National Association of Pediatric Nurse Practitioners (NAPNAP), the American Lung Association, the Center for Science in the Public Interest (CSPI) and NRDC (Natural Resources Defense Council), states that the Sunset Rule violates the Administrative Procedure Act and would eliminate thousands of existing health programs and safety regulations.

Reports

Commonwealth Fund’s Prediction for Healthcare Industry Post COVID-19

In a March 9 article for the Harvard Business Review, Commonwealth Fund’s Lovisa Gustafsson and David Blumenthal, M.D., predict that large healthcare systems and insurers will attempt to purchase struggling providers once the pandemic subsides, likely leading to consolidation of the healthcare industry, and potentially increasing prices.

Gustafsson and Blumenthal recommend that actions be taken to:

  • Determine the impact of integrated payer and provider groups on the cost, quality, access and equity of healthcare.
  • Measure the effect of pharmacy consolidation on the drug market and pricing.
  • Ban or restrict anticompetitive contract provisions.
  • Mandate reporting of merger-and-acquisition activities in healthcare to state attorneys general.

Women Facing Higher Impact of COVID-19’s Mental Health Toll

On Feb. 22, a survey of small-business owners carried out by Goldman Sachs found that 64 percent of women under 45 years old and 46 percent of women over 45 years old stated they or their employees have experienced mental health-related issues influenced by COVID-19. This compares to 55 percent of men under 45 years of age and 35 percent of men over 45 stating that they or their employees dealt with the same issues.

The survey 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.

© 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.