Washington Healthcare Update - July 2021 #3

McGuireWoods Consulting
Contact

This week in Washington: Infrastructure talks continue, Labor HHS Appropriations bill clears House Committee and is on the way to the floor.

Upcoming Hearings/Markups

Congress

House

  • Reps. Guthrie and Nunes Announce Panels as Part of Healthy Future Task Force
  • House Energy and Commerce Committee Advances Health Care Bills
  • New Congressional Social Determinants of Health Caucus Requests Input

Senate

  • Senators Leahy and Daines Request Update on Expanded FTC and DOJ Antitrust Authorities in the Health Insurance Market
  • Bipartisan Group of Sens. and Reps. Write to HHS Secretary and CMS Administrator Expressing Concern with OPO Rule Timeline

Administration

  • Public Health Emergency Extended Another 90 Days
  • CDC Advisory Committee Supports Continued Use of J&J Vaccine
  • Acting FDA Commissioner Says States Should Keep Expiring COVID-19 Vaccines
  • FDA Process Likely to Slow After Pandemic

Proposed Rules

  • Calendar Year 2022 Medicare Hospital Outpatient Prospective Payment System Proposed Rule
  • CMS Issues CY 2022 Medicare Physician Fee Schedule Proposed Rule
  • CMS Issued Proposed Rule for End-Stage Renal Disease Prospective Payment System
  • CMS Proposes 2022 Home Health Prospective Payment System Rate Update
  • CMS Issues Proposed Rule to Delay Medicaid Multiple Best Price Policy
  • CMS Interim Final Rule Requires LTC Providers to Report Vaccination Rates and Educate Staff and Residents

Courts

  • Federal Judge Denies Attempt to Block Indiana University’s Vaccine Mandate
  • Missouri Supreme Court Upholds Medicaid Expansion

Reports

  • GAO Report on Need to Enhance Federal COVID-19 Preparedness and Response
  • GAO Report on Planned Parenthood Affiliate Expenditures

Upcoming Hearings/Markups

July 27

Senate Health, Education, Labor and Pensions Committee Hearing: The Path Forward: Building on Lessons Learned from the COVID-19 Pandemic
10:00 a.m.
For more information, click here.

House Veterans’ Affairs Committee Subcommittee on Health: Aging in Place: Examining Veterans’ Access to Home and Community Based Services
10:00 a.m.
For more information, click here.

Congress

House

Reps. Guthrie and Nunes Announce Panels as Part of Healthy Future Task Force

On July 19, Reps. Brett Guthrie (R-KY) and Devin Nunes (R-CA) announced the Healthy Future Task Force’s five health panels, which will focus on lowering health care costs, increasing access to therapies and medical devices, strengthening U.S. supply chains, increasing care choices and expanding providers available. The Healthy Future Task Force, which was announced by House Minority Leader Kevin McCarthy (R-CA) in June, will create legislative proposals and lay out the Republican health care agenda. Each of the panels will have one chair and two members, and the membership is listed below.

  • The Security Panel will be chaired by Rep. Richard Hudson (R-NC), with Reps. Jim Banks (R-IN) and Tom Cole (R-OK) as members.
  • The Affordability Panel will be chaired by Rep. Kevin Hern (R-OK), with Reps. Rick Allen (R-GA) and Victoria Spartz (R-IN) as members.
  • The Treatment Panel will be chaired by Rep. Brad Wenstrup (R-OH), with Reps. John Joyce (R-PA) and Bruce Westerman (R-AR) as members.
  • The Doctor/Patient Relationship Panel will be chaired by Rep. Larry Bucshon (R-IN), with Reps. Greg Murphy (R-NC) and Beth Van Duyne (R-TX) as members.
  • The Modernization Panel will be chaired by Rep. Mariannette Miller-Meeks (R-IA), with Reps. Morgan Griffith (R-VA) and Mike Kelly (R-PA) as members.

House Energy and Commerce Committee Advances Health Care Bills

On July 21, the House Energy and Commerce Committee held a markup of 24 bills. The following health care bills were approved by the committee and will go next to the House for a vote.

  • H.R. 4369, the “National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act”
  • H.R. 654, the “Drug-Free Communities Pandemic Relief Act”
  • H.R. 2051, the “Methamphetamine Response Act of 2021”
  • H.R. 2379, the “State Opioid Response Grant Authorization Act of 2021”
  • H.R. 2364, the “Synthetic Opioid Danger Awareness Act”
  • H.R. 2355, the “Opioid Prescription Verification Act of 2021”
  • H.R. 4026, the “Social Determinants of Health Data Analysis Act of 2021”
  • H.R. 3743, the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act”
  • H.R. 550, the “Immunization Infrastructure Modernization Act”
  • H.R. 1550, the “Promoting Resources to Expand Vaccination, Education, and New Treatments for HPV Cancers Act of 2021” or the “PREVENT HPV Cancers Act of 2021”
  • H.R. 951, the “Maternal Vaccination Act”
  • H.R. 4387, the “Maternal Health Quality Improvement Act of 2021”
  • H.R. 3742, the “Vaccine Information for Nursing Facility Operators Act” or the “Vaccine INFO Act”
  • H.R. 2347, the “Strengthening the Vaccines for Children Act of 2021”
  • H.R. 3894, the “Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2021” or the “CARING for Social Determinants Act of 2021”
  • H.R. 4406, the “Supporting Medicaid in the U.S. Territories Act”

The markup page can be found here.

New Congressional Social Determinants of Health Caucus Requests Input

On July 21, Reps. Cheri Bustos (D-IL), Tom Cole (R-OK), G.K. Butterfield (D-NC) and Markwayne Mullin (R-OK) launched the Congressional Social Determinants of Health Caucus. The caucus will highlight opportunities to address social determinants of health such as food, housing and transportation. The caucus requests feedback from stakeholders and members of Congress before Sept. 21.

Senate

Senators Leahy and Daines Request Update on Expanded FTC and DOJ Antitrust Authorities in the Health Insurance Market

On July 20, Sens. Patrick Leahy (D-VT) and Steve Daines (R-MT) wrote a letter to Attorney General Merrick Garland and Federal Trade Commission (FTC) Chair Lina Khan regarding the expansion of FTC and Department of Justice (DOJ) antitrust authorities over the health insurance industry. The Competitive Health Insurance Reform Act (CHIRA) of 2020, which recently went into effect, repeals the McCarran-Ferguson Act’s antitrust exemption for the health insurance industry. In the letter, the senators request additional information on how DOJ and FTC have exercised their expanded antitrust authorities.

The letter can be found here.

Bipartisan Group of Sens. and Reps. Write to HHS Secretary and CMS Administrator Expressing Concern with OPO Rule Timeline

On July 20, a bipartisan group consisting of members of the Senate Finance Committee and the House Oversight and Reform Committee wrote to Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, voicing their support of the CMS Organ Procurement Organizations (OPOs) Conditions for Coverage Final Rule. The letter requests that CMS consider ways to accelerate the Final Rule’s implementation.

The letter was signed by Sens. Ron Wyden (D-OR), Chuck Grassley (R-IA), Todd Young (R-IN), Ben Cardin (D-MD), Joni Ernst (R-IA), Michael Bennet (D-CO) and Jerry Moran (R-KS) and Reps. Carolyn Maloney (D-NY), James Comer (R-KY), Raja Krishnamoorthi (D-IL), Michael Cloud (R-TX) and Katie Porter (D-CA).

The letter can be found here.

Administration

Public Health Emergency Extended Another 90 Days

On July 20, the Secretary of Health and Human Services (HHS) Xavier Becerra extended the COVID-19 public health emergency designation for an additional 90 days, as was expected.

CDC Advisory Committee Supports Continued Use of J&J Vaccine

On July 22, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices met to discuss the data and risks of Guillain-Barre Syndrome (GBS), a neurological disorder, linked to the Johnson & Johnson vaccine. There have been 100 identified reports of GBS after use of the J&J vaccine, with a majority of cases occurring in males in the 21 days after vaccination. The CDC Advisory Committee concluded that the J&J vaccine should continue to be used, as the benefits outweigh the potential risks. The committee noted that having three available vaccines is important with the increase in Delta variant cases.

Acting FDA Commissioner Says States Should Keep Expiring COVID-19 Vaccines

During a July 20 hearing, Acting Commissioner of the Food and Drug Administration (FDA) Janet Woodcock said that states with unused COVID-19 vaccines that are set to expire soon should keep the doses in case data supports extending expiration dates.

FDA Process Likely to Slow After Pandemic

During the Food and Drug Administration’s (FDA) Regulatory Education for Industry Conference, an FDA official stated that the agency will not be able to maintain the same pace of operations once the pandemic is over. The FDA has issued 76 COVID-19 guidances since March 2020, a rate that the official stated is unsustainable.

Proposed Rules

Calendar Year 2022 Medicare Hospital Outpatient Prospective Payment System Proposed Rule

On July 19, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Calendar Year (CY) 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule.” CMS is required by the Jan. 2021 Hospital Price Transparency Final Rule to update Medicare payment policies for OPPS hospitals and ASCs on an annual basis. In the proposed rule, CMS proposes several changes aimed at increasing compliance and reducing hospital burden. These changes include setting a minimum civil monetary penalty (CMP) of $300 a day that would apply to smaller hospitals and apply a $10/bed/day charge for hospitals with a bed count over 30, not to exceed a daily amount of $5,500. The minimum total penalty amount for a full year of noncompliance would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.

CMS is seeking input on how to make data on health disparities based on social risk factors more comprehensive. The proposed rule includes a request for information (RFI) to seek public input on establishing rural emergency hospitals (REHs). CMS is also proposing changes to the Radiation Oncology (RO) Model and halting the elimination of the inpatient-only list. The final rule will be published in early November.

The comment period will end on Sept. 17.

The fact sheet on the proposed rule can be found here.

The proposed rule can be found here.

CMS Issues CY 2022 Medicare Physician Fee Schedule Proposed Rule

On July 13, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Calendar Year (CY) 2022 Medicare Physician Fee Schedule Proposed Rule.” The proposed rule includes policy changes for Medicare payments under the Physician Fee Schedule (PFS) and would continue the coverage of Medicare telehealth services through the end of 2023, among other changes.

The proposed CY 2021 PFS conversion factor is $33.58, a decrease from the CY 2021 factor of $34.89. The proposed rule would also waive the provider enrollment Medicare application fee for organizations that apply as a Medicare Diabetes Prevention Program (MDPP) supplier on or after Jan. 1, 2022. In the proposed rule, CMS requests feedback on how to best update pay rates for the administration of preventive vaccines covered under Part B and whether to assign certain Section 505(b)(2) drug products to existing multiple source codes.

Comments will be accepted until Sept. 13, 2021.

The proposed rule can be found here.

The fact sheet for the rule can be found here.

For additional information on the proposed rule, click here.

CMS Issued Proposed Rule for End-Stage Renal Disease Prospective Payment System

On July 1, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model.” The proposed rule would update payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services starting Jan. 1, 2022. The rule also would update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services and the ESRD Treatment Choices (ETC) Model.

Comments will be accepted until Aug. 31, 2021.

The proposed rule can be found here.

A CMS fact sheet on the proposed rule can be found here.

CMS Proposes 2022 Home Health Prospective Payment System Rate Update

On June 28, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Calendar Year (CY) 2022 Home Health Prospective Payment System Rate Update.” The rule would expand the Home Health Value-Based Purchasing (HHVBP) Model. In addition, the rule would update the Medicare Home Health Prospective Payment System (HH PPS) and the home infusion therapy services payment rates for CY 2022. In addition, the proposed rule would also make permanent changes to the home health Conditions of Participation (CoP) implemented during the COVID-19 public health emergency.

Comments will be accepted until Aug. 27.

The proposed rule can be found here.

The CMS Fact Sheet on the rule can be found here.

CMS Issues Proposed Rule to Delay 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.

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.

Federal Judge Denies Attempt to Block Indiana University’s Vaccine Mandate

On July 18, a federal judge denied an attempt to block Indiana University’s requirement that students and employees receive the COVID-19 vaccine in order to be on campus. In June, eight students filed a lawsuit claiming that the university’s vaccination mandate violates the Fourteenth Amendment and state law. In the decision, Judge Damon Leichty wrote that Indiana University has reasonably determined the best course of action for the health of students and employees. Indiana University does offer medical and religious exemptions to the mandate, but does require unvaccinated individuals to wear masks, social distance and receive periodic COVID-19 tests.

Missouri Supreme Court Upholds Medicaid Expansion

On July 22, the Missouri Supreme Court unanimously upheld the state’s Medicaid expansion, stating that the voter-approved initiative to expand eligibility does not violate the state’s constitution. The decision reverses a prior circuit court decision.

In August 2020, Missouri voters approved a constitutional amendment that would expand Medicaid eligibility under the Affordable Care Act (ACA) to individuals earning up to 138 percent of the poverty line. The expansion was set to go into effect July 1, but Missouri’s Republican-led state legislature did not appropriate funds, which led Governor Mike Parson to pull the amendment to expand Medicaid due to a lack of appropriated funds. Three women sued the state of Missouri in May, claiming that the decision to stop implementation violates state law and there are adequate funds for Medicaid in the state budget.

Reports

GAO Report on Need to Enhance Federal COVID-19 Preparedness and Response

On July 19, the Government Accountability Office (GAO) published a report titled “COVID-19: Continued Attention Needed to Enhance Federal Preparedness, Response, Service Delivery, and Program Integrity.” The report is the seventh comprehensive report on how federal programs can be improved to better address the pandemic and future emergencies. The report includes 15 recommendations, such as improving surge capacity for laboratory testing and restructuring the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), among other things.

The full report can be found here.

GAO Report on Planned Parenthood Affiliate Expenditures

On July 22, the Government Accountability Office (GAO) published a report on 39 Planned Parenthood Federation of America (PPFA) affiliates, which receive federal funding and operate over 600 centers. The report states that 39 affiliates spent more than $270 million in federal funds from 2016-2018, with a majority of the funds—$256 million—provided by the Department of Health and Human Services (HHS).

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.

© 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.