Jul 6, 2021

Washington Healthcare Update

This week in Washington: Senate in recess, conversations continue on infrastructure and administration’s health initiatives. 




Final Rules

Proposed Rules




Bipartisan Bill to Alter Language on Substance Use Disorder Agencies and Programs

On June 29, Reps. David Trone (D-MD) and Lisa McClain (R-MI) introduced the Stopping Titles that Overtly Perpetuate (STOP) Stigma Act, which would change the name of several federal agencies and programs with the objective of decreasing stigma surrounding substance use disorder.

The bill text can be found here. A summary of the bill can be found here.

Rep. Trone Introduces CARA 3.0 Act

On July 1, Rep. David Trone (D-MD) introduced the Comprehensive Addiction and Recovery Act (CARA) 3.0 Act. The bill aims to mitigate the impact of COVID-19 on the addiction epidemic by dedicating resources to prevention, education, research, treatment and recovery. The bill would build on the original CARA Acts of 2016 and the CARA 2.0 Act of 2018.

The bill was cosponsored by Reps. Annie Kuster (D-NH), Brian Fitzpatrick (R-PA), Jaime Herrera Beutler (R-WA), Tim Ryan (D-OH), David McKinley (R-WV), Paul Tonko (D-NY) and Dave Joyce (R-OH). A Senate version of the bill was introduced in March.

The bill text can be found here. A summary of the bill can be found here.

Rep. Suozzi Introduces Bill to Create a Long-Term Care Insurance Program

On July 1, Rep. Tom Suozzi (D-NY) introduced the Well-Being Insurance for Seniors to be at Home (WISH) Act, which would create a public-private partnership to provide long-term care insurance for older Americans who want to receive care at home instead of in a care facility. The bill would create a Long-Term Care Insurance Trust Fund and enable private insurance companies to offer affordable coverage plans for the initial years of potential disability. The proposed changes in the bill would be paid for by workers’ social insurance contributions equivalent to 0.3 percent of wages.

The bill text can be found here. A summary of the bill can be found here.

Reps. Introduce Bill to Increase Mental and Behavioral Health Care Resources for the IHS

On July 1, Reps. Frank Pallone (D-NJ) and Raul Ruiz (D-CA) and Sens. Tina Smith (D-MN) and Kevin Cramer (R-ND) introduced the Native Behavioral Health Access Improvement Act. The bill would create a special behavioral health program within the Indian Health Services (IHS).

The bill text can be found here, and a summary of the bill can be found here.


FEMA Alters COVID-19 Funeral Aid Program Requirements

On June 29, the Federal Emergency Management Agency (FEMA) changed its funeral assistance policy to allow family members of individuals who died from COVID-19 to submit for reimbursement even if the death certificate does not identify COVID-19 as the cause of death. In cases where COVID-19 was not officially identified as a cause of death, family members will need a letter signed by a coroner, medical examiner or official linking the relative’s death to COVID-19. This change could allow thousands of people who had family members die of COVID-19 before testing was accurate or widespread to access the funeral aid program.

HHS Opens Provider Relief Portal

On July 1, the Department of Health and Human Services (HHS) opened the Provider Relief Fund (PRF) Reporting Portal for provider relief recipients to access their reporting requirements and receive information on how to apply their relief to revenue lost during the pandemic.

The Provider Relief Fund Reporting Portal can be found here.

Daniel Tsai Appointed to Lead CMS Medicaid and CHIP Services

The Biden administration has appointed Daniel Tsai as the Centers for Medicare and Medicaid Services (CMS) deputy administrator and Center for Medicaid and Children’s Health Insurance Program (CHIP) Services director. Tsai is currently the Massachusetts Medicaid director and MassHealth assistant secretary He will start his new role on July 6.

CMS Implements Maximum Tax Credits for Individuals Receiving Unemployment

Starting July 1, the Centers for Medicare and Medicaid Services (CMS) will begin its implementation of the American Rescue Plan provision that gives maximum tax credits to anyone who is receiving or approved for unemployment benefits. CMS is encouraging consumers to visit to fill out or update their applications. The COVID-19 special enrollment period ends on Aug. 19.

CMS 2020 Summary Risk Adjustment Report

On June 30, the Centers for Medicare and Medicaid Services (CMS) published its annual summary risk adjustment (RA) report for the 2020 benefit year. The report states that CMS transferred $11 billion between small group and individual plan insurers under the Affordable Care Act’s budget-neutral risk adjustment program in 2020. The report also observes that telehealth claims jumped 484 percent from 2019, and that there was $8.4 billion in transfers among non-catastrophic individual plans and $2.5 billion among small group plans.

The full report can be found here.

FDA Removes EUA from Respirator Decontamination Systems

On June 30, the Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) for all respirator decontamination systems and some masks, stating that an increase in domestic supply of N95 respirators made the EUA no longer necessary. The decision was made following the Centers for Disease Control and Prevention’s (CDC) recommendation that health care facilities use domestic availability instead of crisis capacity solutions.

FDA Approves Rylaze for Cancer Treatment

On June 30, the Food and Drug Administration (FDA) approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to be used as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoma in individuals who are allergic to asparaginase products most commonly used for treatment.

Final Rules

DEA Releases Final Rule That Lifts Mobile Opioid Use Disorder Treatment Moratorium

On June 28, the Drug Enforcement Administration (DEA) released a final rule titled “Registration Requirements for Narcotic Treatment Programs with Mobile Components.” The rule will lift a moratorium on mobile opioid use disorder treatments that had been in place for 14 years. The rule also streamlines the registration of the mobile units. The rule will allow federally registered narcotics or opioid treatment programs (OTPs) to open mobile units under their existing DEA registration, instead of requiring a separate registration. The rule aims to improve rural and suburban access to OTPs.

The final rule can be found here.

The rule will go into effect July 28.

CMS Issues Surprise Billing Interim Final Rule

On July 1, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule titled “Requirements Related to Surprise Billing; Part I.” The rule will restrict surprise billing for patients in job-based and individual health plans who get care from out-of-network providers at in-network facilities. The rule would also protect against surprise billing from air ambulance services from out-of-network providers.

The interim final rule is effective 60 days after publication, and comments will be accepted during that period.

The interim final rule can be read here.

A fact sheet on the interim final rule can be found here.

CMS Issues Funding Methodology for Basic Health Program

On July 2, CMS issued the final funding methodology for the Basic Health Program (BHP) titled “Federal Funding Methodology for Program Year 2022.” The Affordable Care Act provided states with an option to establish a Basic Health Program.  If a state elected to operate a BHP, the BHP assists with affordable health benefit coverage for individuals under age 65 and whose household incomes are between 133 percent and 200 percent of the federal poverty level and are otherwise eligible for Medicaid, the Children’s Health Insurance Program or affordable employer sponsored coverage, or for individuals whose income is below these levels bur are lawfully present non-citizen ineligible for Medicaid.  States may find a BHP a useful option for several reasons, including the ability to potentially coordinate standard health plans in the BHP with their Medicaid managed care plans, or to potentially reduce the costs to individuals by lowering premiums or cost-sharing requirements. Federal funding for a BHP is based on the amount of premium tax credit (PTC) and cost-sharing reductions (CSRs) that would have been provided for the fiscal year to eligible individuals enrolled in BHP standard health plans in the state if such eligible individuals were allowed to enroll in a qualified health plan (QHP) through Health Insurance Exchanges (“Exchanges”). These funds are paid to trusts established by the states and dedicated to the BHP, and the states then administer the payments to standard health plans within the BHP.

The final rule can be found here.

Proposed Rules

CMS Issues Proposed Rule to Establish Standards for Issuers, Exchanges and Navigators

On June 28, the Centers for Medicare and Medicaid Services released a proposed rule titled “Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond Proposed Rule.” The proposed rule includes new standards for issuers, exchanges and navigators and is a continuation of the rulemaking process for the Health and Human Services (HHS) Notice of Benefit and Payment Parameters for the 2022 final rule published Jan. 19 and May 5, 2021.

The proposed rule aims to expand access to health insurance coverage through the exchanges by expanding the open enrollment period, increasing navigator duties and increasing transparency for consumers. Comments for the proposed rule will close on July 28, 2021.

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

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.


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

Supreme Court Will Not Take Up Lawsuits Brought by Hospitals Over Site-Neutral Cuts

On June 28, the Supreme Court announced it would not take up lawsuits brought by hospitals over the Trump-era Centers for Medicare and Medicaid Services’ (CMS) Medicare Part B pay cuts for outpatient clinic visits at certain off-campus hospital facilities. The Supreme Court decision allows the Department of Health and Human Services (HHS) to move forward with the reimbursement cuts included in the 2019 Outpatient Prospective Payment System rule.

In February, hospitals asked the Supreme Court to take up the two cases after they won lawsuits over the site-neutral cuts and the Part B pay cuts, but the U.S. Court of Appeals for the District of Columbia Circuit overturned the rulings.

Supreme Court Will Hear 340B Reimbursement Lawsuit by Hospitals

On July 2, the Supreme Court stated that it would hear a lawsuit by hospitals over cuts to Medicare reimbursement for 340B drugs, and will also hear arguments on whether the issue is one judges can review or if a review is precluded by statute.

The Centers for Medicare and Medicaid Services (CMS) cut Medicare pay for 340B drugs by approximately 30 percent in 2018, and the district court ruled that CMS did not have the authority to make this change. CMS appealed the decision, and an appeals court upheld the pay cuts.

Supreme Court Takes Up Case Concerning Medicare Disproportionate Share Payments

On July, 2, the U.S. Supreme Court accepted the Department of Health and Human Services’ (HHS) request to review HHS Secretary Xavier Becerra v. Empire Health Foundation since the courts’ decisions are split.  This case concerns whether the Centers for Medicare and Medicaid Services (CMS) must include patients who have exhausted their Medicare Part A benefits when calculating disproportionate share payments for hospitals.  The issue stems from a 2005 rule in which HHS decided that even though patients are entitled to benefits under Medicare if they have used all of their Part A benefits, Medicare will no longer pay providers for their care.  Hospitals sued HHS, accusing them of equating the statutory language of “entitled” to with “eligible” for benefits. Two circuit courts sided with HHS, finding the law was ambiguous and the secretary’s interpretation of the law was reasonable, but the 9th Circuit Court ruled earlier this year in favor of the hospitals.  In that case, the judges determined that entitled and eligible cannot be interchangeable if the statute includes both words.

Supreme Court Will Hear Case on Whether States Can Recover Costs Related to Settlements for Medicaid Beneficiaries

The Supreme Court agreed to hear a case on whether state Medicaid agencies can recover costs for Medicaid beneficiaries’ past medical expenses from settlements that are aimed at compensating them for their future medical costs.  

The case revolves around a Florida woman, “Gallardo,” who has been in a vegetative state since 2008 after being hit by a truck while getting off a school bus. Eventually she received an $800,000 settlement which applied to her medical expenses, as well as other damages, though it only covered a fraction of each category. The Florida Agency for Health Care Administration wanted to recover about $300,000 from the settlement after its state Medicaid program paid over $860,000 for Gallardo’s care, but only $35,000 of Gallardo’s settlement was earmarked for past medical expenses. Florida statute says Medicaid can recoup its costs from payments earmarked for future expenses. However, lawyers argue Florida’s law violates federal Medicaid statute. The District Court for the Northern District of Florida agreed that the Medicaid statute preempted Florida’s statute.  Three years later, however, the11th Circuit Court reversed the decision.  

States have differing laws on whether costs can be recouped from settlements designated for future medical costs and across the country there have been differing decisions from state Supreme Courts.

Federal Judge Declines to Dismiss 340B Lawsuit Following Advisory Opinion Withdrawal

On June 30, a federal judge for the U.S. District Court for the District of Delaware decided not to dismiss AstraZeneca’s case against a 340B advisory opinion regarding contract pharmacies. Although the Department of Health and Human Services (HHS) withdrew the 340B advisory opinion, HHS still plans to enforce the policy. The judge stated that since HHS and HRSA plan to enforce the policy, the litigation is still relevant.


GAO Report on Recommendations for HHS Cybersecurity Efforts

On June 28, the Government Accountability Office (GAO) published a report titled “Cybersecurity: HHS Defined Roles and Responsibilities, but Can Further Improve Collaboration.” The report states that the Department of Health and Human Services (HHS) Office of Information Security is responsible for managing the department’s cybersecurity. The report recommends that HHS entities tasked with cybersecurity improve their information sharing and coordination.

The full report, which includes the recommendations in more detail, can be found here.

GAO Report on Veterans Community Care Program

On June 28, the Government Accountability Office (GAO) published a report titled “Veterans Community Care Program: VA Took Action on Veterans’ Access to Care, but COVID-19 Highlighted Continued Scheduling Challenges.” The report states that the Veterans Affairs (VA) Veterans Community Care Program (VCCP) allows eligible veterans to receive health care from community providers, and that during COVID-19, the VA increased telehealth and prioritized appointments for those with urgent needs. However, the report notes that the VA does not have a measure for wait time and recommends that the VA implement this recommendation. In addition, the GAO recommends that the VA direct its medical facilities to assess community care staffing needs.

The full report can be found here.

GAO Report on COVID-19 Preparedness at Veterans Affairs Medical Centers

On June 30, the Government Accountability Office (GAO) released a report titled “COVID-19: Implementation and Oversight of Preparedness Strategies at Veterans Affairs Medical Centers.” The report states that in January 2020, the Veterans Health Administration (VHA) took action to help the Department of Veterans Affairs medical centers (VAMC) to prepare for the COVID-19 pandemic by developing plans for testing and screening, training staff on the use of personal protective equipment, collecting medical center data and sharing best practices. The VHA provides health care to more than 10 million veterans each year at approximately 170 VAMCs. As part of the CARES Act, the GAO was tasked with reporting on VHA pandemic efforts.

The full report can be found here.

GAO Report on Efforts to Address COVID-19 in Detention Facilities

On June 30, the Government Accountability Office (GAO) published a report titled “Immigration Detention: ICE Efforts to Address COVID-19 in Detention Facilities.” The report states that U.S. Immigration and Customs Enforcement (ICE) has responded to COVID-19 in its detention facilities by addressing protocols such as social distancing, screening and testing. However, the report notes that quarantine measures were sometimes difficult due to infrastructure limitations, and mask compliance was also an issue.

The full report can be found here.

GAO Report on VA Efforts to Modernize Health Information and Financial IT Systems

On July 1, the Government Accountability Office (GAO) published a report titled “Veterans Affairs: Systems Modernization, Cybersecurity, and IT Management Issues Need to Be Addressed.” The report states that the Department of Veterans Affairs (VA) has made progress in modernizing electronic health records, although challenges remain. The report recommends that the VA do more to strengthen cybersecurity, and recommends that the Veterans Health Information Systems and Technology Architecture (VistA) and the non-integrated financial and acquisition management systems be modernized.

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.

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