This week in Washington: Biden Administration expresses support for WTO TRIPS Waiver.

Upcoming Hearings/Markups

Congress

House

• House Energy and Commerce Hearing to Discuss HHS 2022 Budget Request
• House Energy and Commerce Committee Republicans Ask Blinken to Declassify Documents Related to Chinese Military Research

Senate

• Sen. Cornyn Continues Hold on Brooks-LaSure’s CMS Administrator Nomination
• MACPAC Announces New Appointments

Administration

• Biden Administration Announces Support for TRIPS Waiver
• White House to Launch Plan to Vaccinate Adolescents as Soon as Pfizer Authorization is Issued
• President Biden Signs Law to Extend Fentanyl Analogue Scheduling
• FDA Withdraws Trump-Era Policy That Required Publishing of Drug Review Timelines
• FDA Announces It Will Likely Not Complete Half of Planned Inspections in FY 2021
• CMS Announces Medicare Will Begin Reimbursing Ambulances for Treatment in Place
• CMS Increases Reimbursement for Home Infusion of COVID-19 Monoclonal Antibodies
• New HHS Data on Obamacare Enrollment

Proposed Rules

• CMS Issues Proposed Rule to Address Medical Workforce Needs of Rural and Underserved Communities
• CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals
• CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities
• CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase
• CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System

Reports

• GAO Report on the Veterans Affairs Department Use of COVID-19 Funding

Upcoming Hearings/Markups

May 11

Senate Health, Education, Labor, and Pensions Committee Hearing: “An Update from Federal Officials on Efforts to Combat COVID-19”
10:00 a.m.
For more information, click here.

May 12

House Science, Space and Technology Subcommittee on Investigations and Oversight Hearing: “COVID-19 Variants and Evolving Research Needs”
10:00 a.m.
For more information, click here.

House Energy and Commerce Committee, Subcommittee on Health: “Hearing on the Fiscal Year 2022 HHS Budget”
10:30 a.m.
For more information, click here.

Senate Committee on Veterans’ Affairs Hearing: “Supporting Disabled Veterans: The State of Claims Processing During and After COVID-19”
3:00 p.m.
For more information, click here.

May 13

House Appropriations Committee, Subcommittee on Departments of Labor, Health and Human Services, Education and Related Agencies Hearing: “Mental Health Emergencies: Building a Robust Crisis Response System”
10:00 a.m.
For more information, click here.

House Foreign Affairs Committee, Subcommittee on Western Hemisphere, Civilian Security, Migration, and International Economic Policy Hearing: “A Race Against Time: Deploying Vaccines and Addressing the Disproportionate Impacts of COVID-19 in Latin America and the Caribbean”
2:00 p.m.
For more information, click here.

House

House Energy and Commerce Hearing to Discuss HHS 2022 Budget Request

The House Energy and Commerce Subcommittee on Health will hold a hearing on May 12 with the Department of Health and Human Services (HHS) Secretary Xavier Becerra to discuss the HHS 2022 discretionary budget request. Representatives will likely use the hearing to ask Becerra about the Biden administration’s plans to cut prescription drug costs and expand coverage.

More information about the hearing can be found here.

House Energy and Commerce Committee Republicans Ask Blinken to Declassify Documents Related to Chinese Military Research

On May 6, House Energy and Commerce Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-KY) and Morgan Griffith (R-VA) sent a letter to Secretary of State Antony Blinken requesting a release of unclassified and declassified documents related to a statement in a Jan. 15 fact sheet. The fact sheet, which can be found here, references Chinese military research taking place at the Wuhan Institute of Virology (WIV). The WIV has been a focus of U.S. government concerns regarding possible links to the COVID-19 virus origin.

In the letter, the representatives argue that declassifying and releasing these documents will help inform a complete investigation into the origins of the COVID-19 pandemic. The letter requests a response from Secretary Blinken by May 20.

The complete letter can be found here.

Senate

Sen. Cornyn Continues Hold on Brooks-LaSure’s CMS Administrator Nomination

Sen. John Cornyn (R-TX) has not lifted his hold on a floor vote for Chiquita Brooks-LaSure’s nomination for Centers for Medicare and Medicaid Services (CMS) administrator. Sen. Cornyn placed a hold on Brooks-LaSure’s nomination in response to the Biden administration’s April 16 decision to reverse an extension of Texas’s 1115 Medicaid waiver that was passed by the Trump administration. Brooks-LaSure’s nomination cannot move forward until the hold is lifted.

MACPAC Announces New Appointments

On May 3, the Government Accountability Office (GAO) announced five new appointments and two reappointments to the Medicaid and CHIP Payment and Access Commission (MACPAC).

Current MACPAC Chair Melanie Bella will serve a second term. Commissioner Kisha Davis was named vice chair of MACPAC, and her term will end in 2023. Commissioner Katherine Weno was reappointed for a term that ends in 2023.

New appointees to MACPAC include Heidi Allen, an associate professor at Columbia University School of Social Work; Robert Duncan, executive vice president of Children’s Wisconsin and president of Children’s Community Health Plan and Children’s Service Society of Wisconsin; Laura Herrera Scott, vice president of clinical strategy and product at Anthem; and Verlon Johnson, senior vice president of corporate strategy at CNSI.

Administration

Biden Administration Announces Support for TRIPS Waiver

On May 5, U.S. Trade Representative Katherine Tai announced that the U.S. would support a proposed waiver of World Trade Organization (WTO) trade-related aspects of intellectual property rights (TRIPS) for COVID-19 vaccines and therapeutics in negotiations in Geneva. The decision is a win for many civil society advocates and Democratic members of Congress who had supported the waiver. It should be noted that WTO decisions require a consensus of all 164 members and negotiations on a waiver plan could take months. The next TRIPS Council meeting is scheduled for June 8-9.

PHRMA, a trade group representing companies in the pharmaceutical industry, released a public statement the same day to express their disapproval of the Biden administration announcement. In the statement, PHRMA president Stephen Ubl said that the waiver will undermine the global pandemic response, weaken supply chains and foster the proliferation of counterfeit vaccines.

On April 30, 109 House Democrats sent a letter to President Biden in support of the WTO waiver, which they state would increase access to COVID-19 vaccines and therapeutics. In addition, 12 Republican members of the House Judiciary Committee wrote a letter on May 4 urging U.S. Trade Representative Katherine Tai to oppose the WTO waiver.

The official May 5 statement from the Office of the U.S. Trade Representative can be found here.

White House to Launch Plan to Vaccinate Adolescents as Soon as Pfizer Authorization is Issued

On May 4, White House officials stated that as soon as the Food and Drug Administration (FDA) authorizes Pfizer’s COVID-19 vaccines for children aged 12-15, the Biden administration will launch a comprehensive plan to get as many adolescents vaccinated by July 4 as possible.

This announcement comes amid reports that the FDA will announce the emergency authorization by early next week.

President Biden Signs Law to Extend Fentanyl Analogue Scheduling

On May 4, President Biden signed into law a temporary extension of the class-wide Schedule 1 classification of fentanyl-like substances. The schedule was set to expire on May 6. The current scheduling of fentanyl analogues will now last until Oct. 22.

FDA Withdraws Trump-Era Policy That Required Publishing of Drug Review Timelines

On April 30, the Biden administration withdrew a Trump-era policy that would have required the Food and Drug Administration (FDA) to publish review timelines for certain drug product applications. The policy was signed by former HHS Secretary Alex Azar on Jan. 15, 2021. The FDA and the Department of Health and Human Services (HHS) stated the policy would be revoked as it did not take into consideration the publicly available information about FDA’s drug application review.

FDA Announces It Will Likely Not Complete Half of Planned Inspections in FY 2021

On May 5, the Food and Drug Administration (FDA) announced that the pandemic will prevent the agency from conducting at least half of its planned inspections of medical products for fiscal year 2021. Medical products impacted by the inspections include drugs, medical devices and tobacco. The FDA stated that a 50 percent reduction in non-food domestic surveillance is the best-case scenario. To maximize the number of potential inspections going forward, the FDA plans to prioritize higher-risk facilities and will launch an “Inspectional Affairs Council” to coordinate inspection activities across the FDA.

In March 2020 the FDA made the decision to decrease the number of in-person inspections domestically and abroad. Inspections have also been limited by travel restrictions in U.S. states. As a result, the FDA has needed to defer or deny some drug and medical device approvals.

CMS Announces Medicare Will Begin Reimbursing Ambulances for Treatment in Place

On May 5, the Centers for Medicare and Medicaid Services (CMS) released a waiver that allows Medicare to reimburse ground ambulances for treating a patient in place when a community’s pandemic emergency protocols prevent the ambulance from taking a patient to a medical facility.

Ambulances serving areas hard-hit by COVID-19 were often instructed not to transport patients with less serious illnesses to hospitals so they could reduce possible exposure to COVID-19 and keep beds open. Until now, Medicare did not reimburse ambulances for services provided on-site. The waiver will retroactively apply to claims dating back to March 2020 and will last throughout the public health emergency.

CMS Increases Reimbursement for Home Infusion of COVID-19 Monoclonal Antibodies

On May 6, the Department of Medicare and Medicaid Services (CMS) more than doubled the reimbursement for home infusion of COVID-19 monoclonal antibodies to treat people with COVID-19. The reimbursement went from an average rate of $310 to $750 and raised the pay rate for most health care settings from $310 to $450.

CMS’s toolkit to help the health care system administer the monoclonal antibody treatment with the updated rates can be found here.

New HHS Data on Obamacare Enrollment

On May 6, the Department of Health and Human Services (HHS) released new data showing that 940,000 customers have signed up for Obamacare plans during the special enrollment season. 469,000 people signed up in April, when the Affordable Care Act subsidies in the COVID-19 relief bill took effect, a 45 percent increase from March.

Proposed Rules

CMS Issues Proposed Rule to Address Medical Workforce Needs of Rural and Underserved Communities

On April 27, the Center for Medicare and Medicaid Services (CMS) issued a proposed rule that would fund medical residency positions in hospitals located in rural and underserved communities to address workforce shortages. In addition, the rule would require hospitals to report COVID-19 vaccination rates among their workers.

The interim final rule with a comment period goes into effect May 10.

The proposed rule can be found here.

CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals

On April 27, the Centers for Medicare and Medicaid Service (CMS) issued a proposed rule titled “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program.”

The proposed rule would update Medicare fee-for-service payment rates and policies for inpatient hospitals and long-term care hospitals for fiscal year (FY) 2022. CMS is publishing this proposed rule to meet the legal requirements to update Medicare payment policies for IPPS hospitals and LTCHs on an annual basis. A fact sheet that discusses major provisions of the proposed rule can be downloaded from the Federal Register here.

The public comment period closes on June 28.

The rule can be found here.

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

On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed 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 (FY) 2022.” In the rule, CMS proposes increasing skilled nursing facilities’ (SNF) pay a net 1.3 percent, or $444 million, in FY 2022 and adding two new quality reporting measures in FY 2021: vaccination rates among health care workers and health care–acquired infections.

The proposed rule also asks for public comments on potential ways to readjust the Patient Driven Payment Model (PDPM), a patient payment classification system created in 2019 to be budget-neutral but that data shows caused an unintended $1.7 billion increase in payments in fiscal year 2020. It is possible that the data was affected by the COVID-19 pandemic.

CMS proposes to add a new claims-based measure, health care–associated infections (HAI), to the quality reporting, which would use Medicare fee-for-service claims data to estimate the rate of health care–associated infections acquired during nursing home care that result in hospitalization. The goal is to assess which nursing homes have higher rates of infections acquired during care. The proposed rule also suggests several changes to the SNF Quality Reporting Program and seeks feedback on plans to define digital quality measures for the program. The proposed rule would also alter the SNF Value-Based Purchasing Program, which offers incentive payments to nursing homes based on the quality of care.

Public comments on the proposed rule will be accepted until June 7.

The rule can be found here.

CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase

On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program: FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements.” The proposed rule would increase payments in FY 2022 by 2.3 percent, or $530 million. Providers that do not meet the quality reporting requirements will receive a 2 percentage point reduction to their annual market basket update. The proposed rule also would increase the aggregate payment cap from $30,683.93 in 2021 to $31,389.66 for fiscal year 2022, a 2.3 percent increase.

The proposed rule would also revise the labor shares based on the compensation cost weights for each level of care, with labor share at 74.6 percent for continuous home care, 64.7 percent for routine home care, 60.1 percent for inpatient respite care and 62.8 percent for general inpatient care. In addition, the proposed rule would make the pseudo-patient waiver for hospice aide competency testing permanent and let pseudo-patients be used for hospice aide competency training. It would also have hospices conduct a competency evaluation related to whatever deficiencies and related skills a hospice aide supervisor noted. Also, the rule would allow CMS to modify the Hospice Quality Reporting Program by adding measures meant to promote health equity measures.

Comments are accepted until June 7.

The proposed rule can be found here.

CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System

On April 7, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program.” The proposed rule would update Medicare payment policies and rates for facilities under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program (QRP) for fiscal year (FY) 2022. CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for IRFs on an annual basis.

For FY 2022, CMS proposes to update the IRF PPS payment rates by 2.2 percent based on the proposed IRF market basket update of 2.4 percent, less a 0.2 percentage point multi-factor productivity (MFP) adjustment. IRFs that do not meet reporting requirements are subject to a 2 percentage point (2.0 percent) reduction in their annual increase factor. With the objective of advancing racial equity, CMS plans to utilize several social determinants of health measures and is seeking feedback. In addition, the rule proposes using COVID-19 vaccination coverage measures and updating transfer of health (TOH) information to determine quality of care.

Comments are accepted until June 7.

The proposed rule can be found here.

Courts

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

Reports

GAO Report on the Veterans Affairs Department Use of COVID-19 Funding

On May 5, the Government Accountability Office (GAO) published a report on how the Department of Veterans Affairs (VA) utilized funding to respond to the COVID-19 pandemic. The report states that the VA received $19.6 billion in supplemental funding in March 2020, and by March 2021, the VA had spent $8.1 billion and committed to spending $9.9 billion of this funding. A majority of the committed funding paid for veterans’ care from non-VA providers, additional salary costs and helping homeless veterans. The remaining funding will be used on testing, equipment and distributing vaccines. The report comes after an April 14 VA report stated that 224,538 veterans contracted COVID-19 and 11,366 died.

The GAO report, with a more detailed breakdown of the VA COVID-19 relief spending, can be found here.