May 2, 2022
Washington Healthcare Update
This Week in Washington: CMS announces the 2023 Notice of Benefit and Payment Parameters Final Rule
Senate Committee on Veterans’ Affairs Hearing: “The VA Workforce: Assessing Ways to Bolster Recruitment and Retention”
Senate Committee on Commerce, Science, and Transportation Subcommittee eon Consumer Protection, Product Safety, and Data Security Hearing: “Ensuring Fairness and Transparency in the Market for Prescription Drugs”
Republican Healthy Future Task Force Announces Solutions to Drug Costs and Increasing Access to Cures
On April 29, the Healthy Future Task Force announced its solutions for lowering drug costs and increasing the availability of cures and therapies. The Healthy Future Task Force is a 17-member task force that is working to develop healthcare policy solutions that align with the Republican party’s healthcare agenda. The recently announced solutions focus on promoting medicines produced in the U.S., lowering out-of-pocket costs and reducing bureaucracy in healthcare.
A one-pager on the Healthy Future Task Force solutions can be found here.
Reps. Rodgers, Banks and Wenstrup Introduce Bill to Prohibit QALYs in Federal Programs
On April 28, Reps. Cathy McMorris Rodgers (R-WA), Jim Banks (R-IN) and Brad Wenstrup (R-OH) introduced the Protecting Health Care for All Patients Act. The bill would prohibit the use of quality-adjusted life years (QALYs) in all federal programs. QALYs are currently used in federal programs, except for Medicare, to determine if a treatment is cost-effective and should be covered. The representatives argue that the metric devalues treatments for disabled individuals and people with chronic illness.
Sen. Crapo and Rep. Brady Express Concern with Proposed “Family Glitch” Fix
On April 28, Sen. Mike Crapo (R-ID) and Rep. Kevin Brady (R-TX) wrote to the Secretary of the Treasury Department Janet Yellen expressing their concern with a recent proposed rule by the Internal Revenue Service (IRS) that presents a solution to the “family glitch” in the Affordable Care Act (ACA). In the letter, Sen. Crapo and Rep. Brady argue that the statutory language of the ACA cannot be changed in this manner, and the proposed rule does not consider the potential economic effect on employees and employers.
Sens. Hassan and Braun Call on FDA to Update Opioid Prescription Labels
On April 28, Sens. Maggie Hassan (D-NH) and Mike Braun (R-IN) wrote to the Food and Drug Administration (FDA) Commissioner Robert Califf calling for the FDA to update its policies for labeling opioid prescriptions. The senators recommended that the FDA update opioid labels by removing unsupported claims of long-term efficacy and taking off the term “abuse deterrent,” which can be misleading to consumers.
Sens. Durbin and Braun Introduce the Dietary Supplement Listing Act of 2022
On April 26, Sens. Dick Durbin and Mike Braun introduced the Dietary Supplement Listing Act of 2022. The bill would require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA) and provide basic information about ingredients and labels that would be made available to the public.
Sens. Rubio, Blackburn and Others Introduce Bill to Prohibit the President from Issuing a TRIPS Waiver Without Congressional Authorization
On April 26, Sens. Marco Rubio (R-FL), Marsha Blackburn (R-TN), Thom Tillis (R-NC), Tommy Tuberville (R-AL), Kevin Cramer (R-ND), Bill Hagerty (R-TN), Cynthia Lummis and Mike Lee (R-UT) introduced the No Free TRIPS Act. The bill would prohibit the president from engaging in negotiations or making any changes to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) without congressional authorization. The Biden administration has announced it would seek TRIPS waivers to increase global access to COVID-19 vaccines.
CMS Releases Enrollment Figures for Medicare, Medicaid and CHIP
On April 28, the Centers for Medicare and Medicaid Services (CMS) released the most recent enrollment figures for Medicare, Medicaid and the Children’s Health Insurance Program (CHIP). The data shows that as of January 2022, 64.2 million people were enrolled in Medicare, and approximately 87 million people were enrolled in Medicaid and CHIP, with both of these numbers representing an increase from the last report.
CMS Announces SEP for Consumers Who Enrolled in Salvasen Health Plans
On April 27, the Centers for Medicare and Medicaid Services (CMS) announced a special enrollment period (SEP) for consumers who purchased health plans from Salvasen Health that were not compliant with the Affordable Care Act (ACA), although they were marketed as providing minimum essential coverage. The SEP will last until June 9.
FDA Announces Advisory Committee Tentative Meeting Schedule to Discuss COVID-19 Vaccines
On April 29, the Food and Drug Administration (FDA) announced tentative meeting plans for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss COVID-19 vaccines. The meeting dates are tentative because the manufacturers’ submissions are incomplete at this time. On June 7, VRBPAC will discuss an emergency use authorization (EUA) request from Novavax to prevent COVID-19 in individuals 18 years old and above. On June 8, 21 and 22, VRBPAC will discuss updating Moderna and Pfizer’s EUAs for COVID-19 vaccines to include children. On June 28, VRBPAC will discuss if the strain composition of COVID-19 vaccines should be changed.
FDA Explains Which At-Home COVID-19 Tests Can be Used Past Original Expiration Date
On April 28, the Food and Drug Administration (FDA) published a chart explaining which brands of COVID-19 tests can be used after their listed expiration date. Some at-home COVID-19 tests have been granted an extended expiration after data showed that the shelf-life was longer than what was known when the test was authorized.
FDA Extends Approval of Veklury (Remdesivir) to Treat COVID-19 in Young Children
On April 25, the Food and Drug Administration (FDA) announced the approval of COVID-19 treatment Veklury (remdesivir) was extended to some pediatric patients. Veklury is now approved for patients 28 days of age and older that weigh at least 3 kilograms and have tested positive for COVID-19, who are either hospitalized or have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19. This is the first COVID-19 treatment for young children to be approved by the FDA.
Indian Health Service Announces $5 Million for the Ending the HIV Epidemic in the U.S. Initiative
On April 25, the Indian Health Service (IHS) announced that $5 million in grant funding from the Ending the HIV Epidemic in the U.S. initiative would be made available to address HIV and hepatitis C in Indian Country. $2.48 million will be allocated to three-year cooperative agreements with tribes, tribal organizations and urban Indian organizations to support activities that address HIV/HCV and sexually transmitted infections. Applications for the funding are due on June 17, 2022. Application information can be found here.
SAMHSA Publishes Guidance on Mental Health and Substance Use Disorder Benefits
On April 27, the Substance Abuse and Mental Health Services Administration (SAMHSA) published resources to inform Americans of their rights on coverage for mental health benefits. The guidance provides information on insurance benefits under law, and will help state insurance regulators and behavioral health staff better understand parity laws.
MACPAC Chooses Kate Massey for Executive Director
On April 29, the Medicaid and CHIP Payment and Access Commission (MACPAC) named Kate Massey to serve as executive director. Massey is currently the director of the Michigan Medicaid program and will take on the role of MACPAC executive director next month.
FDA Issues Proposed Rules to Ban the Sale of Menthol Cigarettes and Flavored Cigars
On April 28, the Food and Drug Administration (FDA) issued two proposed rules, the “Tobacco Product Standard for Menthol in Cigarettes,” and the “Tobacco Product Standard for Characterizing Flavors in Cigars.” Together, the proposed rules would ban the sale of menthol cigarettes and flavored cigars, citing the need to protect public health, combat youth tobacco use and promote health equity. The FDA will hold listening sessions to discuss the proposed rules on June 13 and 15.
Public comment on both rules will be open until June 6.
CMS Releases FY 2023 Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System Rule
On April 18, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program; 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 (FY) 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation.” The proposed rule, which is referred to as the FY 2023 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) rule, updates the Medicare fee-for-service payment rates for long-term care hospitals (LTCHs). The rule also establishes new requirements for hospitals and critical access hospitals participating in the Medicare Promoting Interoperability Program. In addition, the proposed rule adds three health equity measures to hospital quality programs.
A CMS fact sheet on the proposed rule can found here.
CMS Releases FY 2023 Skilled Nursing Facilities Prospective Payment System Proposed Rule
On April 15, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program: Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program; Long Term Care Facilities to Establish Mandatory Minimum Staffing Levels.” The proposed rule, which is referred to as the fiscal year (FY) 2023 Skilled Nursing Facilities Prospective Payment System (SNF PPS) proposed rule, adds three new measures to the SNF Value-Based Purchasing (VBP) Program. As part of the proposed rule, CMS is seeking public input on how to best establish minimum staffing requirements at nursing homes. CMS is also seeking public comment on how to address staff turnover in nursing homes.
Comments will be accepted until June 10, 2022.
CMS Issues Proposed Rule to Delay Start of Radiation Oncology Model
On April 8, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Radiation Oncology (RO) Model.” The proposed rule delays the start of the RO to an undetermined future date that will be determined by future rulemaking.
Comments will be accepted until June 7, 2022.
IRS Publishes Proposed Rule to Address Affordable Care Act “Family Glitch”
On April 7, the Internal Revenue Service (IRS) published a proposed rule titled “Affordability of Employer Coverage for Family Members of Employees.” The proposed rule would make changes to the eligibility for the premium tax credit to ensure that the affordability of employer-sponsored minimum essential coverage for family members of an employee is determined on the employee’s share of the cost of covering themselves and their family members. Currently, regulations define “affordable” employer-based coverage as coverage that is affordable for the employee, not considering whether it is affordable for the employee’s family members. This can lead family members to be ineligible for a premium tax credit, and this situation is referred to as the “family glitch.”
Public comment will be accepted until June 6, 2022.
HHS’ Office for Civil Rights Announces RFI on Security Practices and Monetary Settlements Included in the HITECH Act
On April 6, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced it was seeking public input on two provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, which was amended in 2021. The Request for Information (RFI) will inform the OCR’s policies to support the healthcare industry’s security practices going forward. In addition, the RFI will inform how the OCR will share funds collected from HIPAA rule violation enforcement.
Comments will be accepted until June 6, 2022.
CMS Releases Proposed Rule with Updates for the Inpatient Psychiatric Facilities Prospective Payment System
On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Fiscal Year 2023 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update and Quality Reporting.” The proposed rule would make updates to prospective payment rates, the outlier threshold and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF). The proposed rule would also establish a mitigation policy to facilitate the yearly changes in IPF payments. The changes are summarized in this CMS fact sheet. The proposed changes would be in effect from Oct. 1, 2022, to Sept. 30, 2023.
Public comments will be accepted until May 31, 2022.
CMS Releases Proposed Rule to Update the Hospice Wage Index, Payment Rate and Hospice Quality Reporting Requirements
On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” The proposed rule would establish a mitigation policy to facilitate the yearly changes to the hospice wage index. The proposed rule would also update the hospice wage index, payment rates and aggregate cap amount for Fiscal Year 2023, and make changes to the Hospice Quality Reporting Program (HQRP). The changes are summarized in this CMS fact sheet.
Public comments will be accepted until May 31, 2022.
CMS Releases Proposed Rule to Update Medicare Inpatient Rehabilitation Facility Prospective Payment System and Quality Reporting Program
On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the Inpatient Rehabilitation Facility Quality Reporting Program.” The proposed rule would update Medicare payment policies and rates under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program for Fiscal Year 2023. The changes are summarized in this CMS fact sheet.
Public comments will be accepted until May 31, 2022.
FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
On March 22, the Food and Drug Administration (FDA) issued a notice titled “Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database” to establish a public docket and request public comment. The public comments will help the FDA determine how to best prioritize maximum daily exposure (MDE) information for inactive ingredients that are not currently included in the Centers for Drug Evaluation and Research’s Inactive Ingredient Database, as well as if the database should be restructured by removing dosage form information.
Public comments will be accepted until June 21, 2022.
FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs
On March 9, the Food and Drug Administration released draft guidance titled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The draft guidance details the statutory verification system requirements that products need to comply with under the Federal Food, Drug, and Cosmetic Act as amended by the Drug Supply Chain Security Act. Specifically, the draft guidance provides information on verification system requirements to quarantine and investigate products determined to be illegitimate. The guidance document includes non-binding recommendations.
Comments will be accepted until May 9, 2022.
HHS Issues RFI on the Impact of COVID-19 Misinformation
On March 7, the Department of Health and Human Services’ (HHS) Office of the Surgeon General published a notice titled “Request for Information: Impact of Health Misinformation in the Digital Information Environment in the United States Throughout the COVID-19 Pandemic.” The Office of the Surgeon General is seeking input on COVID-19 misinformation online to better understand the impact of misinformation on healthcare infrastructure and public health.
Public comments will be accepted until May 2, 2022.
FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements
On Feb. 23, the Food and Drug Administration (FDA) published a proposed rule titled “Medical Devices; Quality System Regulation Amendments.” The proposed rule would amend the Quality System Regulation’s device current good manufacturing practice (CGMP) requirements to align more closely with international device standards.
Public comments are accepted until May 24, 2022.
FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers
On Feb. 4, the Food and Drug Administration (FDA) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers.” The proposed rule includes proposed national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers.
Public comments are accepted until June 6, 2022.
CMS Releases Notice of Benefit and Parameters for 2023 Final Rule
On April 28, the Centers for Medicare and Medicaid Services (CMS) announced the 2023 Notice of Benefit and Payment Parameters Final Rule, which aims to strengthen plan coverage offered on the federal Marketplace. The final rule will require healthcare.gov plans to offer a standardized version of each product an issuer sells in each metal tier for plan year 2023. The final rule also finalizes exchange user fees, updates quality improvement standards related to health equity and reduces the number of verification requirements for special enrollment periods.
A CMS fact sheet on the final rule can be found here.
CMS Releases Final Rule for Medicare Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing
On April 14, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicare Program; Maximum Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing Standards.” The rule finalizes the maximum out-of-pocket (MOOP) limits for Medicare Parts A and B services and cost sharing limits for Medicare Parts A and B services. CMS is also requesting public comment on new ways to update cost sharing limits in the future. The regulations go into effect on June 13, 2022.
Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that aims to increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.
The White House Fact Sheet on the final rule can be found here.
SUNSET Final Rule Implementation Delayed
On March 4, the Department of Health and Human Services (HHS) released a final rule to postpone the final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET Final Rule). The SUNSET final rule was first published on Jan. 19, 2021, and was set to go into effect on March 22, 2022. The final rule would establish a new process to review HHS regulations, with automatic expiration of regulations that meet certain circumstances. The final rule will now be delayed further and will go into effect on Sept. 22, 2022.
GAO Report on Scientific Integrity at Public Health Agencies
On April 29, the Government Accountability Office (GAO) published a report titled “Scientific Integrity: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference.” The report notes that public health agencies’ policies to ensure scientific integrity do not specifically address political interference. The GAO recommended that public health agencies develop policies to report and address political interference and carry out staff training on this topic.
GAO Report on DOD Suicide Prevention Efforts at Remote Installations
On April 28, the Government Accountability Office (GAO) released a report titled “Suicide Prevention: DOD Should Enhance Oversight, Staffing, Guidance, and Training Affecting Certain Remote Installations.” The report notes that the Department of Defense (DOD) has collected the required suicide data for servicemembers and dependents, which includes data on servicemembers and dependents assigned to remote installations outside the contiguous United States. The GAO report found that remote installations accounted for a higher proportion of reported suicide attempts, and recommended that the DOD establish a process to assess suicide risk at these installations. In addition, the GAO recommended that the DOD improve guidance and training for commanders.
HHS OIG Report on Medicare Advantage Organization’s Denial
On April 27, the Department of Health and Human Services’ (HHS) Office of Inspector General released a report titled “Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care.” The report found that Medicare Advantage Organizations (MAOs) would sometimes deny or delay Medicare Advantage (MA) beneficiaries access to services. In addition, MAOs said that some prior authorization requests did not have enough documentation to merit approval, but the researchers found that the existing medical records were sufficient to demonstrate medical necessity of the services. The HHS OIG recommends that the Centers for Medicare and Medicaid Services (CMS) issue new guidance on MAO clinical criteria in medical necessity reviews, update its audit protocols and direct MAOs to identify and address vulnerabilities that can lead to review errors.
GAO Report on How to Improve Federal Preparedness
On April 27, the Government Accountability Office (GAO) published a report titled “COVID-19: Current and Future Federal Preparedness Requires Fixes to Improve Health Data and Address Improper Payments.” The report includes 15 recommendations for Congress to consider regarding payment oversight, data collection, critical manufacturing and supply chain issues, among other things.
CBO Presentation on Health Care Prices
On April 27, the Congressional Budget Office (CBO) published a presentation titled “A Discussion of Recent Research on Health Care Prices: Prescription Drugs, Hospitals’ Services, and Physicians’ Services.” The presentation summarizes analyses in two recent CBO reports.
GAO Report on the VA Financial Management System
On April 25, the Government Accountability Office (GAO) released a report titled “VA Financial Management System: Additional Actions Needed to Help Ensure Success of Future Deployments.” The report states that the Department of Veterans Affairs (VA) Financial Management Business Transformation (FMBT) program has started deploying the Integrated Financial and Acquisition Management System (iFAMS). The GAO reviewed the progress of the FMBT program, and recommended that the VA establish target values for success and mitigate conversion timing risks for future deployments.
GAO Report on VA Oversight of Nutrition Assistance Programs
On April 25, the Government Accountability Office (GAO) published a report titled “Nutrition Assistance Programs: Federal Agencies Should Improve Oversight and Better Collaborate on Efforts to Support Veterans with Food Insecurity.” The report notes that the Department of Veterans Affairs (VA) uses a screening tool to identify veterans experiencing food insecurity and started collaborating with the Department of Agriculture to offer Supplemental Nutrition Assistance Program (SNAP) in 2020. However, the VA has not monitored the effectiveness of these efforts. The GAO recommended that the VA monitor these efforts and collaborate more with the Department of Agriculture.
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Stephanie Kennan, Senior Vice President
Alexandra Gale, Research Associate
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