This Week in Washington: White House Releases National Drug Control Strategy

Upcoming Hearings

Congress

House

• Reps. Rodgers, Guthrie and Griffith Call on Secretary Becerra to Investigate Cause of Overdose Deaths
• Reps. Porter, DeLauro and Schakowsky and Sen. Warren Call on CMS to Address Medicare Advantage Program Overpayments
• Rep. Kelly Calls for Action on Medicaid Priorities
• Reps. Buchanan, Kelly and Wenstrup Reintroduce the American Innovation Act

Senate

• Sens. Whitehouse and Markey Ask NIH About Slow Pace of Long COVID Research

Administration

• White House Releases National Drug Control Strategy
• ARPA-H Transferred to NIH
• CMS Releases Data on Hospital and Nursing Home Ownership
• CMS Releases Strategic Plan to Advance Health Equity
• FDA Advisory Committee Votes to Require Randomized Controlled Trials for Blood Cancer Drugs
• FDA Seeks Public Comment on Changes to the Opioid Analgesic Risk Evaluation and Mitigation Strategy
• HRSA Announces $90 Million to Support Health Centers’ Efforts to Reduce Health Disparities
• HRSA to Hold National Telehealth Conference
• SAMHSA Awards $105 Million in Grants to Prepare for the Suicide Prevention Lifeline Transition
• CDC Launches Center for Forecasting and Outbreak Analytics

Other Activity

• Department of Justice Brings Criminal Charges Against Healthcare Fraud Related to COVID-19
• Federal Judge Rules Against CDC Mask Mandate for Air Travel and Public Transportation

Proposed Rules

• CMS Releases FY 2023 Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System Rule
• CMS Releases FY 2023 Skilled Nursing Facilities Prospective Payment System Proposed Rule
• CMS Issues Proposed Rule to Delay Start of Radiation Oncology Model
• IRS Publishes Proposed Rule to Address Affordable Care Act “Family Glitch”
• HHS’ Office for Civil Rights Announces RFI on Security Practices and Monetary Settlements Included in the HITECH Act
• CMS Releases Proposed Rule with Updates for the Inpatient Psychiatric Facilities Prospective Payment System
• CMS Releases Proposed Rule to Update the Hospice Wage Index, Payment Rate and Hospice Quality Reporting Requirements
• CMS Releases Proposed Rule to Update Medicare Inpatient Rehabilitation Facility Prospective Payment System and Quality Reporting Program
• FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
• FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs
• HHS Issues RFI on the Impact of COVID-19 Misinformation
• FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements
• FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

Final Rules

• CMS Releases Final Rule for Medicare Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing
• Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
• SUNSET Final Rule Implementation Delayed

Courts

• Supreme Court Throws Out Cases Related to Medicaid Work Requirements

Reports

• HHS OIG Report Finds California Improperly Claimed at Least $23 Million in Medicaid Reimbursement for Opioid Treatment Program Services
• GAO Report on Scientific Integrity at HHS
• GAO Report on VA Management of Loans Under the Native American Direct Loan Program

Upcoming Hearings

April 26

Senate Health, Education, Labor and Pensions Committee Hearing: “FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients, FDA Center Directors”
10:00 a.m.

House Committee on Veterans Affairs Subcommittee on Technology Modernization Hearing: “Next Steps: Examining Plans for the Continuation of the Department of Veterans Affairs Electronic Health Record Modernization Program”
2:00 p.m.

April 27

House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Hearing: “Fiscal Year 2023 Budget Request for the Food and Drug Administration”
10:00 a.m.

House Oversight and Reform Committee Hearing: “McKinsey and Company’s Conduct and Conflicts at the Heart of the Opioid Epidemic”
10:00 a.m.

House Committee on Energy and Commerce Subcommittee on Health Hearing: “The Fiscal Year 2023 HHS Budget”
10:15 a.m.

House Committee Hearing on Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies Hearing: “Meeting Veterans’ Full Needs: Update on Women’s Health, Mental Health, Homelessness, and Other Programs”
2:00 p.m.

House Committee on Veterans Affairs Subcommittees on Disability Assistance and Memorial Affairs and Oversight and Investigations Hearing: “At What Cost? Ensuring Quality Representation in the Veteran Benefit Claims Process”
2:00 p.m.

April 28

House Veterans’ Affairs Committee Hearing: “U.S. Department of Veterans Affairs Budget Request for Fiscal Year 2023”
10:00 a.m.

House Committee on Natural Resources Subcommittee on Oversight and Investigations Hearing: “Preventing Pandemics Through U.S. Wildlife-borne Disease Surveillance”
10:00 a.m.

House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies Hearing: “A Review of the President’s Fiscal Year 2023 Budget Request for the Food and Drug Administration”
10:00 a.m.

Congress

House

Reps. Rodgers, Guthrie and Griffith Call on Secretary Becerra to Investigate Cause of Overdose Deaths

On April 20, Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-KY) and Morgan Griffith (R-VA) wrote to Health and Human Services Department (HHS) Secretary Xavier Becerra calling for the Department to investigate the cause of overdose deaths in the U.S.

Reps. Porter, DeLauro and Schakowsky and Sen. Warren Call on CMS to Address Medicare Advantage Program Overpayments

On April 20, Reps. Katie Porter (D-CA), Rosa DeLauro (D-CT) and Jan Schakowsky (D-IL) along with Sen. Elizabeth Warren (D-MA) wrote to the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure expressing their concern about overpayments to Medicare Advantage plans. The letter calls on CMS to mitigate payment increases to keep them in line with Medicare and increase transparency within Medicare Advantage.

Rep. Kelly Calls for Action on Medicaid Priorities

On April 18, Rep. Robin Kelly (D-IL), on behalf of the Congressional Tri-Caucus, wrote to President Biden and congressional leadership calling for the inclusion of four Medicaid provisions in the next economic reconciliation agreement. The four policies Rep. Kelly is pursuing include: 12 months of continuous Medicaid and Children’s Health Insurance Program (CHIP) eligibility, 12 months of Medicaid and CHIP postpartum coverage and a solution to close the Medicaid coverage gap in states that have not expanded coverage.

Reps. Buchanan, Kelly and Wenstrup Reintroduce the American Innovation Act

On April 18, Reps. Vern Buchanan (R-FL), Mike Kelly (R-PA) and Brad Wenstrup (R-OH) reintroduced the American Innovation Act. The bill, which passed the House in 2018 with bipartisan support, aims to facilitate the creation of American drug companies by providing special tax treatment.

Senate

Sens. Whitehouse and Markey Ask NIH About Slow Pace of Long COVID Research

On April 20, Sens. Sheldon Whitehouse (D-RI) and Edward Markey (D-MA) wrote to the Acting Director of the National Institutes of Health (NIH) Lawrence Tabak requesting information on why research into post-acute sequelae of SARS-CoV-2 infection, or “long COVID,” is taking such a slow pace. In the letter, the senators note that Congress requested that the NIH study the long-term effects of COVID-19 over two years ago.

Administration

White House Releases National Drug Control Strategy

On April 21, the White House released its National Drug Control Strategy, which aims to reduce drug overdoses by focusing on untreated addiction and drug trafficking. The strategy calls on federal agencies to take action to improve access to harm reduction interventions like naloxone, increase the reach of evidence-based treatment to people at highest risk of overdose and improve data systems that inform drug policy development. In addition, the strategy calls on agencies to disrupt the financial activities of transnational criminal organizations and reduce the supply of illicit drugs through international and domestic coordination.

ARPA-H Transferred to NIH

On April 20, the Department of Health and Human Services (HHS) released a notice titled “Transfer of ARPA-H to NIH.” The notice states that the Advanced Research Projects Agency for Health (ARPA-H) will be transferred to the National Institutes of Health (NIH).

CMS Releases Data on Hospital and Nursing Home Ownership

On April 20, the Centers for Medicare and Medicaid Services (CMS) released data on mergers, acquisitions, consolidations and changes of ownership for hospitals and nursing homes enrolled in Medicare. The data spans from 2016-2022. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) also released a report analyzing the CMS data. The ASPE report found that over the past six years, changes of ownership were more common in nursing homes than hospitals. In addition, ownership varies considerably by state.

CMS Releases Strategic Plan to Advance Health Equity

On April 20, the Centers for Medicare and Medicaid Services (CMS) released a strategic plan as part of its effort to advance health equity. As part of the announcement, CMS Administrator Chiquita Brooks-LaSure invited industry leaders to commit to advancing health equity and to working with CMS. The CMS health equity strategy is focused on closing gaps in healthcare access and outcomes, promoting culturally appropriate services and expanding the collection of demographic data, among other things.

FDA Advisory Committee Votes to Require Randomized Controlled Trials for Blood Cancer Drugs

On April 21, the Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted unanimously to approve a requirement that certain blood cancer drugs seeking FDA approval demonstrate safety and efficacy via randomized controlled trials. Currently, these drugs only require single-arm trials.

FDA Seeks Public Comment on Changes to the Opioid Analgesic Risk Evaluation and Mitigation Strategy

On April 20, the Food and Drug Administration (FDA) announced it was seeking public comment on a potential policy change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid envelopes. The FDA is also proposing that pharmacies provide patient education on the safe disposal of opioids. The FDA states that these changes could help reduce unnecessary exposure to opioids.

HRSA Announces $90 Million to Support Health Centers’ Efforts to Reduce Health Disparities

On April 21, the Health Resources and Services Administration (HRSA) announced it would be awarding $90 million in American Rescue Plan funding to help HRSA Health Center Program-supported centers to use data to identify and reduce health disparities. Applications are due by May 23, 2022.

HRSA to Hold National Telehealth Conference

On April 18, the Health Resources and Services Administration (HRSA) announced that it would be hosting a National Telehealth Conference with Telehealth.HHS.gov on May 16-17. The conference will discuss telehealth best practices and lessons learned during the course of the COVID-19 pandemic.

SAMHSA Awards $105 Million in Grants to Prepare for the Suicide Prevention Lifeline Transition

On April 19, the Substance Abuse and Mental Health Administration (SAMHSA) announced that it would be awarding $105 million in grant funding to help states prepare for the transition of the National Suicide Prevention Lifeline from the current 10-digit number to the dialing code 988. The transition is scheduled for July.

CDC Launches Center for Forecasting and Outbreak Analytics

On April 19, the Centers for Disease Control and Prevention (CDC) formally launched the Center for Forecasting and Outbreak Analytics, which aims to improve the nation’s ability to predict and prepare for future disease outbreaks.

Other Activity

Department of Justice Brings Criminal Charges Against Healthcare Fraud Related to COVID-19

On April 20, the Department of Justice announced it was bringing criminal charges against 21 defendants for their alleged participation in healthcare-related fraud schemes during the COVID-19 pandemic. The Department of Justice stated that the cases allegedly involved $149 million in COVID-19 false billings to federal programs and theft from pandemic assistance programs.

Federal Judge Rules Against CDC Mask Mandate for Air Travel and Public Transportation

On April 18, a federal judge ruled against the Centers for Disease Control and Prevention’s (CDC) mask mandate for air travel and public transportation, effectively voiding the mandate. On April 20, the Department of Justice announced that it would appeal the decision. The CDC mask requirement for trains and public transportation was set to expire on May 3 before it was voided.

Proposed Rules

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.

Final Rules

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.

Courts

Supreme Court Throws Out Cases Related to Medicaid Work Requirements

On April 18, the Supreme Court threw out cases that challenged Medicaid work requirements in Arkansas and New Hampshire, stating that the cases were now moot as the Biden administration has dismissed the requirements. The lawsuits, which had been pending at the Supreme Court for over a year, argued that the Arkansas and New Hampshire Medicaid work requirements approved under the Trump administration would result in a reduction of insurance coverage among low-income Americans.

Reports

HHS OIG Report Finds California Improperly Claimed at Least $23 Million in Medicaid Reimbursement for Opioid Treatment Program Services

On April 20, the Health and Human Services (HHS) Department Office of the Inspector General (OIG) released a report following an audit into the stewardship of federal funds allocated to fight the opioid crisis. The report found that the state of California improperly claimed at least $23 million in Medicaid reimbursement for opioid treatment programs during 2018 and 2019.

GAO Report on Scientific Integrity at HHS

On April 20, the Government Accountability Office (GAO) released a report titled “Scientific Integrity: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference.” The report states that the GAO reviewed four agencies within the Department of Health and Human Services (HHS): the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Office of the Assistant Secretary for Preparedness and Response (ASPR). The GAO found that these agencies do not have procedures that define political interference in scientific decision-making or explain how to report and address it. In the report, the GAO made seven recommendations to the agencies studies to develop reporting procedures for scientific integrity.

GAO Report on VA Management of Loans Under the Native American Direct Loan Program

On April 19, the Government Accountability Office (GAO) published a report titled “Native American Veterans: Improvements to VA Management Could Help Increase Mortgage Loan Program Participation.” The report notes that the Department of Veterans Affairs (VA) makes loans under the Native American Direct Loan Program, and although the VA is working to improve the program, it has not collected relevant information on program outreach or loan processing. The GAO recommended that the VA act to address this.

On April 20, the Health and Human Services (HHS) Department Office of the Inspector General (OIG) released a report following an audit into the stewardship of federal funds allocated to fight the opioid crisis. The report found that the state of California improperly claimed at least $23 million in Medicaid reimbursement for opioid treatment programs during 2018 and 2019.