This Week in Washington: FDA Approves Narcan OTC Nasal Spray, Senate Finance Committee Investigates Pharmacy Benefit Manager Practices

Congress

House

• VALID Act Re-introduced
• House Energy and Commerce Committee Chair Presses FDA on Gain-of-Function Research

Senate

• Reentry Act Introduced
• Senate Finance Committee Examines PBMs
• Senate Finance Committee Holds Hearing on Oral Health Disparities

Administration

• CMS Releases Updated IDR Process Guidance
• FDA Approves Narcan Over-the-Counter Nasal Spray
• FDA Launches Public-Private Partnership on Lupus Research
• FDA Schedules Joint Advisory Committee Meeting to Discuss OTC Contraceptive
• HHS Urges States to Address Lead Exposure Risk in Drinking Water
• HHS Authorizes SAMSHA Emergency Response Grants for Ohio

Proposed Rules

• FDA Proposes New Tobacco Product Manufacturing Practices Requirements
• CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation
• CMS Proposes Rule to Clarify Changes to DSH Payment Calculations
• ACF Proposes Rule to Revise Foster Family Home Definition
• CMS Proposes Rule to Increase Nursing Home Transparency

Final Rules

• FDA Issues Final Rule Regarding Mammography Quality Standards
• CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• HHS OIG Report Reveals Improper Medicare Payments to Physicians

House and Senate on Recess

House

VALID Act Re-introduced

On March 29, Reps. DeGette (D-CO) and Bucshon (R-IN) reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. The bill would give the Food and Drug Administration (FDA) explicit authority to regulate certain laboratory-developed tests (LDT). The FDA has sought to regulate LDTs that are currently overseen by the Centers for Medicare and Medicaid Services (CMS).

In the last days of the Obama administration, the FDA published a guidance to use a risk-based approach to oversee LDTs. The guidance was rejected by the Trump administration. The then-FDA Commissioner Scott Gottlieb said he believed that Congress needed to legislate. Current FDA Commissioner Robert Califf has said he would consider rule-making but has also said he would prefer Congress provide explicit authority to regulate these tests.

For more information, click here.

House Energy and Commerce Committee Chair Presses FDA on Gain-of-Function Research

On March 27, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Reps. Guthrie (R-KY) and Griffith (R-VA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf requesting that the FDA provide specifics regarding any gain-of-function experiments conducted during coronavirus research experiments. The Energy and Commerce Committee is investigating whether the FDA is adequately monitoring and overseeing FDA-funded research that has the potential of creating biosafety and biosecurity risks.

For more information, click here.

Senate

Reentry Act Introduced

On March 30, Sens. Baldwin (D-WI) and Braun (R-IN) introduced the Reentry Act. The bipartisan legislation would expand access to healthcare and mental health services for Medicaid-eligible individuals who are within 30 days of being released from prison or jail. The bill would also make it easier for states to provide substance-use disorder treatment services and provide previously incarcerated individuals a smoother transition back into their communities.

For more information, click here.

Senate Finance Committee Examines PBMs

On March 30, the Senate Finance Committee held a hearing on pharmacy benefit managers (PBMs). The committee is interested in learning more about what impacts PBM tactics are having on the prescription drug supply chain, particularly on prescription drug pricing. Witnesses included:

• Robin Feldman, Arthur J. Goldberg Distinguished Professor of Law and Director of the Center For Innovation at the University of California Hastings College of Law
• Karen Van Nuys, Ph.D., Executive Director of the Value of Life Sciences Innovation Leonard D. Schaeffer Center at the University of Southern California Center for Health Policy and Economics
• Lawton Robert Burns, Ph.D., James Joo-Jin Kim Professor of Health Care Management and Co-Director of the Roy and Diana Vagelos Program in Life Sciences and Management at the University of Pennsylvania Wharton School
• Matthew Gibbs, Pharm.D., President of Capital Rx
• Jonathan E. Levitt, Founding Partner of Frier Levitt Attorneys at Law

For more information, click here.

Senate Finance Committee Holds Hearing on Oral Health Disparities

On March 29, the Senate Finance Committee held a hearing on identifying and addressing oral health disparities. Witnesses included:

• Warren A. Brill, DMD, MS (HYG), FAAPD, FACD, FICD, Owner of Eastpoint Pediatric Dental Associates
• Jonathan P. Forte, MHA, FACHE, President and CEO of RiverStone Health
• Cherae M. Farmer-Dixon, DDS, MSPH, FACD, FICD, Dean and Professor of Meharry Medical College, School of Dentistry
• Marko Vujicic, Ph.D., Chief Economist and Vice President of the American Dental Association Health Policy Institute

For more information, click here.

Administration

CMS Releases Updated IDR Process Guidance

On March 30, the Centers for Medicare and Medicaid Services (CMS) released an updated guidance regarding the federal independent dispute resolution (IDR) process. The guidance intends to inform IDR entities on how the process works, and what confidentiality, record-keeping and revocation standards they must adhere to when reviewing dispute cases. This guidance is only applicable to payment determinations made on or after Feb. 6, 2023, for items and services obtained on or after Oct. 25, 2022.

For more information, click here.

FDA Approves Narcan Over-the-Counter Nasal Spray

On March 29, the Food and Drug Administration (FDA) approved the over-the-counter (OTC) non-prescription use version of Narcan. It is the first naloxone hydrochloride product approved for use without a prescription. Narcan was first approved by the FDA in 2015 but was only obtainable via a prescription. The drug is used to rapidly reverse the effects of an opioid overdose.

For more information, click here.

FDA Launches Public-Private Partnership on Lupus Research

On March 29, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) announced that it was establishing a public-private partnership with the Lupus Research Alliance (LRA), to address lupus clinical trial challenges. The Lupus Accelerating Breakthroughs Consortium (Lupus ABC) will help incorporate patient feedback in the lupus therapeutic process and will focus on refining measurement tools used to test the efficacy of therapeutics and drugs.

For more information, click here.

FDA Schedules Joint Advisory Committee Meeting to Discuss OTC Contraceptive

On March 28, the Food and Drug Administration (FDA) announced an upcoming joint committee meeting between its Nonprescription Drugs Advisory and its Obstetrics, Reproductive and Urologic Drugs Advisory committees. The committees will discuss a supplemental new drug application for OPILL, a norgestrel contraceptive tablet manufactured by Laboratoire HRA Pharma. Laboratoire HRA Pharma is requesting that the drug be granted over-the-counter (OTC), non-prescription use. The meeting will be held virtually on May 9, and comments will be accepted until April 25.

For more information, click here.

HHS Urges States to Address Lead Exposure Risk in Drinking Water

On March 28, the Department of Health and Human Services (HHS) joined the Environmental Protection Agency (EPA) in sending a letter to state governors, urging them to take action and remove lead toxins from elementary school and childcare facility drinking water systems. HHS and the EPA have been encouraging state and local governments to replace lead pipes and remediate lead paint to ensure clean drinking water, particularly for children.

For more information, click here.

HHS Authorizes SAMSHA Emergency Response Grants for Ohio

On March 27, the Department of Health and Human Services (HHS) authorized the use of Substance Abuse and Mental Health Services Administration (SAMHSA) Emergency Response Grants (SERGs) to support behavioral health and wellness needs in East Palestine, Ohio. The funds come in response to the Norfolk Southern freight train derailment and chemical spill that occurred in February. The initial SERG grant will be valid for 90 days, after which additional funding is expected to follow.

For more information, click here.

Proposed Rules

FDA Proposes New Tobacco Product Manufacturing Practices Requirements

On March 8, the Food and Drug Administration (FDA) released a proposed rule that would improve the manufacture, design, packing and storage of tobacco products. The proposed rule seeks to ensure that tobacco products comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA has noted that it will help minimize and prevent tobacco product contamination, as well as inconsistencies in e-cigarette liquid concentrations and labeling. The proposed rule will also:

• Establish tobacco product design and development controls
• Ensure that tobacco products meet established specifications
• Crack down on tobacco products that do not meet specifications
• Require manufacturers to take action in cases of product contamination
• Require investigations of products that do not meet specifications
• Establish the ability to trace all components, ingredients, additives and materials used by tobacco product manufacturers

Public comments will be accepted until Sept. 6, 2023. For more information, click here.

CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation

On Feb. 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change how it defines Medicaid-eligible patients who can be included in Medicare disproportionate share hospital (DSH) payment calculations. CMS is proposing to do this by limiting the types of Medicaid Section 1115 waiver days that can be used by hospitals when calculating their disproportionate patient percentage (DPP) Medicaid fraction. CMS is proposing to allow hospitals to only count Section 1115 waiver days for patients who received a health insurance plan directly from a Section 1115 demonstration, that covers inpatient hospital services or who received, with the help of Section 1115 demonstration premium assistance, a health insurance plan that covers 100 percent of the patient’s premium costs.

Public comments will be accepted until May 1, 2023. For more information, click here.

CMS Proposes Rule to Clarify Changes to DSH Payment Calculations

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would clarify changes made to the Medicaid disproportionate share hospital (DSH) payment limit calculation by the Consolidated Appropriations Act of 2021. The proposed rule is intended to give states and hospitals a better understanding of how the limit is calculated. It also outlines technical and administrative changes CMS made recently to the DSH program.

Public comments will be accepted until April 25, 2023. For more information, click here.

ACF Proposes Rule to Revise Foster Family Home Definition

On Feb. 14, the Department of Health and Human Services (HHS) Administration for Children and Families (ACF) released a proposed rule that would revise the current definition of “foster family home” and allow Title IV-E agencies to adopt foster family home licensing and approval standards for foster family homes of individuals related to children by “kin” (blood, marriage or adoption). Title IV-E agencies would also be allowed to adopt licensing and approval standards for individuals related by emotionally significant relationships. The proposed rule would also allow Title IV-E agencies to claim federal financial participation (FFM) for the costs of foster care maintenance payments (FCMP) and would make changes to the requirement that Title IV-E agencies review FCMP amounts to ensure that children placed in “kin” foster homes receive the same FCMP as those in non-kin foster family homes.

Public comments will be accepted until April 17, 2023. For more information, click here.

CMS Proposes Rule to Increase Nursing Home Transparency

On Feb. 15, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to increase the transparency of nursing home facility information. The proposed rule would require Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities to disclose the following information:

• Names, titles and period of service for every member of the nursing home facility’s governing body
• Names, titles and period of service for the nursing home facility’s officer, director, member, partner, trustee and managing employee
• Names, titles and period of service for any additional disclosable parties of the nursing home facility
• A description of the relationship the additional disclosable parties have with the nursing home facility and other disclosable parties

Public comments will be accepted until April 14, 2023. For more information, click here.

Final Rules

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

• Improve the delivery of mammography services;
• Strengthen communication of healthcare information;
• Require mammography facilities to provide patients with additional health information;
• Ensure the availability of qualified mammography personnel;
• Bolster medical outcome audits;
• Modernize technological aspects of mammography services; and
• Implement enforcement tools to deal with noncompliant facilities.

The rule will go into effect on Sept. 10, 2024. For more information, click here.

CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)

On Jan. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will update the Healthcare Common Procedure Coding System (HCPCS) codes for required Face-to-Face Encounter and Written Order Prior to Delivery (F2F/WOPD) requirements applicable to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) orders. The update follows CMS’ decision to add new non-statutorily required DMEPOS items to the F2F/WOPD list. CMS believes the addition of these items will protect Medicare enrollees and further reduce Medicare fraud, waste and abuse.

The rule will go into effect on April 17, 2023. For more information, click here.

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

On Nov. 25, the Food and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court for the Eastern District of Texas, delayed the effective date of a final rule published on March 18, 2020, titled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” The rule, which was originally supposed to go into effect on June 18, 2021, establishes new cigarette health warnings for cigarette packages and advertisements.

The rule will go into effect on Nov. 6, 2023. For more information, click here.

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Reports

HHS OIG Report Reveals Improper Medicare Payments to Physicians

On March 24, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report that revealed that improper Medicare payments had been made to physicians for spinal facet-joint procedures. The OIG analyzed 51 of 100 spinal facet-joint intervention sessions, specifically the medical records of Medicare beneficiaries, and discovered that several contractors had not complied with Medicare payment requirements when submitting payments. The OIG estimates that approximately $29.6 million was improperly paid, and is recommending that the Centers for Medicare and Medicaid Services (CMS) direct Medicare Administrative Contractors (MACs) to recover the improper payments. OIG conducted this study because a previous audit had also revealed improper payments being made for spinal facet-joint sessions.

For more information, click here.