This Week in Washington: CMS releases first list of Inflation Rebate Program drugs, initial guidance on Medicare Drug Negotiation Program

Upcoming Hearings

Congress

House

• Chiropractic Medicare Coverage Modernization Act Reintroduced

Senate

• Rural Health Legislation Announced
• Maximizing Opioid Recovery Emergency (MORE) Savings Act Introduced
• Senate Finance and Veterans’ Affairs Committee Chairmen Send Letter to CMS Regarding IRA Medicare Part B Coinsurance

Administration

• CMS Releases Initial Guidance on Medicare Drug Negotiation Program
• CMS Releases List of First Medicare Part B Drugs Subject to Inflation Rebate Program
• CMS and FDA Release FY2024 Budget Justification of Estimates
• CDC Rescinds COVID-19 Testing Requirement for Air Travelers From China
• FDA Denies Marketing of Two Menthol E-Cigarette Products
• FDA Grants Modified Risk Tobacco Product Authorization to U.S. Smokeless Tobacco
• FDA Releases Industry Guidance on Local Anesthetic Drug Development
• FDA Releases Industry Guidance on Electronic Systems, Records and Signatures
• FDA Releases Industry Guidance on Suspect and Illegitimate Drug Products
• FDA Authorizes Pfizer Bivalent COVID-19 Booster Vaccine for Children
• FDA Approves First Rett Syndrome Treatment
• HRSA Announces $25 Million Funding Opportunity
• SAMSHA Awards States $1 Million Planning Grants for Behavioral Health Clinics

Other Activity

• MEDPAC Releases March 2023 Report to Congress
• MACPAC Releases March 2023 Report to Congress

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
• HHS Proposes Rule to Expand Access to ACA Birth Control Coverage
• HHS Proposes Adopting Healthcare Attachments Standards

Final Rules

• FDA Issues Final Rule Regarding Mammography Quality Standards
• CMS Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program
• 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

• GAO Releases Report Revealing Stakeholder View of Orange Book Patent Information
• CDC Report Indicates Spike in 2021 U.S. Maternal Mortality Rate

Upcoming Hearings

March 22

Senate Committee on Finance Hearing: “The President’s Fiscal Year 2024 Health and Human Services Budget”

10:00 a.m., Dirksen Senate Building 215
Announced witnesses are:

• The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services

Senate Committee on Health, Education, Labor and Pensions Hearing: “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?”
10:00 a.m., Hart Senate Building 216
Announced witnesses are:

• Stéphane Bancel, MBA, MEng., MSc, Chief Executive Officer and Director, Moderna Inc.
• Christopher J. Morten, PhD, JD, Associate Clinical Professor of Law, Columbia Law School
• Ameet Sarpatwari, PhD, JD, Assistant Professor of Medicine, Harvard Medical School
• Craig Garthwaite, PhD, MPP, Herman Smith Research Professor in Hospital and Health Services Management, Kellogg School of Management, Northwestern University

Senate Committee on Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee Hearing: “A Review of the President’s FY 2024 Funding Request and Budget Justification for the Department of Health and Human Services”

2:30 p.m., Dirksen Senate Building 138
Announced witnesses are:

• The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services

March 23

House Appropriations Committee Labor, Health and Human Services, Education, and Related Agencies Subcommittee Public Witness Day Hearing

10:00 a.m., Rayburn House Office Building 2358C
Announced witnesses are:

• Jared Bass, Senior Director of Higher Education, Center for American Progress
• Katherine Brunett McGuire, Chief Advocacy Officer, American Psychological Association Services
• Clarke Forsythe, Senior Counsel, Americans United for Life
• Katie Hoff Anderson, Olympic Medalist and Pulmonary Embolism Survivor, National Blood Clot Alliance
• Michael Kutcher, Cerebral Palsy and Disability Advocate, Cerebral Palsy Foundation
• Kevin Longino, Chief Executive Officer, National Kidney Foundation
• Amanda Peel Crowley, Founding Member, National Alliance for Pediatric Acute-Onset Neuropsychiatric Syndrome and Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcus
• Brian Persing, M.D, Medical Oncologist and Hematologist, Association for Clinical Oncology
• Jonathan Plucker, Professor of Education, Johns Hopkins University School of Education
• Sarah Rittling, Executive Director, Five Years Fund
• Paul W. Schroeder, Vice President for Impact and Outreach, American Printing House for the Blind
• Felicia Simpson, Co-Director, Alabama Expanded Learning Alliance
• Dorothea Staursky, Volunteer and Bone Marrow Donor, National Marrow Donor Program
• Richard Stern, Director, Grover M. Hermann Center for the Federal Budget, The Heritage Foundation
• Amy Templeton, President and Chief Executive Officer, McWane Science Center, on behalf of American Alliance of Museums
• Yolanda Wilson, President, College of Southern Maryland
• Anne Zink, M.D, FACEP, President and Chief Medical Officer, Association of State and Territorial Health Officials and Alaska Department of Health

House Committee on Ways and Means Health Subcommittee Hearing: “Why Health Care is Unaffordable: The Fallout of Democrats’ Inflation on Patients and Small Businesses”

2:00 p.m., Longworth House Office Building 1100
Witnesses to be announced.

Congress

House

Chiropractic Medicare Coverage Modernization Act Reintroduced

On March 14, Reps. Steube (R-FL), Higgins (D-NY), Alford (R-MO) and Larson (D-CT) reintroduced the Chiropractic Medicare Coverage Modernization Act. The legislation would expand Medicare coverage to include chiropractic services, and would ensure that Medicare patients have access to chiropractic care as an alternative to using prescription drugs for pain management. Sens. Blumenthal (D-CT) and Cramer (R-ND) introduced a companion bill in the Senate.

For more information, click here.

Senate

Rural Health Legislation Announced

On March 16, Sens. Blackburn (R-TN) and Warner (D-VA) reintroduced the Save Rural Hospitals Act. The legislation would reduce hospital closures in rural areas by establishing a minimum Medicare Area Wage Index of 0.85. The wage index is used to calculate the overall Medicare payment hospitals receive based on the average labor costs in the area in which the hospital is located.

Sen. Blackburn and Sen. Hickenlooper (D-CO) intend to introduce the Rural Health Innovation Act. The legislation would:

• Create two 5-year grant programs administered by the Health Resources and Services Administration (HRSA) Community-Based Division;
• Ensure that the first grant program go toward establishing Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), aimed at addressing a community’s urgent care and triage needs. Grants awarded by the program would be limited to $500,000 for existing facilities and $750,000 for startup facilities; and
• Ensure that the second grant program go toward expanding existing rural health departments. Grants awarded by the program would be limited to $500,000. Grants would only be awarded to communities that are rural and are located at least 30 minutes away from the nearest emergency department. Communities that have lost a hospital in the past seven years will be given priority.

Additionally, Sen. Blackburn and Sen. Durbin (D-IL) intend to introduce the Rural America Health Corps Act. The legislation would:

• Create a new loan repayment program titled “NHSC Rural Provider Loan Repayment Program”;
• Ensure practitioners would be eligible for flexible loan repayments, based on the severity of healthcare staff shortages in the area;
• Waive associated income tax liability for the loan repayment program; and
• Allow nurse practitioners and physician assistants to participate in the loan repayment program.

For more information, click here.

Maximizing Opioid Recovery Emergency (MORE) Savings Act Introduced

On March 15, Special Committee on Aging Chairman Bob Casey (D-PA) introduced the Maximizing Opioid Recovery Emergency (MORE) Saving Act. The goals of the legislation are to lower the cost of treatment for opioid use disorder (OUD) and eliminate the cost of treatment and recovery services for privately insured individuals, as well as those enrolled in a new Medicare pilot program. It would also increase federal funding for Medicaid treatment programs and establish a pilot program in 15 states, which would allow individuals to seek Medicare OUD services at no cost for the next five years. Rep. Dean (D-PA) will be introducing a companion bill in the House.

For more information, click here.

Senate Finance and Veterans’ Affairs Committee Chairmen Send Letter to CMS Regarding IRA Medicare Part B Coinsurance

On March 13, Senate Finance Committee Chairman Ron Wyden (D-OR) and Senate Veterans’ Affairs Committee Chairman Jon Tester (D-MT) led 20 senators in sending a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, asking CMS to announce which Medicare Part B medications would be subject to the Inflation Reduction Act’s (IRA) Medicare Part B and D inflation rebate provision. The senators also asked CMS to announce what the coinsurance percentage and amount would be for each applicable Part B drug.

This request came just as CMS released on March 15 a list of the first 27 drugs that fall under the rebate provision.

The other senators who signed the letter include Democratic senators Bennet (CO), Klobuchar (MN), Brown (OH), Gillibrand (NY), Casey (PA), Cortez Masto (NV), Cardin (MD), Kaine (VA), Blumenthal (CT), Manchin (WV), Warnock (GA), Merkley (OR), Baldwin (WI), Warner (VA), Carper (DE), Welch (VT), Whitehouse (RI), Kelly (AZ), Murray (WA) and Murphy (CT).

For more information, click here.

Administration

CMS Releases Initial Guidance on Medicare Drug Negotiation Program

On March 15, the Centers for Medicare and Medicaid Services (CMS) released initial guidance on the Medicare Drug Negotiation Program. The Medicare Drug Negotiation Program, which will allow CMS to negotiate Medicare Part D drug prices directly with drug companies, will officially go into effect on Jan. 1, 2026. CMS announced that it will publish the first 10 drugs selected for price negotiation by Sept. 1, 2023, and that it will release the negotiated maximum fair prices for the drugs by Sept. 1, 2024. More Part B and D drugs will be selected for negotiation in the coming years.

For more information, click here.

CMS Releases List of First Medicare Part B Drugs Subject to Inflation Rebate Program

On March 15, the Centers for Medicare and Medicaid Services (CMS) released a list of the first Medicare Part B prescription drugs that are subject to the Inflation Reduction Act’s (IRA) Medicare Prescription Drug Inflation Rebate Program. The Inflation Rebate Program requires drug manufacturers to pay a rebate to Medicare if they raise the price of their Part B prescription drugs and biologics faster than the annualized rate of inflation. From April 1 to June 30, 27 Part B drugs that CMS selected will have adjusted coinsurance rates.

For more information, click here.

CMS and FDA Release FY2024 Budget Justification of Estimates

On March 14, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) released their respective fiscal year (FY) 2024 Budget Justification of Estimates for Appropriations Committees.

For more information on the CMS Justification of Estimates, click here.

For more information on the FDA Justification of Estimates, click here.

CDC Rescinds COVID-19 Testing Requirement for Air Travelers From China

On March 10, the Centers for Disease Control and Prevention (CDC) rescinded its COVID-19 testing requirement for air travelers departing from China. The CDC had originally issued the requirements on Jan. 5, following a surge of COVID-19 cases in China.

For more information, click here.

FDA Denies Marketing of Two Menthol E-Cigarette Products

On March 17, the Food and Drug Administration (FDA) issued marketing denial orders (MDOs) for two e-cigarette products marketed by R.J. Reynolds Vapor Company. The Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2 may no longer be marketed or distributed in the U.S. The FDA decided to issue the MDOs after the R.J. Reynolds Vapor Company failed to show that the menthol cartridges added any benefits to adult smokers over tobacco-flavored e-cigarettes.

For more information, click here.

FDA Grants Modified Risk Tobacco Product Authorization to U.S. Smokeless Tobacco

On March 16, the Food and Drug Administration (FDA) granted authorization to U.S. Smokeless Tobacco Company to market its Copenhagen Classic Snuff product as a modified risk tobacco product (MRTP). Copenhagen Classic Snuff has been sold in the U.S. for several years without modified risk information. The FDA decided to grant the MRTP authorization, after the FDA Tobacco Products Scientific Advisory Committee concluded that the use of Copenhagen Classic Snuff reduced the risk of lung cancer in smokers compared to if they continued using traditional cigarettes. The MRTP authorization is valid for five years and can be rescinded by the FDA at any time.

For more information, click here.

FDA Releases Industry Guidance on Local Anesthetic Drug Development

On March 15, the Food and Drug Administration (FDA) released a guidance for industry regarding the development of local anesthetic drug products. The guidance outlines steps that drug manufacturers should follow, when developing local anesthetic drug products that are designed to produce postoperative analgesia for a prolonged duration. It also details what variables drug manufacturers should measure when conducted efficacy trials of such anesthetics.

For more information, click here.

FDA Releases Industry Guidance on Electronic Systems, Records and Signatures

On March 15, the Food and Drug Administration (FDA) released a guidance for industry regarding the use of electronic systems, records and signatures in clinical investigations of medical products, foods, tobacco products and new animal drugs. The guidance is intended to inform stakeholders, such as clinical investigators, institutional review boards and sponsors, on what the FDA considers to be reliable and trustworthy electronic systems, records and signatures.

For more information, click here.

FDA Releases Industry Guidance on Suspect and Illegitimate Drug Products

On March 15, the Food and Drug Administration (FDA) released a final guidance for industry regarding “suspect” and “illegitimate” products as defined in the Drug Supply Chain Security Act (DSCSA). The guidance is intended to help prescription drug manufacturers and distributors identify counterfeit, diverted or stolen drugs in the prescription drug supply chain. The guidance also provides detailed definitions of what the FDA considers to be a counterfeit, diverted, stolen, fraudulent or unfit product.

For more information, click here.

FDA Authorizes Pfizer Bivalent COVID-19 Booster Vaccine for Children

On March 14, the Food and Drug Administration (FDA) authorized the Pfizer Bivalent COVID-19 booster vaccine for children 6 months through 4 years of age. The booster vaccine will be offered to children in this age range, who received a monovalent COVID-19 vaccine for their entire three-dose primary vaccination regimen, and who are at least two months out of receiving their third dose.

For more information, click here.

FDA Approves First Rett Syndrome Treatment

On March 10, the Food and Drug Administration (FDA) approved Daybue, the first treatment for Rett syndrome in adults and children over the age of two. Rett syndrome is a rare, genetic neurological disorder that impairs the normal development of the brain. Daybue, an oral solution drug, was shown to have a statistically significant impact on Rett syndrome patients who participated in a randomized, double-blind, placebo-controlled 12-week study.

For more information, click here.

HRSA Announces $25 Million Funding Opportunity

On March 10, the Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) announced a $25 million funding opportunity for health centers and schools. Applicants who are selected to receive funds will be required to add or expand mental health services in order to receive school-based funding. HRSA had previously offered $35 million to increase access to health center services in schools, in September 2021. Applications will be accepted on Grants.gov until March 31 and on the HRSA Electronic Handbooks until May 1.

For more information, click here.

SAMSHA Awards States $1 Million Planning Grants for Behavioral Health Clinics

On March 16, the Substance Abuse and Mental Health Services Administration (SAMSHA) awarded 15 states a $1 million, one-year Certified Community Behavioral Health Clinic (CCBHC) planning grant. CCBHCs are clinics that can provide individuals with mental health crisis services 24 hours a day, 7 days a week. They also provide substance use care. Ten of the 15 states that received a planning grant will be eligible to join the CCBHC demonstration program in 2024. States that are not selected in 2024 will have the opportunity to join the demonstration program in 2026.

The 15 states that received planning grants include AL, DE, GA, IA, KS, ME, MS, MT, NC, NH, NM, OH, RI, VT and WV.

For more information, click here

Other Activity

MEDPAC Releases March 2023 Report to Congress

On March 15, the Medicare Payment Advisory Committee (MEDPAC) released their March 2023 Report to Congress. In the report MEDPAC evaluates payment adequacy and makes recommendations concerning Medicare FFS payment policy in 2024 for seven FFS payment systems: acute care hospital, physician and other health professional, outpatient dialysis facility, skilled nursing facility, home health agency, inpatient rehabilitation facility and hospice services.

MEDPAC also includes recommendations to redistribute current disproportionate share hospital and uncompensated care payments, and to provide additional resources to Medicare safety-net hospitals and clinicians who furnish care to Medicare beneficiaries with low incomes.

The report also reviews the status of the MA program (Medicare Part C). The report also reviews the status of the Medicare program that provides prescription drug coverage (Medicare Part D).

For more information, click here.

MACPAC Releases March 2023 Report to Congress

On March 15, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) released their March 2023 Report to Congress.

• Chapter 1 makes recommendations to improve the collection of Medicaid race and ethnicity data.
• Chapter 2 makes recommendations on increasing the transparency and improving the collection of nursing facility payment data.
• Chapter 3 focuses on states’ concerns about covering drugs that have limited evidence of a clinical benefit and makes recommendations that would give states the flexibility to align with a Medicare decision to link coverage with participation in clinical trials or comparative studies.
• Chapter 4 fulfills MACPAC’s annual, statutorily required report on Medicaid disproportionate share hospital allotments to states for payments to hospitals that serve a high proportion of Medicaid beneficiaries and other low-income patients.

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.

HHS Proposes Rule to Expand Access to ACA Birth Control Coverage

On Jan. 30, the Department of Health and Human Services (HHS) released a proposed rule that seeks to strengthen and expand health insurance birth control coverage for women. The proposed rule would prevent private health plans and insurers from excluding coverage of contraceptive services based on moral exemptions. It would also establish an independent birth control pathway for women covered under an objecting entity, which would allow them to access contraceptive services from a willing provider without any cost. Private health plans and insurers would still be allowed to deny birth control coverage based on religious exemptions and objecting private employers and universities would still have the right to choose whether to allow plan participants access to optional contraceptive services.

Public comments will be accepted until April 3, 2023. For more information, click here.

HHS Proposes Adopting Healthcare Attachments Standards

On Dec. 15, the Office of the Secretary of the Department of Health and Human Services (HHS) released a proposed rule that would implement standards for “health care attachments” transactions, to support healthcare claims and prior authorization transactions. The proposed rules would also implement a standard for electronic signatures and modify the standard for referral certification and authorization transactions.

Public comments will be accepted until March 21, 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 Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program

On Jan. 30, the Centers for Medicare and Medicaid Services (CMS) released a final rule that alters the audit methodology for the Medicare Advantage Risk Adjustment Data Validation (RADV) program and implements new requirements on Medicare Advantage Organizations (MAOs). The final rule establishes that CMS will begin extrapolating RADV audit findings with payment year (PY) 2018 and will not extrapolate audit findings for PYs 2011 through 2017. It also codifies CMS’ intention of not applying a fee-for-service adjustment factor to RADV program audits. The final rule will also require Medicare Advantage Organizations (MAOs) to remit improper payments identified by CMS during RADV audits.

The rule will go into effect on April 3, 2023. 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

GAO Releases Report Revealing Stakeholder View of Orange Book Patent Information

On March 15, the Government Accountability Office (GAO) released a report revealing stakeholders’ views on patent information published in the Food and Drug Administration (FDA) Orange Book.

All stakeholders agreed that the Orange Book was helpful for making product development decisions. Six stakeholders said that the FDA role in overseeing the Orange Book was sufficient, while seven stated they would like the FDA to play a more active role in reviewing product patent information. Additionally, 13 stakeholders stated that it would be helpful for the FDA to clarify which device-related patents should be listed in the Orange Book.

GAO conducted the study because it was asked to gather stakeholder feedback regarding Orange Book patent listings by a provision of the Orange Book Transparency Act of 2020.

For more information, click here.

CDC Report Indicates Spike in 2021 U.S. Maternal Mortality Rate

On March 16, the Centers for Disease Control and Prevention (CDC) released a report on maternal mortality rates in the U.S. in 2021. The data shows the rate of maternal mortality rose considerably in 2021 compared to previous years. In 2021, 1,205 women died of maternal causes, compared to 861 in 2020 and 754 in 2019. The rate of maternal mortality for non-Hispanic Black women was 2.6 times higher when compared to non-Hispanic white women, and was 6.8 times higher for women over the age of 40 compared to those 25 and under.

For more information, click here.