This Week in Washington: Workforce issues studied, PBMs under more scrutiny

Upcoming Hearings

Congress

House

• House Oversight and Accountability Committee Chairman Launches Investigation into Pharmacy Benefit Manager Practices
• Patient Access to Higher Quality Health Care Act of 2023 Introduced

Senate

• Senate HELP Committee Chair and Ranking Member Request Input from Healthcare Providers on Workforce Shortages
• Primary Care Enhancement Act Introduced
• Thirty-Two Senators Send Letter Concerning Short-Term Health Plans

Administration

• CMS Innovation Center Releases Model and Project Findings
• CMS Issues Update Regarding IDR Payment Processing
• CMS Releases Updated COVID-19 PHE Unwinding Fact Sheet
• HHS Announces Changes to Office for Civil Rights
• FDA CDER Requesting Feedback on Role of AI in Drug Manufacturing
• FDA CDER Releases Drug Safety Priorities 2022 Report
• FDA Office of Generic Drugs Releases 2022 Report
• FDA Approves First Friedreich’s Ataxia Treatment Drug
• FDA Issues Warning on Unlawful Importation of Xylazine
• FDA Announces Rare Neurodegenerative Disease Funding Opportunity
• FDA Grants EUA to First Over-the-Counter Combined Influenza/COVID-19 Test
• FDA Announces Paxlovid New Drug Application Public Meeting
• FDA Warns Healthcare Providers About Neonatal Incubator Chemical Risk
• FDA Warns Against Use of Delsam Pharma Eye Ointment
• FDA Files Civil Money Penalty Complaints Against E-Cigarette Companies
• FDA Announces Public Meeting on Long COVID Treatments
• FDA Grants Pfizer RSV Maternal Vaccine Priority Approval

Other Activity

• Eli Lilly Caps Insulin Out-of-Pocket Costs to $35 Per Month

Proposed Rules

• 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
• SAMSHA Issues Proposed Rule to Eliminate X-Waiver Requirement
• HHS Proposes Rule to Expand Access to ACA Birth Control Coverage
• HHS Proposes Rule to Clarify Beneficiary Religious Protections
• CMS Proposes Healthcare Plan Exchange Rule for 2024
• HHS Proposes Adopting Healthcare Attachments Standards
• FDA Proposed Rule Would Replace Investigational New Drug Annual Report
• FDA Proposes Exempting Certain Conventional Food, Dietary Supplements and Cosmetics From Investigational New Drug Requirements

Final Rules

• 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 Report Analyzes Community Health Center Revenue and Grants Trends
• GAO Report Analyzes Effectiveness of Prison Healthcare Reentry Policies
• GAO Report Analyzes VA Hiring Practices During COVID-19 Pandemic
• KFF Releases Health Spending and Federal Budget FAQs Report
• KFF Analysis Reveals High Medicare Advantage Gross Margins
• CBO Report Analyzes Prescription Drug Provision Budgetary Impacts

Upcoming Hearings

March 7

Senate Committee on Appropriations Briefing: “A Review of the Department of Defense Health Program”

10:00 a.m., Dirksen Senate Office Building SD-192

Announced briefers are:

• Lester Martinez-López, Assistant Secretary of Defense for Health Affairs
• Gen. Telita Crosland, Director of the Defense Health Agency
• Gen. R. Scott Dingle, Surgeon General of the Army
• Gen. Robert I. Miller, Surgeon General of the Air Force
• RADM Bruce L. Gillingham, Surgeon General of the Navy

Congress

House

House Oversight and Accountability Committee Chairman Launches Investigation into Pharmacy Benefit Manager Practices

On March 1, House Oversight and Accountability Committee Chairman James Comer (R-KY) announced that he is launching an investigation to analyze whether pharmacy benefit managers’ (PBM) tactics are harming patient care and increasing the costs of healthcare programs. Chairman Comer is requesting that the Office of Personnel Management (OPM), Centers for Medicare and Medicaid Services (CMS) and Defense Health Agency (DHA) provide information related to PBM practices, to analyze the impact on patients, the pharmaceutical market and federal healthcare programs.

For more information, click here.

Patient Access to Higher Quality Health Care Act of 2023 Introduced

On Feb. 21, Reps. Burgess (R-TX) and Cuellar (D-TX) introduced the Patient Access to Higher Quality Health Care Act of 2023. The bipartisan bill would repeal the Affordable Care Act’s (ACA) ban on new physician-owned hospitals.

For more information, click here.

Senate

Senate HELP Committee Chair and Ranking Member Request Input from Healthcare Providers on Workforce Shortages

On March 2, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA) sent a letter to healthcare providers, requesting their input on current healthcare workforce shortages. The senators are asking healthcare providers to propose potential solutions to resolve the ongoing shortages. The letter comes in the wake of a hearing the Senate HELP Committee held on Feb. 16 titled “Examining Health Care Workforce Shortages: Where Do We Go From Here?,” which focused on understanding the root causes of current healthcare workforce shortages.

For more information, click here.

Primary Care Enhancement Act Introduced

On March 2, Sens. Cassidy (R-LA), Shaheen (D-NH), Scott (R-SC) and Kelly (D-AZ) introduced the Primary Care Enhancement Act. The bipartisan bill seeks to expand patient access to primary care providers by allowing patients to use health savings accounts (HSAs) to pay for primary care services sought out by them without specialist or hospital referrals.

For more information, click here.

Thirty-Two Senators Send Letter Concerning Short-Term Health Plans

On Feb. 22, Sens. Baldwin (D-WI) and Murphy (D-CT) led a group of 32 senators in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra. The letter asks HHS to take immediate action on short-term limited duration insurance (STLDI) plans. The senators are concerned over the expansion of STLDI plans in the weeks leading up to the COVID-19 public health emergency (PHE) unwinding. Millions of Americans are expected to lose their Medicaid coverage when the PHE comes to an end.

The other senators who signed the letter include Democratic Sens. Blumenthal (CT), Booker (NJ), Brown (OH), Cardin (MD), Casey (PA), Coons (DE), Cortez Masto (NV), Duckworth (IL), Durbin (IL), Feinstein (CA), Hassan (NH), Heinrich (NM), Hickenlooper (CO), Kaine (VA), Klobuchar (MN), Luján (NM), Markey (MA), Menendez (NJ), Merkley (OR), Murray (WA), Padilla (CA), Peters (MI), Reed (RI), Shaheen (NH), Smith (MN), Stabenow (MI), Van Hollen (MD), Warner (VA), Warnock (GA), Warren (MA) and Welch (VT). Sen. King (I-ME) also signed.

For more information, click here.

Administration

CMS Innovation Center Releases Model and Project Findings

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) Innovation Center released the following:

• Primary Care First (PCF) Model – First Evaluation Report
• For more information, click here.

• Dementia Care Projects: Synthesis of Evaluation Results 1989-2020 White Paper
• For more information click here.

• Palliative Care Projects: Synthesis of Evaluation Results 2012-2021 White Paper
• For more information, click here.

CMS Issues Update Regarding IDR Payment Processing

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) announced that certified independent dispute resolution (IDR) entities should resume processing payment determinations for item and service disputes submitted before Oct. 25, 2022. CMS had on Feb. 10 ordered certified IDR entities to immediately stop issuing payment determinations following a judgment and order issued by the U.S. District Court for the Eastern District of Texas in response to a lawsuit filed against the Department of Health and Human Services (HHS) by the Texas Medical Association. CMS has asked certified IDR entities to wait for further guidance and updates, and to recall all payment determinations issued on or after Feb. 6, 2023.

For more information, click here.

CMS Releases Updated COVID-19 PHE Unwinding Fact Sheet

On Feb. 27, the Centers for Medicare and Medicaid Services (CMS) released an updated fact sheet outlining changes that will occur to insurance plan coverage, telehealth services and vaccine and testing access, following the COVID-19 public health emergency (PHE) unwinding. The fact sheet is intended to inform healthcare providers and individuals on what steps they can take to minimize the impact the PHE unwinding will have on them.

For more information, click here.

HHS Announces Changes to Office for Civil Rights

On Feb. 27, the Department of Health and Human Services (HHS) announced that it was opening three new divisions within the HHS Office for Civil Rights (OCR). The newly established Enforcement Division, Policy Division and Strategic Planning Division will support the OCR in reviewing civil rights, conscience/religious freedom and health information privacy violation complaints. HHS decided to open the new divisions after statistics from the OCR revealed a rapid increase in the number of complaints submitted to the office in recent years. Over 51,000 complaints were submitted to the OCR in 2022, indicating a 69 percent increase between 2017 and 2022.

For more information, click here.

FDA CDER Requesting Feedback on Role of AI in Drug Manufacturing

On March 1, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released a paper discussing the role that artificial intelligence (AI) could play in monitoring and controlling advanced drug manufacturing processes. The paper outlines how AI can assist pharmaceutical manufacturers with process design and scale-up, advanced process control (APC), process monitoring and fault detection, and trend monitoring. The CDER is requesting that manufacturers submit feedback and recommendations regarding their use of AI, to assist the FDA in drafting guidance on the use of AI in pharmaceutical manufacturing.

For more information, click here.

FDA CDER Releases Drug Safety Priorities 2022 Report

On March 2, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released its Drug Safety Priorities 2022 Report. The report outlines actions the CDER undertook to ensure the quality and safety of medications used to treat and prevent COVID-19 in 2022. The report also details how the CDER addressed the opioid drug crisis, ensured the safety and effectiveness of generic medications and worked toward minimizing medication labeling and packaging errors.

For more information, click here.

FDA Office of Generic Drugs Releases 2022 Report

On March 1, the Food and Drug Administration (FDA) Office of Generic Drugs (OGD) released its 2022 Annual Report. The report details what actions the OGD took to increase access and advance scientific research on generic drugs in 2022. The report outlines which generic drugs the OGD approved in 2022, what international research collaborations the OGD participated in and which draft and final guidelines the OGD published throughout the year.

For more information, click here.

FDA Approves First Friedreich’s Ataxia Treatment Drug

On Feb. 28, the Food and Drug Administration (FDA) approved Skyclarys, the first treatment drug for the rare degenerative neurological disease Friedreich’s Ataxia. Friedreich’s Ataxia typically develops in children and teenagers, and can cause damage to the spinal cord, peripheral nerves and brain. The FDA approved the drug after it received data from a double-blind study that showed improvements in individuals who were given the drug versus a placebo.

For more information, click here.

FDA Issues Warning on Unlawful Importation of Xylazine

On Feb. 28, the Food and Drug Administration (FDA) announced that it would begin taking action against the illicit importation of xylazine. The FDA is concerned about reports of high levels of xylazine being found in illicit drugs such as fentanyl, methamphetamine and cocaine. Xylazine, typically used to sedate large animals such as horses and deer, is not safe for human consumption and can cause breathing, blood pressure, heart rate and body temperature distress.

For more information, click here.

FDA Announces Rare Neurodegenerative Disease Funding Opportunity

On Feb. 27, the Food and Drug Administration (FDA) announced that it will be accepting applications for its Rare Neurodegenerative Disease Grant Program. The program aims to support natural history and biomarker studies in children and adults with rare neurodegenerative diseases, address critical knowledge gaps and facilitate rare neurodegenerative disease treatment development. The deadline to submit applications is May 4.

For more information, click here.

FDA Grants EUA to First Over-the-Counter Combined Influenza/COVID-19 Test

On Feb. 24, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the first over-the-counter (OTC) at-home diagnostic test that can detect Influenza A and B alongside COVID-19. The test is manufactured by Lucira Health and will be sold under the name “Lucira COVID-19 and Flu Home Test.” The test demonstrated similar performance to lab-based PCR tests.

For more information, click here.

FDA Announces Paxlovid New Drug Application Public Meeting

On Feb. 24, the Food and Drug Administration (FDA) announced that the agency’s Antimicrobial Drugs Advisory Committee will host a public meeting to discuss Pfizer’s new drug application for Paxlovid. The meeting will be held virtually on March 16 and public comments must be submitted on or before March 9 to be considered by the committee.

For more information, click here.

FDA Warns Healthcare Providers About Neonatal Incubator Chemical Risk

On Feb. 23, the Food and Drug Administration (FDA) issued a warning to healthcare providers and facilities, informing them that some neonatal incubators may be releasing dangerous airborne chemicals such as formaldehyde and cyclohexanone. The FDA stated it has not received reports of adverse events related to the use of neonatal incubators and announced that it was working with neonatal incubator manufacturers to examine the potential problem. The agency is urging healthcare providers and facilities to run new incubators in a well-ventilated space for at least a week, before using on patients.

For more information, click here.

FDA Warns Against Use of Delsam Pharma Eye Ointment

On Feb. 22, the Food and Drug Administration (FDA) announced that consumers and healthcare professionals should immediately stop purchasing and using Delsam Pharma Artificial Eye Ointment, due to potential bacterial contamination. The FDA has recently issued warnings surrounding the use of other eye products including EzriCare Artificial Tears and Delsam Pharma Artificial Tears, after a multistate outbreak of the Pseudomonas aeruginosa bacteria was linked to individuals’ using EzriCare Artificial Tears.

For more information, click here.

FDA Files Civil Money Penalty Complaints Against E-Cigarette Companies

On Feb. 22, the Food and Drug Administration (FDA) announced that it had filed four civil money penalty (CMP) complaints against e-cigarette companies VapEscape, Great American Vapes, Vapor Corner and 13 Vapor, for manufacturing and selling products without FDA marketing authorization. The FDA had previously warned the companies that they were in violation of the Federal Food, Drug and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products. The FDA has decided to impose the maximum CMP amount of $19,192. The companies have 30 days to take action on the complaint.

For more information, click here.

FDA Announces Public Meeting on Long COVID Treatments

On Feb. 22, the Food and Drug Administration (FDA) announced that it will be holding a public meeting to discuss Long COVID challenges and treatment options. The meeting will feature a patient panel, where Long COVID patients and patient representatives will be able to share their personal experiences with Long COVID, and reveal the challenges it has brought to their daily lives. The meeting will be held virtually on April 25 and public comments will be accepted until June 26.

For more information, click here.

FDA Grants Pfizer RSV Maternal Vaccine Priority Approval

On Feb. 21, the Food and Drug Administration (FDA) granted priority approval to Pfizer’s Respiratory Syncytial Virus (RSV) maternal vaccine. The vaccine would be administered to pregnant women and aims to protect newborn infants from contracting RSV. The FDA granted priority approval after Phase 3 trial data showed that the vaccine was 81.1 percent effective against RSV severe lower respiratory tract illness in infants. The FDA is expected to make a final decision on the vaccine in the second half of this year.

For more information, click here.

Other Activity

Eli Lilly Caps Insulin Out-of-Pocket Costs to $35 Per Month

On March 1, Eli Lilly and Company announced that it was expanding its Insulin Value Program and capping the out-of-pocket cost for its insulin products at $35 or less per month. The company announced that it is cutting costs to help expand access to affordable insulin products for Americans who are not covered by the Inflation Reduction Act’s Medicare Part D Prescription Drug Insulin price cap.

For more information, click here.

Proposed Rules

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.

SAMSHA Issues Proposed Rule to Eliminate X-Waiver Requirement

On Feb. 10, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice of proposed rulemaking to solicit public comment on its proposal to remove certain provisions under the Controlled Substances Act (CSA). The removal of these provisions is a result of the Consolidated Appropriations Act (CAA) of 2023. The CAA amended the CSA by eliminating the requirement that practitioners obtain a waiver to prescribe certain Schedule III-V drugs to treat opioid use disorder (OUD).

Public comments will be accepted until March 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 Rule to Clarify Beneficiary Religious Protections

On Jan. 13, nine federal agencies, including the Department of Health and Human Services (HHS), released a proposed rule that seeks to clarify and restore religious liberty protections for individuals who receive federally funded social services. The proposed rule would require federal grantees who administer social service programs to notify individuals that they may not be discriminated against based on their religion. The rule would also advise federal agencies on how they can assist individuals with finding providers that are more reflective of their beliefs.

In addition to HHS, the Departments of Agriculture, Education, Homeland Security, Housing and Urban Development, Justice, Labor and Veterans Affairs and the U.S. Agency for International Development are proposing the rule.

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

CMS Proposes Healthcare Plan Exchange Rule for 2024

On Dec. 12, the Centers for Medicare and Medicaid Services (CMS) released the 2024 proposed rule for plans in the exchange. The proposed rule includes key changes to network adequacy standards and will slightly lower user fees for 2024. In addition, the rule:

• Proposes to limit to two the nonstandardized plan options for each product network type and metal tier level, with an exception for catastrophic plans. This requirement only applies to HealthCare.gov, which residents in 38 states use to buy ACA plans. It does not apply to state-run marketplaces.
• Seeks to add to the standardized plan option requirements including a proposal to no longer include a standard option for the nonexpanded bronze plan tier.

Public comments will be accepted until March 13, 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.

FDA Proposed Rule Would Replace Investigational New Drug Annual Report

On Dec. 9, the Food and Drug Administration (FDA) released a proposed rule that would change the investigational new drug (IND) annual reporting requirement. The proposed rule would replace the IND annual report with a new report titled the Food and Drug Administration Development Safety Update Report (FDA DSUR). The FDA intends to make the new report consistent with the format and content of the development safety update report that is supported by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Public comments will be accepted until March 9, 2023. For more information, click here.

FDA Proposes Exempting Certain Conventional Food, Dietary Supplements and Cosmetics From Investigational New Drug Requirements

On Dec. 9, the Food and Drug Administration (FDA) released a proposed rule that seeks to exempt certain clinical investigations of lawfully marketed conventional foods, dietary supplements and cosmetics from the investigational new drug application (IND) requirement, when the clinical investigations are conducted for the purposes of studying the products’ potential use as a drug. Although these products would be exempt from IND requirements, they would still be subject to other investigations to ensure the rights and safety of individuals. The FDA believes the proposed rule will reduce regulatory burden on the agency.

Public comments will be accepted until March 9, 2023. For more information, click here.

Final Rules

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 Report Analyzes Community Health Center Revenue and Grants Trends

On March 2, the Government Accountability Office (GAO) released a report that analyzes trends in community health center revenue and grants. The GAO was interested in seeing from where community health centers receive their annual revenue. GAO found that the revenue comes from a variety of sources, including reimbursements from Medicaid, Medicare, private insurance plans, federal grants, state grants and grants funded through the Health Resources and Services Administration (HRSA) Community Health Center Fund (CHCF). The GAO also determined that community health centers’ revenue doubled from fiscal years (FYs) 2010 to 2017, from $12.7 billion to $26.3 billion. The GAO conducted this study to provide an update to previous reports it conducted on community health center revenues and grants.

For more information, click here.

GAO Report Analyzes Effectiveness of Prison Healthcare Reentry Policies

On Feb. 27, the Government Accountability Office (GAO) released a report analyzing how effective the Federal Bureau of Prisons (BOP) healthcare reentry policies and procedures for recently released inmates are. Federal law requires the BOP to establish procedures to help inmates apply for federal and state health benefits, such as Medicaid, upon their release. GAO found that BOP has not assessed the effectiveness of their policies and procedures. GAO has recommended that the BOP begin assessing the effectiveness of their reentry policies to ensure the continuity of healthcare coverage for former prisoners. The GAO conducted this study because a provision in the Consolidated Appropriations Act of 2021 asked the GAO to investigate inmate healthcare.

For more information, click here.

GAO Report Analyzes VA Hiring Practices During COVID-19 Pandemic

On Feb. 24, the Government Accountability Office (GAO) released a report analyzing the hiring practices of the Veterans Health Administration (VHA) during the COVID-19 pandemic. In response to the nurse and doctor shortages the VHA faced during the COVID-19 pandemic, the VHA modified its hiring practices in an effort to allow newly hired staff to begin working before time-consuming onboarding tasks such as fingerprint checks and physical examinations were completed. The GAO found that the VHA’s staff onboarding system did not accurately track the progress of these tasks, and that much of the data was incomplete, inaccurate and untimely. The lack of this data suggests that some of the new VHA staff may have been unqualified to fulfill their job responsibilities. The GAO has asked the Undersecretary of Health to require all VHA offices to use the USA Staffing onboarding system to monitor onboarding tasks, and to ensure that VHA offices know how to use and enter data into the onboarding system.

For more information, click here.

KFF Releases Health Spending and Federal Budget FAQs Report

On March 1, the Kaiser Family Foundation (KFF) released a report analyzing the federal budget and federal spending on health insurance programs such as Medicare, Medicaid and the Children’s Health Insurance Program (CHIP). The report also outlines federal spending on health-related agencies such as the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA). The report discusses various tax benefits the federal government provides to support health-related activities and discusses how the looming federal debt limit may impact federal spending on health programs and services.

For more information, click here.

KFF Analysis Reveals High Medicare Advantage Gross Margins

On Feb. 28, the Kaiser Family Foundation (KFF) released an analysis of health insurer financial performance in 2021. KFF looked specifically at medical loss ratio and gross margins data reported to the National Association of Insurance Commissioners (NAIC), for Medicare Advantage (MA), Medicaid managed care and individual and employer-sponsored health insurance markets. KFF’s analysis found that gross margins for MA insurance market enrollees had returned to pre-pandemic levels by the end of 2021, while individual and employer-sponsored insurance market plans’ gross margins remained lower. Medicaid managed care insurance plans’ gross margins were higher than pre-pandemic levels. Additionally, the per person gross margins for MA plans were more than double those of other insurance plan markets.

For more information, click here.

CBO Report Analyzes Prescription Drug Provision Budgetary Impacts

On Feb. 17, the Congressional Budget Office (CBO) released a report that analyzes what impact the prescription drug provisions of the 2022 Inflation Reduction Act (IRA) will have on the U.S. federal budget. The CBO estimates that the prescription drug provisions will reduce the federal deficit by roughly $237 billion from 2022 to 2031. The CBO believes that the price negotiation, inflation rebate and Medicare Part D redesign provisions alone will account for an approximately $31 billion decrease in the federal deficit.

For more information, click here.