Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, the House Energy and Commerce Committee Subcommittee on Health held a hearing on Medicare proposals to increase access to care and minimize red tape for doctors, and CMS released the 2024 Medicare Advantage and Medicare Part D Star Ratings. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On October 16, 2023, the Food and Drug Administration (FDA) issued a notice entitled, Determination That Zofran ODT (Ondansetron) Orally Disintegrating Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness. FDA decided not to withdraw Zofran ODT (ondansetron) orally disintegrating tablets (4 milligrams (mg) and 8 mg) from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
- On October 16, 2023, FDA issued a guidance entitled, Diabetic Foot Infections: Developing Drugs for Treatment; Draft Guidance for Industry. The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections (DFI) without concomitant bone and joint involvement.
- On October 16, 2023, FDA issued guidance entitled, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry. This guidance is intended to alert pharmaceutical manufacturers and pharmacists in state-licensed pharmacies or federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. During the COVID-19 public health emergency (PHE), FDA became aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizer products that were manufactured with methanol or methanol-contaminated ethanol. FDA is concerned that other drug products containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which are widely used active ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination. This guidance replaces the January 2021 guidance for industry entitled, Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19).
- On October 16, 2023, the Department of Health and Human Services (HHS) issued a notice entitled, Announcement of Solicitation of Written Comments on Healthy People 2030 Objectives. HHS solicits written comments from the public on the current Healthy People 2030 objectives, and written comments from the public proposing additional new core, developmental, or research objectives or topics to be included in Healthy People 2030. Public comment informed the development of Healthy People 2030. HHS will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2030 reflects current public health priorities and public input.
- On October 16, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, Rural Health and Economic Development Analysis Program. HRSA provided additional award funds to the Rural Health and Economic Development Analysis Program recipients to produce a research project that quantifies the relationships between health care and economic factors in rural communities.
- On October 17, 2023, FDA issued guidance entitled, Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements. The guidance addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements in FDA’s regulations regarding donation suitability, donor eligibility, and quarantine hold for Source Plasma. FDA expects that the compliance policy described in the guidance will increase the availability of blood and blood components, including Source Plasma, while maintaining the health of blood donors and the safety of blood and blood components. The guidance finalizes the draft guidance of the same title dated May 2022, and supersedes the guidance entitled Alternative Procedures for Blood and Blood Components During the COVID19 Public Health Emergency; Guidance for Industry that was published in April 2020.
- On October 17, 2023, FDA issued a notice entitled, Improving the Quality and Representativeness of the Treatment Center Program Data--Data Modifications to the Current Survey Instrument Format to Minimize Misclassification. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection entitled Improving the Quality and Representativeness of the Treatment Center Program Data- Data Modifications to the Current Survey Instrument Format to Minimize Misclassification.
- On October 17, 2023, FDA issued a notice entitled, Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Naropin (Ropivacaine Hydrochloride) Solution, 50 Milligrams/10 Milliliters and 75 Milligrams/10 Milliliters. FDA has decided not to withdraw Naropin (ropivacaine hydrochloride) solution (50 milligrams (mg)/10 ml and 75mg/10mL) from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of ANDAs that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these drug products as long as they meet relevant legal and regulatory requirements.
- On October 17, 2023, FDA issued guidance entitled Guidance Documents Referencing Pre-Existing Tobacco Products; Withdrawal. FDA announced the availability of revised final guidance for industry entitled Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions, and Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007. Following the issuance of the final rules entitled “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports” (SE) and “Premarket Tobacco Product Applications and Recordkeeping Requirements” (PMTA), FDA has made minor updates to these guidance for consistency with the terminology used in those rules. FDA is also announcing the withdrawal of the final guidances entitled “Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products,” and “Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods,” and a draft guidance entitled “Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product,” which are obsolete due to the issuance of the SE final rule or the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on August 8, 2016.
- On October 18, 2023, FDA issued a notice entitled, Center of Drug Evaluation and Research Guidance Documents Related to Coronavirus Disease 2019, Expiration. FDA announced the withdrawal of guidances for industry entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, which posted March 2020 to communicate recommendations for notifying the Agency about the permanent discontinuance or interruption in manufacturing of certain drug products; and COVID-19: Potency Assay Consideration for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV2 Infectivity which posted January 2021 to communicate information on the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics. FDA is withdrawing these two guidance documents because new draft guidances are available that reflect comments received on the COVID-19 guidances, and many of the recommendations set forth in the COVID-19 guidances are applicable outside the context of the PHE and included in the draft guidances.
- On October 18, 2023, FDA issued a notice entitled, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability. The enforcement policy described in this guidance applies to modified devices where the original device was a legally marketed, noninvasive remote monitoring device listed in the guidance that measures or detects common physiological parameters and that is used to support patient monitoring. The guidance is intended to describe the enforcement policy for limited modifications to the indications, functionality, hardware, or software of device types in the scope of the guidance without prior submission of a 510(k) where such submission would be required.
- On October 18, 2023, the National Institutes of Health (NIH) issued a notice entitled, Prospective Grant of Exclusive Patent Commercialization License: Human Monoclonal Antibodies that Broadly Target Coronaviruses. The National Institute of Allergy and Infectious Diseases, an institute of NIH, is contemplating the grant of an exclusive patent license to Leyden Laboratories B.V., located in the Netherlands, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
- On October 19, 2023, FDA issued guidance entitled, Development and Licensure of Vaccines to Prevent COVID-19. This guidance is being issued to assist FDA and sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19. This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate. This guidance document is being implemented immediately, but it remains subject to comment in accordance with FDA’s good guidance practices.
- On October 19, 2023, FDA issued guidance entitled, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies. This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. CBER encourages the use of appropriate standards in the development of CBER-regulated products. The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. This program is modeled after the formal standards and conformity assessment program or S-CAP for medical devices.
- October 25, 2023: The Agency for Health Research and Quality (AHRQ) announced a meeting entitled, Meeting for Software Developers on the Common Formats for Patient Safety Data Collection. This is a virtual meeting open to the public.
- October 25 and October 26, 2023: HHS announced a meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. This is a hybrid meeting that is open to the public.
- October 25, October 26, and October 27, 2023: The Centers for Disease Control and Prevention (CDC) announced it will hold a meeting of the Advisory Committee on Immunization Practices. This meeting is open to the public and time will be available for public comment.
- October 26, 2023: NIH announced a meeting of the Office of AIDS Research Advisory Council that will focus on focus on HIV and health disparities, guest speakers and a discussion panel. This is a virtual meeting open to the public.
- October 26, 2023: HHS announced a meeting of the President’s Council on Sports, Fitness, and Nutrition. This is a virtual meeting open to the public.
- October 31, 2023: NIH announced a meeting of the National Advisory Child Health and Human Development Council Stillbirth Working Group. This is a virtual meeting open to the public.
- October 31 and November 1, 2023: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. The committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the Department of Labor (DOL), HHS, the Department of the Treasury, and relevant States, and the prevention of balance billing to consumers. This is a virtual meeting that is open to the public.
- November 2 and 3, 2023: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting open to the public.
- November 2 and 3, 2023: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
- November 7, 2023: FDA announced a meeting of the Radiological Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
- November 13 and 14, 2023: The Administration for Strategic Preparedness and Response (ASPR) announced its Biomedical Advanced Research and Development Authority (BARDA) Industry Day 2023. BARDA annually hosts a two-day conference with industry and government partners to share BARDA’s goals and objectives, increase awareness of U.S. government medical countermeasure (MCM) priorities, and facilitate collaboration between public and private sectors within the health security space. This year, BARDA plans to discuss implementation efforts for the 2022-2026 Strategic Plan. This is a hybrid event open to the public.
- November 14, 2023: CDC announced a meeting of the Advisory Committee to the CDC Director. This is a hybrid meeting that is open to the public. There will be an opportunity for public comment.
- November 16, 2023: NIH announced that the Diabetes Mellitus Interagency Coordinating Committee will hold a public online meeting entitled, The Application of Digital Health Technology to Type 2 Diabetes Management: Current Status, Research Gaps, and Opportunities.
- November 16, 2023: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a virtual meeting that will be open to the public and the agency is establishing a docket for public comment on this document.
- November 17, 2023: NIH announced a meeting of the National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group. This is a virtual meeting open to the public.
- November 28, 29, 30, 2023: CMS announced a virtual public meeting entitled, New Revisions to the Healthcare Common Procedure Coding System (HCPCS) to discuss preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and nonbiological products.
- November 29, 2023: NIH announced the National Cancer Institute will hold a meeting of their Frederick National Laboratory Advisory Committee. This is a virtual meeting open to the public.
- November 30, 2023: FDA announced a public workshop entitled, Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients with Renal Impairment. The workshop will discuss the current landscape of drug dosing in pediatric patients with renal impairment, discuss the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
- December 4 and 5, 2023: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The meeting will be videocast and is open to the public.
- December 5 and 6, 2023: HRSA announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.
- December 6, 2023: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include reports from the ISUDCC Working Groups and discussion of the ISUDCC’s recommendations to HHS on how the federal government can further integrate and coordinate harm reduction approaches and strategies across the continuum of prevention, treatment, and recovery policies, programs, and practices. This is a virtual meeting open to the public.
- December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting of the Sleep Disorders Advisory Board. This is a virtual public meeting that requires registration to attend.
- December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting to update their Advisory Board and public stakeholders on research agendas across NIH for fiscal year (FY) 2024. This is a virtual public meeting that requires registration to attend.
- December 12 and 13, 2023: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This is a virtual meeting open to the public.
- December 13 and December 14, 2023: HHS announced it will hold a virtual public town hall meeting to discuss FY 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).
- January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.
II. Hearings & Markups
- On Wednesday, October 18, 2023, the Senate Finance Committee held a hearing entitled, Medicare Advantage Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences. Witnesses present included: Christina Reeg, Ohio Senior Health Insurance Information Program Director, Ohio Department of Insurance; Cobi Blumenfeld-Gantz, Co-Founder & Chief Executive Officer, Chapter; and, Krista Hoglund, Chief Executive Officer, Security Health Plan.
- On Wednesday, October 18, 2023, the Senate Budget Committee held a hearing entitled, Improving Care, Lowering Costs: Achieving Health Care Efficiency. Witnesses present included: Dr. Matthew Fiedler, Senior Fellow, the Brookings Institution; Dr. Leemore Dafny, Professor, Harvard Business School and Harvard Kennedy School; Dr. G. Alan Kurose, Chair, Rhode Island Foundation and Former President, Coastal Medical; Mr. Theo Merkel, Director of Private Health Reform Initiative, Senior Research Fellow at the Paragon Health Institute and Senior Fellow at the Manhattan Institute; and, Dr. Chapin White, Director of Health Analysis, Congressional Budget Office (CBO).
- On Wednesday, October 18, 2023, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, Nomination of Monica Bertagnolli to be Director of the National Institutes of Health. Witnesses present included Monica Bertagnolli.
- On Thursday, October 19, the House Energy & Commerce Committee Subcommittee on Health held a hearing entitled, What’s the Prognosis?: Examining Medicare Proposals to Improve Patient Access to Care and Minimize Red Tape for Doctors. Witnesses present included Dr. Meena Seshamani, MD, PhD, Director, Center for Medicare, CMS; Ms. Leslie Gordon, MPP, Director, Health Care, U.S. Government Accountability Office (GAO); Mr. Paul Masi, MPP, Executive Director, Medicare Payment Advisory Commission (MedPAC); Dr. Steven Furr, MD, FAAFP, President-Elect, American Academy of Family Physicians (AAFP); Dr. Debra Patt, MD, PhD, MBA, Executive Vice President, Texas Oncology; Mr. Joe Albanese, MPP, Senior Policy Analyst, Paragon Health Institute; Dr. Matthew Fiedler, PhD; and, Joseph A. Pechman Senior Fellow in Economic Studies, Brookings Scheffer Initiative on Health Policy, the Brookings Institution. Legislation included
- R.___, to amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program;
- R.___, to amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program and to improve the accuracy of geographic adjustment factors under such program;
- R. 2377, the Saving Access to Laboratory Services Act;
- R.___, to amend title XVIII of the Social Security Act to revise the phase-in of clinical laboratory test payment changes under the Medicare program;
- R.___, to amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models;
- R.___, the Improving Seniors Timely Access to Care Act of 2023;
- R. 1352, the Increasing Access to Biosimilars Act of 2023;
- R.___, the Provider Reimbursement Stability Act of 2023; H.R. 5526, the Seniors’ Access to Critical Medications Act of 2023;
- R. 1406, the Sustainable Cardiopulmonary Rehabilitation Services in the Home Act;
- R. 2583, the Increasing Access to Quality Cardiac Rehabilitation Care Act of 2023;
- R. ___, to amend title XVIII of the Social Security Act to exempt certain practitioners from Merit-based Incentive Payment System (MIPS) payment adjustments under the Medicare program based on participation in certain payment arrangements under Medicare Advantage (MA);
- R. 4402, to amend title XI of the Social Security Act to clarify manufacturer transparency reporting requirements for certain transfers used for educational purposes;
- R. 3674, the Providing Relief and Stability for Medicare Patients Act of 2023;
- R.___, to amend title XVIII of the Social Security Act to revise certain physician self-referral exemptions relating to physician-owned hospitals;
- R.___, the Fewer Burdens for Better Care Act of 2023;
- R. 5395,the Small Practice, Underserved, and Rural Support Program (SURS) Extension Act;
- R.___, to amend title XVIII of the Social Security Act to promote provider choice using real time benefit information;
- R. 5555,the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Relief Act of 2023;
- R. 4104, the Preserving Patient Access to Home Infusion Act;
- R. 4878, the Enabling More of the Physical and Occupational Workforce to Engage in Rehabilitation (EMPOWER) Act;
- R.___,the Telehealth Privacy Act of 2023; and,
- R.___, to amend title XVIII of the Social Security Act to allow for the use of alternative measures of performance under MIPS under the Medicare program.
III. Reports, Studies, & Analyses
- On October 18, 2023, the Office of the Inspector General (OIG) released a report entitled, The Strategic National Stockpile Was Not Positioned To Respond Effectively to the COVID-19 Pandemic. The objective of OIG’s investigation was to determine whether the Strategic National Stockpile (Stockpile), under the direction of ASPR, was effective in responding to the COVID-19 pandemic. The report found that the Stockpile was operationally effective in distributing its limited inventory in response to the COVID-19 pandemic, based on established policies and procedures and consistent with its statutory obligations. However, OIG determined the strategic effectiveness of the Stockpile, and its ability to meet COVID-19 demands, were impacted by external and internal factors outside of its control. According to the report, the Stockpile used established processes to effectively distribute its limited supply of personal protective equipment (PPE) and other items during the first three months of 2020, but the Stockpile could not meet demand and was not equipped to handle the COVID-19 pandemic overall.
- On October 18, 2023, the Kaiser Family Foundation (KFF) released a report entitled, the 2023 Employer Health Benefits Survey. The report provides a detailed look at trends in employer-sponsored health coverage, including premiums, employee contributions, cost-sharing provisions, offer rates, wellness programs, and employer practices. The report also looks at employers’ views on certain topics including abortion coverage, mental health and substance use services, and wellness programs. According to the report, annual premiums for employer-sponsored family health coverage reached $23,968 in 2023, with workers on average paying $6,575 toward the cost of their coverage. Additionally, the report showed that the average deductible among covered workers in a plan with a general annual deductible was $1,735 for single coverage. Survey responses showed that workers at smaller employers on average contribute $2,445 more toward the cost of family coverage than workers at larger firms.
- On October 18, 2023, the Bipartisan Policy Center released a report entitled, Provisions Relevant to Reauthorization of the SUPPORT Act. The reported focused on four major policy areas for Congress’s consideration in the reauthorized Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. The four policy areas highlighted in the report include: 1) enhancing community-based programs and services; 2) maintaining Medicaid coverage for high need patients; 3) updating behavioral health metrics, and; 4) improving workforce capacity. The report provides recommendations to address these policy focus areas through both Congressional and administrative action.
IV. Other Health Policy News
- On October 13, 2023, CMS released the 2024 premiums, deductibles, and coinsurance amounts for Medicare Part A and Part B programs. The agency also released the 2024 Medicare Part D income-related monthly adjustment amounts. Specifically, the standard monthly premium for Medicare Part B enrollees will be $174.70 for 2024 (an increase of $9.80 from $164.90 in 2023) and the annual deductible for all Medicare Part B beneficiaries will be $240 in 2024 (an increase of $14 from the annual deductible of $226 in 2023). The Medicare Part A inpatient hospital deductible will be $1,632 in 2024 (an increase of $32 from $1,600 in 2023). In 2024, beneficiaries must pay a coinsurance amount of $408 per day for the 61st through 90th day of a hospitalization ($400 in 2023) in a benefit period and $816 per day for lifetime reserve days ($800 in 2023). For beneficiaries in skilled nursing facilities (SNFs), the daily coinsurance for days 21 through 100 of extended care services in a benefit period will be $204.00 in 2024 ($200.00 in 2023). In addition, enrollees aged 65 and older who have fewer than 40 quarters of coverage and certain persons with disabilities pay a monthly premium to voluntarily enroll in Medicare Part A. Individuals who have at least 30 quarters of coverage or are married to someone with at least 30 quarters of coverage may buy into Part A at a reduced monthly premium rate of $278 in 2024 (the same amount as 2023). Certain uninsured individuals who have less than 30 quarters of coverage and certain individuals with disabilities who have exhausted other entitlements will pay the full premium of $505 a month in 2024 ($1 decrease from 2023). Individuals with Medicare Part D will pay the income-related monthly adjustment amount in addition to their Part D premium. Part D premiums vary by plan and regardless of how a beneficiary pays their Part D premium, the Part D income-related monthly adjustment amounts are deducted from Social Security benefit checks or paid directly to Medicare. The CMS fact sheet is available here.
- On October 13, 2023, CMS announced the publication of the Medicare Advantage (MA) and Medicare Part D Star Ratings. Plans are rated on a one-to-five scale, with one star representing poor performance and five stars representing the highest level of performance. Star Ratings are intended as a tool to guide beneficiaries to better performing MA plans which can help beneficiaries choose the appropriate plan for their needs. Star Ratings are based on 40 quality measures. People with Medicare can compare quality through the Star Ratings, along with other information, such as cost and coverage, on Medicare’s online platform. According to a press release from CMS, approximately 74 percent of people currently in MA plans that offer prescription drug coverage are enrolled in a plan that earned at least four stars in 2024. CMS also states that 42 percent of MA plans that offer prescription drug coverage have an overall rating of four stars or higher. A press release from CMS is available here.
- On October 18, 2023, Senate Finance Committee Chair Ron Wyden (D-OR) along with committee members, Senators Michael Bennet (D-CO) and Thom Tillis (R-NC), introduced the Requiring Enhanced and Accurate Lists (REAL) of Health Providers Act, which is intended to strengthen requirements for MA plans to maintain adequate provider directories and protect seniors from unexpected healthcare costs. The bill was introduced during October 19th Senate Finance Committee hearing entitled, Medicare Advantage Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences. Many seniors enrolled in MA rely on provider directories to find in-network physicians and practitioners; however, inaccurate data can make it difficult for enrollees to find a provider and lead to unexpected costs. The sponsors refer to these inaccurate provider directories as “ghost networks”, which often list providers that are not accepting new patients or are no longer in business. The REAL Health Providers Act would help address these issues by: (1) strengthening requirements for MA plans to maintain accurate and updated provider directories; (2) ensuring patients do not pay out-of-network costs for appointments with providers incorrectly listed as in-network in their plan’s provider directory; and, (3) directing CMS to publish guidance for plans to maintain accurate provider directories. The text of the bill is available here. A summary of the bill is available here.
- On October 18, 2023, HHS issued two resource documents to help explain to patients the privacy and security risks to their protected health information (PHI) when using telehealth services and ways to reduce these risks. The first resource is for health care providers entitled, Educating Patients about Privacy and Security Risks to Protected Health Information when Using Remote Communication Technologies for Telehealth. Although health care providers are not required under Health Insurance Portability and Accountability Act (HIPAA) to provide this education, the resource supports the continued and increased use of telehealth by providing information to help health care providers who choose to discuss telehealth privacy and security with patients. The Office for Civil Rights (OCR) also issued a resource for patients entitled, Telehealth Privacy and Security Tips for Patients. This resource provides recommendations that patients can implement to protect and secure their health information. A press release with more information is available here.
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