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FDA Announces Transition Plan of Withdrawing COVID-Related Guidance Post-PHE | Medicare Payment Advisory Commission Holds March Meeting | Bipartisan Group of House Representatives Urge FDA to Approve OTC Naloxone| New Coalition Shares Best Practices to Support Medicaid Redeterminations | Executive Action | Administrative Action | Congressional Action | Medicaid | Marketplace| Regulatory Action |Research
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FDA Announces Transition Plan of Withdrawing COVID-Related Guidance Post-PHEThe FDA released a notice on its plan to withdraw certain COVID-era guidance documents once the COVID-19 Public Health Emergency (PHE) ends on May 11th. The notice addresses the 72 guidance documents that are currently in effect:
- 22 of these guidance documents will expire immediately at the end of the COVID-19 PHE.
- 22 additional documents will be subject to a wind-down period of 180 days to ensure an orderly transition.
- 24 documents will be retained with appropriate changes after the expiration of the COVID-19 PHE.
- 4 documents have durations not tied to the COVID-19 PHE declaration, and will remain in effect after the PHE expires.
Medicare Payment Advisory Commission Holds March MeetingThe Medicare Payment Advisory Commission (MedPAC) held its March public meeting to discuss a number of issues related to Medicare payment policy. Specifically, the Commission held sessions on:
- Reforming Medicare’s wage index systems
- Addressing the high prices of drugs covered under Medicare Part B
- Favorable selection and future directions for Medicare Advantage payment policy
- Aligning fee-for-service payment rates across ambulatory settings
Bipartisan Group of House Representatives Urge FDA to Approve OTC NaloxoneYesterday, a bipartisan group of 28 House Members, led by Representative Angie Craig (D-MN) submitted a letter to the Food and Drug Administration (FDA) urging them move forward with making naloxone available over the counter (OTC) without a prescription. Naloxone is used to safely reverse the effects of an opioid overdose without major side effects and is often packaged in easy-to-use nasal sprays and auto-injectors. Last month the FDA Nonprescription Drugs Advisory Committee and the Anesthetic Drug Products Advisory Committee both unanimously voted to recommend allowing OTC naloxone. The FDA is expected to make their final determination based on their recommendation at the end of March.
New Coalition Shares Best Practices to Support Medicaid RedeterminationsYesterday, a group of leading organizations representing millions of American patients, people with disabilities, care providers, employer-related groups, and health insurance providers announced the launch of the Connecting to Coverage Coalition (CCC). The CCC, led by AHIP, is a national coalition focused on sharing information related to the Medicaid redetermination process. The coalition will convene stakeholders to support information sharing, build on best practices, and develop solutions to ensure Americans are able to enroll in coverage that is right for themselves and their families. CCC will share resources, such as surveys of how people understand and perceive the Medicaid redetermination process, frequently asked questions for Medicaid enrollees and their families, links to guidance from the Centers for Medicare & Medicaid Services (CMS), and toolkits for engaging enrollees about what they need to do to determine their eligibility for Medicaid or an alternate form of coverage. Other founding members of the CCC include the American Cancer Society Cancer Action Network, the Arc of the United States, Cystic Fibrosis Foundation, Cancer Support Community, Mental Health America, Catholic Health Association of the United States, Unidos US, American Benefits Council, National Association of Benefits and Insurance Professionals, National Association of Community Health Centers, Federation of American Hospitals, American Health Care Association, Association for Community Affiliated Plans, Blue Cross Blue Shield Association, and Medicaid Health Plans of America.
- Last Tuesday, the President’s Domestic Policy Advisor Susan Rice and Surgeon General Dr. Vivek Murthy hosted a roundtable (summary here) on addressing the mental health crisis among young Black men. Ambassador Rice and Dr. Murthy were joined by selected young people speaking about their lived experience on this issue, as well as a provider discussing how to improve treatment and support for the community. The conversation outlined challenges and opportunities to address mental health among Black young men in America including: 1) Understanding stressors and stigmas that are unique to young Black men including the issue of racism and racial trauma. 2) Increasing access to treatment by expanding the mental health workforce and supporting policies that remove barriers to workforce diversity, including addressing the cost of education and debt. 3) Considering young Black men’s and their communities’ strengths to support their mental health.
- Last Monday, HHS announced the formation of several new divisions within the Office for Civil Rights (OCR) to address rapidly increasing cybersecurity breaches to better protect patient and federal data. OCR is responsible for enforcing the Health Insurance Portability and Accountability Act of 1966 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 20090 by mandate. Further, OCR’s caseload increased 69 percent between 2017 and 2022, with 51,000 complaints to investigate. Due to the significant increase in cases and the continued increase in large data breaches of health care providers, OCR is reorganizing by forming a new Enforcement Division, Policy Division, Strategic Planning Division, and renaming the Health Information Privacy Division (HIP) to the Health Information Privacy, Data, and Cybersecurity Division (HIPDC).
- Recently, CMS released CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency. The fact sheet covers information for those with Medicare, Medicaid and CHIMP, and private health insurance on COVID-19 vaccines, testing, and treatments, access to telehealth services, waivers and administrative flexibilities, and Inpatient Hospital Care at Home.
- Senator Elizabeth Warren’s office published a report on harmful Medigap marketing practices. “Medigap” coverage, also known as Medicare Supplemental Insurance, is relied on by millions of seniors nationwide to fill coverage and cost gaps in their Medicare coverage. Overall, the investigation finds that: 1) Offers of luxury vacations or other incentives to agents are pervasive in the Medigap market. 2) Bonuses and perks can incentivize agents and brokers to steer seniors to the wrong products. 3) Bonus perks for agents and brokers are both legal and minimally regulated.
- The Senate Committee on Health, Education, Labor, and Pensions (HELP) Ranking Member Bill Cassidy (R-LA) issued a request for an updated report on Community Health Center funding titled “Health Centers: Trends in Revenue and Grants Supported by the Community Health Center Fund.” The current report covers Community Health Center revenue during Fiscal Years 2011 through 2017. The HELP committee’s request seeks to update this data to include funding provided by COVID-19-related legislation and the American Rescue Plan Act. Senator Cassidy notes in the letter his aims to assess the effectiveness of the overall program in achieving its statutorily defined goals amid the potential reauthorization of the Community Health Center Fund.
- The Senate Committee on Health, Education, Labor, and Pensions (HELP) Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA) released a request for information on the drivers of health care workforce shortages and potential shortages. The request follows the committee’s recent hearing on February 16th examining the current state of workforce shortages, and how Congress can address this challenge. Healthsperien’s comprehensive summary of the HELP hearing can be found here. In their letter, Senators Sanders and Cassidy note that they plan to use the responses to develop bipartisan legislation in the future. Comments are due to HealthWorkforceComments@help.senate.gov by Monday, March 20th.
- Last Monday, CBO issued (IHP subscription required) an informal score of $10 billion for the Improving Seniors’ Timely Access To Care Act. CBO initially issued a score of $16 billion shortly after the bill passed the House last year. House Speaker Kevin McCarthy’s staff requested that CBO re-score the bill in mid-January, and strongly encouraged the Agency to use a cost analysis included in CMS’ proposed rule on prior authorization. Proponents of the bill are reassessing their next steps, including a potential second informal rescore or potential tweaks to the bill. Legislators plan to meet with CBO to understand the revised baseline and to what degree the resources they provided had been considered. They noted plans to work with House and Senate Committees of jurisdiction and leadership to adjust the legislation to bring the score down to a negligible amount.
- CMS posted the anticipated state timelines for initiating unwinding-related renewals. This chart details the expected first month for each state or territory’s unwinding-related renewals, as well as the anticipated effective date for the first procedural terminations. The anticipated termination date is generally the first month that members who have not had their eligibility successfully renewed in the past 12 months may be disenrolled for procedural reasons, such as non-response to a renewal form, per CMS guidelines. Terminations for individuals the state has redetermined as ineligible for Medicaid and CHIP may occur on or after April 1, 2023.
- Last Monday, the American Benefits Council sent a letter to House and Senate leadership detailing their priority legislative health care objectives for the 118th Congress. The letter offers recommendations for how Congress can best support employers’ efforts to address health care challenges and continue to provide affordable, high-quality health care coverage to workers and their families. Their letter calls upon Congress to: 1) Preserve and Strengthen Employer-Provided Health Coverage 2) Lower cost and improve value 3) Leverage telehealth to improve access and value 4) Combat the mental health crisis.
- Last Friday, the Drug Enforcement Administration (DEA) announced proposed rules for the permanent prescribing of controlled medications via telemedicine. The proposed rules would reimpose some restrictions on telehealth prescribing of controlled substances following the end of the COVID-19 public health emergency (PHE) on May 11. For medical practitioners who have never conducted an in-person evaluation of a patient, but a telemedicine consultation results in the prescribing of a controlled medication, the proposed rules would allow clinicians to prescribe: 1) a 30-day supply of Schedule III-V non-narcotic controlled medications; 2) a 30-day supply of buprenorphine for the treatment of opioid use disorder. The public has 30 days to review and comment on the proposed rules.
- Last week, researchers at the RAND Corporation and University of Texas at Austin published a new study analyzing Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey data collected from family caregivers of individuals receiving hospice care between 2017 and 2019. The CAHPS survey measures care experiences, a core element of hospice care quality, related to communication, timeliness of care, symptom management, and emotional and religious support. The researchers found that caregivers reported worse experiences at for-profit hospices across all CAHPS measures analyzed. Over 31% of for-profit hospices scored three or more points below the national hospice average, while just 12% of non-profit hospices received below average ratings.
- Recently, KFF released an analysis of the 988 Crisis lifeline system’s performance since the official launch in July 2022. Nationally, the 988-lifeline received over 2 million contacts, including calls, text messages, and chat messages, an increase of 43% over the previous year, which required a 10-digit number. At the same time, the state and national 988 call centers responded to 91% of contacts, up from 64% the previous year, and experienced shorter wait times. However, the researchers caution that seven states still have lower than 70% response rates. In addition, when an in-state facility cannot answer 988 calls, they are automatically routed to out-of-state response centers, which may be less familiar with the behavioral health resources available in the caller’s area.
- On Wednesday, CDC released a report on emergency department (ED) visits related to mental health disorders among adults by race and ethnicity. Of the 6,000 mental health-related ED visits between 2018 and 2020, Black Americans had the highest rates for any mental health disorder, including substance use, anxiety, and mood. Specifically, Black and Hispanic patients were more likely to wait more than an hour to be seen by a clinician compared to white patients. In addition, a higher percentage of Black and Hispanic adult visits had Medicaid as the expected primary payment source. This report comes at a time of increased demand for behavioral health services and growing pressures on emergency departments nationwide.