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, HHS issued proposed rules on the 340B drug pricing program and changes to substance use disorder patient record sharing, as well as a request for information on the ACA’s essential health benefits. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On November 21, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, CDC Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children—United States, 2023; Request for Comment and Notice of Informational Webinar. CDC announced the opening of a docket to obtain comment on proposed new recommendations for perinatal hepatitis C virus (HCV) infection testing to identify infants who may go on to develop chronic hepatitis C. Recommendations include: HCV testing of all perinatally exposed infants at age 2-6 months with a Nucleic Acid Test (NAT) for detection of HCV ribonucleic acid (RNA); and referral of infants with detectable HCV RNA to a healthcare provider with expertise in pediatric hepatitis C management. CDC also announced that they will hold an information webinar on December 6, 2022 to explain the public comment period to stakeholders. Written comments must be received on or before January 27, 2023.
- On November 21, 2022, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to serve on the Advisory Committee on Infant and Maternal Mortality. HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Infant and Maternal Mortality (ACIMM). ACIMM advises the Department of Health and Human Services (HHS) Secretary on department activities, partnerships, policies, and programs directed at reducing infant mortality, maternal mortality and severe maternal morbidity, and improving the health status of infants and women before, during, and after pregnancy.
- On November 25, 2022, FDA issued a notice entitled, Request for Nominations for Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee. FDA is requesting nominations for voting members to serve on the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health (CDRH). This annual notice is also in accordance with the 21st Century Cures Act, which requires the HHS Secretary to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels.
- On November 28, 2022, FDA issued final guidance entitled, Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies; Guidance for Industry. The guidance document informs members of the medical and scientific community and other interested persons that, at this time, FDA intends to exercise enforcement discretion with respect to the investigational new drug application (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat Clostridioides difficile (C. difficile) infection not responding to standard therapies under limited circumstances described in the guidance. The guidance announced in this notice finalizes the draft guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies” dated March 2016, and supersedes the guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies” dated July 2013.
- On November 28, 2022, CDC issued a notice entitled, Proposed Update to the CDC Framework for Program Evaluation in Public Health. CDC is announcing the opening of a docket to obtain comments and suggestions to update the CDC Framework for Program Evaluation in Public Health (CDC Evaluation Framework) and associated resources (e.g., checklists, self-study guide). Updates to the CDC Evaluation Framework are needed to continue its valuable use and service to the evaluation field and public health. Public comments, along with input gathered through other mechanisms, will help identify how the framework may have been adapted and used in different settings, what aspects of the framework have been useful, any challenges in using the framework across different contexts, and gaps that may need to be addressed.
- On November 28, 2022, HHS issued a notice of proposed rulemaking (NPRM) entitled, Confidentiality of Substance Use Disorder (SUD) Patient Records. HHS is issuing this NPRM to solicit public comment on its proposal to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. In this NPRM, HHS proposes to modify certain provisions of part 2 of title 42 of the Code of Federal Regulations (42 CFR part 2 or “Part 2”) to implement certain statutory amendments enacted in section 3221 of the CARES Act. In addition to changes mandated by the CARES Act, HHS proposes to address concerns about potential unintended consequences for government agencies of the change in enforcement authority and penalties for violations of Part 2. Specifically, HHS proposes to create a limitation on liability for agencies and persons acting on their behalf, that investigate and prosecute Part 2 programs and unknowingly receive records subject to Part 2 before applying for the requisite court order, provided they first exercise reasonable diligence by attempting to determine if the targeted provider is a Part 2 program. Comments are due by January 31, 2023.
- On November 28, 2022, FDA issued a proposed rule entitled, Food Labeling: Nutrient Content Claims; Definition of Term “Healthy;” Extension of Comment Period. FDA is extending the comment period for the proposed rule entitled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy’” that appeared in the Federal Register of September 29, 2022. FDA is taking this action in response to a request from stakeholders to extend the comment period to allow interested persons additional time to submit comments. Comments are now due by February 16, 2023.
- On November 29, 2022, HHS issued a proposed rule entitled, 340B Drug Pricing Program; Administrative Dispute Resolution. HRSA implements section 340B of the Public Health Service (PHS) Act, which is referred to as the “340B Drug Pricing Program” or the “340B Program.” This notice of proposed rulemaking (NPRM) proposes to revise the current 340B administrative dispute resolution (ADR) final rule (Dec. 14, 2020) with a new process. HHS is proposing that the 340B ADR process be revised to be more accessible, administratively feasible and timely and are soliciting comment on the proposal.
- On November 30, 2022, FDA issued a notice entitled, Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. (FDA) is requesting nominations for voting members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in CDRH. Nominations will be accepted for current and upcoming vacancies effective January 1, 2023, with this notice. Nominations must be received by January 30, 2022 for first consideration for membership on TEPRSSC.
- On November 30, 2022, HHS issued a proposed rule entitled, Request for Information: Essential Health Benefits. This request for information (RFI) solicits public comment on issues related to the Essential Health Benefits (EHB) under the Patient Protection and Affordable Care Act (the Affordable Care Act or ACA). The Centers for Medicare & Medicaid Services (CMS) is issuing this RFI to gather input from the public regarding a variety of topics related to the coverage of benefits in health plans subject to the EHB requirements of the ACA. These topics include: the description of the EHB, the scope of benefits covered in typical employer plans, the review of EHB, coverage of prescription drugs, and substitution of EHB.
- On December 1, 2022, FDA issued a notice entitled, Statement of Organization, Functions, and Delegations of Authority. The Secretary of HHS delegates to the National Institutes of Health (NIH) Director and the FDA Commissioner the authorities vested in the Secretary of HHS under Section 3 of the Accelerating Access to Critical Therapies for ALS Act, as amended, to establish and implement a Public-Private Partnership for rare neurodegenerative diseases. These authorities may be redelegated. Exercise of this authority shall be in accordance with established policies, procedures, guidelines, and regulations as prescribed by the Secretary. The Secretary retains the authority to submit reports to Congress and promulgate regulations.
- On December 1, 2022, HHS issued a notice entitled, Federal Financial Participation in State Assistance Expenditures: Federal Matching Shares for Medicaid, the Children’s Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons. The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2024 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2023 through September 30, 2024. This notice announces the calculated FMAP rates, in accordance with sections 1101(a)(8) and 1905(b) of the Act, that HHS will use in determining the amount of federal matching for Medicaid, Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Title IV-E Foster Care Maintenance payments, Adoption Assistance payments and Kinship Guardianship Assistance payments, and the eFMAP rates for Children’s Health Insurance Program (CHIP) expenditures. This notice reminds states of adjustments available for states meeting requirements for disproportionate employer pension or insurance fund contributions and adjustments for disaster recovery.
- On December 2, 2022, CMS issued a notice entitled, Medicare, Medicaid, and Children’s Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2023. This notice announces a $688.00 calendar year (CY) 2023 application fee for institutional providers that are initially enrolling in Medicare, Medicaid, or CHIP; revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2023 and on or before December 31, 2023.
- On December 2, 2022, FDA issued draft guidance for industry entitled, ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions. For purposes of implementing the Generic Drug User Fee Amendments of 2022 (GDUFA III), the Pre Submission Facility Correspondence (PFC) process was revised as part of the performance goals and program enhancements agreed to by FDA and industry, as described in the GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter). FDA assesses facility information submitted in a PFC to inform the Agency’s decision regarding the need for facility inspections that support assessment of the abbreviated new drug application (ANDA). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned ANDA submission for priority ANDAs, allowing the Agency more time to make preapproval inspection decisions. A PFC meeting the conditions outlined in the revised draft guidance will qualify the ANDA for a shorter, 8-month priority review goal. This revised draft guidance describes the content, timing, and assessment of a complete and accurate PFC for purposes of GDUFA III. Additionally, this revised draft guidance provides information on the FDA’s rationale for and current approach to assessing a PFC and replaces the previous draft guidance for industry, ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence), issued in November 2017.
- On December 2, 2022, FDA issued draft guidance for industry entitled, Statistical Approaches to Establishing Bioequivalence. This draft guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), ANDAs, and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. When finalized, this guidance will replace FDA’s 2001 guidance for industry of the same name.
- December 5-7, 2022: NIH announced a public meeting of the National Cancer Institute (NCI) National Cancer Advisory Board (NCAB) and NCI Board of Scientific Advisors (BSA). The meeting agenda will include NCAB subcommittee meetings, the NCI director’s report and presentations, and an NCI BSA concepts review.
- December 6, 2022: HHS announced a public meeting of the National Committee on Vital and Health Statistics (NCVHS). The meeting agenda will include an update on collaborations between NCVHS and the Workgroup on Electronic Data Exchange (WEDI) to inform deliberations on potential recommendations pertaining to new standards and operating rules.
- December 8, 2022: FDA announced a public meeting of the Science Board to the Food and Drug Administration (Science Board). The Science Board provides advice to the FDA Commissioner and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. The meeting agenda will include Science Board consideration of research needs for the evaluation of potential adverse health effects in children associated with oral cadmium exposure. The Science Board will also hear about FDA’s cross-cutting regulatory science research activities and its recent Focus Areas of Regulatory Science
- December 8, 2022: NIH announced a public meeting of the Advisory Committee to the Director. The meeting agenda will include updates on COVID-19 and the Advanced Research Projects Agency for Health (ARPA-H), as well updates from various working groups. Additionally, the meeting will include updates on NIH’s Diversity, Equity, Inclusion and Accessibility (DEIA) Strategic Plan.
- December 9, 2022: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The committee is charged with advising the CDC Director on the use of immunizing agents. The meeting agenda will include discussions on use of Monkeypox vaccines. A recommendation vote is not scheduled.
- January 9, 2023: FDA announced a public meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC). The committee will discuss supplemental biologics license application (sBLA) 125387, aflibercept solution for intravitreal injection, submitted by Regeneron Pharmaceuticals, Inc. The supplement was submitted in response to FDA’s pediatric written request. FDA’s written request was for studies of aflibercept in the treatment of retinopathy of prematurity.
- January 19-20, 2023: NIH announced a partially open meeting of the Council of Councils. The open agenda will include a call to order and introductions, announcements, NIH program updates, strategic plans, and other business of the committee. The closed agenda will include review and evaluation of grant applications.
- January 24, 2023: FDA announced a public meeting of the Antimicrobial Drugs Advisory Committee (AMDAC). The committee will discuss new drug application 217417, for rezafungin lyophilized powder for injection, submitted by Cidara Therapeutics, Inc., for treatment of candidemia and invasive candidiasis in adults.
- February 2, 2023: NIH announced a public meeting of the National Institute of General Medical Sciences (NIGMS) National Advisory General Medical Sciences Council. The meeting agenda will include discussion of program policies and issues, a report from the NIGMS Director, and other business of the Council.
- February 16, 2023: CDC announced a public meeting of the Subcommittee for Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH). The meeting agenda will include discussions on the following: a) technical guidance documents for dose reconstruction, the site profile for Grand Junction facilities, and a case review related to the Paducah Gaseous Diffusion Plant; (b) newly issued SC&A reviews; and (c) preparation for the April 2023 full ABRWH meeting.
II. Congressional Hearings
- On November 30, 2022, the Senate Committee on Health, Education, Labor & Pensions (HELP) Subcommittee on Children and Families held a hearing entitled, Caring for Our Kids: Supporting Mental Health in the Transition from High School to College. Witnesses present included: Dr. Sharon Hoover, PhD, Professor of Psychiatry and Co-Director of the National Center for School Mental Health, University of Maryland School of Medicine; Dr. Curtis Wright, EdD, Vice President of Student Affairs, Xavier University of Louisiana; Dr. Ashley Weiss, DO, MPH, Director of Medical Student Education in Psychiatry, Tulane University School of Medicine; and Brooklyn Williams, high school senior and founder of the Chill Club.
III. Reports, Studies & Analyses
- On November 21, 2022, HHS published a report entitled, Health+ Long COVID. The report highlights patients’ Long COVID experiences to recommend innovative solutions and treatment approaches. Specifically, the report builds upon two previous HHS reports that detailed services and supports and a national research plan for Long COVID by providing patient experiences and perspectives on the proposed research plan and recommendations. The report also seeks to understand how conditions associated with Long COVID vary between each patient, their social determinants of health, and other factors that may affect disparities in health outcomes and care. Patients also shared their ideal treatment approaches, barriers to care, and opportunities to improve care delivery.
- On November 21, 2022, the Congressional Research Service (CRS) published a report entitled, Global Pandemics: Gain-of-Function Research of Concern. Gain-of-Function (GOF) research is a broad area of scientific inquiry where scientists study both naturally occurring and experimentally induced changes in organisms that confer a new or enhanced ability. Many debate the benefits and risks of GOF research, including if it has the ability to provide insight into how viruses evolve and if the risks of such research outweigh any benefits. The report details current oversight mechanisms for GOF research, including HHS’ Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (P3CO), which establishes a review process for GOF research proposals. CRS notes that although they do not know how many applications have been submitted for review, only three research projects have been approved through the P3CO process initiated in 2017. The report notes that the debate on the origin of COVID-19 has renewed focus on GOF research and outlines a few additional federal policies and guidelines that attempt to implement biosafety and biosecurity protocols for GOF research.
- On November 21, 2022, the Congressional Budget Office (CBO) published a report entitled, Cost Estimate: Mental Health Care Legislation. CBO developed this cost estimate after the House Committee on Ways and Means ordered legislation in the form of five committee prints (117-1 through 117-5) to be reported in September 2022. The committee prints contain 13 sections in all, with each section corresponding to a bill that has been introduced in the 117th Generally, the committee prints are all related to mental health and would make changes such as revising Medicare payments for inpatient psychiatric services and adding new mental health services and provider classes to the Medicare Part B program. CBO estimated that Committee Print 117-1 would increase the deficit by $864 million, Committee Print 117-2 would increase the deficit by $902 million, Committee Print 117-3 would increase the deficit by $8 million, and Committee Prints 117-4 and 117-5 would increase the deficit by $24 million and $15 million respectively.
- On November 22, 2022, CRS published a report entitled, Long-Term Care Insurance: Overview. Long-term care insurance (LTCI) is designed to cover the costs of care associated with a chronic condition or disability that may require extended or long-term care. Generally, LTCI decisions are complex, requiring individuals to purchase them years or decades in advance of their need for long-term care. The report describes several features of the policy, including covered services, coverage length, and the waiting period. CRS also outlines the LTCI insurance market by describing three types of LTCI policies: traditional, linked-benefit, and the federal Long-Term Care Insurance Program. CRS also notes that states have primary jurisdiction for regulating the private LTCI market and that federal law provides tax benefits and consumer protections for purchasers of “tax-qualified” LTCI policies. Finally, the report discusses market stability, noting that annual LTCI premiums have increased significantly over the past two decades, which reflect an increased demand for more comprehensive benefit packages and inadequately medical underwriting and investment to cover future claims.
- On November 23, 2022, HHS’ Office of Inspector General (OIG) published a report entitled, Medicare Providers Did Not Always Comply With Federal Requirements When Billing for Advance Care Planning. OIG investigated whether Medicare providers who received payments for advance care planning (ACP) services in an office complied with federal requirements. To do so, OIG audited a stratified sample of claims for 691 ACP services received in an office during CY 2019. OIG found that of the 691 ACP services, Medicare providers complied with federal requirements for 225 services totaling $15,874 but did not comply with federal requirements for 466 services totaling $33,332. OIG hypothesized that incompliance for ACP service billing requirements may have occurred because providers did not understand federal requirements. Thus, OIG recommends that CMS educate providers on documentation and time requirements for ACP services, instruct the Medicare Administrative Contractors (MACs) to recoup $33,332 for ACP services paid in error, and establish Medicare requirements that address when it is appropriate to provide multiple ACP services for a single beneficiary.
- On November 25, 2022, the HHS’ OIG published a report entitled, Medicare Improperly Paid Physicians for Co-Surgery and Assistant-at-Surgery Services That Were Billed Without the Appropriate Payment Modifiers. CMS makes a reduced payment to physicians who work together as co-surgeons to perform a surgical procedure on the same patient during the same operative session. OIG’s objective in this report was to determine whether Medicare Part B payments to physicians for potential co-surgery procedures complied with federal requirements. OIG found that out of 100 statistically sampled services, 69 did not comply with federal requirements. Specifically, these statistically sampled services included 49 that were incorrectly billed without the co-surgery modifier, 14 that were incorrectly billed without an assistant-at-surgery modifier, and 6 that were incorrectly billed as duplicate services. These statistically sampled service errors resulted in overpayments of $31,545. Based on the results of its statistical sample, OIG estimated that Medicare made $4.9 million in improper payments for physician surgical services from 2017 to 2019.
- On November 29, 2022, CRS published a report entitled, Unauthorized Immigrants’ Eligibility for Federal and State Benefits: Overview and Resources. This report summarizes unauthorized immigrants’ eligibility for federal and state public benefits, as outlined by the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), which established comprehensive restrictions on the eligibility of noncitizens for federal public benefits. Under PRWORA’s definition of federal public benefits, noncitizens are not eligible for programs such as non-emergency Medicaid, the Supplemental Nutrition Assistance Program (SNAP), TANF, housing assistance programs, and Affordable Care Act (ACA) healthcare subsidies. However, PRWORA offers exceptions for certain circumstances, including treatment under Medicaid for emergencies, immunizations, select services and programs designated by the Attorney General or administered by the Department of Housing and Urban Development (HUD), and nutrition programs under the National School Lunch Program and School Breakfast Program. PRWORA outlines similar restrictions and exceptions for state policies and grants ultimate authority to each state to make unauthorized noncitizens eligible for any benefits paid with state or local funds. CRS suggests that Congress could look to amending PRWORA if they are interested in changing benefit eligibility for unauthorized noncitizens.
- On November 29, 2022, Alston & Bird published another edition of its Healthy Byte series entitled, CMS Finalizes Rules for Remote Therapeutic Monitoring for 2023. Alston & Bird’s Sean Sullivan and Tania Khan discuss CMS’ 2023 Medicare Physician Fee Schedule (PFS) final rule for CPT codes for remote therapeutic monitoring (RTM). The proposed rule intended to replace two previously finalized RTM codes from the 2022 final rule, with four new G-codes. In this Healthy Byte, Sean Sullivan and Tania Khan discuss CMS’s decision to keep the existing RTM codes in the final rule and the final proposal for pricing cognitive behavioral therapy monitoring.
- On November 30, 2022, CRS released a report entitled, The Opioid Crisis in the United States: A Brief History. The report begins by describing that the rise in opioid use in the U.S. grew exponentially in the 1990s with the marketing of new reformulated prescription opioid medications (e.g., OxyContin) and the advocacy of increased pain management. In fact, the rate of opioid-involved overdose deaths doubled from 2.9 to 6.8 deaths per 100,000 people between 1999 and 2010 overall, with even greater rates with heroin and fentanyl-related deaths. CRS then outlines U.S. efforts to address the opioid crisis, including major federal legislation such as the Comprehensive Addiction and Recovery Act of 2016; increased availability of substance abuse prevention, treatment, and recovery services; efforts to address opioid trafficking and diversion of prescription opioids; and efforts to reduce foreign supplies of opioids entering the U.S.
- On December 1, 2022, HHS’ OIG released a report entitled, Insights on Telehealth Use and Program Integrity Risks Across Selected Health Care Programs During the Pandemic. OIG’s Pandemic Response Accountability Committee (PRAC) Health Care Subgroup studied the use of telehealth across selected health care programs in six federal agencies during the first year of the pandemic. PRAC found that all programs took similar steps to make telehealth available and experienced dramatic increases in telehealth use. For example, PRAC noted that during the first year of the pandemic, 37 million individuals used telehealth across the select programs, which was 13 times the number of individuals who used telehealth the previous year. The report also identified several program integrity risks, including inappropriate billing and a lack of oversight, and found limited information on the impact of telehealth on quality of care. Thus, PRAC outlines additional safeguards that could strengthen program integrity: (1) programs could conduct additional monitoring and oversight of telehealth services; (2) programs could conduct educational efforts to providers and individuals on telehealth; and (3) programs could collect additional data on telehealth services, such as data on the impact on care quality.
- On December 1, 2022, CRS published a report entitled, Federal Support for Financially Distressed Hospitals. Following recent growing concerns of rural hospital closures and hospitals having to reduce services due to financial strain and limited resources, CRS examined federal support for hospitals and potential options to aid financially distressed hospitals. This report addresses Medicare hospital payments, other sources of federal support for hospitals, and temporary financial assistance available for expenses related to COVID-19. The report also explains that federal insurance programs such as Medicare pay for services furnished to beneficiaries and enrollees, but generally do not provide general financial support to hospitals. CRS also details a few grant and technical assistance programs that directly provide financial support to hospitals, including the COVID-19 relief funding through the Provider Relief Fund (PRF).
IV. Other Health Policy News
- On November 22, 2022, HRSA announced $350 million in funding for HRSA-supported health centers aimed at increasing COVID-19 vaccinations in local communities, with a specific focus on reaching underserved populations. The funds will support a variety of methods of administering vaccines including mobile, drive-up, walk-up, or community-based events. HRSA is expecting that health center hosted COVID-19 vaccination events will also increase the administration of flu and childhood vaccines through combined vaccination efforts. HHS has reported that to date, health centers have administered more than 22 million vaccines in underserved communities across the country, with 70 percent of those vaccines provided to racial and ethnic minority patients. More information on this funding can be found here.
- On November 22, 2022, the Biden Administration provided an update on activity since the start of the 2023 Marketplace Open Enrollment Period (OEP) on November 1. They announced that nearly 3.4 million people nationwide have selected an Affordable Care Act (ACA) Marketplace health plan, which represents a 17 percent increase in total plan selections over last year. Of those who have selected an ACA Marketplace plan, 19 percent are new to the Marketplaces for 2023, and 2.7 million people (81 percent of total) have active 2022 coverage and returned to their respective Marketplaces to renew or select a new plan for 2023. The 2023 Marketplace OEP runs from November 1, 2022 to January 15, 2023 for states using the HealthCare.gov platform. More information on this announcement can be found here.
- On November 28, 2022, the Biden Administration announced its support for the World Health Organization (WHO) announcement that it is renaming monkeypox disease to mpox. The WHO renamed the disease to minimize unnecessary negative impact on any cultural, social, ethnic groups; regions; or trade, travel, tourism, and animal welfare. Therefore, the adoption of the new name, mpox, will help the U.S. and all countries address the disease without eliciting implicit bias or stigma. The U.S. hopes the renaming will help avoid the marginalization of groups most affected by the disease and improve resource and treatment distribution. More information on this announcement can be found here.
- On December 1, 2022, the U.S. Public Health Service (USPHS) Commissioned Corps, a uniformed service of HHS, announced it is changing its medical standards to accept future applicants living with chronic hepatitis B and HIV. Previously, individuals with hepatitis B and HIV were disqualified to serve in the USPHS but given scientific and treatment advancements that have made both hepatitis B and HIV into manageable chronic conditions, USPHS is updating its medical standards. Now, applicants with HIV on antiretroviral therapy (ART) and applicants with chronic hepatitis B who show undetectable or low viral loads respectively, will no longer be medically disqualified to serve as a Public Health Officer. More information on this announcement can be found here.
- On December 1, 2022, HHS’ OCR issued a bulletin to highlight covered entities and business associates’ obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) HIPAA Privacy, Security, and Breach Notification Rules (HIPAA rules) when using online tracking technologies. OCR notes that some entities may share electronic protected health information (ePHI) with online tracking technology vendors (e.g., Google Analytics or Meta Pixel) in a manner that violates HIPAA rules. The bulletin explains what tracking technologies are, lists specific examples of impermissible disclosures of ePHI, and outlines steps entities must take to protect ePHI when using tracking technology to comply with the HIPAA rules. More information on this bulletin can be found here.
- On December 2, 2022, HHS issued a factsheet to outline its Roadmap for Behavioral Health Integration (“HHS Roadmap”) to provide integrated, equitable, evidence-based, culturally appropriate, and person-centered behavioral health care. Specifically, HHS has identified opportunities to integrate behavioral health into primary care settings; recruit, train, and support a diverse workforce; strengthen the implementation and enforcement of behavioral health parity; engage with high-risk and vulnerable populations; integrate care into community-based settings and schools; test value-based payment arrangements; improve technology access and use; and advance the use of quality measures to improve quality of care. The fact sheet also outlines specific actions taken by agencies within HHS to further each of these initiatives. More on this fact sheet and the HHS Roadmap can be found here.
- On December 2, 2022, HHS released a factsheet to mark the one-year anniversary of HHS’s Overdose Prevention Strategy. HHS announced progress made including expanded treatment capacity, lives saved from overdose, and commitment to long-term recovery supports. For example, CDC awarded nearly $300 million in grants through Year 4 of its Overdose Data to Action program, FDA issued guidance that that certain naloxone products may be safe and effective for over-the-counter (OTC) use, CMS’ Medicare Physician Fee Schedule (PFS) Final Rule allowed for telehealth visits for behavioral health care, the NIH Helping to End Addiction Long-term (HEAL) Initiative is developing medications and biologics to prevent and treat SUDs, and HHS created the Office of Recovery within SAMHSA. More on this announcement can be found here.