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 declared a Public Health Emergency (PHE) for Puerto Rico due to the flooding impact of Hurricane Fiona and released its 2022 National Strategy to Support Family Caregivers. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On September 20, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a request for nominations entitled, Supplemental Solicitation for Nominations of Members from Populations Underrepresented in Medicine (URIM) to Serve on Scientific Peer Review Committee. This notice invites the public to nominate individuals from populations underrepresented in medicine to serve as members to the AHRQ Initial Review Group (IRG), which is responsible for the scientific peer review of AHRQ grant applications. The AHRQ IRG conducts scientific and technical reviews for health services research and training grant applications and is comprised of five subcommittees or study sections, each with a particular research focus. AHRQ is seeking nominations from the public, including minority serving institutions, academic health centers, community-based organizations (CBOs), professional societies, or other state and federal agencies. Nominations are due on or before December 31, 2022.
- On September 21, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Electronic Submission Template for Medical Device 510(k) Submissions. This final guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This guidance document provides further standards for the submission of 510(k)s by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.
- On September 21, 2022, the Centers for Medicare & Medicaid Services (CMS) issued guidance entitled, Guidance on Nursing Facility State Plan Payment and Upper Payment Limit Approaches in Medicaid Relying on the Medicare Patient-Driven Payment Model (SMD 22-005). This letter issued to State Medicaid Directors, provides guidance to states as they consider transitioning from Resource Utilization Groups (RUGs) to the Patient-Driven Payment Model (PDPM) to pay Medicaid nursing facilities, as well as incorporating PDPM payments as the basis for nursing facility upper payment limit (UPL) demonstrations. CMS will no longer support RUG-III and RUG-IV on federally required assessments for patients residing in Nursing Facilities (NFs) and Skilled Nursing Facilities (SNFs) as of October 1, 2023. As most states historically used the RUGs categories and the Minimum Data Set (MDS) data for all SNF residents to categorize Medicaid patients and calculate the Medicare-equivalent payment amount, states will now need to consider the transition to PDPM.
- On September 21, 2022, FDA issued draft guidance entitled, How To Obtain a Covered Product Authorization. This guidance describes how eligible product developers can obtain a Covered Product Authorization (CPA) from FDA under the CREATES Act. The CREATES Act provides a pathway for eligible product developers to obtain access to the product samples they need to fulfill testing and other regulatory requirements to support their applications. To make use of this pathway, an eligible product developer seeking to develop a product subject to a Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) must obtain from the Agency a Covered Product Authorization (see 21 U.S.C. 355-2(b)(2)).
- On September 21, 2022, FDA issued final guidance entitled, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of Food and Drug Administration-Approved Naloxone Products During the Opioid Public Health Emergency; Guidance for Industry; Availability. Combating the opioid overdose epidemic is an urgent public health priority for FDA. Naloxone hydrochloride (“naloxone”) is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programs and is aware of concerns that harm reduction programs are having difficulty acquiring naloxone. This guidance clarifies the scope of the public health emergency (PHE) exclusion and exemption under the Drug Supply Chain Security Act as they apply to the distribution of FDA-approved naloxone products indicated for the emergency treatment of opioid overdose to harm reduction programs during the opioid PHE.
- On September 22, 2022, FDA issued final guidance entitled, Electronic Submission Template for Medical Device 510(k) Submissions. This guidance introduces submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support 510(k) electronic submissions to FDA. This guidance represents one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This guidance facilitates the implementation of the FDA’s mandate to provide further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.
- On September 23, AHRQ issued a notice entitled, Challenge Competition: Announcement of AHRQ Challenge on Integrating Healthcare System Data with Systematic Review Findings. AHRQ is announcing a challenge competition to explore the resources and infrastructure needed to integrate real-world data from healthcare systems into systematic review findings. This healthcare systems data can augment study findings synthesized in systematic reviews in a number of ways, including by filling evidence gaps identified in the systematic review to strengthen the available evidence, and by examining the applicability of systematic review findings to real-world populations, including population subgroups not examined in published studies. Ultimately, this work will help AHRQ understand if and how sources of data and information outside of traditional systematic reviews, particularly from healthcare systems themselves, could be used alongside systematic reviews to improve healthcare decision making, healthcare delivery and potentially patient outcomes. This competition will start on September 26, 2022 and will be completed in two phases, with submissions for phase 1 due January 9, 2023 and cash prizes awarded to those who advance and win Phase 2.
- On September 23, 2022, FDA issued draft guidance entitled, Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and Institutional Review Boards. This draft guidance describes FDA’s current thinking regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices involving children. The draft guidance is intended to assist industry, sponsors, and IRBs when considering the enrollment of children in clinical investigations of medical products.
- On September 23, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Invitation to Become a Healthy People 2030 Champion. This notice announces HHS Office of Disease Prevention and Health Promotion’s (ODPHP) invitation to public and private sector organizations that support Healthy People 2030, the nation's disease prevention and health promotion plan, to become a Healthy People 2030 Champion. The selected Healthy People 2030 Champions will be recognized for their commitment and work toward achieving Healthy People 2030's vision of a society in which all people can achieve their full potential for health and well-being across the lifespan. Online applications will be accepted starting September 21, 2022 and reviewed on a rolling basis.
- On September 23, 2022, CMS issued a notice entitled, Medicaid Program; Temporary Increase in Federal Medical Assistance Percentage (FMAP) in Response to the COVID-19 Public Health Emergency (PHE); Reopening of Public Comment Period. On November 6, 2020, CMS published an interim final rule with request for comments (IFR) entitled, Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency. The IFR set forth certain requirements in CMS regulations that states must follow in order to claim a temporary increase in federal matching funds for their Medicaid programs under the Families First Coronavirus Response Act (FFCRA). In light of the possibility of changed circumstances since publication of the IFR and other policy considerations, CMS is considering modifying those requirements. CMS is soliciting additional information from the public on any issues that may be pertinent to these potential modifications by reopening the public comment period for an additional 30 days.
- September 22-23, 2022: HHS announced a public meeting of the National Vaccine Advisory Committee (NVAC). NVAC will hear presentations on COVID-19, monkeypox, influenza, and polio vaccination, as well as vaccine safety, innovation, and gaps in rural vaccination coverage.
- October 12, 2022: The National Institutes of Health (NIH) announced a meeting of the National Cancer Institute (NCI). The agenda will consist of discussions of ongoing and new activities at the Frederick National Laboratory for Cancer Research.
- October 14, 2022: NIH announced a partially open meeting of the National Eye Institute (NEI). The open agenda will include a presentation of the NEI Director’s report and discussion of NEI programs. The closed agenda will include review and evaluation of grant applications.
- October 25, 2022: NIH announced a partially open meeting of the National Institute on Aging (NIA) Board of Scientific Counselors. The open agenda will include committee discussions, individual presentations, and a laboratory overview. The closed agenda consists of an executive session.
- October 26, 2022: NIH announced a meeting of the National Institute of Mental Health (NIMH). The agenda will include discussions of business, updates, and issues related to autism spectrum disorder (ASD) research and services activities.
- November 1-3, 2022: The Health Resources and Services Administration (HRSA) announced a meeting of the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC). CHAC will discuss issues related to HIV and the workforce, including non-traditional partnerships to address people with HIV who are out of care, AIDS Education and Training Center program and integrating innovative programs to address HIV workforce challenges into the Ryan White HIV/AIDS Program, and how to use community health workers and disease intervention specialists more effectively in HIV and STD prevention, care, and treatment, along with a federal update on Monkeypox.
- November 22, 2022: FDA announced a meeting of the Oncologic Drugs Advisory Committee. The committee will hear an update on supplemental new drug application 208447/S-025, for ZEJULA (niraparib) capsules, submitted by GlaxoSmithKline, LLC., for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The update includes the final overall survival data from the NOVA trial. Based on the information provided, the committee will consider whether the indication should remain in the U.S. labeling
II. Congressional Hearings
U.S. House of Representatives
- On September 21, 2022, the House Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Examining Long-Term Care In America: The Impact Of The Coronavirus In Nursing Homes. Witnesses present included: Daniel Arbeeny, Family member of nursing home resident; Dr. Alice Bonner, Senior Advisor for Aging, Chair, Institute for Healthcare Improvement, Moving Forward Nursing Home Quality Coalition; Dr. David Grabowski, Professor of Health Care Policy, Department of Health Care Policy, Harvard Medical School; Adelina Ramos, Certified Nursing Assistant; Dr. Jasmine Travers MHS, RN, Assistant Professor of Nursing, New York University Rory Meyers College of Nursing.
- On September 21, 2022, the House Committee on Energy and Commerce held a markup entitled, Markup of 24 Bills. In total, the Committee discussed six bills and 18 resolutions. Notable bills under consideration included: H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 5141, the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act; and H.R. 8163, the Improving Trauma Systems and Emergency Care Act.
- On September 21, 2022, the House Committee on Ways and Means held a markup entitled, Markup of Worker and Family Support and Health Legislation. The Committee considered H.R. 8876, the Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022, as well as Committee Prints 117-1, 117-2, 117-3, 117-4, and 117-5.
III. Reports, Studies & Analyses
- On September 19, 2022, the HHS Office of Inspector General (OIG) published a report entitled, Certain Life Care Nursing Homes May Not Have Complied With Federal Requirements for Infection Prevention and Control and Emergency Preparedness. OIG investigated whether select Life Care Centers of America (Life Care) nursing homes complied with Federal requirements for infection prevention and control and emergency preparedness during the COVID-19 pandemic. OIG conducted this audit because older adults, especially those living in nursing homes, were particularly vulnerable to COVID-19. As such, OIG collected documentation related to infection prevention and control program (IPCP) and emergency preparedness program policies and procedures that were in effect from January 2019 through May 2020 in 24 Life Care nursing homes that had been cited for infection prevention and control program deficiencies as of February 2020. OIG found that 23 of the 24 nursing homes had possible noncompliance to Federal requirements related to: (1) annual reviews of the IPCP, (2) training, (3) designations of an infection preventionist who met Federal regulations, and (4) quality assessment and assurance committees (QAAC) meetings. OIG recommended that CMS require state survey agencies (SSAs) to follow up with the 23 nursing homes to verify that they have taken corrective actions.
- On September 20, 2022, OIG published a report entitled, Medicare Part B Overpaid and Beneficiaries Incurred Cost-Share Overcharges of Over $1 Million for the Same Professional Services. OIG conducted this study to determine whether Medicare Part B payments to critical access hospitals (CAHs) for professional services and payments made to health care practitioners for the same services complied with federal requirements. OIG examined 40,026 Medicare Part B claims submitted by CAHs and health care practitioners (20,013 claims each) and found that Medicare paid CAHs $1.0 million and paid health care practitioners $872,858 for these 40,026 claims. OIG determined that because Medicare should generally not pay both a CAH and a health care practitioner for the same date of service, only one of the claims would comply with federal requirements; therefore, Medicare administrative contractors (MACs) paid providers $907,438 more than they should have been paid, and beneficiaries were held responsible for $281,321 more than they should have been. OIG recommended that CMS direct the MACs to recover the overpayments from (1) CAHs from when health care practitioners did not reassign their billing rights to the CAH, which resulted in overpayments and cost-sharing overcharges to beneficiaries; and (2) from health care practitioners when they had reassigned their billing rights but still had cost-sharing overcharges to beneficiaries.
- On September 21, 2022, OIG published a report entitled, FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing. OIG conducted this review to assess how FDA used its Emergency Use Authorization (EUA) authority to authorize COVID-19 tests during the first months (January through May 2020) of the pandemic. OIG found that CDC, who typically is the first to receive an EUA, did not have enough tests to meet the needs of Americans, which revealed vulnerabilities in the federal approach. Furthermore, due in part to its limited engagement with the public health labs that were using CDC's test, FDA was slow to realize that testing by public health labs was far more limited than it initially expected. OIG also expressed concern that FDA’s decisions to increase the availability of testing inadvertently compromised the quality of tests. To better prepare for future emergencies, OIG recommends that FDA: (1) assess and revise guidance for test EUAs; (2) develop a suite of EUA templates for future emergences; (3) expand the FDA Center for Devices and Radiological Health's (CDRH) existing device-tracking platform to facilitate EUA submission and monitoring; (4) expand and improve resources for test developers; (5) establish formal emergency communication channels between FDA and the lab community; and (6) work with federal partners to implement a national testing strategy beyond EUAs.
- On September 22, 2022, OIG released a report entitled, National Institutes of Health Grant Program Cybersecurity Requirements Need Improvement. OIG conducted this study to determine whether NIH has adequate requirements in place to ensure grant awards have risk-based cybersecurity provisions to protect sensitive and confidential data, as well as NIH's intellectual property. OIG found that NIH did not have an adequate pre-award risk assessment process that could capture cybersecurity threats, that NIH does not include specific cybersecurity provisions in its policies, and that NIH does not conduct adequate post-award monitoring to ensure award recipients maintain cybersecurity preventions. Therefore, OIG recommended that NIH bolster its cybersecurity protections and policies, assess all grant awards for cybersecurity concerns and compliance, and strengthen its pre- and post-award standards for cybersecurity protections.
- On September 22, 2022, OIG published a report entitled, CMS Has Opportunities To Strengthen States' Oversight of Medicaid Managed Care Plans' Reporting of Medical Loss Ratios. OIG conducted this study to assess states’ medical loss ratio (MLR) process and reporting. The MLR is a policy tool that has replaced fee-for-service as the predominant payment model in Medicaid. MLR requires Medicaid managed care to spend a minimum amount annually on covered health care services and quality-improvement activities. In assessing states’ MLR reports, OIG found that although most Medicaid managed care plans submit MLR reports as required, nearly 50 percent of the reports were incomplete; most reports were missing non-claims costs (administrative costs). Therefore, OIG recommends that CMS (1) design an annual MLR reporting template; (2) issue clarifications that states should verify completeness and accuracy of their plans’ MLR reports; and (3) provide additional guidance to states regarding reporting of non-claims costs.
- On September 22, 2022, the Government Accountability Office (GAO) released a report entitled, Public Health Emergencies: Data Management Challenges Impact National Response. This report outlines the three major and longstanding challenges in the federal government’s management of public health data: (1) the lack of common data standards and collection of certain elements such as race; (2) the lack of interoperable data collection systems; and (3) the lack of adequate public health information technology (IT) infrastructure that allows public health entities to quickly report and retrieve information. GAO emphasizes the importance of improving data management to bolster the U.S.’ ability to respond quickly to public health emergencies. As such, GAO highlights numerous recommendations for improvement, including that (1) HHS establish an expert committee on data collection and reporting standards; (2) HHS include consideration of interoperability in their efforts to build the public health situational awareness network; and (3) HHS prioritize the improvement of the HHS Protect platform, a public health IT infrastructure created to help address challenges in data management for COVID-19.
- On September 23, 2022, OIG published a report entitled, CMS's System Edits Significantly Reduced Improper Payments to Acute-Care Hospitals After May 2019 for Outpatient Services Provided to Beneficiaries Who Were Inpatients of Other Facilities. OIG conducted this audit to determine whether Medicare appropriately paid acute-care hospitals for outpatient services they provided to beneficiaries who were inpatients of other facilities. OIG found that Medicare inappropriately paid acute-care hospitals $39.3 million for such outpatient services, because the inpatient facilities were responsible for payment. OIG clarified that inpatient facilities are responsible for providing all services furnished during an inpatient stay and arrange for any outpatient services, which are to be included in their inpatient claims to Medicare. Therefore, OIG recommends that CMS: (1) direct the MACs to recover improper payments within and after the audit period, (2) notify providers so they can return any overpayments, (3) instruct acute-care hospitals to refund beneficiaries, and (4) continue to review and determine whether any other refinements are necessary to prevent overpayments.
IV. Other Health Policy News
- On September 19, 2022, HHS’ Office of Minority Health (OMH) announced $3 million in grant funding to eight organizations for a new initiative to demonstrate policy effectiveness and to promote Black youth mental health (BYMH). This three-year initiative will help identify health and wellness policies that are successful in improving BYMH, including suicide prevention. Recent data shows that Black children under age 13 years are twice as likely to die by suicide compared to White children. In response, the eight awardees will identify existing policies they can expect to promote mental health in Black youth and test the impact of them on Black youths’ mental health. More on this announcement can be found here.
- On September 20, 2022, HHS’ Office on Women’s Health (OWH) announced two grants of $496,000 to the Washington University in St. Louis and $485,490 to George Mason University to improve early detection and prevention of eating disorders in adolescent girls. The grants will support development of evidenced-based interventions that target COVID-19-related stressors and potential barriers to early diagnosis; expand prevention awareness; improve care; and reduce stigma. Washington University and George Mason University will also use the funds to create partnerships that integrate physical and mental health aspects of eating disorders between care providers and community organizations. More on this announcement can be found here.
- On September 21, 2022, HHS Secretary Xavier Becerra declared a PHE for Puerto Rico due to the flooding impact of Hurricane Fiona. The declaration allows greater flexibility and resources for meeting emergency health needs. For example, HHS has deployed a 15-person Health and Medical Task Force from its National Disaster Medical System (NDMS) and a 10-person incident management team to work with health authorities and emergency response officials to determine what additional federal public health and medical resources are necessary to aid Puerto Rico in responding to the hurricane. More information on this announcement can be found here.
- On September 21, 2022, HHS released its 2022 National Strategy to Support Family Caregivers. Nearly 56 million known family caregivers provide a broad range of assistance for family members or loved ones who need care as they age or due to a chronic health condition or disability. Often, family caregivers lack the resources to maintain their health, wellbeing, and financial security while providing crucial support for others. This national strategy highlights nearly 350 actions the federal government will take to support family caregivers in the coming year and more than 150 actions that can be adopted at other levels of government and across the private sector to build a system to support family caregivers. It aims to advance health equity and will be updated every two years. More on this announcement can be found here.
- On September 21, 2022, CMS announced additional resources and flexibilities for the Commonwealth of Puerto Rico to aid in their recovery and response to Hurricane Fiona. Key actions include: (1) CMS waivers and COVID-19 waivers for health care providers who need additional flexibilities; (2) a disaster toolkit and an inventory of Medicaid and Children’s Health Insurance Program (CHIP) flexibilities and authorities available to ensure continuity of coverage; (3) activation of the Kidney Community Emergency Response (KCER) program and the End-Stage Renal Disease (ESRD) Network 3, which is responsible for assessing the status of dialysis facilities and for providing dialysis care; and (4) CMS waivers for lost or realized damage to Medicare beneficiaries’ durable medical equipment, prosthetics, orthotics, and supplies. CMS will continue to assess and take action to ensure people in Puerto Rico have access to care. More on this announcement can be found here.
- On September 23, 2022, HHS announced it had awarded more than $1.6 billion in investments for communities throughout the country addressing the addiction and overdose crises, as a part of President Biden’s comprehensive effort to combat the drug overdose epidemic. The investments were made through the Substance Abuse and Mental Health Services Administration’s (SAMHSA) State Opioid Response (SOR) and Tribal Opioid Response (TOR) grant programs and HRSA’s rural communities opioid response programs. The funding is aimed to help communities utilize a variety of tools, from prevention to harm reduction to treatment and recovery supports for people in need. More information on this funding can be found here.
- On September 23, 2022, HHS announced it had awarded $5 million to 11 HRSA-funded community health centers (CHCs) to facilitate access to life-saving cancer screenings and early detection services for underserved populations. The partnerships will bring together CHCs and NCI-Designated Cancer Centers. The awards focus on increasing equitable access to cancer screening for breast, cervical, and colorectal cancer. Health centers will conduct patient outreach in underserved communities to promote early detection of cancer, connect patients to screening services, and provide hands-on assistance with accessing high quality cancer care and treatment as needed. The CHCs receiving Accelerating Cancer Screening awards must work with NCI-Designated Cancer Centers, which will deploy their outreach specialists and patient navigators in the health center’s service area. Example activities may include care coordination; patient engagement and activation; enhancing virtual care capabilities; tracking patient screening, referrals, and follow-up; enhancing health IT workflows; and workforce engagement, training, and recruitment. More information on this announcement can be found here.
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