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, CMS issued a proposed rule that would place new requirements on Medicare Advantage (MA) organizations and other payors to improve the electronic exchange of healthcare data and streamline the prior authorization process. Read more about this action and other news below.
I. Regulations, Notices & Guidance
- On December 5, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability. The final guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance revises the draft guidance for industry entitled “E19 Optimization of Safety Data Collection” issued in June 2019. The final guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or post-marketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The final guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information.
- On December 5, 2022, FDA issued final guidance entitled, Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 or Programmed Cell Death-Ligand 1 Blocking Antibodies for Treatment of Patients with Cancer; Guidance for Industry; Availability. This guidance provides recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. This guidance is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs, and as such, does not address development of alternative dosing regimens for other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD-1/PD-L1 products.
- On December 6, 2022, the National Institutes of Health (NIH) issued a request for information (RFI) entitled, Request for Information on Proposed Simplified Review Framework for NIH Research Project Grant Applications. The purpose of this RFI is to solicit public input on a proposed revised framework for evaluating and scoring peer review criteria for NIH research project grant (RPG) applications. NIH is proposing a revised simplified framework that will reorganize five major regulatory criteria under three scored categories and reduce the number of non-score driving review considerations that reviewers evaluate in judging the scientific merit of RPG applications. The proposed changes pertain to those RPGs with standard review criteria. All the factors required by regulation will continue to be evaluated. NIH is not proposing to revise the regulatory criteria. Rather, NIH is proposing to revise its policy of how peer reviewers score the criteria, and how NIH organizes the criteria for review purposes. NIH believes that these changes will allow peer reviewers to refocus on the critical task of judging scientific merit and will improve those judgements by reducing bias. The deadline for comments is March 10, 2023.
- On December 6, 2022, FDA issued final guidance entitled, Homeopathic Drug Products; Guidance for Food and Drug Administration Staff and Industry; Availability. The guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the U.S. without the required FDA approval.
- On December 6, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children’s Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, Merit-based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program. This proposed rule would place new requirements on Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children’s Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of healthcare data and streamline processes related to prior authorization, while continuing CMS’ drive toward interoperability in the healthcare market. This proposed rule would also add a new measure for eligible hospitals and critical access hospitals (CAHs) under the Medicare Promoting Interoperability Program and for Merit-based Incentive Payment System (MIPS) eligible clinicians under the Promoting Interoperability performance category of MIPS. These policies taken together will play a key role in reducing overall payer and provider burden and in improving patient access to health information.
- On December 7, 2022, the Centers for Disease Control and Prevention (CDC) issued final guidance entitled, Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns. The 2022 Guidelines provide updates to the 2013 publication, Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from the CDC and the Council of State and Territorial Epidemiologists (CSTE). The updates provide state, tribal, local, and territorial health departments guidance for a revised and expanded approach to evaluating concerns about unusual patterns of cancer in communities, including those associated with local environmental concerns.
- On December 7, 2022, FDA issued final guidance entitled, Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry; Availability. The guidance document provides blood establishments that collect blood and blood components with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, except Source Plasma.
- On December 8, 2022, FDA issued a proposed rule entitled, Investigational New Drug Application Annual Reporting. FDA is proposing to replace its current annual reporting requirement for INDs with a new requirement: the annual FDA development safety update report (FDA DSUR). The proposed annual FDA DSUR is intended to be consistent with the format and content of the DSUR that is supported by the ICH, which is described in FDA’s ICH guidance for industry entitled “E2F Development Safety Update Report” (E2F DSUR) from August 2011. The proposed annual FDA DSUR regulation, if finalized, would require an annual report that is more comprehensive and informative than the IND annual report currently required under FDA regulations.
- On December 8, 2022, FDA issued a proposed rule entitled, Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic. FDA is proposing to amend its regulations on INDs to exempt from the IND requirements certain clinical investigations of lawfully marketed foods for human consumption (including both conventional foods and dietary supplements) and cosmetics when the product is to be studied to evaluate its use as a drug. Under the proposal, clinical studies to evaluate a drug use of such products would not have to be conducted under an IND when, among other things, the study is not intended to support a drug development plan or a labeling change that would cause the lawfully marketed product to become an unlawfully marketed drug, and the study does not present a potential for significant risk to the health, safety, or welfare of subjects. Though exempt from the IND requirements, such investigations would still be subject to other regulations designed to protect the rights and safety of subjects, including requirements for informed consent and review by institutional review boards (IRBs). By exempting from the IND requirements certain clinical investigations of products lawfully marketed as a food or cosmetic, the proposed provisions are intended to reduce the regulatory burden of conducting such studies while retaining protections for human subjects.
- On December 8, 2022, FDA issued draft guidance entitled, Content of Human Factors Information in Medical Device Marketing Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. This draft guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health (CDRH) to facilitate the efficiency of the FDA review process.
- On December 8, 2022, FDA issued draft guidance entitled, Voluntary Malfunction Summary Reporting Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is publishing this draft guidance document to help manufacturers better understand and use the Voluntary Malfunction Summary Reporting (VMSR) Program. It is intended to further explain, but not change, the conditions of the VMSR Program. The VSMR Program is intended to streamline reporting for device malfunctions as outlined in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. As such, it is intended to yield benefits for FDA, the public, and manufacturers, such as by increasing transparency for the public, helping FDA to process certain malfunction reports more efficiently, allowing both FDA and the public to identify malfunction trends more readily, and reducing the burden on manufacturers.
- On December 9, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued an RFI entitled, Request for Information on Creating a National Healthcare System Action Alliance to Advance Patient Safety. AHRQ seeks public comment on advancing patient and healthcare workforce safety through the development of a National Healthcare System Action Alliance to Advance Patient Safety (Action Alliance) in partnership with healthcare systems, patients, families and caregivers, the Department of Health and Human Services (HHS) and other federal agencies, and other stakeholders to support sustained improvements in patient safety. Specifically, the RFI seeks input on how the Action Alliance can be most effective. In addition, the RFI seeks comments about innovative models of care, approaches, promising strategies, and solutions for overcoming some of the common impediments to safety being experienced in healthcare today. This request for information will inform HHS’s work and more specifically the work of the Action Alliance.
- On December 9, 2022, AHRQ issued two notices entitled, Supplemental Evidence and Data Request on Patient and Provider Level Strategies to Address Racial/Ethnic Disparities in Health and Healthcare and Supplemental Evidence and Data Request on Healthcare System Level Strategies to Address Racial/Ethnic and Related Disparities in Health and Healthcare. AHRQ is seeking scientific information submissions from the public to inform the development of “Healthcare System Level Strategies to Address Racial/Ethnic and Related Disparities in Health and Healthcare” and “Patient and Provider Level Strategies to Address Racial/Ethnic Disparities in Health and Healthcare”, which are projects currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Program.
- January 18, 2023: HHS announced a public meeting of the National Advisory Committee on Children and Disasters (NACCD). The meeting is being held to discuss, finalize, and vote on an initial set of recommendations to the HHS Secretary and the Office of the Assistant Secretary for Strategic Preparedness and Response (ASPR) regarding challenges, opportunities, and priorities for national public health and medical preparedness, response and recovery, specific to the needs of children and their families in disasters.
- January 19, 2022: NIH announced a public meeting of the National Institute on Aging (NIA) National Advisory Council on Aging (NACA). The meeting agenda will include a report from the Director; a discussion of future meeting dates; consideration of minutes from last meeting; reports from the Task Force on Minority Aging Research and the Working Group on Program.
- January 20, 2022: NIH announced a public meeting of the National Center for Complementary & Integrative Health (NCCIH) National Advisory Council for Complementary and Integrative Health (NACCIH). The meeting agenda will include a report from the NCCIH Director and reports from other members of NCCIH staff.
- February 13-14, 2022: CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). This meeting will examine the general requirements for clinical studies submitted for CMS coverage requiring coverage with evidence development (CED). The MEDCAC will evaluate the CED criteria to assure that CED studies are evaluated with consistent, feasible, transparent and methodologically rigorous criteria. MEDCAC will also advise CMS on whether the criteria are appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary
II. Reports, Studies & Analyses
- On December 6, 2022, the HHS Office of Inspector General (OIG) published a report entitled, Labs With Questionably High Billing for Additional Tests Alongside COVID-19 Tests Warrant Further Scrutiny. OIG conducted this review because preliminary analysis of Medicare Part B claims data indicated that some diagnostic testing laboratories billed for other diagnostic tests at high rates—such as individual respiratory tests (IRTs), respiratory pathogen panels (RPPs), genetic tests, and allergy tests—along with COVID-19 tests, between spring 2020 and the end of 2020. OIG reported that while it is not unusual for labs to bill for COVID-19 tests and other diagnostic tests on the same claim, certain billing patterns—such as a high volume of or high payments for add-on tests—raise concerns of potential waste or fraud. After its analysis, OIG found that 378 labs billed Medicare Part B for add-on tests at questionably high levels—in volume, payment amount, or both—compared to the 19,199 other labs. This includes 276 labs that billed for high volumes of add-on tests on claims for COVID-19 tests, and 263 labs that billed for high payment amounts from add-on tests on claims for COVID-19 tests. OIG flagged the outlier labs for further review by CMS.
- On December 7, 2022, the Kaiser Family Foundation (KFF) published a report entitled, How Much Could COVID-19 Vaccines Cost the U.S. After Commercialization? The report illustrates the potential total cost of Pfizer and Moderna COVID-19 vaccines, based on their publicly-announced expected prices, once they enter the U.S. commercial market. Specifically, KFF compared the average price paid by the federal government for the COVID-19 bivalent boosters to the estimated average commercial prices that have been suggested by manufacturers to calculate an overall cost for purchasing vaccines for the adult population (ages 18 and older) across different scenarios of vaccine uptake. KFF calculated that the federal government has so far purchased 1.2 billion doses of Pfizer and Moderna COVID-19 vaccines combined, at a cost of $25.3 billion, or a weighted average purchase price of $20.69 per dose. Based on anticipated pricing, if equal amounts of each manufacturer’s vaccine are used, the average commercial price per dose would range from a low of $96 to a high of $115. This range is 3 to 4 times greater than the weighted average price per dose paid by the federal government for Moderna and Pfizer bivalent doses ($28.90). Overall, KFF concluded that even under low uptake scenarios, the total cost to purchase COVID-19 vaccines at the commercial price would still exceed the cost of purchasing vaccines at the federal bivalent booster price.
- On December 7, 2022, the Congressional Budget Office (CBO) published two reports entitled, Options for Reducing the Deficit, 2023 to 2032 - Volume I: Larger Reductions and Reducing the Deficit, 2023 to 2032 - Volume II: Smaller Reductions. The reports detailed large and small policy options, respectively, that Congress could pursue to reduce the national deficit. CBO’s May 2022 baseline projections, which reflect the assumption that current laws governing taxes and spending generally remain unchanged, estimated that federal debt held by the public will rise from 98 percent of gross domestic product (GDP) in 2022 to 110 percent of GDP in 2032 and 185 percent of GDP by 2052. In its report on large-scale policy options, CBO estimated that establishing caps on federal Medicaid spending could save the government between $501 and $871 billion over 10 years, while increasing premiums for Medicare Part B plans could save between $57 and $448 billion over the same period. CBO also estimated that reducing MA benchmarks could save $392 billion over 10 years. In its report on policy options that would lead to smaller deficit reductions, CBO estimated that changing cost-sharing rules for Medicare (e.g., implementing a single annual deductible or restricting new medigap policies) and limiting Medigap plan usage could save between $27 and $122 billion over the next decade and that reducing the Medicare program’s coverage of bad debt could save between $23 and $74 billion.
- On December 7, 2022, the Congressional Research Service (CRS) published a report entitled, FDA Regulation of Laboratory-Developed Tests (LDTs). Laboratory-developed tests (LDTs) are a class of in vitro diagnostic (IVD) devices that is designed, manufactured, and used within a single laboratory. While both CMS and FDA are involved in the regulation of LDTs, this report only focuses on FDA’s role in the regulation of LDTs. The report first provided an overview of past FDA activity on LDT regulation, including summaries of draft guidance released in 2014 and a discussion paper released in January 2017. CRS noted that the key issues related to FDA oversight of LDTs include regulation and oversight for direct-to-consumer (DTC) genetic tests and pharmacogenetic testing. Finally, the report covers recent relative legislative activity to regulate LDTs, including the Verifying Accurate, Leading-edge, IVCT Development (VALID) Act, which was introduced during both the 116th and 117th
III. Other Health Policy News
- On December 7, 2022, HHS provided an updated on Affordable Care Act (ACA) Marketplace enrollment for the 2023 Marketplace Open Enrollment Period (OEP), which opened on November 1, 2022. HHS announced that 5.5 million people have selected an Affordable Care Act (ACA) Marketplace health plan nationwide since the beginning of the OEP. This update represents activity through December 3, 2022 (Week 5) for the 33 states using HealthCare.gov and through November 26, 2022 (Week 4) for 17 states and the District of Columbia with state-based Marketplaces (SBMs). Total plan selections were made by those including 1.2 million people (22 percent of total) who are new to the Marketplaces for 2023, and 4.3 million people (78 percent of total) who have active 2022 coverage and returned to their respective Marketplaces to renew or select a new plan for 2023. The 5.5 million total plan selections represent an 18 percent increase from 4.6 million this time last year. More information on this announcement can be found here.
- On December 8, 2022, the Biden Administration launched the National Opioid Overdose Tracker, which will be maintained by the National Highway Traffic Safety Administration (NHTSA) using ambulance data from all 50 states and the District of Columbia. The dashboard aims to highlight trends in overdoses that can help policymakers make informed decisions, including about geographic inequities in ambulance response times. The dashboard will track four factors: population rate of nonfatal opioid overdose in a community, average number of naloxone administrations per patient, average emergency medical services (EMS) time in transit to reach an overdose patient, and the percentage of overdose patients who are transported to a medical facility for additional treatment. It will highlight the jurisdictions with the highest rates of nonfatal overdoses in rolling 12-month and 28-day periods. More information on this new tracker can be found here.
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