Below is Alston & Bird's Health Care Week in Review, which provides a synopsis of the latest news in healthcare 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, Labor, Treasury, and OPM released the Prescription Drug and Health Care Spending interim final rule, and the House passed the Build Back Better Act. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On November 15, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; CY 2022 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts. This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2022 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2022, the inpatient hospital deductible will be $1,556. The daily coinsurance amounts for CY 2022 will be: $389 for the 61st through 90th day of hospitalization in a benefit period; $778 for lifetime reserve days; and $194.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
- On November 15, 2021, CMS issued a notice entitled, Medicare Program; CY 2022 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. This notice announces Medicare's Hospital Insurance Program (Medicare Part A) premium for uninsured enrollees in calendar year 2022. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the "uninsured aged") and by certain individuals with disabilities who have exhausted other entitlement. The monthly Medicare Part A premium for the 12 months beginning January 1, 2022 for these individuals will be $499. The premium for certain other individuals as described in this notice will be $274.
- On November 15, 2021, CMS issued a notice entitled, Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2022. This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2022. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2022, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2022 are $334.20 for aged enrollees and $368.90 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2022 is $170.10, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus the $3.00 repayment amount required under current law. (The 2021 standard premium rate was $148.50, which included the $3.00 repayment amount.) The Part B deductible for 2022 is $233.00 for all Part B beneficiaries. (The 2021 Part B deductible was $203.00.) If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, 80, or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60, or $10.20, respectively.
- On November 16, 2021, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Regulation of Telepharmacy Practice. DEA issued advanced notice of proposed rulemaking to obtain further information regarding the practice of telepharmacy. Telepharmacy is not specifically defined by the Controlled Substances Act (CSA) or DEA regulations; however, to the extent telepharmacies dispense controlled substances, they are under the purview of the CSA and DEA. DEA is considering promulgating regulations regarding telepharmacy and seeks to be fully informed about the practice, industry, and state regulation of telepharmacy.
- On November 16, 2021, the Centers for Disease Control and Prevention (CDC) issued an interim final rule entitled, Possession, Use, and Transfer of Select Agents and Toxins - Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the HHS list of Select Agents and Toxins. CDC is amending its select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. HHS/CDC intends to regulate this agent and to require the regulated entity to obtain prior approval from CDC to conduct deliberate manipulation of SARSCoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.
- On November 16, 2021, the Department of Labor's Occupational Safety and Health Administration (OSHA) issued an interim final rule entitled, COVID-19 Vaccination and Testing; Emergency Temporary Standard; Ratification of Department's Actions. On November 12, 2021, the Secretary of Labor ratified this interim final rule codifying an emergency temporary standard to protect unvaccinated employees of large employers from the risk of contracting COVID-19.
- On November 17, 2021, the Department of Health and Human Services (HHS), along with the Department of Labor (DOL), Department of the Treasury, and Office of Personnel Management (OPM), issued an interim final rule with request for comments entitled, Prescription Drug and Health Care Spending. The rule implements provisions of the Internal Revenue Code (the Code), the Employee Retirement Income Security Act (ERISA), and the Public Health Service Act (PHS Act), as enacted by the Consolidated Appropriations Act, 2021 (CAA). The provisions are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage. The provisions increase transparency by requiring group health plans and health insurance issuers in the group and individual markets to submit certain information about prescription drugs and health care spending to HHS, DOL, and the Department of the Treasury. The Departments are issuing these interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage. OPM is also issuing interim final rules that require Federal Employees Health Benefits (FEHB) carriers to report information about prescription drugs and health care spending in the same manner as a group health plan or health insurance issuer offering group or individual health insurance coverage.
- On November 17, 2021, CMS issued a final rule entitled, Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States. This final rule will delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing (VBP) arrangement, of the final rule entitled, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements. This final rule will also delay for 9 months the April 1, 2022 effective date of inclusion of the U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended regulatory definitions of "States" and "United States" for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States.
- On November 19, 2021, the Food and Drug Administration (FDA) issued a final order entitled, Effective Date of Requirement for Premarket Approval for Blood Lancets. The final order requires the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.
- On November 19, 2021, FDA issued a final order entitled, Medical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets. The final order reclassifies three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket notification, specifically, single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is designating special controls for these three types of blood lancets based on the determination that general controls only are not sufficient and there is sufficient information to establish special controls to provide a reasonable assurance of their safety and effectiveness. FDA is also reclassifying a fourth type of blood lancet, multiple use blood lancets for multiple patient use, from class I (general controls) exempt from premarket notification into class III (premarket approval).
- On November 19, 2021, FDA issued a final order entitled, Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests. The final order reclassifies certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named "hepatitis C virus (HCV) antibody tests." FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.
- On November 19, 2021, FDA issued a final order entitled, Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests. The final order reclassifies nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named "nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests." FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.
- December 1, 2021: HHS announced a public meeting of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). For this meeting, the committee will discuss and vote on a recommendation pertaining to a proposed update to the 2020 Public Health Service (PHS) Guideline for Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection.
- December 1-2, 2021: CMS announced two public virtual meetings for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set. The meetings will discuss CMS' preliminary coding recommendations for new revisions to the HCPCS Level II code set.
- December 9, 2021: The National Institutes of Health (NIH) announced a public meeting of the Advisory Committee to the Director. The meeting will discuss the NIH Director's Report, an update on COVID-19 science, ACD Working Group updates, and other business of the Committee.
- December 14-15, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). The ACIMM advises the Secretary of Health and Human Services (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.
- December 16, 2021: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting for Software Developers on the Common Formats for Patient Safety Data Collection. AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning.
- December 16, 2021: CDC announced a public meeting of the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). The Board is charged with providing advice and guidance concerning strategies and goals for the programs and research within CPR, monitoring the overall strategic direction and focus of the CPR Divisions and Offices, and administration and oversight of peer review for CPR scientific programs.
- December 20, 2021: NIH announced a public meeting of the Muscular Dystrophy Coordinating Committee (MDCC). The purpose of this meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
- January 21, 2022: NIH announced a public meeting of the National Advisory Council for Complementary and Integrative Health. The meeting will discuss a report from the Director of the Center and other staff, as well as review and evaluate grant applications.
II. Congressional Hearings
U.S. House of Representatives
- On November 17, 2021, the House Committee on Energy & Commerce held a markup of 12 bills. Legislation under consideration included: H.R. 5561, the Early Hearing Detection and Intervention Reauthorization Act; H.R. 5487, the Stillbirth Health Improvement and Education for Autumn Act of 2021" or the "SHINE for Autumn Act of 2021; H.R. 1193, the Cardiovascular Advances in Research and Opportunities Legacy Act; H.R. 1667, the Lorna Breen Health Care Provider Protection Act; H.R. 3320, the Allied Health Workforce Diversity Act of 2021; H.R. 4555, the Oral Health Literacy and Awareness Act of 2021; H.R. 5551, the Improving the Health of Children Act; H.R. 3537, the Accelerating Access to Critical Therapies for ALS Act; H.R. 1218, the Data Mapping to Save Moms' Lives Act; H.R. 2501, the Spectrum Coordination Act; H.R. 5502, the Integrity, Notification, and Fairness in Online Retail Marketplaces for Consumers Act; and H.R. 4594, the Restoring Brand USA Act.
III. Reports, Studies & Analyses
- On November 16, 2021, HHS Office of Inspector General (OIG) published a report entitled, 2021 Top Management & Performance Challenges Facing HHS. The 2021 Top Management and Performance Challenges Facing HHS is an annual publication. In this edition, OIG has identified six top management and performance challenges (TMCs) that HHS faces as it strives to fulfill its mission to enhance the health and well-being of all Americans by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.
- On November 16, 2021, the Government Accountability Office (GAO) published a report entitled, Vaccine Development: Capabilities and Challenges for Addressing Infectious Diseases. This report discusses technologies, approaches, and associated challenges for vaccine (1) research and development, (2) testing, and (3) manufacturing, as well as (4) the economic factors that affect vaccine investment.
- On November 17, 2021, GAO published a report entitled, Medicare: Information on the Transition to Alternative Payment Models by Providers in Rural, Health Professional Shortage, or Underserved Areas. In recent years, CMS has developed and implemented new Medicare payment models, including alternative payment models (APM), in an effort to shift from paying providers based on the volume of care provided to the quality of care provided (value-based payments). One type of APM, Advanced APMs, are designed to encourage providers to share in both the financial rewards and risk of caring for Medicare beneficiaries. GAO's analysis of CMS data found that a smaller percentage of providers eligible to participate in Advanced APMs (eligible providers) in rural or health professional shortage areas (shortage areas) participated in them each year from 2017 through 2019 compared to providers not located in these areas.
- On November 18, 2021, the Congressional Budget Office (CBO) published a cost estimate on the Estimated Budgetary Effects of Title III, Committee on Energy and Commerce, H.R. 5376, the Build Back Better Act. CBO estimates that enacting this title would result in a net increase in the deficit totaling $281.5 billion over the 2022-2031 period. That increase in the deficit would result from an increase in direct spending of $304.4 billion and an increase in revenues of $22.9 billion.
- On November 18, 2021, CBO published a cost estimate on the Estimated Budgetary Effects of Title XIII, Committee on Ways and Means, H.R. 5376, the Build Back Better Act. CBO estimates that enacting this title would result in a net decrease in the unified deficit totaling $797.7 billion over the 2022-2031 period. That decrease in the deficit would result from an increase in direct spending of $411.5 billion and an increase in revenues of $1,209.3 billion.
- On November 18, 2021, the Bipartisan Policy Center (BPC) published a report entitled, Guaranteeing Integrated Care for Dual Eligible Individuals. This report builds upon the BPC's July 2020 report urging integration of Medicare and Medicaid services for all individuals who are eligible for both programs (commonly referred to as dual eligible individuals). In that report, BPC recommended that Congress and HHS provide incentives to states to integrate care for this population, including technical assistance and financial resources. The report also recommended a federal "fallback" program for states that choose not to integrate care.
IV. Other Health Policy News
- On November 15, 2021, CMS announced that CMS' aggressive corrective actions led to an estimated $20.72 billion reduction of Medicare Fee-for-Service (FFS) improper payments over seven years. The 2021 Medicare FFS estimated improper payment rate (claims processed July 1, 2019 to June 30, 2020) is 6.26% ? an historic low. This is the fifth consecutive year the Medicare FFS improper payment rate has been below the 10% threshold for compliance established in the Payment Integrity Information Act of 2019. More information on this announcement can be found here.
- On November 15, 2021, the White House issued an Executive Order on the implementation of the Infrastructure Investment and Jobs Act. In the Executive Order, President Joseph Biden said the Infrastructure Investment and Jobs Act is an investment in U.S. infrastructure and competitiveness. It will help rebuild America's roads, bridges, and rails; expand access to clean drinking water; work to ensure access to high-speed Internet throughout the Nation; tackle the climate crisis; advance environmental justice; and invest in communities. More information can be found here.
- On November 18, 2021, HHS announced that the Biden Administration has secured 10 million treatment courses of Pfizer's promising COVID-19 oral antiviral drug, contingent on emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA). The investigational drug, Paxlovid, is being developed to treat non-hospitalized, symptomatic adults diagnosed with COVID-19 who are at increased risk of progressing to severe illness that could lead to hospitalization or death. The company recently announced the results of a pivotal phase 2/3 clinical trial which found that a treatment course of one dose every 12 hours for five days reduced the rate of hospitalization due to COVID-19 or death by nearly 90 percent in patients treated within three days of symptom onset. Similar results were found when treated within five days of symptom onset. More information on this announcement can be found here.
- On November 18, 2021, HHS, through the Administration for Children and Families (ACF) and Office for Civil Rights (OCR), announced actions to further civil rights and equal opportunity for all people, irrespective of their sexual orientation, gender identity, and religion. HHS through OCR and ACF reestablished its commitment to furthering nondiscrimination and upholding the law by rescinding waivers issued by the prior Administration. More information on this announcement can be found here.
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