Alston & Bird’s Week in Review 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.
I. Regulations, Notices, & Guidance
- October 9, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Product-Specific Guidances. The FDA is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications.
- On October 10, 2018, the Department of Health and Human Services (HHS) issued a final rule entitled, Annual Civil Monetary Penalties Inflation Adjustment. HHS is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvement s Act of 2015.
- On October 12, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; CY 2019 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) 2019 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2019, the inpatient hospital deductible will be $1,364. The daily coinsurance amounts for CY 2019 will be: $341 for the 61st through 90th day of hospitalization in a benefit period; $682 for lifetime reserve days; and $170.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
- On October 12, 2018, CMS issued a notice entitled, Medicare Program; CY 2019 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. This annual notice announces Medicare’s Part A premium for uninsured enrollees in CY 2019. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2019 for these individuals will be $437. The premium for certain other individuals as described in this notice will be $240.
- On October 12, 2018, CMS issued a notice entitled, Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2019. 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, 2019. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2019, 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 2019 are $264.90 for aged enrollees and $315.40 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2019 is $135.50, 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 2018 standard premium rate was $134.00, which also included the $3.00 repayment amount.) The Part B deductible for 2019 is $185.00 for all Part B beneficiaries. 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.
- October 27, 2018: The FDA announced a public meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general functions of the committees is to provide advice and recommendations to the FDA on regulatory issues.
- November 5, 2018: The FDA announced a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in the above notice and associated web content that will be published before the hearing.
- November 7, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The CLIAC will hear updates from other agencies on a range of laboratory-related issues, including laboratory interoperability.
- November 8, 2018: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will hear an overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review.
- November 27, 2018: The FDA announced a public meeting entitled, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. The purpose of the hearing is to give stakeholders the opportunity to provide input on the underlying systemic causes of drug shortages and make recommendations for actions to prevent or mitigate drug shortages.
II. Congressional Legislation & Committee Action
- There were no health-related hearings this week.
House of Representatives
- There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On October 8, 2018, the University of Pennsylvania’s Leonard Davis Institute of Health Economics released a study entitled, Medicaid Expansion and the Opioid Epidemic. The study analyzed trends in drug overdose deaths in three states (Arizona, Maine, and New York) that expanded Medicaid before the Affordable Care Act. The study found that rates of drug overdose deaths rose less sharply in the expansion states than in all non-expansion states. The study is available here.
IV. Other Health Policy News
- On October 10, 2018, the Department of Justice (DOJ) announced its conditional approval of the Aetna-CVS merger. The DOJ said it is requiring CVS and Aetna to divest Aetna’s Medicare Part D prescription drug plan business in order to proceed with the $69 billion merger. Additional information on DOJ’s announcement is available here.