Tag Archives: guidance

CMS Issues New Guidance for States to Address Social Determinants of Health

Before discussing the new Medicaid guidance on social determinants of health, Medicaid and the Law would like to formally introduce its readers to Regina DeSantis, a new Law Clerk in the Washington, DC office who will become a regular contributor to the blog.

The social determinants of health (SDOH) describe the range of environmental, social, and economic factors that can impact health outcomes.  According to the Centers for Disease Control and Prevention (CDC),… More

CMS Weighs in on FDA Importation Rule

 On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from Canada, and a Final Guidance describing procedures to allow manufacturers to obtain National Drug Codes (NDC) for FDA-approved drugs originally intended to be marketed in a foreign country ( referred to as “multi-market approved products” or “MMA products”).… More

CMS Releases Block Grant Guidance: Answers to your FAQs

On January 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its long awaited and highly anticipated State Medicaid Director Letter (SMD Letter) announcing the “Healthy Adult Opportunity” (HAO) initiative that will allow states to carry out demonstrations to implement either an aggregate or per-capita cap financing model for certain Medicaid populations.  We’ve previously previewed and highlighted some of the key expectations for this long-awaited guidance.… More

CMS enters the Hepatitis C drug pricing debate

Although outpatient prescription drugs are not a mandatory benefit under the Medicaid program, all 50 states do provide at least some coverage for prescription drugs.  Manufacturers that want their drugs covered under Medicaid must agree to pay rebates to the Medicaid program (for brand name drugs, rebates must equal at least 23.1% of the average manufacturers price of the drug); must agree to participate in the 340B program; and must agree to provide federal supply schedule pricing to federal government agencies.… More