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- December 6, 2021
Q&A: State Contraceptive Equity Laws
Read moreThe Affordable Care Act (ACA) requires most health insurance plans to provide coverage for a broad range of women’s preventive health services without cost-sharing, including all Food and Drug Administration (FDA)-approved methods of contraception. While this requirement is a welcome and significant step forward, gaps in comprehensive coverage remain,…
- December 3, 2020
NHeLP Comments on HHS Regulations Rule (aka SUNSET Rule)
Read moreIn the Regulations Rule, HHS seeks to retroactively impose a mandatory expiration date on an estimated 18,000 duly promulgated regulations. Even long-standing rules would be automatically rescinded unless they survive a complex process of assessment and review. Programs like Medicaid and the Children's Health Insurance Program (CHIP) could be…
- September 17, 2020
NHeLP comments on Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”)
Read moreThe Orange Book is an important and informative drug resource for a range of stakeholders. In a request for comments, FDA seeks feedback on the types of people or entitles using the Orange Book, additional information and features to incorporate into the Orange Book, and therapeutic equivalence information. NHeLP…
- July 20, 2020
NHeLP comments on Medicaid Prescrption Drug Rebate Program and Value- based Purchasing Proposed Rulemaking
Read moreIn a proposed rule, CMS seeks to expand value-based purchasing arrangements for prescription drugs in commercial plans and the Medicaid program. However, the proposed changes offer a cost-containment strategy with no safeguards to ensure that Medicaid enrollees can continue to access needed outpatient prescription drugs. NHeLP comments warn against“cost…
- December 4, 2019
Coverage of Over-the-Counter Drugs in Medicaid (Revised February 2022)
Read moreDrug coverage is an important facet of the Medicaid program. Although it is an optional benefit, all states cover outpatient prescription drugs in their Medicaid programs. States have significantly more leeway, however, in whether they cover over-the-counter (OTC) drugs. This Fact Sheet provides an overview of Medicaid rules for…
- April 8, 2019
National Health Law Program Comments on HHS Safe Harbor Rule for Outpatient Prescription Drugs
Read moreThe U.S. Department of Health and Human Services (HHS) proposed new regulations that would remove safe harbor protections for prescription drug rebates. Currently, rebates paid by manufacturers to Medicare Part D plans and Medicaid managed care organizations (MCOs), including pharmacy benefit managers (PBMs) are shielded from federal anti-kickback laws.…