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- 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 Even long-standing rules would be automatically rescinded unless they survive a complex process of assessment and review.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 18, 2018
Amicus Brief in Support of Maryland’s Anti-Price Gouging Law for Prescription Drugs
Read moreThe National Health Law Program filed an amicus brief with the United States Supreme Court asking it to review a 4th Circuit decision that struck down Maryland's anti-price gouging law for prescription drugs as unconstitutional. The brief focuses on the impact of high drug costs on low-income people and…
- December 14, 2018
Comments to the FDA Urging Approval of Over the Counter Naloxone
Read moreThe National Health Law Program strongly urges the Food and Drug Administration (FDA) to initiate the process of moving at least one naloxone product from prescription to over the counter (OTC) status. Naloxone, a safe and effective medication, reverses opioid overdose if given in time, but is often not…
