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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 Even long-standing rules would be automatically rescinded unless they survive a complex process of assessment and review.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…
- December 21, 2018
Comments Urging HIV Prevention Drug be Designated an ACA “A” Recommended Service
Read morePeople who are at risk for HIV can prevent infection by taking a daily medication - Pre Exposure Prophylaxis (PrEP). However, many cannot access PrEP due to its high cost. The Affordable Care Act (ACA) recognizes that even small investments in preventive screenings and services can yield significant 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…
- December 1, 2016
Fact Sheet: Utilization Controls for Medicaid Prescription Drugs
Read moreState Medicaid programs that elect to provide outpatient prescription drug coverage must cover all FDA-approved drugs that are offered by a manufacturer that agrees to provide rebates. Nevertheless, states have substantial discretion to use utilization control techniques to steer Medicaid beneficiaries toward or away from certain drugs, within limits.…
