Opioids

FDA and Customs and Border Protection (CBP) signed an agreement Thursday (April 4) to expand how information is shared between the two agencies and coordinate shared space to target entry of illicit drugs coming into the country through international mail facilities (IMFs).

CMS on Monday (April 1) finalized its call for Medicare Advantage and Part D plans to do more to reduce opioid dependence among beneficiaries and expand access to naloxone, the opioid overdose reversal drug, by reducing beneficiaries’ costs through new tiering policies, among other possible actions.

New York state has filed a lawsuit against opioid makers and distributors and the Sackler family, which founded Purdue Pharma and developed OxyContin, for false and deceptive marketing of opioids that the state alleges helped spur the opioid epidemic, New York Attorney General Letitia James announced Thursday (March 28).

A prominent consumer advocacy group and an FDA advisory committee chair are calling for FDA drug center chef Janet Woodcock to step down from her post in order to clear a path for the agency to revamp its regulation of opioids and implement recommendations made in 2017 by the National Academies of Sciences, Engineering, and Medicine.

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.

Specialists in the fields of addiction and mental health urged Congress on Wednesday (March 6) to give more federal money to providers on the front lines of the opioid crisis -- including by funding several programs that were authorized in last year’s major opioid bill.

Bipartisan duo Reps. Markwayne Mullin (R-OK) and Earl Blumenauer (D-OR) plan to introduce legislation that would align the strict privacy scheme for substance abuse treatment records, 42 CFR Part 2, with the less stringent Health Insurance Portability and Accountability Act (HIPAA) sometime in March, spokespersons for their offices told Inside Health Policy Wednesday (Feb. 27).

HHS Secretary Alex Azar highlighted the administration’s efforts to lower drug prices at the top of his State of the Department speech Friday (Feb. 22), though his half-hour presentation covered a broad range of initiatives and accomplishments.

Physician and hospital groups called for aligning the strict privacy scheme that requires explicit patient consent to share substance abuse treatment records with the more lax Health Insurance Portability and Accountability Act (HIPAA) standards, as well as for fewer regulations, in response to the HHS Office of Civil Rights’ (OCR) request for feedback on how HIPAA might be getting in the way of value-based care.