Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals directed at lowering the cost of prescription drugs. These proposals are presented across the Budget volumes that reflect the Administration’s policy and fiscal priorities. Since many of these proposals require  Congressional […]

Nevada Issues Regulations and Guidance Related to Pharmaceutical Manufacturer Transparency Reporting Requirements

The Nevada Department of Health and Human Services (Department) recently released draft regulations implementing SB 539, which was signed into law in June 2017. The regulations require drug manufacturers and pharmacy benefits managers to submit a report in the format listed on the Department website by April 1st for the […]

New Jersey Adopts Regulations Targeting Gifts and Payments from Pharmaceutical Manufacturers to Prescribers

Regulations adopted by the New Jersey Attorney General Division of Consumer Affairs titled LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS became effective last week. These Regulations provide the rules under which prescribers may receive anything of value from pharmaceutical and biologics manufacturers. ‘Prescribers’ is defined […]

OIG Permits Drug Companies To Provide Free Medications in Limited Circumstances to Patients for 2018 Following Advisory Opinion Rescission

As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that the PAP failed to fully, completely and accurately disclose all relevant and material facts to the OIG and failed […]

FDA Releases Digital Health Guidance to Spur Innovation

On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the regulatory requirements for digital health technologies.  By clarifying what is – and what is not – subject to regulation, this set of guidance could create significant opportunities for […]

OIG Releases December Work Plan Items; Focus on Opioid Prescribing Continues

As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The December updates include 6 new Work Plan items: Status Update on States’ Efforts on Medicaid-Provider Enrollment. OIG will follow-up on a previous review to determine the extent to […]

OIG Revokes Patient Assistance Program Advisory Opinion Protection

The Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04) on November 28, 2017, retroactive to its original issuance date of April 20, 2006. Opinion 06-04 had been modified by the OIG on December 23, 2015. Issued to a nonprofit, tax-exempt, charitable patient assistance program that provides aid […]