Category: Healthcare

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 […]

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As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that the PAP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 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The Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04) on November 28, 2017, retroactive to its original issuance date of April 20, 2006.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 […]

White House Declares Opioid “Public Health Emergency” However, Many Questions Remain

Last week, the White House declared the opioid crisis a “public health emergency.” The declaration outlined a number of steps the Administration will take to address the epidemic. The public health emergency declaration, while acknowledging the scope and tragic costs of opioid abuse, falls short of a “national emergency” declaration […]

With Congress stuck, Administration starts process of unwinding ACA – Updated

Last week, the Administration took two actions aimed at rattling the foundations of the Affordable Care Act (ACA).  The President signed an Executive Order (EO) directing federal agencies to relax restrictions on insurance plans that do not have to comply with certain ACA rules.  The Administration followed that with an announcement […]

CMS Withdraws Part B Demo Rule…for good

Earlier today, the Centers for Medicaid Services (CMS) released a notice withdrawing the “Medicare Program; Part B Drug Payment Model”, also known as the “Part B Demo.”  As we discussed in a previous post, in December 2016, the Obama Administration announced it would not move forward with the program.  This, coupled with […]