Health care remains a hot political issue, and it was ranked the top concern among voters in the 2018 midterm elections. With a new Congress in place, a number of new health care-related bills could be signed into law. During a presentation at the AMCP Annual Meeting, Mary Jo Carden, RPh, JD, vice president of government and pharmacy affairs, and Elisabeth Brisley, MPH, legislative analyst of government affairs, both of AMCP, provided a look back at recent health care legislation and offered a view of what is projected to come.
Congress passed some key health care legislature in 2018, including closure of Medicare Part D donut holes, including for biologics and biosimilars; opioid legislation; and legislation to eliminate “gag clauses” that do not allow communication on medication costs at the point of sale. The Congressional agenda for this year may include drug pricing, Medicare for All and revision of the Affordable Care Act; promotion of market competition for generics and biosimilars; anti-kickback statute and Stark law reforms; and a proposed bill to allow access to medical records for patients with substance use disorder.
The previous Congress approved the following bills:
- Right to Try Act, which provides certain unapproved, investigational drugs to terminally ill patients who have exhausted approved treatment options and are unable to participate in a clinical trial for the investigational treatment.
- Prohibitions on Gag Clauses by Pharmacy Benefit Managers and Health Plans, which prohibits Medicare Advantage, Medicare Part D plans, and private insurers from blocking or penalizing a pharmacy or pharmacist from informing an enrollee of the differential in out-of-pocket costs and paying for a drug without using insurance.
- The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which requires programs to have safety edits in place for opioid refills, monitor concurrent prescribing of opioids and certain other drugs, and monitor antipsychotic prescribing in children. It also clarifies states’ ability to access and share opioid data from prescription drug monitoring programs. This provision requires Schedule II, III, IV, or V controlled substances covered under Part D or Medicare Advantage Drug Plans to be transmitted using an electronic prescription drug program starting January 1, 2021.
Legislation that did not pass in 2018, but may be approved with the new Congress, includes:
- Overdose Prevention and Patient Safety Act, which would make substance use disorder patient records subject to HIPAA. This would allow disclosure for treatment, operations, and payment without additional consent and provide protections against the use of these records in criminal and administrative proceedings.
- Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), which would encourage competition in the market for biological products by facilitating the entry of lower-cost generic and biosimilar versions.
- Pharmacy and Medically Underserved Areas Enhancement Act, which would add pharmacist services to Medicare Part B where authorized by state law and provided in a health professional shortage area, medically underserved area, or to a medically underserved population.
Other drug policy legislation that may come to light this year includes Medicare drug price negotiation, the promotion of products for which no competition exists in the market, a set International Price Index, and the ability to import drugs.
Presentation L1: Federal and State Legislative and Regulatory Update. AMCP Annual Meeting 2019.