A major bill to curb opioid abuse and the Trump administration's blueprint to rein in drug prices highlighted a busy year in the legislative and regulatory arena for the Academy of Managed Care Pharmacy.
When President Donald Trump signs H.R.6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, the new law will fold in several priorities that the Academy of Managed Care Pharmacy (AMCP) had long pursued to rein in the opioid crisis, according to a pair of government affairs experts who addressed the AMCP Nexus 2018 meeting in Orlando, Florida.
Mary Jo Carden, RPh, JD, vice president of Government and Pharmacy Affairs for AMCP, said 2018 has been a busy year—from closing the Medicare Part D “donut hole” to reacting to the Trump administration blueprint to lower drug prices. Elisabeth Brisley, BS, MPH, AMCP’s legislative analyst, explained that the SUPPORT Act merged more than 70 bipartisan elements, including items that AMCP had long supported:
Brisley explained that AMCP had sought measures that would align patient disclosure rules so that records could be shared for treatment purposes, but this was not included in the final bill. It may be revisited in the lame duck session after the election, she said. Senator Joe Manchin, D-West Virginia, is working on a measure that would ensure a patient’s medical history is available in appropriate circumstances—based on a case from his state in which a young woman recovering from addiction was prescribed opioids and died, because her doctor did not have access to her medical history.
A Busy Lame Duck Session
If Republicans lose control of the House, Brisley said there could be a push to finish several items affecting the pharmaceutical sector, including the CREATES Act, which would promote the generic and biosimilar industry by creating a cause of civil action if drug makers refuse to provide samples. A different bill, the Fair Access for Safe and Timely Generics Act (FAST) offers a regulatory solution to the same problem, she said.
Brisley did not see much chance that bills calling for drug importation or Medicare for All would succeed, given opposition to these ideas, and their cost.
Carden discussed efforts to promote H.R. 2026, the Pharmaceutical Information Exchange Act of 2018, which would codify current efforts contained in an FDA guidance and allow healthcare economic and scientific information to be shared between drug makers and payers prior to approval. “Without that, if you don’t have the teeth, another administration can withdraw it,” Carden said. “If you put teeth into it with a law, you have more assurances.”
However, Carden said it’s important to watch for efforts to reverse progress on closing the Medicare “donut” hole, which the pharmaceutical industry attempted with the opioid bill.
The Blueprint to Lower Drug Prices
Carden praised some of the immediate steps taken—including steps to experiment with value-based purchasing, to promote biosimilars, and to end manufacturer “gaming” of the Risk Evaluation and Managements System or REMS program to avoid sharing samples with generic manufacturers.
But other elements will prove more controversial—particularly, proposals to shift coverage and payment from Medicare Part B to Part D. Carden said AMCP’s recommendation is to permit utilization management in Part B but to reconsider the impact of letting Part B drugs be negotiated by Part D plans. AMCP also supports the CMS provision to let health plans use step therapy in Medicare Part B, although this is opposed by oncologists’ groups, and it has been difficult to find out which plans are pursuing it for 2019.
What’s next? Carden expects to hear more about the following:
Carden noted that Congress must ratify the new trade agreement with Canada and Mexico, which extends protections for drug data to the 10-year mark. Several experts believe this will harm the biosimilars industry just as it is gaining stem, and Carden said AMCP opposes this provision.
The other front for biosimilars is at the state level, she said. “Most states do not recognize interchangeable products,” Carden said. “This does impact the availability and willingness to use them.”