WASHINGTON — The latest version of a bill to address the opioid crisis will not include an unrelated, drug industry-backed provision that would relieve drug companies of some of their responsibility for certain Medicare drug costs, multiple lobbyists with knowledge of the bill told STAT.
The bill also will not include any version of the CREATES Act, a long-stalled bill to incentivize the production of cheaper generic and biosimilar drugs.
The opioids legislation, which both the House and Senate have identified as a priority throughout the past year, has been beset by a number of controversies as it has moved through Congress. As lobbyists — especially for drug makers — have come to view it as the final piece of major legislation Congress will consider before November, they have intensified their attempts to attach unrelated or controversial provisions.
The House and Senate are currently working to reconcile separate versions passed by each chamber, before sending them to President Trump’s desk.
The central ask for the industry group PhRMA is a change to the prescription drug coverage gap for Medicare beneficiaries, known as the “donut hole.” Currently, drug makers will have to pay 70 percent of the costs of that coverage beginning in 2019. They had pushed Congress to reduce that number by at least several percentage points.
Lobbyists on both sides of the debate tell STAT that PhRMA will likely need to wait until after the midterm elections to try again to get the change enacted.
Two advocates who oppose the change nevertheless speculated Monday that PhRMA could attempt to pass the Part D provision in a bill separate from the opioids package, using a process typically reserved for uncontroversial items. That process would require some Democratic support in the House and unanimous support in the Senate, making its chances of success slim.
One lobbyist said it was unlikely Republicans would attempt the maneuver — but doing so could give House Speaker Paul Ryan (R-Wis.) cover to tell PhRMA he had tried his best to change standing law back to their liking.
The pharmaceutical lobby’s failure to reverse a setback suffered in February is sure to anger the manufacturers who pay exorbitant membership fees to trade associations including PhRMA and the Biotechnology Innovation Organization.
The negotiations, however, lit fire under the House Energy and Commerce and Judiciary Committees to hash out a version of the CREATES Act that would be acceptable to both committees. The bill would allow generic drug companies to sue their brand competitors when they’re allegedly blocking generics from coming to market.
One lobbyist said as many as eight versions of the bill were hashed out in recent days, and that stakeholders previously opposed to the bill were forced to admit that some of their objections weren’t defensible.
Lawmakers are still negotiating several other unresolved issues in the legislation with a more direct link to the opioid crisis.
One controversial proposal would relax privacy standards for patients with a history of addiction, a provision the lobbyists said will not be included in the final bill — at least as it appeared in a separate bill passed by the House.
STAT reported last week that the American Medical Association had weighed in to forcefully oppose the House’s measure, though major health insurers, the American Hospital Association, and numerous addiction treatment groups had supported it.
Another unresolved issue is that of the IMD exclusion, which prevents Medicaid programs from reimbursing inpatient mental health treatment providers with more than 16 beds, which many advocates have long cited as a bottleneck to treatment.
The House passed a partial repeal of the exclusion, while the Senate — despite the advocacy of Sen. Rob Portman (R-Ohio) — did not. The change would authorize billions in new annual Medicaid spending and is among the costliest items in the opioids legislation.
A separate provision in the Senate’s bill, which authorizes a new Department of Justice grant program, alarmed Democrats when it was found that the legislative language was written so narrowly that just a single group would be eligible for the funding: the controversial Addiction Policy Forum.
While that language was included in the Senate bill that passed 99-1 last week, lawmakers have tentatively agreed to broaden the provision in a final version of the bill so that additional groups are eligible to apply for the grants.