WASHINGTON — As legislation to address the opioid epidemic gains momentum, drug makers, insurers, and other interest groups are engaging in a concerted drive to tailor the bills to their liking.
The effort, in some cases, has resulted in lawmakers softening, or entirely backing off, some of their most far-reaching proposals.
Members of Congress have advanced dozens of bipartisan bills that advocates say are needed, commonsense steps to address the public health crisis. Later this month, the House is likely to consider legislation that would speed approvals for non-opioid painkillers, strengthen drug enforcement programs, improve care for children impacted by addiction, strive to reduce prescription levels, and improve prescription monitoring programs.
But not all of the proposals have gone unopposed. The pharmaceutical trade group PhRMA, the American Medical Association, and a major drug distributor are among a handful of players maneuvering to shape the legislation, according to a review of lobbying disclosures by STAT and interviews with Capitol Hill aides, lawmakers, and lobbyists.
“This is the big time, and the price of working on major legislation is that insurance companies and pharmaceutical companies get involved,” said Andrew Kessler, a longtime advocate on addiction treatment issues who represents a number of behavioral health associations and treatment providers. “We’ve got work to do, they’ve got work to do, and let’s hope we’re better than they are.”
The push from Congress comes after a year of the White House and Congress promising action to address the crisis. And any legislation will almost certainly mean a surge in funding to health care providers and others, ensuring the bills are high on the radars of drug makers, drug distributors, insurers, and physician groups.
In four cases, outlined below, the ambitions of some lawmakers to staunch the opioid crisis may be colliding with the reality of other interests on Capitol Hill.
Widening access to addiction treatment
One of the most contentious issues is how far Congress should go in expanding access to any particular addiction treatment, resurfacing concerns that lawmakers could be playing favorites.
One of the treatments backed by the strongest scientific evidence involves the drug buprenorphine. Under the law, doctors must be licensed to prescribe it and face a cap on how many patients they can treat to ensure that it is used safely. (The medication itself can be addictive.)
A bill sponsored by Rep. Paul Tonko (D-N.Y.) would increase those caps and allow nurse practitioners and physician assistants to continue to prescribe the drug. But the proposal has languished in the House Energy and Commerce Committee, which has assembled an opioids package that the House is expected to consider soon.
It is one of few proposals with bipartisan support to be left out so far.
“Every single American public health expert who has spoken out and testified on this issue has said we need broader access to buprenorphine to address the opioid epidemic,” Tonko said. “We introduced a bipartisan bill to solve that problem, but we seem to be hitting roadblocks every step of the way. Each organization that has spoken out against our bill has a stake in preserving the status quo.”
According to federal disclosures, representatives of PhRMA and the drug maker GlaxoSmithKline (GSK) lobbied on the Tonko proposal. PhRMA told STAT it had not taken a position on the legislation. A spokeswoman for GSK said the company had likely been asked for input by a congressional office, meaning it was required to list the bill in its disclosures.
Democratic aides and some lobbyists said in interviews that they were also concerned about the influence of Alkermes, a drug company that manufactures Vivitrol, a non-opioid treatment widely seen as an alternative to buprenorphine.
The day after Tonko’s bill was defeated, the congressman’s office received an unsolicited call from Alkermes staff asserting that the company had not been responsible for killing the proposal, according to his office. Indeed, an Alkermes spokeswoman said the company had not lobbied on Tonko’s bill, and its lobbying disclosures make no specific mention of it.
But negotiations on the bill had been delegated to Rep. Larry Bucshon (R-Ind.), who has received more in campaign contributions from Alkermes in the current cycle than any other lawmaker: $8,000 for a House race that is not seen as competitive. While the company has contributed in small increments to other members, large contributions have also gone to the committee’s chairman, vice chairman, and former chairman.
Alkermes employs two lobbyists who previously worked for key committee members. Bucshon also authored a bill in 2015 that would have placed new requirements on physicians wishing to prescribe buprenorpine.
A Bucshon spokesman brushed aside the concerns about the campaign contributions, saying the congressman’s opposition to the bill stemmed entirely from concerns about “adequate training” for those licensed to prescribe the drug.
The Alkermes spokeswoman, Jennifer Snyder, said in an email that “impliedly or expressly connecting Congressman Bucshon’s actions on this particular bill to Alkermes — based on Alkermes’ historical campaign contributions — is not factually accurate and is misleading,” and that the company is one of many to have contributed to Bucshon’s campaigns.
Asked about Tonko’s proposal, GOP committee aides pointed to the Drug Enforcement Administration as a reason the bill had not advanced. The DEA had initially opposed the Tonko legislation because of concerns that wider access to buprenorphine increased the risk it could be used illicitly.
The agency rescinded its opposition last week, according to multiple House offices.
Expanding DEA authority
In the Senate, the drug distributor AmerisourceBergen (ABC) has waded into a debate about whether expanding the DEA’s authority would help interdict some suspicious drug shipments and ultimately help curb the opioid crisis.
A 2016 law had set a new threshold for the DEA before it could freeze drug shipments, mandating that the agency must demonstrate that a company’s actions represent “a substantial likelihood of an immediate threat.”
When the Washington Post and “60 Minutes” revisited the history of the legislation last year, and highlighted that it was authored by Rep. Tom Marino (R-Pa.), at the time President Trump’s nominee to be his drug czar, it set off a political firestorm in Washington. Marino withdrew from consideration, and lawmakers, mostly Democrats, quickly called for the law to be repealed.
Still, Sen. Claire McCaskill (D-Mo.), who introduced a bill last year to restore much of the agency’s discretion on suspicious shipments, has been unable to secure a Republican cosponsor.
In an interview, McCaskill said “pharma is working its magic” to prevent her bill from receiving a co-sponsor or a vote.
AmerisourceBergen, one of the country’s “Big Three” drug distributors, has lobbied on McCaskill’s bill in each of the last two quarters, according to lobbying disclosures.
The company denied directly opposing the bill, but any expanded authority for the DEA could increase the likelihood that drug distributors face increased scrutiny for drug shipments seen as suspicious.
“To the extent it can be proven there were any unintended consequences of the legislation, including lessened enforcement authority by DEA, we support parts of the law being re-evaluated,” the company said in a statement, emphasizing it supported the DEA taking “more steps — not fewer” to regulate opioids.
“The idea they came to the Hill in order to lobby offices in support of our legislation seems like a stretch,” said Drew Pusateri, a top aide to McCaskill on the Senate Homeland Security and Governmental Affairs Committee.
Several House Republicans have signed onto a bill to repeal the 2016 provisions, but it was not included in a broader package of bills that recently cleared the Energy and Commerce Committee, and McCaskill’s bill is not expected to receive a floor vote this year.
Limiting first-time opioid prescriptions
As drug makers and insurers have worked behind the scenes on the opioids legislation, physician groups — most notably, the American Medical Association — have forcefully pushed back on proposals to limit first-time opioid prescriptions to three days.
The Centers for Disease Control and Prevention, in updated prescribing guidelines issued in 2016, said that three days or less of opioid treatment “will often be sufficient” and that “more than seven days will rarely be needed.” Addiction experts have also sought to curb the prescription of opioids.
But doctors groups have largely argued that any attempt by Congress to restrict opioids patients would represent an unwelcome intervention by the government in patient-doctor relationships and could deprive patients of medication they legitimately need.
“The CDC guidelines are voluntary and do not include a hard limit,” Dr. Patrice Harris, who chairs the AMA’s Opioid Task Force, said in a statement. “They were intentionally drafted with flexibility, and they were not intended to be codified. Congressional efforts to codify a strict limit on prescribing opioids are inconsistent with both the language and spirit of the guidelines.”
A PhRMA spokeswoman told STAT that the organization had not taken a position on the legislation proposing the stricter cap. The organization’s CEO, Stephen Ubl, endorsed seven-day limits on first-time prescriptions when testifying before a White House commission in 2017.
Providing mental health treatment
Experts have stressed the importance of providing treatment to those struggling with mental health and addiction, and advocates are hoping to bolster laws that enforce “mental health parity” — provisions that require insurers to offer mental health benefits on par with other benefits.
Labor Secretary Alex Acosta had previously expressed support for a proposal that would allow the department to fine insurers out of compliance with those laws — a proposal endorsed last year by the White House opioids commission.
“The Secretary of Labor testified he needs the ability to fine violators and to individually investigate insurers not just employers,” the panel wrote. “We agree with Secretary Acosta.”
Such efforts, however, have been aggressively opposed by the insurance lobby, which is fearful of broad federal authority being conferred to impose fines on specific insurers or plans.
According to lobbyists and numerous Senate aides, Sens. Bill Cassidy (R-La.) and Chris Murphy (D-Conn.) had prepared legislation that would allow the Labor Department to fine insurers found to not be compliant with federal parity law. No such legislation has been unveiled, however, and the proposal fell short when Murphy introduced it as an amendment at a recent hearing.
A Cassidy spokesman forcefully pushed back on the suggestion that Cassidy had abandoned his support for the proposal, citing late-arriving guidance from the Labor Department and saying the senator remains open to the idea.
But Senate aides and multiple outside consultants who closely monitored or helped draft the policy said that at one point Murphy and Cassidy had planned to introduce a bill. And while Murphy stuck with his proposal in spite of aggressive insurer lobbying, they said, the proposal effectively died when they lost Cassidy’s support and GOP support with it.
America’s Health Insurance Plans, which represents insurers including Anthem (ANTM), Blue Cross Blue Shield presences in several states, Cigna (CI), and Kaiser Permanente, did not respond to request for comment on whether it had lobbied against the proposal.
A policy staffer for the ERISA Industry Committee (ERIC), which represents large employers on insurance policy, said the Labor Department had been unable to articulate why the ability to impose fines would prove helpful in enforcing parity law. Capitol Hill offices, he said, had also demonstrated a poor grasp of which mental health coverage gaps qualified as parity violations.