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Special Opioid Report

Administration's Delays In Implementing Major Opioid Law Hinder Efforts To Curb Crisis

SPECIAL REPORT

Administration's Delays In Implementing Major Opioid Law Hinder Efforts To Curb Crisis

BY: JAMES ROMOSER

February 24, 2020

Each day, an average of 130 Americans die from an opioid overdose. In the fall of 2018, amid bipartisan fanfare, Congress passed the SUPPORT for Patients and Communities Act, a wide-ranging law that aimed to give federal and state officials new tools to combat the epidemic of opioid dependence and other drug addictions. The following Inside Health Policy Special Report examines the implementation of the SUPPORT Act and finds that HHS and CMS have fallen behind in fulfilling many of the law’s requirements.

Sixteen months after Congress passed a landmark bipartisan law that was meant to reinvigorate the government’s response to the nation’s addiction crisis, the federal health agencies charged with administering much of the law have failed to comply with many of its statutory deadlines, hamstringing the ability of states, clinicians and policymakers to fight the epidemic in new ways, an Inside Health Policy investigation shows.

Some health policy experts see the pattern of delays at HHS and CMS as emblematic of an administration-wide failure to prioritize a crisis that, since 1999, has led to more than 770,000 deaths from opioid dependence and other drug overdoses.

The delays are slowing the development of dozens of new programs and government recommendations envisioned by the 2018 law known as the SUPPORT Act. One missed deadline is preventing state Medicaid programs from helping incarcerated individuals with substance use disorders safely re-enter their communities. Another protracted delay has left the federal government without a key coordinating committee -- a gap that experts say is exacerbating the government’s fragmented and sometimes contradictory response to the crisis.

Officials at HHS and CMS say they are using all available tools to fight the epidemic, and they attribute the missed deadlines to limited resources. Congress, meanwhile, has not conducted vigorous oversight of the agencies’ delays.

Critics of the administration believe the addiction crisis has taken a backseat to other, more contentious elements of President Donald Trump’s health policy agenda, such as undoing the Affordable Care Act and bringing work requirements and block grants into Medicaid.

“President Trump certainly has given the opioid crisis lip service, campaigned on it, and even designated it a national emergency,” said Andrew Kolodny, the co-director of opioid policy research at Brandeis University. “But the rhetoric has never really been matched with any kind of appropriate action or a clear plan from the administration on how to address the crisis.”

Congress said it was providing the outline of such a plan when it passed the SUPPORT for Patients and Communities Act, a 250-page bundle of mostly bipartisan bills that was arguably the signature legislative achievement of the 2017-2018 Congress. It is the nation’s primary law targeted at drug-related overdoses -- or, in the words of HHS Secretary Alex Azar, “the single largest legislative package to address a single drug crisis in history.”

The SUPPORT Act, which Trump signed into law on Oct. 24, 2018, set various new policies in Medicare and Medicaid and directed HHS and its constituent agencies to undertake an array of regulatory and subregulatory actions. Most of those actions have deadlines attached.

The agencies implemented some of the new provisions on time. For instance, at the start of this year, Medicare for the first time began paying for treatment programs that prescribe methadone to patients with opioid use disorder, as required by the SUPPORT Act. In Medicaid, CMS instructed states and managed care plans last summer on the law’s new requirements for stricter monitoring of opioid prescriptions. CMS also complied with a requirement in the law to publish, within a year of the law’s enactment, the first nationwide report on substance use disorders using Medicaid claims data.

But numerous other provisions of the SUPPORT Act are proceeding at a glacial pace. Guidance documents to states, hospitals and other stakeholders are unsent. Grant money for educating medical providers is unspent. Mandatory reports to Congress are stalled. Panels of experts are behind schedule -- or are not meeting at all.

The response from lawmakers has been mixed. Members of both parties told Inside Health Policy that the administration should be doing more, but Congress has not held hearings to investigate whether HHS and CMS are meeting the law’s requirements, nor has it followed up with any other major opioid-related legislation since 2018.

“The reason we wrote the law the way we did was that’s how we thought it would work best. It’s up to the agency to implement it correctly,” said Rep. Michael Burgess (TX), the ranking Republican on the House Energy & Commerce health subcommittee. He added he is concerned by the implementation delays and supports more congressional oversight of the issue.

Holdups in executing major legislation are not uncommon. In all administrations, the day-to-day work of the bureaucracy -- writing reports, issuing guidance, convening task forces -- is complex and often takes longer than planned, or longer than Congress might wish.

“They’re not the first administration to miss congressionally mandated deadlines on things,” Jocelyn Guyer, a managing director at Manatt Health, said. “I think the difference here is that the epidemic is so pressing, and it is at such a crisis point.”

Guyer and other experts emphasized that the crisis remains urgent even in light of new data from the Centers for Disease Control and Prevention showing a 4% decline in fatal drug overdoses in 2018 and a concomitant uptick in life expectancy. The decrease in overdose deaths was the first time in 28 years that overdose deaths fell -- a fact Trump highlighted in his recent State of the Union address as he touted an “unyielding commitment” to ending the crisis.

The welcome decline in overall overdoses is largely the result of years of efforts to limit opioid prescriptions, which have been falling since 2012, experts say. The new CDC data, however, also show a concerning trend in the opposite direction. Deaths tied to illicit fentanyl and other synthetic opioids rose 10% in 2018, and deaths involving methamphetamine and other drugs in its class rose 22%. Those increases have some experts worried that the nation’s addiction crisis, rather than abating, may be entering a new wave.

“The current administration and Congress shouldn’t just think, ‘The SUPPORT Act passed. We can wash our hands and move to the next issue,’” said Anand Parekh, the chief medical adviser at the Bipartisan Policy Center. “This challenge is going to stay with us for some time.”


Delayed Medicaid Guidance

CMS has failed to issue six required guidance documents related to Medicaid’s treatment and prevention of substance use disorders.

Most stakeholders agree the single most important program in fighting substance use disorders is Medicaid, which pays for more addiction treatment than any other public or private insurer. In 2017, for instance, 54% of non-elderly adults who received any form of treatment for opioid use disorder were on Medicaid, according to the Kaiser Family Foundation. Yet one of the most glaring areas in which SUPPORT Act requirements remain largely unmet is in the issuance of Medicaid-related policy guidance.

Inside Health Policy identified seven guidance documents that CMS was required to issue to state Medicaid programs within the first year of the SUPPORT Act’s enactment in October 2018. Those guides are meant to direct states on how to harness Medicaid in various targeted areas to better assist beneficiaries who have or are at risk of substance use disorders.

So far, CMS has issued only one of the required guidance documents. That document was an informational bulletin on non-opioid options for chronic pain management in Medicaid, and it was issued on Feb. 22, 2019 -- seven weeks past the Jan. 1 deadline set by the law.

The six missing documents are far more belated. One was due in April 2019; the rest were due in October. They are supposed to cover topics such as:

  • Reimbursement options for substance use disorder treatments -- including medication-assisted treatment -- that can be delivered via telehealth.
  • Opportunities to finance and improve family-focused residential treatment programs.
  • Recommendations for improving care for infants with neonatal abstinence syndrome and their families.
  • Best practices for ensuring Medicaid coverage of former foster youth.
  • Best practices for prescription drug monitoring programs and privacy protections for Medicaid beneficiaries.

Many of those issues play a critical role in the ability of state Medicaid programs to respond to the addiction crisis. Remote prescribing via telehealth, for instance, has the potential to dramatically expand medication-assisted treatment in the rural areas hardest hit by the crisis, public health experts say.

But without proper policy guidance from CMS, states may be hesitant to innovate, according to Sara Rosenbaum, a health law professor at George Washington University.

“The risk involved in administering Medicaid is that you’re going to make errors in what you’re paying for, and the federal government is going to swoop in and try and recoup millions of dollars from you,” Rosenbaum said. “So if the federal government doesn’t tell you what the policy is, it’s a tremendous financial and legal exposure for the states.”


Local Efforts Stymied

Delays at CMS have blocked the District of Columbia and other state Medicaid programs from launching a program in the SUPPORT Act that is intended to reduce the risk of overdoses among incarcerated individuals re-entering their communities.

The prospect that delayed guidance documents will hinder on-the-ground innovation is not just a theoretical concern. A case study of the real-world effects of CMS’ delays occurred last fall in the District of Columbia’s Medicaid program.

The District sought a wide-ranging Medicaid waiver seeking permission to expand inpatient treatment in various ways for people with substance use disorders or serious mental illnesses. In November, CMS approved most of the provisions in the waiver, and CMS even issued a press release praising the District’s new approach.

But CMS did not approve one provision: a request from the District to allow Medicaid to pay for transition planning services for incarcerated individuals who have substance use disorders or mental illness and who are on the verge of being released. Such services allow case workers to meet with inmates during the month before they are released, assess their medical and social needs, and ensure a smooth transition when they return to the community. The idea is to link high-need individuals with appropriate resources and avoid interruptions in their treatment plans.

Research shows that formerly incarcerated people are at heightened risk of overdose upon release from jail or prison, and transitional planning can help reduce that risk. But Medicaid does not pay for transitional services in correctional settings.

The SUPPORT Act sought to change that -- and it sought to do so quickly. The law directed HHS, by April 2019, to convene a stakeholder group to develop best practices for states to ease the health care-related transitions of inmates into the community, including best practices to ensure that eligible individuals have Medicaid coverage. That stakeholder group was required to submit a report with its recommendations to HHS and Congress. Based on the group’s recommendations, CMS was then required to issue a guidance letter by October 2019 inviting states to use waivers to finance transition services for soon-to-be-former inmates.

As of February 2020, the members of the stakeholder group have not yet been selected, and the guidance letter appears to be a long way off.

The delay means that DC’s Medicaid program is blocked from adopting an innovation that, according to the SUPPORT Act, should already be available. Indeed, when CMS rejected the District’s request for Medicaid-funded transition services last fall, the agency was explicit: The District must wait for the agency to issue its guidance.

“They basically said, ‘We’re still working through these details, and we need more time,’” said Alice Weiss, the policy director for DC’s Medicaid program, describing what CMS told the District during negotiations. “They encouraged us to resubmit if and when the guidance is available.”

Weiss did not criticize CMS. Rather, she thanked the agency for what she said was a rapid approval of the other elements of the District's waiver, and she said the District continues to hope it will receive approval for Medicaid-funded transition services.

“We will wait for the right guidance and intend to take up that opportunity when it’s available,” she said.

One advocate for Medicaid beneficiaries was more critical. Joe Weissfeld, the director of Medicaid initiatives for Families USA, said action taken during the brief transitional period when incarcerated individuals are leaving prison and returning to the community is paramount to ensure continuity of treatment.

“I do think that CMS is hiding behind guidance as a way to say no. They are simultaneously not following what Congress told them to do and using that as an excuse to not approve” states’ requests, Weissfeld said. “States want to try, and CMS is preventing that.”

The problem is not limited to the District of Columbia. New York also requested a waiver last year to use Medicaid money for transition services for incarcerated individuals, and that request remains pending. Just last month, the Utah legislature passed a law directing the state’s Medicaid program to apply for a similar waiver aimed at helping inmates with substance use disorders continue treatment after they are released. 

Guyer said the missing CMS guidance has likely deterred even more states from seeking the same new authority under the SUPPORT Act.

“There’s a good chance that additional states would have stepped forward” if CMS had issued the required guidance on time, she said.

A CMS spokesperson said the agency is working to issue the law’s required guidance documents soon.

“CMS hasn’t met the indicated SUPPORT Act provision deadlines due to personnel and time constraints,” the spokesperson wrote in an email. “However, CMS is aware of the urgency of these provisions and is working hard to implement them while simultaneously making progress on the agency-specific Roadmap to Fighting the Opioid Crisis.” The CMS roadmap refers to a four-page document outlining broad policy goals in the areas of prevention, treatment and data analysis.


Absent Grants And Belated Reports

Educational grants, mandatory reports to Congress, updated guidelines for medical providers, and a study on abuse-deterrent opioids all remain unfinished.

On top of the lapses in formal policy guidance to states, CMS and HHS also are not complying with their obligations under the SUPPORT Act to disseminate updated information on the crisis to Congress, health industry stakeholders and the public.

For instance, the law required HHS to conduct a study on access to abuse-deterrent opioid formulations for individuals with chronic pain. Abuse-deterrent opioids are prescription opioids that have been chemically modified to prevent the drugs from being manipulated for non-medical use. FDA has encouraged the development of abuse-deterrent formulations, but these formulations are not widespread because research is lacking.

HHS was supposed to study the issue and submit a report to Congress with its findings by October. The report has not been submitted, and an HHS spokesperson said the study is “in development.”

Separate reports to Congress on at least two other topics were also due in October under the SUPPORT Act: one report on housing-related services for Medicaid beneficiaries with substance use disorders who are at risk of homelessness, and another on potential options for revising payment and coverage of non-opioid treatments for pain in Medicare. Neither of those reports has been submitted.

Certain educational and financial resources for health care providers are lagging as well.

By July 1, 2019, HHS and CMS were supposed to publish guidelines for hospitals on pain management and prevention of opioid addiction among Medicare beneficiaries. By Oct. 24, 2019, HHS was supposed to disseminate materials for pharmacists, health care providers and patients on circumstances in which pharmacists may decline to fill suspicious prescriptions. The agencies have not published the required information.

CMS also has failed to take advantage of a SUPPORT Act provision allowing the agency to award grants to organizations engaged in educating doctors who prescribe an unusually high number of opioids. The law makes $75 million available from the Federal Supplementary Medical Insurance Trust Fund for the purpose, though there is no deadline attached to the program.

Kolodny, the opioid policy expert at Brandeis, said more educational resources would help mitigate years of promotional efforts by the pharmaceutical industry targeting outlier prescribers.

“Many of them are outliers because they have been deceived by pharmaceutical marketing over the years,” Kolodny said. “These are the right people to target, and it’s a shame that CMS hasn’t yet acted on it.”

A CMS spokesperson said the agency intends to start conducting activities under the program this year.


Verma’s Vision Elsewhere

While implementation of the SUPPORT Act lags, CMS Administrator Seema Verma has devoted substantial resources toward new policies such as Medicaid work requirements and block grants.

Public health experts say CMS could make deep inroads in the addiction crisis by exerting its organizational power to reduce over-prescribing and expand access to medication-assisted treatment.

“There are still tens of thousands of Americans dying from opioid overdoses. Many of these are Medicare and Medicaid beneficiaries. CMS still has a critical role here that they could play,” said Parekh, of the Bipartisan Policy Center.

But some blame CMS Administrator Seema Verma for not making overdose prevention more central to her agenda. They say that, under Verma, the nitty-gritty work of fighting addiction has been sidelined by flashy conservative policy proposals geared toward her stated goal of transforming Medicaid.

Perhaps the centerpiece of Verma’s two-year tenure has been her aggressive push to allow states to implement work requirements in Medicaid -- a policy that has been repeatedly blocked by the courts. Last month, she dropped another bombshell when she released a guidance document inviting states to convert portions of their federal Medicaid funding into block grants. The highly technical guidance has been in the works for more than a year and is almost certain to face litigation.

Verma, like all CMS administrators, is directing the agency’s limited resources toward the policy prerogatives she favors, one former agency official under President Barack Obama said.

“In the last administration, we missed deadlines too. That happens,” the official said. “The real question to ask: Is her obsession with block grants and work requirements tying up the time of career staff and thus distracting what they’re required to do by law, which is to provide guidance on the SUPPORT Act provisions? And the answer is probably yes.”

Beneficiary advocates also point to the administration’s efforts in court to have the entirety of the Affordable Care Act declared unconstitutional -- an outcome that would throw Medicaid expansion into chaos and potentially remove coverage from thousands of people receiving treatment for substance use disorders.

These policy goals -- adding work requirements to Medicaid, converting Medicaid into block grants, and repealing the ACA -- have been repeatedly considered and rejected by Congress. The SUPPORT Act, in contrast, passed 393-8 in the House and 98-1 in the Senate.

CMS strongly disputes that the agency is not prioritizing the SUPPORT Act, and the agency says it has launched many new policies to improve Medicaid’s ability to treat addiction. For instance, the agency points to enhanced access to non-opioid pain treatments for Medicaid beneficiaries and various administrative actions to loosen a decades-old restriction that limits Medicaid’s coverage of inpatient treatment for mental illnesses and substance use disorders.

The agency also touts its distribution of $48 million in SUPPORT Act grant money to select states to run demonstration projects with the goal of expanding the capacity of Medicaid providers treating substance use disorders.

But even that program, while generally praised by stakeholders, was a few months late. Under the law, the money was supposed to be issued -- and the projects were supposed to begin -- by April 2019. CMS did not announce the grant opportunity until June, and it did not actually award the grants to the 15 chosen states until September.


Coordinators Missing

A multi-agency, multi-disciplinary committee that is charged with coordinating all federal activities related to the addiction crisis has not yet met, even though its first annual report was due four months ago.

Beyond the lapses at CMS, a key committee designed to coordinate all actions on the addiction crisis across the federal government is far behind schedule. Without these coordinators, the government’s overall response to the addiction crisis is sometimes beset by agencies and stakeholders working at cross purposes, policy experts say.

For instance, Kolodny said, the CDC, the Agency for Healthcare Research and Quality, and the Department of Veterans Affairs all have issued opioid-related guidelines and research cautioning prescribers that opioids are not safe for daily long-term use, yet FDA continues to approve new opioids for the treatment of long-term conditions like lower back pain, fibromyalgia and chronic headache.

“You have the FDA continuing to approve new opioids and allowing manufacturers to promote opioids for the exact same conditions that other federal agencies are discouraging opioid use,” Kolodny said.

“If you’re really trying to tackle a crisis, and you have multiple agencies that have a piece of this problem, what you need is a coordinated plan of action.”

The SUPPORT Act sought to repair the disjointedness by mandating the creation of a major new multi-disciplinary committee housed within HHS and tasked with coordinating all federal activities related to substance use disorders.

That committee, known as the Interdepartmental Substance Use Disorders Coordinating Committee, is supposed to consist of an eclectic group of powerful stakeholders. It is required to include representatives from at least six different cabinet departments, plus at least 15 non-federal members representing the medical community, the advocacy community, state governments, people receiving treatment, and various other experts. The committee's robust portfolio of duties includes:

  • Streamlining and aligning the research, services and prevention activities of all relevant federal agencies.
  • Ensuring that prevention and treatment strategies at the federal level work in tandem with state and local strategies.
  • Making recommendations to HHS on areas for improvement, including areas where more research is needed.

The SUPPORT Act directed the HHS secretary to convene the committee and serve as its chair -- and it set an ambitious timeline for the committee to get up and running.

Under the law, Azar was required to establish the committee within three months of the law’s enactment -- a deadline of Jan. 24, 2019. The committee, once established, is required to meet at least twice a year, and it must publish an annual report each year, starting one year after the law’s enactment -- a deadline of Oct. 24, 2019.

But 16 months after the SUPPORT Act was signed into law, the committee still has never met. On May 15, HHS posted a notice in the Federal Register seeking nominations for the committee’s members, and earlier this month, the department finally announced the committee’s first meeting. That meeting is scheduled for Feb. 28, though the names of the committee’s members still are not publicly available.

Experts and stakeholders interviewed by Inside Health Policy said an overarching coordinating body housed in HHS could be highly beneficial.

“I do think that is extremely important, particularly because what happens with substance use disorder treatment is that we have such silos within federal agencies, and also at the state level,” Guyer said.

Kolodny agreed. “That’s something we’ve needed for a very long time, so we can get agencies working together rather than at odds with each other.”

An HHS spokesperson attributed the delays in convening the committee to the need for its members to receive formal clearance to participate.

“Within the constraints of existing resources, HHS is committed to and in the process of implementing the SUPPORT Act’s more than 100 provisions directed to the department,” the spokesperson said.


Congressional Response

Congress has not conducted significant oversight on the implementation of the SUPPORT Act, but some influential lawmakers say they want more.

When told of Inside Health Policy’s findings on the administration’s lagging implementation of the SUPPORT Act, members of Congress from both parties said it may be time for Congress to step in.

Sen. Patty Murray (WA), the ranking Democrat on the Senate health committee and one of the primary Democratic architects of the law, said she supports more congressional oversight of how it is being executed.

“I absolutely believe we need to continue to push the administration to implement the SUPPORT Act as intended by Congress and continue working to deliver more resources and support to hard-hit communities,” Murray said.

The law’s chief sponsor in the House, Rep. Greg Walden (R-OR), also called for more congressional monitoring. Walden was chair of the House Energy & Commerce Committee when the law was passed but became the committee’s ranking Republican when Democrats won control of the House.

“As chairman, it was a central focus,” Walden said of the SUPPORT Act. “Now, in the minority, I’m doing all I can to tackle this issue and ensure this landmark legislation is being appropriately implemented.”

Both he and Burgess, the ranking Republican on the E&C health committee, said they have pushed E&C Democrats to conduct more oversight on the SUPPORT Act’s implementation.

House Democrats, however, have not made SUPPORT Act oversight a top priority. They have instead devoted more time and resources toward oversight of the administration’s attacks on the ACA and conservative policies in Medicaid.

E&C did hold a hearing earlier this month examining how states are using federal money to combat opioid abuse. Other House efforts at oversight of the administration’s opioid response have focused on the White House Office of National Drug Control Policy. In particular, Democrats on the House Oversight & Reform Committee were upset last year that ONDCP failed to publish a required annual strategic plan in 2017 or 2018. The committee is planning another hearing on Feb. 27 at which ONDCP Director James Carroll will testify about the office’s recently released 2020 strategic plan.

The 2020 plan includes two-year goals to reduce the number of overdose deaths by 15% and double the number of treatment centers that offer medication-assisted treatment. The plan also includes initiatives such as cracking down on the illicit drug trade, encouraging the safe disposal of unused prescription drugs and supporting local drug courts. The plan is a 44-page document that has only one passing reference to the SUPPORT Act.


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