By Alison Knopf
The 660-page opioid bill that passed Congress and was signed October 24 by President Trump has important provisions for opioid treatment programs (OTPs). The most significant provision expands coverage to Medicare patients. Starting in 2020, Medicare will be required to pay a bundled rate for medication-assisted treatment (MAT) in an OTP. This means that when patients turn 65 and lose their Medicaid or commercial insurance, getting Medicare instead, they will be able to stay in treatment.
Other aspects of H.R. 6, also called “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,’’ or the ‘‘SUPPORT for Patients and Communities Act,” have ramifications for OTPs as well (see below).
Opening the Door to Medicare for OTP Patients
The OTP Consortium has expressed its support for this measure since last February, when Rep. George Holding (R-North Carolina) first put forward the measure under House Resolution 5080, the Comprehensive Opioid Management and Bundled Addiction Treatment (COMBAT) Act of 2018. “Congressman Holding’s legislation opens the door to patient access for a vulnerable Medicare population that currently lacks coverage for Opioid Use Disorder (OUD) treatment provided by OTPs. I commend Congressman Holding and his colleagues for crafting a bill that will certainly improve our nation’s response to the opioid crisis by filling this treatment gap and assisting this population on their Road to Recovery,” stated Peter Morris, Group President of Acadia Healthcare.
That measure became incorporated into H.R. 6.
A Major Victory
“The bill is a major victory for patients who are Medicare eligible and who are about to be eligible,” said Mark Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD). “CMS Medicare will construct the rate, and I expect it to be a weekly bundled rate, which will include all three federally approved medications, in addition to lab testing and clinical services,” he told AT Forum. “For the present time, I will be informing programs about how to prepare, and will develop a webinar in order to provide technical assistance.”
The bill “is an extraordinary opportunity for patients, and I do not see any part that is a threat to treatment,” said Mr. Parrino.
“We are extremely pleased that Congress has included Medicare coverage of OTPs in the just-passed opioid package,” said Jason Kletter, PhD, president of BayMark Health Services. “This coverage will, once implemented, provide immediate benefit to the roughly 20,000 Medicare beneficiaries currently receiving treatment in OTPs, as well as create treatment access for the 300,000 beneficiaries with a diagnosis of opioid use disorder,” Dr. Kletter told AT Forum. “In addition, Medicare coverage will likely result in greater coverage of OTP services by commercial health plans, exponentially increasing access to high quality, evidence-based MAT across the country.”
The Need is Clear, and Methadone Works
OTPs provide not only medications—methadone, buprenorphine, and naltrexone—but support services, which may include counseling, toxicology screening and lab services, case management, primary care, and mental health services.
The FDA-approved medication methadone, as part of a MAT program, has been recommended by the National institutes of Health as the most effective treatment option for OUD. OTPs provide medically supervised access to this medication as well as buprenorphine and naltrexone, along with support services.
Medicare beneficiaries show a clear need for OUD treatment: 300,000 beneficiaries have been diagnosed with OUD, Medicare hospitalizations due to complications of opioid misuse increased 10% a year, and 30% of Medicare Part D enrollees used prescription opioids in 2015.
Success—After 10 Years’ Work
It has taken Mark Parrino more than 10 years to get this legislation passed. It was impossible for the Centers for Medicare and Medicaid Services to make the change on its own: Congress needed to act in order to approve the bundled rate. The Senate side had proposed a demonstration project, which would have covered a fraction of Medicare patients at greater cost.
According to the Congressional Budget Office, the full Medicare benefit will cost $243 million, which, if it covers all 300,000 Medicare beneficiaries with an OUD, would cost $810 per person.
The Medicare provision is Section 2005 of H.R. 6.
Now, it’s up to OTPs to gear up to bill Medicare, once CMS sets the bundling rate and codes.
From the bill, below are the Medicare provisions for OTPs:
All opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration for use in the treatment of opioid use disorder would be covered, including dispensing and administration.
Counseling, including individual and group therapy, for substance use would be covered to the extent authorized by state law.
Toxicology testing would be covered.
Medicare will pay OTPs an amount which is equal to 100% of a bundled payment for OUD treatment services, starting January 1, 2020.
Other aspects of the bill with relevance to OTPs:
- Demonstration project to increase substance use provider capacity under the Medicaid program.
- Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder.
- Medicaid health homes for substance-use-disorder Medicaid enrollees.
- More flexibility with respect to medication-assisted treatment for opioid use disorders.
- Medication-assisted treatment for recovery from substance use disorder.
- Grants to enhance access to substance use disorder treatment.
- Access expansion under the Medicare program to addiction treatment in Federally Qualified Health Centers and rural health clinics.
- Review required of quality measures relating to opioids and opioid use disorder treatments furnished under the Medicare program and other federal health care programs.
- Report on addressing maternal and infant health in the opioid crisis.
- Comprehensive opioid recovery centers , which would provide inpatient and outpatient treatment with all FDA-approved medications, including methadone.
For the bill, go to https://docs.house.gov/billsthisweek/20180924/HR6.pdf
Categories: Addiction, Medication-Assisted Treatment (MAT), Newsletter, Opioid Abuse/Addiction, Opioid Legislation, Opioids
Tags: Addiction, Government, Heroin, Legislation, Medicare, Opioid Treatment Programs, Prescription Opioids
By Alison Knopf
42 CFR Part 2 protects the privacy of patient substance use disorder (SUD) treatment records. It’s been under siege for 10 years, but so far, it is still the law.
H.R. 6082 would have replaced the confidentiality regulation, 42 CFR Part 2, with the Health Insurance Portability and Accountability Act (HIPAA). It would also have removed the requirement that patients consent to the release of their SUD treatment information. H.R. 6082 passed the House of Representatives last spring, but did not make it into the Senate version of the final opioid package signed by President Trump October 24.
And Congress received a letter from the American Medical Association (AMA) just days before the final vote in the Senate, clearly stating that H.R. 6082 would deter patients from seeking treatment. Congress may have decided to let the matter drop as a result of that letter.
There was a sigh of relief when 42 CFR Part 2 did not make it into the opioid package. But the regulation remains under siege.
Recommended Actions for CFR Part 2 From Key Groups
|Make No Major Changes||Make Changes,
To Resemble HIPAA
Faces & Voices of Recovery
Legal Action Center
|The American Society of Addiction Medicine
The Insurance Industry
The National Association of Addiction Treatment Providers
Partnership to Amend 42 CFR Part 2
At least two organizations still seeking a way to demolish 42 CFR Part 2 are The Association for Behavioral Health and Wellness (ABHW) (a membership association of behavioral care insurance companies), and the Partnership to Amend 42 CFR Part 2. Tiffany Huth, press person for both organizations, circulated a letter from Elinore McCance-Katz, MD, PhD, assistant secretary of the Department of Health and Human Services, to Rep. Earl Blumenauer (D-Oregon). The letter suggested that the Substance Abuse and Mental Health Services Administration (SAMHSA), which promulgates 42 CFR Part 2, and which Dr. McCance-Katz heads, support replacing the regulation with HIPAA.
In fact, SAMHSA has worked to make 42 CFR Part 2 more appealing to some critics. Last January, responding to many complaints from the insurance industry, SAMHSA issued a final rule on the regulation that did weaken 42 CFR Part 2, However, the final rule did keep the provision requiring SUD treatment providers to obtain consent from patients before sharing their information, as the law requires.
But this wasn’t enough for critics who want to dispose of the patient consent aspect entirely. These critics, including ABHW, want to make 42 CFR Part 2 like HIPAA, which allows information-sharing—without any consent by the patient.
“We’re aware efforts to weaken 42 CFR Part 2 to a HIPAA standard continue,” said Deborah A. Reid, senior health policy attorney with the Legal Action Center. “SAMSHA has been public about it; it’s pretty transparent.” However, some continue to object, among them the Legal Action Center, the American Association for the Treatment of Opioid Dependence (AATOD), patients, and the recovery community. They note that if their treatment isn’t confidential, patients will not want to go. “Weaker privacy rights will serve as a disincentive” to seeking help, said Ms. Reid.
But the role of the AMA is significant. If the AMA wants to preserve 42 CFR Part 2, this is something for the patient community to hold on to. “The AMA is a powerful entity, and what they say is very important, particularly in the medical community,” said Ms. Reid.
“In my judgement, the AMA letter was extremely important in the support of preserving the protections,” Mark W. Parrino, MPA, AATOD president, told AT Forum. “Our position has not changed. I am still of the opinion that 42 CFR Part 2 is critically important to preserve the core protections.”
Protecting Patients: Confidentiality Is Essential
“This would be a disaster for current patients and the opioid epidemic,” said Joycelyn Woods, head of NAMA Recovery. “Confidentiality is very important to patients. Many will not seek treatment because they are afraid, or they will leave treatment early thinking that it is better than nothing. It feeds into the belief that ‘I get on methadone or buprenorphine and get some short term goal and leave.’ The result is usually relapse.”
Furthermore, medication-assisted treatment (MAT) patients, if their information is released, can be denied life insurance, Ms. Woods noted. “It’s not just about medical records. This impacts people’s families.”
If you want to know who you’re up against, listen to the insurance groups. The ABHW and the Partnership to Amend 42 CFR Part 2 “continue to work with patient groups, treatment facilities, providers, Congress, and others, to find a path forward for passage of H.R. 6082 by the end of the year,” Rebecca Klein, chair of the Partnership to Amend 42 CFR Part 2, and director of government affairs for ABHW, told AT Forum.
Ms. Klein added, “Modernizing Part 2 to ensure that HIPAA-covered entities have access to pertinent substance use disorder information will improve patient safety, treatment, and outcomes across the care delivery spectrum, enhancing the entire opioid package passed by the House and Senate and ultimately, helping to save lives.”
But patients know that being unable to have privacy will deter them from seeking treatment; it will not save lives.
NAMA Recovery, the Legal Action Center, Faces & Voices of Recovery, the AMA, and AATOD are the main supporters of keeping 42 CFR Part 2 as it is. The insurance industry, the American Society of Addiction Medicine, and the National Association of Addiction Treatment Providers are among the groups who want to make it like HIPAA.
AT Forum has covered the progression of the 42 CFR Part 2 controversy. For more information, see:
By Barbara Goodheart, ELS
Health care teams are brought up short when they see the words opioid use disorder on the chart, and the patient is scheduled for surgery. Suddenly what had seemed a simple procedure has turned into a real challenge.
Key questions: Is the patient using illicit opioids? Is he in an opioid treatment program (OTP)? If so, what medication is he taking—methadone, buprenorphine, naltrexone? How will this affect his postop pain control?
Managing acute pain in a surgical patient with an opioid use disorder (OUD) can be tricky indeed. Lacking standardized protocols, the team must find a way to control the patient’s pain—without causing an overdose, or triggering a relapse.
A comprehensive review article in Anesthesia-Analgesia offers guidelines and suggestions, based on a computerized search of 35 years of studies on OUD and perioperative pain management. The search covers the perioperative period: from hospital admission through anesthesia, surgery, and recovery. The authors are from the departments of psychiatry and anesthesia, critical care, and pain medicine at Massachusetts General Hospital.
Patients hospitalized with substance use disorders (SUDs) often grapple with feelings of shame and self-stigma, according to the study’s authors. They also worry about pain relief, withdrawal symptoms, and relapse.
Their worries are well founded. OUD patients have lower pain tolerance and greater sensitivity to pain than other people, the authors found. Typically, they need large doses of medication for postsurgical pain relief. Given the alarming statistics about opioid use, and the tragic mortality rate, these issues are timely—and hugely important.
The key to a successful outcome: communication and cooperation between the surgical team and the OTP, based on an understanding of the medications and the underlying pain issues.
Guidelines for Perioperative Management of OUD Patients
Management steps vary with the patient’s specific disorder and current medications, as summarized below. (Consult the publication for details about perioperative management of OUD patients treated with buprenorphine-naloxone, or naltrexone.)
Patients In Remission, Without Medication
Patients in OUD remission are susceptible to relapse related to stress and anxiety associated with surgery. Recommendations include regional anesthesia, adjunct nonopioid agents, and nondrug alternatives.
If opioids are deemed necessary, the lowest effective dose should be prescribed for a short time. Opioid tolerance is lost during abstinence, so a relapse could lead to a fatal overdose.
Patients Treated With Methadone
Preoperative Preparation and Evaluation. The OTP staff shares with the surgical staff details of the dosing that took place in the OTP. The appropriate daily methadone maintenance dose prevents cravings and withdrawal symptoms, but is not high enough to control acute postsurgical pain. So, “strategies to manage acute pain are required,” the authors note. (The usual OTP maintenance dose is 60 mg/d to 120 mg/d, but some patients may require a higher dose.)
Additional steps for the inpatient staff include a pain history, physical examination, assessment of comorbidities (psychiatric and substance use), medication assessment, urine toxicology screen, and online prescription drug monitoring. Among the helpful screening tools are the Pain Catastrophizing Scale and the Opioid Risk Tool.
Postoperative Management. To cover the need for greater pain control after surgery, the authors suggest the surgical staff, in consultation with the OTP, select nonopioid medications and nondrug measures. Partial agonists such as buprenorphine should be avoided; they can cause withdrawal symptoms.
For moderate to severe postoperative pain, the authors recommend adding one of the following to the methadone regimen:
- Regional or peripheral analgesia
- Spinal or epidural anesthesia
- Patient-controlled analgesia (self-administration of opioids by an infusion pump)
They also recommend considering an inpatient acute pain consultation and SUD consultation.
Multimodal analgesia entails using two or more agents with different actions, to improve pain relief and reduce side effects. Examples include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), local anesthetics, ketamine, gabapentin, and short-acting opioids.
Nondrug measures include educational and cognitive behavioral approaches.
Patients should be monitored for pain control, euphoria, constipation (opioid-induced), and sedation. A brief mental status test may be appropriate.
Discharge Planning. At discharge time, the surgical staff shares with the OTP details of the inpatient dosing. A letter from the inpatient facility to the OTP listing current medications, dosing instructions, etc. will help the OTP prepare for the patient’s return.
Discharge planning also includes educating the patient about preventing overdoses; providing a nasal naloxone prescription, to reverse overdose, should it occur; designating someone to manage medications; and planning safe storage of medications. The staff may consider appointing a visiting nurse to dispense medications. When necessary, the team can arrange medical take-homes.
Patients Who Continue to Use “Should Not Be Tapered”
Good news: Attitudes are changing! Currently, hospital inpatient departments generally provide only for managing opioid withdrawal. But the authors emphasize “patients should not be tapered.” They point to “a changing attitude among practitioners in providing more clinically appropriate care,” and advocate arranging, with the patient’s agreement, “transition to an OTP for methadone or a [buprenorphine-naloxone] provider”—instead of tapering the patient off medication before discharge. An inpatient consultation is necessary to arrange the referral and follow-up. The authors highlight the feasibility of “engaging patients with OUD and initiating medication treatment in general hospital settings.”
That “changing attitude” is good news, indeed!
Methadone, or Buprenorphine-Naloxone?
According to the authors, data indicate that buprenorphine-naloxone and methadone “are equally effective in treating signs and symptoms of withdrawal,” and that, when moderate to high postoperative pain is anticipated, “methadone may be preferred to treat the withdrawal symptoms and manage pain postoperatively.”
Otherwise, when choosing between the two medications, the team should consider “patient preference, drug-drug interactions, side effect profile, existing conduction problems,” and management options for acute pain.
Teamwork is key. Throughout the article, the authors emphasize the importance of teamwork. They stress that efforts are needed to “ensure collaboration between inpatient care teams and linkage to outpatient SUD treatment.”
Ward EN, Quaye A N-A, Wilens TE. Opioid use disorders: Perioperative management of a special population. Narrative Review Article. Anesth Analg. 2018;127:539-547. doi:10.1213/ANE.0000000000003477.
By Alison Knopf
Healthy Women, a group that has been active for 30 years, is expanding its work around policy and advocacy, and recently released a toolkit for female state legislators to use in getting support for legislation to address the opioid epidemic.
“The toolkit was designed as a way to get resources and insights to women legislators,” explained Michael D. Miller, MD, HealthyWomen’s senior policy advisor, in an interview with AT Forum. Healthy Women, joined by the Legal Action Center, presented the toolkit at the Women in Government conference in Washington in early October.
The toolkit is primarily for state, not federal, legislators. While the huge 660-page opioid package (H.R. 6) has been signed, there are still initiatives that need to take place on state levels.
“States are very different, and legislators are very different, and each have their own needs and areas of focus” said Dr. Miller. The toolkit gives a broad array of information, which is a useful reference piece, regardless of the state. Some states have much easier rules than others.
Legal Action Center
“We’ve seen states like Indiana—one of the states we identified—that changed their policies to allow the opening of new OTPs [opioid treatment programs],” said Gabrielle de la Gueronniere, director of policy for the Legal Action Center. The Center is working on an additional toolkit on state strategies, along with HealthyWomen. “It’s a matter of the patient community being really active, and also the provider community,” she said.
West Virginia and Indiana are two states that had moratoriums on new OTPs. In Indiana, the moratorium was lifted; in West Virginia, advances have been made as well.
A notable example of a state doing cutting-edge work is Vermont, which almost 10 years ago initiated the hub-and-spoke model, noted Ms. de la Gueronniere. The hubs are OTPs, which do all of the assessments and provide treatment with methadone (and other medications) for patients who need it in that setting. The spokes are buprenorphine prescribers. “When you look at the hub-and-spoke model and the role of OTPs, you see this is a real positive that helps people have better health outcomes,” she told AT Forum.
The focus is on medication-assisted treatment (MAT) for opioid addiction. “MAT has been shown to work—it’s the gold standard,” said Dr. Miller. This message, along with the fact that opioid use disorder is a disease, is a key point for legislators to get across. Legislators sometimes have an uphill battle when it comes to promoting legislation that supports MAT, and the toolkit is hoped to help.
“HealthyWomen’s perspective is to reduce barriers to access to treatment,” said Dr. Miller. “One way to do this is to help dispel the stigma.”
The problem—that many people (voters and legislators) think methadone and buprenorphine are “replacing one addiction with another”—can be combatted only with education and information. The toolkit will help to do that.
An example was the Medicare bill, included in the opioid package, which allows coverage for treatment with methadone in an OTP. When federal lawmakers heard that methadone was involved, some were confused. “They say, ‘We get it,’ but they didn’t really get it,” noted Dr. Miller. This is where the role of the Legal Action Center was essential. “It’s a great resource when it comes to looking at what states have done that works well,” he said. OTPs are a particularly good example of how to treat opioid use disorders.
Dr. Miller knows that if you’ve seen one state, you’ve seen one state. “While working at the National Governor’s Association I saw how each state is unique,” he said. “Every state has different challenges, in terms of drug issues infrastructure (such as OTPs), regulations, and of course politics.”
Part of the challenge is the terminology, said Dr. Miller. “People being treated with methadone are not addicts,” he said. “There is a clinical difference between dependence and addiction.” These facts are well known to OTPs, but not to most lawmakers. “We’re really trying to guide them,” he said. “People who have opioid use disorder have a disease. The word addiction shouldn’t be used except in a purely clinical sense, and not in public discussion of this disease.”
The Legal Action Center’s toolkit is expected to be released shortly, but is just awaiting final approval. In the meantime, the HealthyWomen toolkit is essential as well.
One of the reasons HealthyWomen got involved in this issue—and why Women in Government was interested – is that women are the primary health care decision makers, both in buying insurance and in care decisions, said Dr. Miller. “When it comes to an impact on the family member, it’s often the woman in the family who is responsible for the care,” he said. “They’re mothers, wives, sisters, aunts.” He recalled the old aphorism about the group that provides the more health care than any other. The answer is: “moms.”
Finally, Dr. Miller noted that the Centers for Medicare and Medicaid Services will be providing funding for states to develop demonstrations—small-scale projects testing out protocols—for treating pregnant women who have opioid use disorders. “This is the type of program/opportunity that Women in Government members might take advantage of, for improving OUD treatment and access in their states, since states will have to apply for this program/demonstration in partnership with a care-delivery organization.”
The opioid epidemic has many components and causes. To address it requires multiple approaches and collaborations. Each region, state, and community must consider its own situation in developing and implementing plans and actions. The HealthyWomen toolkit is intended to support these efforts; the toolkit is organized into the following sections:
For the toolkit, go to https://www.healthywomen.org/policy-center/legislator-toolkit
By Alison Knopf
I spent hours visiting with Robert Newman, MD, beloved methadone advocate, over the past 30 years. He gave me my first tour of a large opioid treatment program (OTP). He taught me priceless lessons about the value of integrity, and even though he was not a journalist but a physician, he understood journalism better than most reporters and medical writers. When he died this summer, five weeks after getting hit by a car and not recovering, the field lost “a great fighter on behalf of patients and treatment,” in the words of Mark Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD).
Dr. Newman was the founding director of the Baron Edmond de Rothschild Chemical Dependency Institute at Beth Israel, a position he held from 2001 until his retirement in 2014. As assistant commissioner of health for New York City, he established the city’s first methadone program in the early 1970s. As president and chief executive officer of Beth Israel Medical Center, he led the center through its most profound period of growth and expansion in the 1980s and 1990s. He was founding president and chief executive officer of Continuum Health Partners in 1997, the parent company for the partnership between Beth Israel, St. Luke’s and Roosevelt Hospitals, Long Island College Hospital and the NY Eye and Ear Infirmary. He retired as its president emeritus in 2001, and went on to be founding director of the Baron Edmond de Rothschild Chemical Dependency Institute at Beth Israel, a position which he held until he retired in 2014.
Tony Newman, media director for the Drug Policy Alliance, and Bob’s nephew, said “his greatest passion was helping people who struggled with drugs.” He noted that his uncle was “simultaneously the leading advocate for methadone (in the United States and globally) and the leading critic of the methadone treatment industry.”
Dr. Newman’s family fled the Holocaust. He leaves behind his wife of 50 years, Seiko, and two children, Seiji and Hana. The last time I saw him was at the AATOD conference in New York City last spring, where he was as charming and generous as ever.
The Evolution of Addiction Treatment Conference
January 24-27, 2019
Los Angeles, CA
New York Society of Addiction Medicine (NYSAM) Annual Medical-Scientific Conference
February 1-2, 2019
New York, New York
American College of Psychiatrists (ACP) Annual Meeting
February 20-24, 2019