HHS prescribes regulations for opioid addiction treatment reports

Medical practitioners who treat up to 275 patients in an office-based setting must provide various information to assist HHS in complying with newly established regulations regarding medication assisted treatment (MAT) of opioid use disorders. In an advance release of a Final rule set to publish in the Federal Register September 27, 2016, HHS requires information related to: (1) a practitioner’s annual caseload of patients to be reported monthly; (2) the number of patients provided behavioral health services and referred to behavioral health services; and (3) the features of the practitioner’s diversion control plan.


Buprenorphine is used in MAT to help people reduce or quit their use of heroin or other opiates, such as pain relievers like morphine. Unlike methadone treatment, which must be performed in a highly structured clinic, buprenorphine is the first medication to treat opioid dependency that is permitted to be prescribed or dispensed in physician offices, significantly increasing treatment access.

HHS had increased access to MAT in an office-based setting by allowing eligible physicians to request approval to treat up to 275 patients if certain conditions are met in a previous Final rule titled “Medication Assisted Treatment for Opioid Use Disorders” (81 FR 44712, July 8, 2016) (MAT rule). The MAT rule had originally proposed requirements to ensure that patients received the full array of services that comprise evidence-based MAT and minimize the risk that the medications provided for treatment are misused or diverted (see Proposal could push up patient limit for opioid abuse treatment, Health Law Daily, March 29, 2016).

HHS also made changes to the original proposed reporting requirements based on earlier comments by adding a requirement proposing that practitioners provide reports to the Substance Abuse and Mental Health Services Administration (SAMHSA) to maintain their approval to treat up to 275 patients in a supplemental Notice of Proposed Rulemaking (SNPRM) (81 FR 44576, July 8, 2016). The purpose of the reporting requirements is to help HHS assess practitioner compliance with the additional responsibilities of practitioners who are authorized to treat up to the highest patient limit.

Reporting requirements

HHS recognized that asking practitioners to calculate and report average monthly caseload of patients receiving buprenorphine-based MAT each year could be could be burdensome and changed this reporting requirement in the Final rule. The revised text requires practitioners to report annual caseloads of patients by month. By seeking information on the annual caseload of patients by month, HHS noted that an appropriate balance between collecting valuable information needed to assess compliance with the rule and avoiding undue burden to practitioners would be struck.

In addition, the reporting requirement has been revised to request the practitioner report on the number of patients provided behavioral health services and referred to behavioral health services. By seeking information on the number of patients that were provided services and referred for behavioral health services will meet the needs of assessing compliance of the MAT rule.

HHS modified the third reporting requirement, which required that the practitioner report on the features of their diversion control plan, by striking requirements related to reporting the number of patients who: (1) completed a buprenorphine course of treatment; (2) were referred to a less intensive level of care; (3) no longer wished to take buprenorphine; or (4) no longer taking buprenorphine for reasons not listed.

Beyond scope

HHS declined to address comments requesting higher patient limits, access to buprenorphine, or SAMHSA audit practitioners to ensure compliance with the MAT rule because the comments did not relate directly to the reporting requirements of the SNPRM.

Highlight on Maryland: Citing prison smuggling, opioid options handcuffed for all

In a change to the dismay of physicians and patients, Maryland’s Medicaid program recently removed Suboxone film, a drug used in the treatment of opioid addiction,  from the state’s list of preferred drugs and substituted it with the tablet form Zubsolv. Suboxone helps people control their opioid habit, but is an opioid as well. While Suboxone does not produce a high as intense as other opioids, it keeps cravings in check while creating some feelings of euphoria in users. The concern underlying Suboxone is that it comes as a tiny, dissolvable film, about the size of a breath mint strip, and thus, transparent and easy to hide. Suboxone will only be covered if prescribing physicians first go through a prior authorization process.

Maryland state officials stressed that the change was made to stop the flow of the drug into jails and prisons. According to the Department of Health and Mental Hygiene (DHMH), Suboxone strips were diverted or smuggled into prisons and resold or traded in criminal activity. The Department of Public Safety and Correctional Services (DPSCS) noted that seizures of the drug were up about 40 percent compared to 2015, with more than 2,300 doses of Suboxone confiscated. The strips are often divided up and sold individually in prisons. DPSCS had argued that the change was necessary because of 13 fatal overdoses in prisons since 2013. Opponents stressed that without Medicaid reimbursement, the well-tolerated Suboxone will be virtually unavailable for the most vulnerable patients, resulting in a serious restriction of access to treatment. The state health department did acknowledge that the overdoses were for opioids in general, not specifically related to Suboxone.

Physicians are against the change because the tablet form is not as effective at keeping opioid withdrawal symptoms in check. Suboxone film, as well as the Zubsolv pill that replaces it, actually protect against overdoses because they contain both the opioid buprenorphine and a drug called naloxone that reverses the effects of an overdose. Naloxone is used by emergency responders to revive people who overdose. Some physicians have reported that patients who were stable and doing well on Suboxone were reacting differently to Zubsolv, in many instances negatively.

HHS throwing water on the opioid epidemic fire

As the opioid epidemic in the United States continues, HHS announced a group of new actions to build on the HHS Opioid Initiative–which focuses on (1) improving opioid prescribing practices; (2) expanding access to medication-assisted treatment (MAT) for opioid use disorder; and (3) increasing the use of naloxone to reverse opioid overdoses–and the National Pain Strategy, the federal government’s first coordinated plan to reduce the burden of chronic pain in the U.S.

The new actions include a Final rule expanding access to buprenorphine, a medication to treat opioid use disorder, and other MATs. HHS also launched more than a dozen new scientific studies on opioid misuse and pain treatment and soliciting feedback to improve and expand prescriber education and training programs. The department took other steps on opioids in response to physician concerns about financial incentives to prescribe the drugs.

MAT Final rule

In a Final rule (81 FR 44712, July 8, 2016), the Substance Abuse and Mental Health Services Administration (SAMHSA) took action allowing more patients to receive buprenorphine prescriptions each year. Practitioners must have a waiver to prescribe buprenorphine–to be eligible for the waiver, the practitioner must have additional credentialing in addiction medicine or addiction psychiatry from a specialty medical board and/or professional society, or practice in a qualified setting. Under the waiver, the number of patients to whom they may prescribe the MAT is limited annually; under the Final rule, practitioners who have had a waiver to prescribe buprenorphine for up to 100 patients for one year or more, may now obtain a waiver to treat up to 275 patients. A supplemental notice of proposed rulemaking (81 FR 44576, July 8, 2016) asked for input on increasing the highest patient limit for qualified physicians to treat opioid use disorder under the Controlled Substances Act to 275. The proposal would help assure compliance with the MAT Final rule by adding reporting requirements for MAT prescribers.

Opioid misuse research and training

According to a request for information (81 FR 44640, July 8, 2016), deaths related to opioid analgesic–a class of prescription drugs such as hydrocodone, oxycodone, morphine, and methadone used to treat both acute and chronic pain–overdose have quadrupled since 1999. To fill knowledge gaps and improve the country’s ability to fight the opioid epidemic, HHS is launching more than 12 new scientific studies on opioid misuse and pain treatment. It released a related report and inventory on the opioid misuse and pain treatment research being conducted or funded by its agencies, which will help stakeholders and external funders of research avoid unnecessarily duplicating research. In addition, HHS developed activities that support opioid prescriber education, and seeks comment on current HHS prescriber education and training programs and proposals that would augment ongoing HHS activities.

Elimination of potential financial incentive to prescribe opioids

In an advance release of its Proposed rule for the hospital outpatient prospective payment system (OPPS), CMS suggested eliminating any potential financial incentive for doctors to prescribe opioids based on patient experience survey questions. The Hospital Value-Based Purchasing (VBP) Program ties payments to performance measures, including a pain management dimension. Providers and other stakeholders have told CMS that they are concerned about the pain management dimension putting pressure on staff to prescribe unnecessary opioids; the agency proposed removing the pain management dimension for purposes of the Hospital VBP Program “in an abundance of caution.” For more on the OPPS Proposed rule, see Patient-focused and physician-supporting changes proposed for OPPS and ASCs, Health Law Daily, July 7, 2016.