In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24, 2018. Last year, the acting Secretary of the Department of Health and Human Services (HHS) declared a public health emergency in response to the abuse of opioids. In response, this Act contains a number of provisions aimed at increasing access to treatment, identifying at-risk individuals, reducing overprescribing, and promoting data sharing with the goal of reducing the use and abuse of opioids. Key provisions of the legislation are summarized below:
Expanded Medicare and Medicaid Coverage
The Act expands Medicare coverage to include opioid use disorder treatment services provided by opioid treatment programs (OTPs), and adds OTPs to the list of entities eligible to be Medicare providers. Similarly, for a limited period—between October 1, 2019 and September 30, 2023—a state may elect to allow Medicaid coverage for patients in an eligible institution for mental diseases, but only up to 30 days per year. With limited exceptions, the Act also requires that medication-assisted treatment (MAT), which includes treatment for opioid use disorder with drugs like methadone and buprenorphine, be covered under Medicaid between October 1, 2020 and September 30, 2025.
Kickback and Fraud Prevention
The Act includes numerous provisions aimed to address fraud and abuse at all points in the distribution chain, from providers and pharmacies to manufacturers and distributors.
Kickbacks. H.R. 6 includes a new all-payor kickback prohibition related to substance abuse treatment. The Eliminating Kickbacks in Recovery Act of 2018 prohibits kickbacks in exchange for referrals to a recovery home, clinical treatment facility or laboratory. Violations are punishable by fines up to $200,000, up to 10 years’ imprisonment, or both, for each occurrence. Unlike the federal Anti-Kickback Statute, this new kickback prohibition is not restricted to referrals for services reimbursable by federal healthcare programs, but rather is a broad all-payor prohibition applying to both government and private payors. The marks the first time the federal government has enacted an all-payor kickback prohibition. There are several exceptions to this broad prohibition, including exceptions for:
Payments by an employer to a bona fide employee or independent contractor that do not vary based on the volume of patients, tests or procedures; or, the amount billed or collected;
Payments for services that satisfy the Anti-Kickback Statute’s personal services and management contracts safe harbor;
Certain waivers or discounts of coinsurance or copayment amounts; and
Remuneration under an alternative payment model or certain other arrangements determined by HHS to be necessary for care coordination or value-based care.
Unfair and Deceptive Acts. H.R. 6 also includes the Opioid Addiction Recovery Fraud Prevention Act of 2018, which makes it a violation of the Federal Trade Commission Act to engage in unfair or deceptive acts or practices regarding any substance use disorder treatment service or substance use disorder treatment product.
Other. Effective for plan years beginning on or after January 1, 2020, prescription drug plan sponsors are authorized to suspend payments to pharmacies pending an investigation of a credible allegation of fraud. Moreover, HHS now has the authority to cease distribution and recall controlled substances if HHS determines there is a reasonable probability that a controlled substance could cause serious adverse health consequences or death.
Several provisions in the Act aim to enable and expand the provision of services through telemedicine and telehealth services.
Expanded Coverage. Effective for telehealth services furnished on or after July 1, 2019, the Act eliminates the geographic requirements for Medicare beneficiaries that are eligible for telehealth services, are diagnosed with a substance use disorder, and are being treated via telehealth for the disorder or a co-occurring mental health disorder. Within the next year, the Center for Medicare and Medicaid Services (CMS) must issue guidance to states regarding options for Medicaid reimbursement for furnishing services and treatment for substance use disorders via telehealth. CMS will implement this provision through an interim final rule, to be published on November 23, 2018, with a comment period ending December 31, 2018.
Controlled Substances. The Act also includes the Special Registration for Telemedicine Clarification Act of 2018, which establishes a one-year deadline for the Drug Enforcement Administration (DEA) to promulgate formal regulations specifying (1) the circumstances under which a special registration to perform telemedicine services may be issued, and (2) the procedure for obtaining such a registration. The Controlled Substances Act allows practitioners to practice telemedicine only in limited circumstances, including when a special registration is issued by the Attorney General. Prior to this legislation, however, no rules were promulgated regarding when and how registered providers could obtain this special registration.
Other Medicare and Medicaid Program Changes
In addition to expanded coverage, the Act revises the Medicare and Medicaid programs to respond to the opioid crisis in several other ways, including implementing best practices to minimize opioid diversion, and identifying patients suffering from, or at risk of, substance use disorders.
Prescribing Practices. Under the Act, state Medicaid programs must establish a program to implement certain drug review and utilization requirements, including safety edits to identify when a beneficiary is prescribed opioids in excess of limits set by the state, and a process to identify controlled substances-related fraud and abuse by beneficiaries, providers, and pharmacies. Effective January 1, 2021, with certain exceptions, prescriptions covered under a prescription drug plan or an MA-PD plan for Schedule II–V controlled substances must be transmitted electronically under an electronic prescription drug program.
Evaluation of Payments Related to Opioid Treatment. By March 15, 2019, the Medicare Payment Advisory Commission must submit a report to Congress that includes identification of incentives under the hospital inpatient and outpatient prospective payment systems for prescribing opioids and non-opioid treatments, and recommend areas for addressing adverse incentives. Similarly, regarding Medicare, the Act requires HHS to (1) review payments for opioids and evidence-based non-opioid alternatives to pain management with a goal of ensuring there are not financial incentives to using opioids instead of non-opioid alternatives, and (2) revise payments as necessary to reduce any such incentives. Within the next two years, HHS must submit to Congress a report on the availability of supplemental healthcare benefits designed to treat or prevent substance use disorders under Medicare plans, including ways to improve the coverage or incentivize plans to offer additional supplemental health benefits relating to the coverage. The Act also requires the creation of a technical expert panel for reviewing quality measures relating to opioids and opioid use disorders and making recommendations for including these measures in the Merit-Based Incentive Payment System, alternative payment models, the shared savings program, the quality reporting requirements for inpatient hospitals, and the hospital value-based purchasing program.
Identifying At-Risk Patients. The Act requires that Medicare’s initial preventative physical exam and annual wellness visits include a review of the patient’s current opioid prescriptions, including a review of risk factors for opioid use disorder, provision of information on non-opioid treatment options, and referral as necessary to a specialist for treatment. Also aimed at helping to identify at-risk beneficiaries, beginning October 1, 2021, the Act requires Medicaid providers to review the relevant prescription drug monitoring program (PDMP) before prescribing a Schedule II controlled substance (or a Schedule III or IV controlled substance if mandated by the state). In addition, beginning on January 1, 2022, Medicare prescription drug plan sponsors are now required to have in place a drug management program for at-risk beneficiaries.
Studies and Demonstrations. The Act mandates numerous other demonstration projects, studies, and Government Accountability Office (GAO) reports regarding various aspects of opioid addiction and treatment.
One hindrance to responding to the opioid crisis is the lack of access to prescribing data. In attempt to reduce this problem and reduce diversion, the Act provides drug manufacturers and distributors with access to certain anonymous information intended to help them to identify, report and prevent suspicious drug orders. Also, to the extent permitted by state and federal privacy and security laws, the Act permits state agencies administering a state Medicaid plan to facilitate access to PDMP databases and share information with the state’s Medicaid providers and managed care entities.
Besides the expanded coverage of opioid treatment discussed above, Congress is creating additional care access points for individuals needing treatment:
Comprehensive Opioid Recovery Centers. The Act requires the creation of at least 10 three- to five-year competitive grants to eligible entities to establish or operate a comprehensive opioid recovery center for treatment of individuals with substance use disorders. Each Center must provide a full continuum of treatment services, including all drugs approved under the federal Food, Drug, and Cosmetic Act (FDCA) for treatment of substance use disorders and reversal of overdoses; treatment for co-occurring substance use and mental disorders; assistance for reintegration into the workforce; and MAT, as appropriate.
Medication–Assisted Treatment. The Act creates more flexibility for practitioners to treat more patients using MAT by (1) increasing the number of ways practitioners can qualify to treat patients with MAT; (2) making permanent the ability of nurse practitioners and physician assistants to prescribe MAT; and (3) expanding, for five years, the practitioners who can qualify to treat patients with MAT to include clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.
The SUPPORT for Patients and Communities Act lays the foundation for a widespread response to the opioid crisis. While its provisions will create momentum in the industry to address the needs of patients affected by opioid addiction, expansions of federal coverage and new fraud and abuse provisions guarantee that treatment providers will be subject to more regulation and increased fraud enforcement efforts and audits of records and patient care. Treatment providers taking advantage of new federal programs will want to revisit their compliance infrastructure and conduct training to ensure that their organizations are equipped to handle the increased regulations and obligations that come with additional federal funding.
 Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, H.R. 6, 115th Cong. (2018), available at https://www.congress.gov/bill/115th-congress/house-bill/6.
 Press Release, Dep’t of Health & Human Servs., HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis (Oct. 26, 2017), available at https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html.
 H.R. 6 at § 2005.
Id. at § 5052.
Id. at § 1006.
Id. at § 8122.
 A “recovery home” is “a shared living environment that is, or purports to be, free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders.” Id.
 A “clinical treatment facility” is “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” Id.
 A “laboratory” is “a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” Id.; 42 U.S.C. § 263a(a).
 H.R. 6 at §§ 8021–23.
 A “substance use disorder treatment service” is “a service that purports to provide referrals to treatment, treatment, or recovery housing for people diagnosed with, having, or purporting to have a substance use disorder, including an opioid use disorder.” Id. at § 8022.
 A “substance use disorder treatment product” is “a product for use or marketed for use in the treatment, cure, or prevention of a substance use disorder, including an opioid use disorder.” Id.
Id. at § 2008.
Id. at § 3012.
Id. at § 2001.
Id. at § 1009.
 CMS, CY 2019 Physician Fee Schedule Final Rule, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
 H.R. 6 at § 3232.
 21 U.S.C. § 802(54)(E); 21 U.S.C. § 831(h)(2).
 H.R. 6 at § 1004.
Id. at § 2003.
Id. at § 6072.
Id. at § 6082.
Id. at § 6084.
Id. at § 6093.
Id. at § 2002.
Id. at § 5042.
Id. at § 2004.
See, e.g., id. at §§ 1003 (demonstration project to increase substance use provider capacity under the Medicaid program), 1005 (GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder), 1009 (GAO evaluation of children’s access to services and treatment for substance use disorders under Medicaid), 3223 (GAO study and report on hospice safe drug management), 3292 (GAO report on the reporting of suspicious controlled substances orders), 6085 (GAO report on mental and behavioral health services under the Medicare program).
Id. at § 3272.
Id. at § 1016.
Id. at 7121.
Id. Previously, their prescribing ability was set to terminate October 1, 2021. 21 U.S.C. § 823(g)(2)(G) (2017).
 H.R. 6 at § 3201.