Addressing the Opioid Crisis: What Life Sciences and Healthcare Companies Need to Know About the SUPPORT for Patients and Communities Act

On October 24, 2018, President Donald Trump signed the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act into law. This legislation is aimed at addressing the opioid epidemic, and comes two years after Congress passed the initial opioid response package, the Comprehensive Addiction Recovery Act (CARA).

Life sciences companies—including those without opioid products—should review the new law, which covers a wide range of issues, including reforms to Medicare and Medicaid payment policies, additional obligations with respect to manufacturing and distributing controlled substances, and authorization for public health programs. Of note, the SUPPORT for Patients and Communities Act significantly expands the Physician Payment Sunshine Act, under which manufacturers are currently required to report payments and other transfers of value to physicians and teaching hospitals.¹ Specifically, with respect to information that must be submitted on or after January 1, 2022, this law will now require manufacturers to also report payments to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse-midwives.

This Advisory provides a summary of select provisions that should be on the radar of life sciences and healthcare companies, with a focus on policies that fall within the jurisdiction of the: (I) Food and Drug Administration; (II) Drug Enforcement Administration; and (III) Centers for Medicare & Medicaid Services.

I. US Food and Drug Administration

• Sec. 3001. Clarifying FDA Regulation of Non-Addictive Pain Products. This section requires the Secretary of Health and Human Services (Secretary), acting through the Commissioner of the Food and Drug Administration (FDA), to hold at least one public meeting to address the challenges of and barriers to developing non-addictive medical products (i.e., drugs, biologicals, devices) intended to treat acute or chronic pain or addiction. Not later than one year after the public meeting(s), the Secretary shall issue one or more final guidance document(s), or update existing guidance documents, to address challenges faced in the development of non-addictive medical products to treat pain or addiction.

• Sec. 3012. Notification, Nondistribution, and Recall of Controlled Substances. This section gives the Secretary the authority to issue an order requiring manufacturers, importers, distributors, and pharmacists to immediately cease distribution of a controlled substance if the Secretary determines that there is a "reasonable probability" that the controlled substance would cause "serious adverse health consequences or death." Before issuing the order, the Secretary must first provide the appropriate person with an opportunity to consult with the agency. Within ten days of the issuance of the order, the appropriate person will have an opportunity for an informal hearing. Then, the Secretary will either: (1) vacate the order, if there are inadequate grounds to support the actions required by the order; (2) continue the order ceasing distribution until a date specified; or (3) amend the order to require a recall. If the Secretary determines, however, that a recall presents a greater health risk than not recalling the controlled substance, then the amended order shall not include either a recall or an order to cease distribution. The Secretary may require the person subject to the order (or amended order) to provide notice to appropriate persons (e.g., manufacturers, distributors, importers, retailers). Failure to comply with the order is a prohibited act.

• Sec. 3013. Single Source Pattern of Imported Illegal Drugs. This section describes the circumstances that authorize the Secretary to determine that all drugs being offered for import by an individual who has been debarred for engaging in a pattern of importing controlled substances or drugs are "adulterated or misbranded."

• Sec. 3014. Strengthening FDA and CBP Coordination and Capacity. Part of the effort to combat the importation of illegal controlled substances and drugs, this section calls for collaboration between the Secretary, acting through the FDA Commissioner, and the Secretary of Homeland Security to enact enhancements to the facilities, technologies, and inspection capacity of sites of import (i.e., international mail facilities) through a memorandum of understanding. Among other improvements, this section calls for innovative technologies that would enable near-real-time information sharing between the FDA, Department of Homeland Security (DHS), and the United States Postal Service (USPS) of controlled substance detection and testing data. Within six months after enactment, the Secretary, in consultation with the Secretary of Homeland Security and USPS, will report to Congress on the implementation status of this section.

• Sec. 3022. Restricting Entrance of Illicit Drugs. This section calls on the Secretary, acting through the FDA Commissioner and in consultation with the US Customs and Border Protection (CBP), to develop and periodically update a list of mutually agreed upon controlled substances. When such substances are offered for import into the US via international mail and appear to violate the Controlled Substances Act or other applicable law, the Secretary will transfer to CBP the controlled substances on such list, and any additional packages, which shall be received consistent with the requirements of the Controlled Substances Act. Within nine months after enactment, the Secretary, acting through the FDA Commissioner and with the consultation of CBP, will report to Congress on the implementation status of the effort.
  
  This section also expands the authority of the Secretary to permissively debar an individual for certain actions related to importing or offering for import a drug into the United States, such as being convicted of a felony relating to the importation of a drug or controlled substances or engaging in a pattern of importing or offering for import illicit drugs and controlled substances. Finally, this section prohibits the import of drugs by an individual debarred for actions related to importing or offering for import a drug into the United States and details when the FDA will treat certain illicit articles being imported or offered for import into the United States as "drugs."

• Sec. 3032. Safety-Enhancing Packaging and Disposal Features. This section authorizes the Secretary to require a risk evaluation and mitigation strategy (REMS) related to packaging or safe disposal requirements for a drug with a "serious risk" of an adverse drug experience resulting from an overdose of the drug (accidental or intentional) or abuse of the drug. The Secretary could require that the drug be: (1) made available to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or (2) be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering the drug non-retrievable, if the Secretary determines that doing so may mitigate serious risk and that the drug is sufficiently available.

• Sec. 3041. Clarifying FDA Postmarket Authorities. This provision expands FDA's postmarket authorities concerning drugs that may have reduced efficacy over time. First, the provision amends the definition of an "adverse drug experience"² to include "any failure of expected pharmacological action of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling." Second, it provides FDA with authority to require a labeling change when the Secretary becomes aware of new information related to reduced effectiveness that the Secretary determines should be included in the labeling of a drug. Finally, this section requires FDA to issue guidance, within one year of enactment, regarding the circumstances under which FDA may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reductions could result in a change to the benefit-risk assessment.

II. Drug Enforcement Administration

• Title III, Subtitle B, Ch. 1. More Flexibility with Respect to Medication-Assisted Treatment for Opioid Use Disorders. This chapter provides for measures to increase avenues for medication-assisted treatment (MAT) of substance use disorders. It expands the types of waivered healthcare practitioners that can prescribe or dispense MAT and permits certain waivered practitioners to treat greater numbers of patients under certain conditions. Additionally, it establishes a grant program to support the development of curricula geared towards helping practitioners obtain a waiver to prescribe MAT. Finally, provided certain requirements are satisfied, it permits delivery of a prescription for an implantable or injectable controlled substance for maintenance or detoxification treatment by a pharmacy to an administering practitioner.

• Sec. 3212. Programs and Materials for Training on Certain Circumstances Under Which a Pharmacist May Decline to Fill a Prescription. This section authorizes the Secretary, in consultation with the Drug Enforcement Administration (DEA) and others, to develop and disseminate materials for pharmacists, healthcare providers, and patients regarding the circumstances under which a pharmacist may decline to fill a prescription for a controlled substance where the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or of suspicious origin. The materials shall include information on how to decline a prescription and the appropriate action to take following a denial, as well as information to other healthcare practitioners and the public on a pharmacist's ability to decline a prescription.

• Ch. 3. Safe Disposal of Unused Medication. This chapter includes provisions authorizing certain employees of a qualified hospice program to dispose of controlled substances on-site without being registered with DEA, subject to certain requirements. Further, DEA may issue guidance to assist hospice programs in complying with the disposal requirements. This chapter also mandates the GAO to conduct a study of hospice programs with regard to the management and disposal of controlled substances in the home of an individual receiving hospice care. The study, conducted no later than 18 months following enactment, shall include an overview of challenges for hospice programs related to disposal as well as an overview of the federal requirements applicable to hospice program disposal practices.

• Sec. 3232. Regulations Relating to a Special Registration for Telemedicine. Within one year after enactment, this section requires DEA in consultation with the HHS to promulgate final regulations addressing a special registration to permit healthcare providers to prescribe controlled substances via telemedicine in legitimate emergency situations.

• Sec 3241. Controlled Substance Analogues. This section amends the Controlled Substance Act by distinguishing factors that may be considered to determine whether a controlled substance analogue was intended for human consumption. If intended for human consumption, a controlled substance analogue is treated as a Schedule I controlled substance.

• Ch. 6. Access to Increased Drug Disposal. This chapter describes a grant program in which up to five states may apply to receive funding for programs designed to increase the participation of "authorized collectors"³ in the state. Grant amounts may only be used for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of authorized collectors.

• Ch. 7. Using Data to Prevent Opioid Diversion. This chapter requires DEA to provide drug manufacturers and distributors with anonymized information through the Automated Reports and Consolidated Orders Systems (ARCOS) to help such manufacturers and distributors to "identify, report, and stop suspicious orders of opioids and reduce diversion rates." DEA is required to update the anonymized information no less than on a quarterly basis. Manufacturers and distributors are required to review the information in connection with the requirements to identify, stop, and report suspicious orders and maintain effective controls against diversion.⁴ Failure to review the most recent ARCOS information made available by DEA is a prohibited act, subject to civil and criminal penalties. The provisions also increase civil and criminal penalties for manufacturers and distributors of opioids for failing to maintain effective controls against diversion of opioids, failing to report suspicious opioid orders, and failing to review the most recent ARCOS information made available by DEA. In addition, this chapter requires DEA to generate an analytic report once every six months on distribution patterns gathered in ARCOS and distribute it to attorneys general, as well as regulatory, licensing, and law enforcement agencies of States determined to have the highest rates of drug abuse.

• Sec. 3282. Strengthening Considerations for DEA Opioid Quotas. In establishing a production or procurement quota for a "covered controlled substance" (i.e., fentanyl, oxycodone, hydrocodone, oxymorphone, hydromorphone), this section requires DEA to estimate the amount of diversion of the substance in the United States. In reaching this estimate, the Secretary must consider rates of overdose deaths and abuse, and the overall public health impact. After estimating the amount of diversion, the Secretary shall make appropriate reductions from the quota that otherwise would have been established if diversion had not been considered. For any year in which the approved aggregate production quota is higher than the previous year, the AG must include in its final order an explanation of why the public health benefits of increasing the quota "clearly outweigh" the consequences of having an increased volume of covered controlled substances available for sale and potential diversion in the United States.

• Sec. 3292. Improvements to Prevent Drug Diversion. This section amends the Controlled Substances Act to codify the definition for a "suspicious order" of a controlled substance.⁵ A suspicious order "includes but is not limited to" an order of unusual size, pattern, or frequency, thus expanding the definition by statute. As currently required under DEA regulations, this section codifies that registrants shall design and operate a system to identify suspicious orders of controlled substances, and upon discovering a suspicious order (or series of orders), must notify the DEA Administrator and the Special Agent in Charge of the Division Office for the area in which the registrant is located or conducts business. Within one year of enactment, this section also requires DEA to establish a centralized suspicious order database. Additionally, DEA must share suspicious order reports with relevant State contacts for the purposes of State oversight and enforcement.

III. Centers for Medicare & Medicaid Services

A. Advancing Non-Opioid Alternatives

The law includes several sections aimed at advancing non-opioid alternatives under the Medicaid and Medicare programs, including:

• Sec. 1010. Enhancing Patient Access to Non-Opioid Treatment Options. By January 1, 2019, this section requires the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services (CMS), to issue one or more guidance documents to States regarding mandatory and optional items and services that may be provided under a Medicaid state plan or waiver for non-opioid treatment and management of pain. The guidance shall include, without limitation, "evidence-based, non-opioid pharmacological therapies and non-pharmacological therapies."

• Sec. 6012. Study on Abuse-Deterrent Opioid Formulations Access Barriers Under Medicare. Within one year of enactment, this section requires the Secretary to conduct a study and submit a report to Congress on the: (1) adequacy of access to abuse-deterrent opioid formulations for individuals enrolled in a prescription drug plan under Parts C and D, taking into account any barriers preventing access to such formulations (e.g., cost-sharing tiers, fail-first requirements, price, prior authorization); and (2) effectiveness of abuse-deterrent opioid formulations in preventing opioid abuse and misuse, the impact of abuse-deterrent formulations on the use and abuse of other prescription or illicit opioids, and other public health consequences of the use of abuse-deterrent opioid formulations (e.g., increase in rates of HIV).

• Sec. 6021. Medicare Opioid Safety Education. This section requires that the annual Medicare & You handbook for Medicare beneficiaries include "a description of categories of alternative, non-opioid pain management treatments covered under this title."

• Sec. 6072. Medicare Payment Advisory Commission Report on Opioid Payment, Adverse Incentives, and Data Under the Medicare Program. Not later than March 15, 2019, this section requires the Medicare Payment Advisory Commission (MedPAC) to report on: (1) Medicare payment for pain management treatments (opioid and non-opioid) in the inpatient and outpatient hospital settings; (2) incentives under the Medicare inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) for prescribing opioids and non-opioids, and recommendations for addressing any such adverse incentives that are identified; and (3) how opioid use is tracked and monitored through Medicare claims data and other mechanisms, and any areas in which further data/methods are needed for improving data and understanding of opioid use.

• Sec. 6082. Review and Adjustment of Payments under Medicare Outpatient Prospective Payment System to Avoid Financial Incentives to Use Opioids Instead of Non-Opioid Alternative Treatments. With respect to payments for covered outpatient department (OPD) services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification (APC), this section calls on the Secretary to review payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) to ensure that there are no financial incentives to use opioids instead of evidence-based non-opioid alternatives. If the Secretary identifies revisions to payments, then the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. This section also requires the Secretary to conduct a similar review for payments for such services in ambulatory surgical centers (ASC).

• Sec. 6084. Studying the Availability of Supplemental Benefits Designed to Treat or Prevent Substance Use Disorders under Medicare Advantage Plans. Within two years after enactment, this section requires the Secretary to develop a report evaluating the extent to which Medicare Advantage plans cover MAT and non-opioid alternative treatments as supplemental benefits. This analysis shall also explore the impact, if any, of increasing the rebate percentage applicable to plans offering such benefits, as well as other ways to incentivize and improve coverage of MAT and non-opioid alternative services.

• Sec. 6086. Dr. Todd Graham Pain Management Study. Within one year of enactment, this section requires the Secretary to conduct a study analyzing best practices, payment, and coverage for pain management services under Medicare Parts A and B. The Secretary is required to submit a report to Congress, containing legislative and administrative options for revising Medicare payment and coverage of multi-disciplinary, evidence-based, non-opioid treatments for acute and chronic pain management.

• Sec. 6092. Developing Guidance on Pain Management and Opioid Use Disorder Prevention for Hospitals Receiving Payment Under Part A of the Medicare Program. By July 1, 2019, this section requires the Secretary to develop guidance on pain management strategies and opioid use disorder prevention strategies for hospitals receiving payment under Medicare Part A.

• Sec. 6094. Technical Expert Panel on Reducing Surgical Setting Opioid Use; Data Collection on Perioperative Opioid Use. Within six months after enactment, the Secretary shall convene a technical expert panel to provide recommendations on reducing opioid use in the inpatient and outpatient surgical settings, and to develop best practices for pain management. The panel shall address a variety of topics, including approaches that limit patient exposure to opioids during the perioperative period. Not later than one year after enactment, the Secretary must submit a report to Congress containing recommendations developed during the panel and an action plan for broader implementation of pain management protocols that limit the use of opioids in the perioperative setting and upon discharge.

• Sec. 6102. Requiring Medicare Advantage Plans and Part D Prescription Drug Plans to Include Information on Risks Associated with Opioids and Coverage of Nonpharmacological Therapies and Non-opioid Medications or Devices Used to Treat Pain. Under current law, a prescription drug plan (PDP) sponsor must disclose to each enrollee, at the time of enrollment and annually, certain information related to such plan. ⁶ For plan years 2021 and after, this section requires the disclosure to include the risks associated with prolonged opioid use, coverage of nonpharmacological therapies, devices, and non-opioid medications under Medicare Advantage (for a MA-PD plan) or Medicare Parts A and B (for a Part D plan).

• Sec. 7091. Emergency Department Alternatives to Opioids Demonstration Program. This section authorizes the Secretary to carry out a demonstration program that awards grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that limit the use and prescription of opioids in emergency departments. Within one year of the completion of the demonstration, this section requires the Secretary to submit a report to Congress on the results of the demonstration project.

B. Prescribing Practices

The law includes the following sections related to the prescribing of opioids and other controlled substances:

• Sec. 2003. Every Prescription Conveyed Securely. This section requires that beginning on January 1, 2021, all prescriptions for Schedule II, III, IV, or V controlled substances under either a Medicare Part D plan or Medicare Advantage Prescription Drug Plan (MA-PD) be transmitted in accordance with an electronic prescription drug program. The Secretary may waive the requirement in defined scenarios, such as concerns over prompt patient access to a prescription or reasonable technological limitations. The section's requirements do not affect the ability of pharmacists to dispense covered medications from otherwise valid prescriptions in any format.

• Sec. 3002. Evidence-Based Opioid Analgesic Prescribing Guidelines and Report. This section requires the FDA Commissioner to develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the relevant therapeutic areas where such guidelines do not exist. In developing the guidelines, the Commissioner shall consult with stakeholders, collaborate with the Centers for Disease Control and Prevention (CDC) and other federal agencies, and provide for a public notice and comment period. Within one year after enactment, the Commissioner shall submit to Congress, and post on a public website, a report on how FDA will use the guidelines to protect the public health, and a description of the public health need with respect to each such indication-specific treatment guideline.

• Sec. 5042. Medicaid Providers Are Required to Note Experiences in Record Systems to Help In-Need Patients. This section mandates that Medicaid providers, using a qualified prescription drug monitoring program (PDMP), check the prescription drug history of a covered patient before prescribing a controlled substance beginning in October 1, 2021. The provision also provides detailed criteria which a PDMP must meet in order to be considered a qualified PDMP. The Secretary must clarify how the PDMP requirement will comply with relevant privacy statutes, such as HIPAA. The Secretary is also required to waive PDMP obligations in the case of natural disasters or in the provision of emergency services. Each State must, in their annual report to the Secretary, include information about provider compliance with PDMP requirements, as well as trends in the prescribing of controlled substances. The CMS Administrator, by October 1, 2023, is required to publish guidance on how States can increase compliance with PDMP rules and utilize the program to reduce abuse of controlled substances. The CMS Administrator, in consultation with CDC, is further required, by October 1, 2019, to issue guidance on best practices for use of PDMPs and the protection of patient information.

• Sec. 6052. Grants to Provide Technical Assistance to Outlier Prescribers of Opioids. This section authorizes the Secretary, through the CMS Administrator, to awards grants, contracts, or cooperative agreements to eligible entities to educate and provide outreach to outlier prescribers about best practices for prescribing opioids and about non-opioid pain management.

• Sec. 6065. Commit to Opioid Medical Prescriber Accountability and Safety for Seniors. Within two years of enactment, this section requires the Secretary to annually notify prescribers who have been identified as outlier prescribers of opioids. Prescribers persistently identified as outliers are subject to additional educational programs and may be required to enroll in the program under section 1866(j) of the Social Security Act, which can result in screening and enhanced oversight. The Secretary is further required to make aggregate information about outlier prescribers available to the public on the CMS website.

• Sec. 6095. Requiring the Posting and Periodic Update of Opioid Prescribing Guidance for Medicare Beneficiaries. Within 180 days after enactment, this section requires the Secretary to publish on the CMS website all Department of Health and Human Services (HHS) guidance published on or after January 1, 2016 related to the prescribing of opioids and applicable to opioid prescriptions under Medicare Parts A and B. In consultation with stakeholders (e.g., medical professional organizations, provider and suppliers of services, healthcare consumers), the Secretary shall periodically update such guidance.

• Sec. 7024. Study on Prescribing Limits. Not later than two years after enactment, this section requires the Secretary, in consultation with the Attorney General, to submit a report to Congress on the impact of federal and state laws and regulations that limit the length, quantity, or dosage of opioid prescriptions. This report shall address the impact of such limits on opioid use and abuse, patient access to treatment, whether such limits lead to significant increases in burdens for prescribers, and the impact of such limits on diversion or misuse of Schedule II, III, and IV controlled substances.

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Although focused on opioids, the SUPPORT for Patients and Communities Act includes provisions that will have a broader impact on drug manufacturers and marketers, as well as clinical researchers and healthcare providers. Companies will want to closely analyze the legislation and keep abreast of agency implementation in order to manage the potential impact of these new authorities and obligations.

© Arnold & Porter Kaye Scholer LLP 2018 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.