The Congressional Research Service (CRS) recently released a report on the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act (the Act). The Act includes: 1) greater oversight of opioid production and distribution; 2) additional reporting and safeguarding requirements to address fraud; 3) limits on coverage for prescription opioids; 4) expansion of coverage for opioid addiction treatment services; and 4) increases to consumer and provider education on opioid use and treatment of individuals with opioid use disorders (OUD). The CRS report summarizes the Act’s provisions that effect Medicare. Summaries of major report provisions in the Act include the following:
Medicare Coverage of Opioids and OUD Treatment
The Department of Health and Human Services (HHS) has taken steps to reduce opioid overutilization in Medicare. For example, HHS has developed a voluntary opioid overutilization monitoring system where Centers for Medicare & Medicaid Services (CMS) and Part D plan sponsors can track enrollees’ use of opioids and enact individual case management or review, when necessary. In addition, HHS, Congress, and outside experts have focused on provider and beneficiary education to combat overutilization. HHS has also focused on medication-assisted treatment (MAT), a combination of medication and counseling treatments. However, Medicare does not currently cover MAT services in federally registered opioid treatment programs (OTP) or methadone clinics.
Medicare Provisions of the Act
The Act implements changes to Medicare to expand coverage and increase oversight through limitation of prescriber and beneficiary overutilization. The significant changes include the following:
- Creating a bundled payment for MAT, including services provided in federally funded OTPs. The payment will be effective in 2022;
- Requiring Part D plans to administer lock-in programs, effective in 2022, which require high-risk enrollees to receive prescriptions from only a limited list of pharmacies;
- Requiring Medicare Part D prescribers to use electronic prescribing (e-prescribing) for controlled substances, starting in 2021; and
- Allowing Part D plans to suspend payments to pharmacies if the pharmacy has a credible allegation of fraud, beginning in 2020.
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Medicare Provisions to Address the Opioid Crisis
Section 2001: Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders. The Act amends the Social Security Act (SSA) to eliminate the requirement that an originating site must either be, located in a rural health professional shortage area or a county not included in a Metropolitan Statistical Area, when the telehealth service is furnished to treat the substance use disorder (SUD) or co-occurring mental health disorders. The interim final rule gives HHS the authority to implement the modifications immediately.
Section 2002: Comprehensive Screenings for Seniors. The Act amends the SSA to include a review of beneficiary’s current opioid prescriptions in the beneficiary’s Initial Preventative Physical Examination (IPPE). In addition, the amendment adds “screening for potential SUDs” as a required element of the IPPE. The Act also amends the annual wellness visit authority to include the same review of the beneficiary’s current opioid prescriptions as the IPPE, as well as “screenings for potential substance use disorders and referral for treatment as appropriate.” These new requirements will apply to visits occurring on or after January 1, 2020.
Section 2003: Every Prescription Conveyed Securely. The Act amends the SSA to require that a prescription for a Part D covered Schedule II, III, IV, or V controlled substance must be transmitted electronically, in accordance with an approved electronic prescription drug program for drugs prescribed on or after January 1, 2021. The amendment allows for waivers to the e-prescribing requirement in certain circumstances. The Secretary will define the circumstances where the waiver may apply, including the following:
- Where the prescriber and dispenser are the same entity;
- Prescriptions that cannot be electronically transmitted due to constraints of recently implemented National Council for Prescription Drug Programs (NCPDP) standards, known as NCPDP SCRIPT;
- Prescriptions by a provider who receives a one-year waiver or renewal of waiver due to economic hardship, technological limitations not within the control of the practitioner, or other exceptional circumstances;
- Situations where the practitioner reasonably determines that it would be impractical for the individual to obtain substances prescribed electronically in a timely manner, and the delay would adversely impact the individual’s medical condition;
- Prescriptions under a research protocol;
- Prescriptions that the Food and Drug Administration (FDA) requires to contain certain elements that cannot be accomplished with e-prescribing; and
Prescriptions provided to individuals who receive hospice care that is not covered under the title or are residents of a nursing facility and are dually eligible for Medicare and Medicaid. The analysis will be based on claims issued under valid National Provider Identifiers (NPI).”
Section 6062: Electronic Prior Authorization for Covered Part D Drugs. The Act amends the SSA to require Medicare Part D e-prescribing systems to allow for processing of formulary prior authorization requirements. Starting no later than January 1, 2021, the Medicare Part D e-prescribing system is to provide secure electronic transmissions of prior authorization requests from the prescribing professional to the plan sponsor, and of responses from the plan to the prescribing professional.
Section 2004: Requiring Prescription Drug Plan Sponsors Under Medicare to Establish Drug Management Programs for At-Risk Beneficiaries. The Act amends the SSA to require Part D plans to implement lock-in programs for beneficiaries at risk of misuse or abuse of opioids. The lock-in plans allow Part D plans to limit the number of pharmacies and prescribers that an at-risk beneficiary can use for plans, beginning on or after January 1, 2022.
Section 2006: Encouraging Appropriate Prescribing Under Medicare for Victims of Opioid Overdose. The Act amends the SSA to require Part D plans to implement drug management programs for Part D-eligible individuals with a previous history of opioid-related overdoses and who are not exempted from the lock-in requirements. The Secretary will identify the Part D-eligible individuals that have a history of opioid-related overdoses and notify the Part D sponsor of the identification, beginning no later than January 1, 2021.
Section 2007: Automatic Escalation to External Review Under a Medicare Part D Drug Management Program for At-Risk Beneficiaries. The Act amends the SSA to expedite appeals for Part D enrollees deemed to be at risk for opioid abuse. Individuals can appeal their designation as an at-risk enrollee. Appeals that have been denied will automatically be forwarded to an independent, outside entity that is contracted with the Secretary. The policy change will apply no later than January 1, 2021.
Section 2005: Medicare Coverage of Certain Services Furnished by Opioid Treatment Programs. The Act amends the SSA to create Medicare coverage for items and services the OTP provide for OUD treatment. The Medicare covered OTP services will include the following: 1) dispensation and administration of various FDA-approved MAT drugs; 2) SUD counseling authorized under state law; 3) individual and group therapy; 4) toxicology testing; and 5) other items and services HHS determines appropriate. In addition, beginning on or after January 1, 2020, Medicare will pay OTPs 100 percent, less any beneficiary co-payments, of a bundled payment for OUD treatments for a Medicare beneficiary, during an episode of care.
Section 2008: Suspension of Payments by Medicare Prescription Drug Plans and MA-PD Plans Pending Ending Investigations of Credible Allegations of Fraud by Pharmacies. The Act amends the SSA to authorize Medicare Part D plan sponsors to suspend payments to pharmacies in the plans’ networks, pending the investigation of a credible fraud allegation. Once a suspension of payment has occurred, the Part D plan sponsor must notify the Secretary. In addition, Part D plan sponsors may conduct post-payment review of the suspected pharmacy’s Part D claims, when a Part D plan sponsor suspends payments pending a credible fraud allegation investigation.
Title IV: Offsets
Section 4002: Requiring Reporting by Group Health Plans of Prescription Drug Coverage Information for Purposes of Identifying Primary Payer Situations Under the Medicare Program. The Act amends the SSA to require group health plan sponsors to identify situations where the plans may be the primary payer for benefits relating to Medicare Part D prescription drug coverage. This provision is effective starting January 1, 2020.
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Title VI: Other Medicare Provisions
Section 6001: Testing of Incentives Payments for Behavioral Health Providers for Adoption and Use of Certified Electronic Health Record Technology. The Act amends the SSA to expand the list of Center for Medicare and Medicaid Innovation-tested models to include a model that provides incentive payments to behavioral health providers, in exchange for the providers’ adoption and use of certified electronic health record technology.
Section 6012: Study on Abuse-Deterrent Opioid Formulations Access Barriers Under Medicare. The Act requires the Secretary to provide Congress with a study determining whether Part D enrollees with chronic pain have adequate access to abuse-deterrent opioids, no later than one year after enactment. The study will: 1) consider barriers to the use of abuse-deterrent opioids; 2) assess the effectiveness of abuse-deterrent opioid formulations in preventing opioid abuse or misuse; 3) assess the impact of abuse-deterrent opioid formulations on the use or abuse of other prescription or illicit opioids; and 4) evaluate other possible public health consequences of abuse-deterrent opioids.
Section 6021: Medicare Opioid Safety Education. The Act amends the SSA to require the Secretary, beginning in 2019, to provide educational resources in the annual notice on topics including opioid use, pain management, and alternative pain management treatments. The annual notice must include a suggestion that Medicare beneficiaries consult with a physician on opioid use and pain management.
Section 6032: Action Plan on Recommendations for Changes Under Medicare and Medicaid to Prevent Opioids Addictions and Enhance Access to Medication-Assisted Treatment. Under the Comprehensive Addiction and Recovery Act of 2016 (CARA), the Secretary was required to establish a Pain Management Best Practices Inter-Agency Task Force (Pain Task Force). The Act requires the Secretary to collaborate with the Pain Task Force to create an action plan and recommendations on changes to Medicare and Medicaid to prevent opioid addiction and increase access to MAT. Within three months of the Act’s enactment, the Secretary must convene a public stakeholder meeting and seek public feedback on the methods in which CMS can address the opioid crisis through the development and application of the action plan. In addition, before June 1, 2020, the Secretary must submit to Congress and make public a report that: 1) summarizes the results of the action plan review and any recommendations; 2) identifies the action plan’s next steps; and 3) evaluates prices trends for drugs used to reverse opioid overdoses and makes recommendations to lower consumer costs.
Section 6042: Opioid Use Disorder Treatment Demonstration Program. The Act amends the SSA to require the Secretary to conduct a four-year demonstration project on ways to increase Medicare beneficiary access to OUD treatment services, improve beneficiary physical and mental health outcomes, and reduce Medicare expenditures. The Secretary must initiate the demonstration project beginning no later than January 1, 2020.
Section 6052: Grants to Provide Technical Assistance to Outlier Prescribers of Opioids. The Act authorizes CMS to award grants, contracts, or cooperative agreements to eligible entities. Eligible entities include, organizations with demonstrated experience in providing technical assistance to health care professionals on a state and regional basis that have at least one consumer representative and one health care provider representative on their governing bodies, and contracted quality improvement organizations.
Section 6065: Commit to Opioid Medical Prescriber Accountability and Safety for Seniors. The Act amends the SSA to require the Secretary, in consultation with stakeholders, to establish technical thresholds for identifying Part D opioid prescribers that are outliers compared to other prescribers in a specific geographic area or practice specialty. The analysis will be based on opioid claims issued under valid National Provider Identifiers (NPI). However, the analysis will exclude claims for Part D enrollees who receive hospice care or are under treatment for cancer, and from prescribers who are the subject of a CMS or HHS Office of Inspector General (OIG) investigation. Starting on January 1, 2021, the Secretary will provide annual notification to prescribers identified as opioid outliers. Prescribers that have been persistently identified as opioid outliers may be required to enroll in a program that has enhanced oversight and monitoring. However, enrollment in such a program will only be required after other remedies have been attempted, including education on opioid prescribing best practices.
Section 6063: Program Integrity Transparency Measures Under Medicare Parts C and D. The Act amends the SSA to require the Secretary, within two years of the enactment date, to establish a secure website portal to communicate and facilitate data sharing with Medicare Advantage (MA) plans and Part D drug-only plans (PDP), and Medicare Drug Integrity Contractors (MEDIC). In addition, the website will enable MA plans and PDPs to refer provider or supplier fraud, waste, and abuse activities to MEDICs, to initiate or assist in investigations. MA organizations and PDP sponsors will have to submit information to the Secretary regarding credible evidence of suspected fraud and other actions related to inappropriate opioid prescribing, beginning with plan year 2021.
Section 6064: Expanding Eligibility for Medication Therapy Management Programs Under Part D. Medicare Part D plans, with some exceptions, are required to offer Medication Therapy Management (MTM) programs, to provide coordinated pharmacy care for patients with multiple medical conditions that may be seeing multiple practitioners and taking multiple covered drugs. The Act amends the SSA to add Part D enrollees identified as at risk of prescription drug abuse, to the list of targeted MTM program enrollees, effective January 1, 2021.
Section 6072: Medicare Payment Advisory Commission Report on Opioid Payment, Adverse Incentives, and Data Under the Medicare Program. The Act requires the Medicare Payment Advisory Commission (MedPAC) to submit a report to Congress on: 1) Medicare’s payment for pain management treatments in inpatient and outpatient hospital settings; 2) incentives for prescribing opioids and non-opioid treatments under hospital inpatient and outpatient payment systems and recommendations to address adverse incentives; and 3) how to track and monitor opioid use through Medicare claims data and other mechanisms. The report musts be submitted to Congress no later than March 15, 2019.
Section 6082. Review and Adjustment of Payments Under the Medicare Outpatient Prospective Payment System to Avoid Financial Incentives to Use Opioids Instead of Non-opioid Alternative Treatments. The Act amends the SSA to require the Secretary to review Medicare payments made to hospitals through the Outpatient Prospective Payment System (OPPS) and ambulatory surgery centers (ASC), to ensure there are no financial incentives to use opioids instead of evidence-based non-opioid alternatives. If the Secretary identifies such financial incentives, then the Secretary must revise the OPPS and ASC payments through rulemaking. In addition, the Secretary must review payments for services covered under the OPPS and ASC systems, to ensure there are no financial incentives to use opioids instead of evidence-based non-opioid alternatives for pain management. If the Secretary identifies revisions to payments for services that satisfy this condition, the Secretary will make such revisions for services furnished on or after January 1, 2020.
Section 6083. Expanding Access Under the Medicare Program to Addiction Treatment in Federally Qualified Health Centers and Rural Health Clinics. The Act amends the SSA to authorize the Secretary to pay for training costs of qualified physicians and practitioners working in Federal Qualified Health Centers (FQHC) or Rural Health Clinics (RHC) that want to obtain DATA 2000 waivers to provide OUD treatment services. FQHCs and RHCs must submit a formal application to the Secretary to receive payment. For each qualified FQHC or RHC physician or practitioner, the Secretary may make one DATA 2000 waiver payment. For physicians or practitioners to qualify for DATA 2000 waiver payments, they must: 1) be employed by or working under contract with a FQHC or RHC that applies for payment; and 2) have first received a DATA 2000 waiver on or after January 1, 2019.
Section 6084: Studying the Availability of Supplemental Benefits Designed to Treat and Prevent Substance Use Disorders Under Medicare Advantage Plans. The Act required the Secretary to submit a report to Congress, no later than two years after enactment, on the availability of supplemental benefits under MA plans that are designed to treat and prevent substance abuse disorders (SUD). In addition, the report must address any differences in the availability of such supplemental benefits between Dual-Eligible Special Needs Plans (D-SNP) and plans that are not D-SNPs. The report must include the following:
- The extent to which MA plans offer coverage of MATs for opioid use, SUD counseling, peer recovery support services, other forms of SUD treatments, and non-opioid alternative pain treatments;
- Challenges associated with offering those supplemental benefits;
- The impact, if any, on the availability of such benefits, if rebates for plans that offer such coverage increases; and
- Ways to potentially improve coverage of such supplemental benefits.
Section 6085: Clinical Psychologist Services Models Under the Center for Medicare and Medicaid Innovation; Government Accountability Office Study and Report. The Act amends the SSA to require the Secretary to educate and inform Medicare beneficiaries about coverage of clinical psychologist services under Medicare Part B. The Secretary must discover ways to avoid unnecessary hospitalizations or emergency department visits for mental and behavioral health services, through a 24-hour, 7-day-a-week help line that may inform beneficiaries of available treatment options, including psychologist services. Further, the comptroller general, no later than 18 months after enactment, must submit a report to Congress on mental and behavioral health services under Medicare, including information about services furnished by psychiatrists, clinical psychologists, and other professionals furnished services and ways to familiarize Medicare beneficiaries of the availability of Medicare payment coverage for clinical psychologist services.
Section 6086: Dr. Todd Graham Pain Management Study. The Act requires the Secretary to conduct a comprehensive study, no later than one year after enactment, to address best practices, payment, and coverage of pain management service under Medicare Parts A and B. The Secretary must also submit, to the House Ways and Means and Energy and Commerce Committees and Senate Finance Committee, a report that discusses options for revising Parts A and B payments to providers and suppliers, and Medicare coverage related to multidisciplinary, evidence-based, non-opioid treatments for acute and chronic pain management.
Section 6092: Developing Guidance on Pain Management and Opioid Use Disorder Prevention for Hospitals Receiving Payment Under Part A of the Medicare Program. The Act requires the Secretary, no later than January 1, 2019, to develop and publish guidance regarding pain management and OUD prevention strategies for hospitals receiving Medicare Part A payment.
Section 6093: Requiring the Review of Quality Measures Relating to Opioids and Opioid Use Disorder Treatments Furnished Under the Medicare Program and Other Federal Health Care Programs. The Act amends the SSA to require the Secretary, no later than 180 days after enactment, to establish a technical expert panel to review opioid and OUD related quality measures. The expert panel must: 1) review existing opioid-related quality measures and those under development; 2) identify gaps and measure development priorities; and 3) recommend quality measure for use under specified Medicare quality programs. In addition, the Secretary must consider: 1) using opioid and OUD measures in Medicare quality programs; 2) prioritizing measure development where the technical panel identifies gaps; and 3) prioritizing National Quality Forum endorsement of measures relating to opioids and OUD.
Section 6094: Technical Expert Panel on Reducing Surgical Setting Opioid Use; Data Collection on Perioperative Opioid Use. The Act requires the Secretary, no later than six months after enactment, to convene a technical expert panel to provide recommendations regarding the reduction of opioid use in inpatient and outpatient settings and best practices for pain management. The Secretary must submit to Congress and make public a report regarding the panel’s recommendations and an action plan for implementation of pain management protocols that limit opioid use in the perioperative settings and at discharge. In addition, the Secretary must submit a report to Congress on perioperative opioid use.
Section 6095: Requiring the Posting and Periodic Update of Opioid Prescribing Guidance for Medicare Beneficiaries. The Act requires the Secretary, within 180 days of enactment, to post all HHS guidance relating to opioid prescribing and applicable opioid prescriptions for Medicare beneficiaries, published on or after January 1, 2016. The guidance must be posted on the CMS public website. In addition, the Secretary must periodically update and revise the postings as the Secretary deems appropriate, in consultation with medical professional organizations, providers, and suppliers of services, consumers or consumer advocates, and other entities.
Section 6102: Requiring Medicare Advantage Plans and Part D Prescription Drug Plans to Include Information on Risks Associated with Opioids and Coverage of Non-pharmacological Therapies and Non-opioid Medications or Devices Used to Treat Pain. The Act amends the SSA to require Medicare Part D plans to provide certain information to enrollees regarding the treatment of pain, including the risks of prolonged opioid use and coverage of non-pharmacological therapies, devices, and non-opioid medications. Plan sponsors must provide this information beginning in plan year 2021.
Section 6103: Requiring Medicare Advantage Plans and Prescription Drug Plans to Provide Information on the Safe Disposal of Prescription Drugs. The Act amends the SSA to require information on safe disposal of controlled substances. MA and MA plans that include a Part D benefit (MA-PD) plans must ensure that information on the safe disposal of prescription drugs that are controlled substances are included in the in-home health risk assessments MA plans conduct, on or after January 1, 2021. In addition, starting with plan years beginning on or after January 1, 2021, Part D plan MTM programs must provide information to enrollees on the safe disposal of prescription drugs that are controlled substances, including information regarding approved drug takeback programs, in-home disposal, and cost-effective means for enrollees to safely dispose of such drugs.
Section 6104: Revising Measures Used Under the Hospital Consumer Assessment of Healthcare Providers and Systems Survey Relating to Pain Management. The Act amends the SSA to require that any Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey that is conducted on or after January 1, 2020, as part of the Medicare Hospital Inpatient Quality Reporting program, may not include questions regarding communication between hospital staff and patients about pain. However, the questions can consider whether the patient that experienced the pain was informed of the associated risks with opioid use and non-opioid alternatives for pain treatment. Further, the Act prohibits the Secretary from including on Hospital Compare and in the Hospital Value-Based Purchasing Program, any measures based on questions from the 2018 or 2019 HCAHPS survey communication from hospital staff with a patient regarding the patient’s pain.
Section 6111: Fighting the Opioid Epidemic with Sunshine. The Act amends the SSA to expand the definition of “covered recipient” to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, excluding employees of applicable manufacturers. Further, the Act ends the exclusion of NPIs of covered recipients on the Open Payments website, a searchable publicly available website that includes submitted information regarding the Open Payments program. The exclusion of NPIs from the Open Payments website will only apply to information submitted prior to January 1, 2022.
The report is available at: https://fas.org/sgp/crs/misc/R45449.pdf