Newly Proposed Rules Regarding Opioid Treatment Programs

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) issued new proposed rules for the coverage of opioid use disorder treatment through an opioid treatment program and the enrollment of opioid treatment programs as Medicare providers.¹ CMS estimates that there are more than 300,000 beneficiaries diagnosed with opioid use disorders, and that Medicare beneficiaries and Medicaid recipients make up the “fastest growing” population for opioid use disorders. Pursuant to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT Act”), opioid use disorder treatment through opioid treatment programs are going to be a covered medical service in an effort to expand access to treatment. This article highlights some of the key features of the proposed rule that providers need to be aware of. However, this article is not a comprehensive overview of the entire proposed rule.

I. Expansion of Covered Services to Include OTPs

Pursuant to the Section 2005 of the SUPPORT Act, a new Medicare Part B benefit was established to cover opioid use disorder (“OUD”) treatment services furnished by an opioid treatment program (“OTP”).²

The amendment defines OUD treatment services as “items and services that are furnished by an [OTP] for the treatment of [OUD], including”:

1. Opioid agonist and antagonist treatment medication (including oral, injected, or implanted versions) that are approved by the FDA to treat OUD;
2. Dispensing and administering the medication;
3. Substance use counseling by a professional authorized under State law;
4. Individual and group therapy with a physician, psychologist, or other mental health professional under authorized State law;
5. Toxicology testing; and
6.Other items and services approved by the Secretary of Health and Human Services (the “Secretary”), but not including meals or transportation.³

In order to qualify as an OTP, the program or practitioner must be engaged in OUD treatment with an opioid agonist medication and be registered under 21 U.S.C. § 823(g)(1). This does not include practitioners waived to provide treatment under 21 U.S.C. § 823(g)(2) (known as “DATA Waived”).

Currently, there are three FDA approved medications: buprenorphine, methadone, and naltrexone. Buprenorphine is a Schedule III controlled substance and is FDA approved to treat acute and chronic pain and opioid dependence. Methadone is a Schedule II controlled substance and FDA approved to treat severe pain and opioid dependence. Naltrexone is a non-controlled substance that is FDA approved to treat alcohol dependence. Historically, because Methadone was neither administered by a physician, administered as incident to a physician’s services, nor dispensed by a pharmacy, it has not been covered under Medicare Part B or Part D.

A. Provider Agreements

The SUPPORT Act also amended the Social Security Act to include an OTP as a provider of services.⁴ This means that an OTP must enter into a provider agreement with Medicare. The Medicare Regulations which apply to providers also applies to OTPs seeking Medicare Reimbursements, such as limitations on charges to beneficiaries.

B.Bundled Payment

The SUPPORT Act requires CMS to reimburse OTPs “an amount equal to 100 percent of a bundled payment” for OUD treatment services during an episode of care.⁵ Thus, this would include the medication, the dispensing or administration of the medication, the counseling, therapy, and toxicology testing.

CMS is proposing to calculate the bundled payment amount based on the drug and non-drug components. This may, in part, be “based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug).”⁶ The methodology used to calculate the bundled payment will be part of the final regulation, currently proposed as 42 C.F.R. § 410.67.

The drug component will be based on multiple factors, including but not limited to:

•  the type of medication;
•  the appropriate dosage for the medication (100 mg daily dose of methadone, 10 mg daily dose of oral buprenorphine, 100 mg monthly dose of injected buprenorphine, 74.2 mg for a six month buprenorphine implant, and 380 mg monthly dose for injectable naltrexone);
•  drug pricing data;
•  whether it is a Part B drug; and
•  whether it is a Part D covered oral drug.

The non-drug component is being proposed based on the TriCare daily cost and converted to a weekly rate of $126.

CMS is proposing that an episode of care would be within a contiguous seven-day period (one week) that can start on any day of the week. CMS is also proposing that in a given episode period there should be one counseling session, one individual therapy session, and one group therapy session. CMS proposes that one toxicology test per month be performed as part of the bundled service. Once an OTP has performed a majority of the services over the course of a week, it could bill for one episode of care.

CMS is also proposing partial episodes of care. Where an OTP has provided one or more items or services (for instance medication and dispensing of that medication), but less than a majority of the services, the OTP could bill for a partial episode of care. CMS is also proposing a non-drug episode of care, to cover instances when a patient is on a lower amount of medication, such as once-a-month implantation, but other services are being provided that would be within the bundled service. Adjustments to the bundled payments using add-on codes for additional counseling or therapy sessions to treat a patient are also being considered.

Finally, to increase access, CMS is proposing a cost-sharing payment of zero for a time-limited duration. CMS also recognizes that there may be adjustments to the bundled payments based on locality, the drug component, the non-drug component, and annual changes in cost.

C. Telemedicine/Telehealth

CMS is proposing that OTPs be permitted to furnish counseling services, individual therapy, and group therapy using a qualified telehealth visit.⁷ The proposal would not include the dispensing or administering of medications and would not change telemedicine rules as to the dispensing of controlled substances

II. Medicare Enrollment for OTPs

The second part of the Proposed Rule discusses how an OTP becomes an enrolled provider. First, the OTP must meet all SAMHSA requirements, including accreditation and certification. Failure to obtain accreditation and certification or loss of either will be a basis of termination of the provider agreement.

Second, the OTP must obtain a provider agreement like all other providers. The OTP will file a Form CMS-855B and include a list of all physicians and eligible professionals who will be legally authorized to prescribe, order, dispense, or administer medications to patients for the OTP. Also, the OTP will be required to certify that it meets and will continue to meet all obligations of enrollment. This is to ensure that the OTP maintains an active compliance program.

CMS is proposing that OTPs fall into the high risk for fraud, waste, and abuse. This means that as part of the enrollment process, an OTP must verify that:

•  it meets all applicable Federal and State requirements;
•  it verifies the licenses of all providers;
•  it conducts checks on all practitioners to ensure he/she continues to meet enrollment requirements (for example, that the provider is not excluded);
•  CMS will conduct on-site visits; and
•  that fingerprints and a background check on all individuals with a five percent or greater direct or indirect (e.g., through a debt instrument or ownership of a parent company) ownership in the OTP are submitted.

However, when a re-enrollment occurs, CMS is proposing that only a moderate level screening is required, which does not include fingerprinting or background checks.

OTPs will be required to identify all managing employees that control the day-to-day operations of the OTP, regardless of whether that person is a W-2 employee or 1099 contractor. OTPs will not be permitted to employ or contract with an individual: (1) who is currently excluded; (2) whose Medicare billing privileges are revoked under 42 C.F.R. § 424.535; (3) who is on the preclusion list under 42 C.F.R. § 4222.222 or 423.120; (4) who has any adverse action against him/her by a state licensing board that CMS determines would be a detriment; or (5) who has been convicted within the preceding 10 years of an offense that is detrimental to the best interest of the Medicare program. “Conviction” means a judgment of a court, a finding of guilt by any court, a plea of guilty or nolo contendere in any court, or participation in a deferred adjudication program.⁸ Crimes considered to be “detrimental to the best interest of the Medicare program” include, but are not limited to:

•  felony crimes against persons, such as murder, rape, assault, and other similar crimes;
•  financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes;
•  any felony that placed the Medicare program or its beneficiaries at immediate risk, such as a malpractice suit that results in a conviction of criminal neglect or misconduct; or
•  any felonies that would result in mandatory exclusion.⁹

Requests for Comments

CMS is requesting comments on all the proposed changes, including:

•  On its discretionary authority to include other items or services in the list of covered services;
•  On including the initial intake activities (such as the initial physical examination, initial assessment, and development of the treatment plan) as a part of the covered services;
•  On telehealth services; and
•  On including other medications or biologicals approved by the FDA for OUD treatment which are not opioid agonist or opioid antagonists.¹⁰

Effects of the Changes

Should the proposed changes go into effect, there will be an increase in treatment of OUD, particularly given that Medicare and Medicaid enrollees are considered the fastest growing population with an OUD diagnosis. However, with increased access and coverage comes increased regulatory and administrative requirements.

To make sure your compliance plan conforms to these new rules, rely on Chapman Law Group’s unique perspective in health care compliance, Controlled Substance Act requirements, and OUD treatment practices. Call us today.

¹ Medicare Program; CY 2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations, CMS-1715-P (July 29, 2019).
² 42 U.S.C. § 1395x(s)(2)(HH).
³ 42 U.S.C. § 1395x(jjj)(1).
⁴ 42 U.S.C. § 1395cc(e)(3).
⁵ 42 U.S.C. § 1395m.
⁶ 42 U.S.C. § 1395m(w)(2).
⁷ See 42 C.F.R. §§ 410.78 & 414.65; see also https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/TelehealthSrvcsfctsht.pdf?utm_campaign=2a178f351b-EMAIL_CAMPAIGN_2019_04_19_08_59&utm_term=0_ae00b0e89a-2a178f351b-353229765&utm_content=90024810&utm_medium=social&utm_source=facebook&hss_channel=fbp-372451882894317.
⁸ 42 C.F.R. § 1001.2.\
⁹ 42 C.F.R. 424.535(a)(3).
¹⁰ This proposal is meant to increase innovation and novel mechanisms for treatment.