Behavioral Health Advisor: The Guide to Navigating Compliance Quarterly Webinar February 13, 2018
Today’s Presenters Shannon Mace , Senior Advisor, National Council for Behavioral Health Dianne Pledgie , Compliance Counsel, Feldesman Tucker Leifer Fidell LLP
Navigating the Control Panel Your Participation The GoToWebinar Control Panel allows attendees to interact with their session. Submit questions and comments via the Questions panel. Note: Today’s presentation is being recorded and will be made available within 48 hours.
Agenda • Sign of the Times: – Addiction & Recovery Treatment: State of the field • In the Field: – Peer Support Staff: Compliance considerations – Updates • The Upshot: – Recent enforcement actions involving addiction and recovery providers • Due Process: – Update and discussion on 42 CFR Part 2 • Resources • Questions and answers
Sign of the Times
Sign of the Times
In the Field
Peer Support Staff: Compliance Considerations • Compliance issues and nonissues related to hiring peer supports and recovery specialists • Hiring individuals with lived experience – Bona fide occupation qualification (BFOQ) – Open-ended questions that do not trigger EEOC or ADA issues • Creating a healthy work environment for peers – Training – Supervision – Reasonable accommodations – Clearly defined roles and responsibilities
In the Field: Updates • CMS authorized work requirements in Medicaid program – CMS approved Indiana and Kentucky’s waivers with work requirements • The Department of Health and Human Services provided updated guidance on HIPAA and behavioral health – Includes resources for professionals, patients and family members – Includes information related to opioid abuse and mental health
The Upshot
Recent Enforcement Actions Involving Addiction and Recovery Providers
Anti-Kickback Triggered by Test Cups • Two organizations, Addiction Medical Care of Norwalk (AMC) and Parallax Center, Inc. entered into settlements with the OIG due to Anti-Kickback and Stark violations for receiving point of care test cups from Millennium Laboratories – AMC entered into a nearly $80,000 settlement – Parallax entered into a $64,000 settlement • Cautionary tale about the risk of “gifts”
Drug Testing Overbilling • APT Foundation, Inc. in Connecticut entered into an $883,859 settlement due to overbilling for urine drug testing. • Drug testing was already included in the weekly bundled rate, but APT was also billing for testing as a separate service through a third-party lab. • Several provider bulletins were published about billing prior to APT’s actions.
Due Process
42 CFR Part 2: Compliance Fundamentals
DISCLAIMER This training has been prepared by the attorneys of Feldesman Tucker Leifer Fidell LLP. The materials are being issued with the understanding that in conducting this training program the authors are not engaged in rendering legal services. If legal assistance is required, the services of a competent attorney should be sought.
AGENDA 42 CFR Part 2 • Overview • Applicability • Compliance Requirements
OVERVIEW • Statute: 42 U.S.C. § 290dd-2 • Regulations: 42 CFR Part 2 (“Confidentiality of Alcohol and Drug Abuse Patient Records”) • Federal Agency: Substance Abuse and Mental Health Services Administration (“SAMHSA”), of the U.S. Department of Health & Human Services (“HHS”) • Generally: Imposes restrictions on the disclosure and use of substance use disorder (SUD) patient records which are maintained in connection with the performance of any Part 2 program, unless certain circumstances exist. • Purpose: Ensure that patients receiving treatment for a SUD in a Part 2 program are not made more vulnerable than others. Enacted to encourage people to get treatment when needed without stigma.
OVERVIEW Relationship to state laws and HIPAA • “ Part 2 ” is a floor; not a ceiling • State law may not authorize or compel any disclosure prohibited by Part 2 • State laws may, however, be more restrictive than those set forth in Part 2 • Some alignment between Part 2 and HIPAA, but in some instances, Part 2 provides more stringent federal protections than those of HIPAA
OVERVIEW SAMHSA ’ s 2017 Final Rule • First substantive revision to Part 2 regulations since 1987 • Issue Date: January 18, 2017 • Effective Date: March 21, 2017 • Available at: • 82 FR 6052 • https://www.gpo.gov/fdsys/pkg/FR-2017-01-18/pdf/2017- 00719.pdf • Purpose: To modernize Part 2 “ by facilitating electronic exchange of [SUD] information for treatment and other legitimate health care purposes while ensuring appropriate confidentiality protections for records that might identify an individual, directly or indirectly, as having or having had a substance use disorder. ” 82 FR 6056.
OVERVIEW SAMHSA ’ s 2018 Final Rule • Additional revisions proposed in NPRM in the 2017 Final Rule • Issue Date: January 3, 2018 • Effective Date: February 2, 2018 (except for certain contracts) • Available at: • 83 FR 239 • https://www.gpo.gov/fdsys/pkg/FR-2018-01-03/pdf/2017- 28400.pdf • Purpose: Allows for an abbreviated notice on redisclosure and addresses the circumstances under which “ lawful holders ” and their legal representatives, contractors, and subcontractors may use and disclose patient identifying information for purposes of payment, health care operations, and audits and evaluations.
APPLICABILITY General Rule Part 2 restricts disclosure and use of substance use disorder records which are maintained in connection with the performance of a federally- assisted Part 2 program .
APPLICABILITY Substance Use Disorder Records ( § 2.11- 2.12) Any information, whether recorded or not, created by, received, or acquired by a Part 2 program relating to a patient. • E.g., diagnosis, treatment and referral for treatment information, billing information, emails, voicemails, and texts. • For Part 2, records include both paper and electronic records.
APPLICABILITY Federally-Assisted ( § 2.12(b)) • Conducted (in whole or in part) by federal government • Supported by federal funding – Includes federal block grants or other funds channeled through state or local governments (e.g., Medicaid) – Funding does not need to be for SUD services • Carried out under federal license, certification, registration or authorization – Certification of provider status under the Medicare program – Authorization to conduct methadone maintenance treatment – Registration to dispense a substance under the Controlled Substances Act to the extent the controlled substance is used in the treatment of substance use disorders • Receives tax exempt status from the IRS
APPLICABILITY Part 2 Program ( § 2.11) 1.An individual or entity (other than a general medical care facility) who holds itself out as providing, and provides , substance use disorder diagnosis, treatment or referral for treatment 2.An identified unit within a general medical facility which holds itself out as providing and provides , substance use disorder diagnosis, treatment, or referral for treatment 3.Medical personnel or other staff in a general medical facility whose primary function is the provision of substance use disorder diagnosis, treatment or referral for treatment and who are identified as such providers
APPLICABILITY Lawful holder • 2017 Final Rule expanded applicability to lawful holders of patient identifying information. – Lawful holder: An individual or entity who has received patient identifying information as the result of a patient consent or as a result of one of Part 2 ’ s limited exceptions to the consent requirements – Patient identifying information: Name, address, social security number, fingerprints, photograph, or similar information by which the identity of a patient can be determined with reasonable accuracy either directly or by reference to other information
APPLICABILITY Notable Exceptions ( § 2.12(c)) • Communication within a Part 2 program or between a Part 2 program and an entity having direct administrative control over that Part 2 program • Qualified service organizations • Crimes on Part 2 program premises or against Part 2 program personnel • Reports of suspected child abuse and neglect
COMPLIANCE Key Compliance Concerns 1. Disclosure requirements 2. Notice to patients 3. Security of records
COMPLIANCE Disclosure – General Rule Information that identifies an individual as a patient of a program is confidential and may not be disclosed without patient consent, unless an exception applies. • Disclosure is permitted under exceptions, but is not required • Unlike HIPAA, patient consent is required even for disclosures for the purposes of treatment, payment or health care operations
COMPLIANCE Minimum Necessary Rule ( § 2.13(a)) Any disclosure made under Part 2 must be limited to that information which is necessary to carry out the purpose of the disclosure.
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