Compliance Hotspots for CCBHCs

Compliance Hotspots for CCBHCs CCBHC COMMUNITY OF PRACTICE Adam Falcone Partner

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OBJECTIVES Understand how the certification criteria and required partnerships that come with CCBHC status have changed the compliance environment for CCBHCs. Recognize the federal and state requirements that pertain to patient choice and understand how to ensure patient choice is protected. Understand confidentiality obligations under 42 CFR Part 2 and HIPAA, and how these obligations play out in communicating about patients with care coordination and community partners. Identifying risks under false claims laws and implement a compliance monitoring plan to mitigate those risks. Have a basic understanding of your obligation as it pertains to sliding fee schedules, relationships with DCOs, and federal antikickback laws. 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 3

PRESENTER: ADAM J. FALCONE Partner in FTLF s national health law practice. Counsels health centers, behavioral health providers, and provider networks on a wide range of health law issues, including fraud and abuse, reimbursement and payment, and antitrust and competition matters. Began his legal career in Washington, D.C. as a trial attorney in the Antitrust Division s Health Care Task Force at the U.S. Department of Justice. Received a B.A from Brandeis University, an M.P.H. from Boston University School of Public Health, and a J.D., cum laude, from Boston University School of Law. Contact information: afalcone@ftlf.com or 202.466.8960 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 4

DISCLAIMER This training is provided for general informational and educational purposes only and does not constitute legal advice or opinions. The information is not intended to create, and the receipt does not constitute, an attorney-client relationship between attorney and participant. For legal advice, you should consult a qualified attorney. 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 5

2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com

FREEDOM OF CHOICE CARE COORDINATION Criteria 3.A: General Requirements of Care Coordination Requirement 3.a.6: Nothing about a CCBHC s agreements for care coordination should limit a consumer s freedom to choose their provider with the CCBHC or its DCOs. Certified Community Behavioral Health Clinics State Certification Guide (Rev. July 2015) Question A. Does the clinic have agreements regarding care coordination with other providers? Question B. Does the clinic agreement for care coordination allow for consumers to choose their providers within the clinic or its DCOs? 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 7

FREEDOM OF CHOICE - COMPLIANCE Contractual Provisions For all Care Coordination Agreements, the Provider Judgment and Freedom of Choice sections should ensure the independent exercise of professional judgment by any and all health care professionals providing services under the Agreements and the patients freedom to present to any provider of his or her choice (regardless of any referral). Example: All health and health-related professionals employed by or under contract with either Party shall retain sole and complete discretion, subject to any valid restriction(s) imposed by participation in a managed care plan, to refer patients to any and all provider(s) that best meet the requirements of such patients. All such patients shall be advised that, subject to any valid restriction(s) imposed by participation in a managed care plan, said patients may request referral to any provider(s) they choose. 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 8

FREEDOM OF CHOICE CCBHC SERVICES Criteria 4.A: General Service Provisions Requirement 4.a.2: The CCBHC ensures all CCBHC services, if not available directly through the CCBHC, are provided through a DCO, consistent with the consumer s freedom to choose providers within the CCBHC and its DCOs. This requirement does not preclude the use of referrals outside the CCBHC or DCO if a needed specialty service is unavailable through the CCBHC or DCO entities. Certified Community Behavioral Health Clinics State Certification Guide (Rev. July 2015) Question A. If not available directly through the clinic, are all clinic services provided through a DCO, with the exception of individually required specialty services for which a referral may be needed? Question B. Do clinic consumers have the freedom to choose providers within the clinic and its DCOs? 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 9

FREEDOM OF CHOICE - COMPLIANCE Policies and Procedures The CCBHC should establish written policies and procedures to ensure that consumers are provided with freedom to choose providers. Sample Documents: Rights and Responsibilities document Referral Policy and Procedure (applicable to internal referrals) Referral Policy and Procedure (applicable to external referrals) 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 10

FREEDOM OF CHOICE - COMPLIANCE Contractual Provisions For all Purchase of Services Agreements and DCO Agreements (as applicable), the Provider Judgment and Freedom of Choice sections should ensure the independent exercise of professional judgment by any and all health care professionals providing services under the Agreements and the patients freedom to present to any provider of his or her choice (regardless of any referral). Example: All health and health-related professionals employed by or under contract with either Party shall retain sole and complete discretion, subject to any valid restriction(s) imposed by participation in a managed care plan, to refer patients to any and all provider(s) that best meet the requirements of such patients. All such patients shall be advised that, subject to any valid restriction(s) imposed by participation in a managed care plan, said patients may request referral to any provider(s) they choose. 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 11

FEDERAL ANTI-KICKBACK STATUTE The Anti-Kickback Statute prohibits persons and entities from knowingly or willingly: Soliciting or receiving remuneration directly or indirectly, in cash or in kind To induce patient referrals or the purchase or lease of equipment, goods or services Payable in whole or in part by a Federal health care program. Violations of the statute can result in: Criminal liability Civil penalties False Claims liability Administrative penalties and proceedings 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 12

FEDERAL ANTI-KICKBACK STATUTE CCBHC-Related Risks Areas Clinical Services Agreements If CCBHC purchased clinical services from another provider (that would be rendered at the CCBHC) and that provider received additional compensation based upon the number of referrals it generated for services within the CCBHC. DCO Agreements If CCBHC purchased clinical services from a DCO and the DCO received additional compensation based upon the number of referrals back to the CCBHC. Care Coordination Agreements If CCBHC compensated the other party for each referral of a patient to the CCBHC for services. 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 13

FEDERAL ANTI-KICKBACK STATUTE Compliance under AKS Safe Harbors arrangements deemed by Congress or OIG to present a low risk of fraud and abuse To be protected, must meet all requirements of particular safe harbor AKS safe harbors include, but are not limited to: Employment arrangements Personal services and management contracts Discounted arrangements Space and equipment rental Practitioner recruitment in underserved areas Referral arrangements for specialty services Sale of practice and investment interests Federally Qualified Health Centers 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 14

FEDERAL ANTI-KICKBACK STATUTE Common AKS Safe Harbor Elements Signed, written contract between the parties Term of not less than one year Specifies the premises, equipment, or services to be provided Total aggregate compensation that is set in advance, reflects the fair market value for the goods and/or service, and does not vary based on volume or value of referrals or business generated between the parties CCBHC s compensation to other providers should be based on objective, documented fair market value such as salary surveys, Medicare or Medicaid fee schedules, percentage of charges, or provider s historical annual costs of delivering services. 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 15

PATIENT INDUCEMENTS The Beneficiary Inducement Prohibition prohibits the: offering or transferring of remuneration and/or inducements to Medicare, Medicaid and CHIP beneficiaries which are likely to influence the beneficiaries to choose goods or services from a particular supplier or provider that is paid for in whole or in part by such program Remuneration includes waivers or reductions of coinsurance and deductible amounts as well as items or services for free or for other than fair market value The OIG has previously taken the position that incentives that are only nominal in value are not prohibited by the statute, and has interpreted nominal in value to mean less than $15 per item and less than $75 in aggregate per patient per year Includes few limited exceptions 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 16

PATIENT INDUCEMENTS CCBHC-Related Risks Areas Examples implicating the Beneficiary Inducement Prohibition include, but are not limited to: Not charging patients for CCBHC services (outside of SFDS) Waiving patient cost-sharing obligations (outside of individualized determinations of need) Providing cash or gift cards (even to incentivize patient visits!) Free transportation to appointments for CCBHC services Free items (e.g., cell phone, video games, ipad, etc.) Free lunch at CCBHC or DCO 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 17

PATIENT INDUCEMENTS Beneficiary Inducements Statutory Exceptions: Non-routine, unadvertised waivers of cost-sharing amounts based on individualized determinations of financial need or exhaustion of reasonable collection efforts Properly disclosed differentials in a health plan s copayments or deductibles Waiver by FQHCs of coinsurance and deductible amounts for patients who qualify for the center s sliding fee scale (individuals or families with annual incomes at or below 200% of FPG) Incentives to promote the delivery of preventive care, defined as: Items or services covered by Medicare or Medicaid and are either prenatal / post-natal well-baby services Services described in the Guide to Clinical Preventive Services (published by the US Preventive Services Task Force 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 18

PATIENT INDUCEMENTS OIG Safe Harbor: Remuneration to Recipients Excepts remuneration for the offer or transfer of items or services for free or at less than fair market value when: Not offered through an advertisement; Not tied to the provision of other items or services reimbursed by Medicare or Medicaid; Reasonably connected to the medical care of the individual; and Transferred only after a good faith determination that the recipient is in financial need. 42 C.F.R. 1003.110 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 19

PATIENT INDUCEMENTS OIG Safe Harbor: Free and Discount Local Transportation Protects transportation provided to established patients within a local area for purposes of obtaining medically necessary items or services. Documentation: Providers must have an established documentation policy Availability: Transportation must be provided without regard to the past or anticipated volume or value of Federal health care program business Mode of Transportation: Excludes air, luxury, and ambulance-level transportation. Marketing: Transportation assistance may not be publicly advertised or marketed to patients or others who are potential referral sources. Providers may inform patients that transportation is available if it is done in a targeted manner. 42 C.F.R. 1101.952(bb) 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 20

PATIENT INDUCEMENTS OIG: Safe Harbor: Remuneration Promoting Access to Care Exempts remuneration that improves a beneficiary s ability to obtain items and services payable by Medicare or Medicaid, and poses a low risk of harm to the Medicare and Medicaid programs or beneficiaries. Low Risk: Unlikely to interfere with, or skew, clinical decision making; Unlikely to increase costs to Federal health care programs or beneficiaries through overutilization or inappropriate utilization; and Does not raise patient-safety or quality-of-care concerns. 42 C.F.R. 1003.110 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 21

FALSE CLAIMS ACT The False Claims Act makes it unlawful for any person or entity to knowingly present[], or cause[] to be presented, a false or fraudulent claim for government reimbursement. Factually false claims are those that request reimbursement for products or services that the entity or individual did not provide (e.g., submitting claim for service not rendered) Legally false claims can occur when provider violates a condition of payment imposed by law or contract Example: claim for billable visit when CCBHC did not comply with CCBHC-related license, certification, other legal precondition for payment. Most states have equivalent state laws 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. www.ftlf.com 22

FALSE CLAIMS ACT LIABILITY Recently Increased Penalties The Bipartisan Budget Act of 2015 (passed in November 2015) substantially revised the Inflation Adjustment Act, which adjusts penalties under the False Claims Act. Under the new rule published on June 30, 2016, the FCA penalties rise to a minimum of $10,781 and a maximum of $21,563 per false claim plus three times the amount of the overpayment. OIG can also impose civil monetary penalties (CMPs) or exclude a provider from participation in Federal health care programs The new penalties are effective August 1, 2016 and will be applied for violations occurring after Nov. 2, 2015. 23

FALSE CLAIMS ACT RISK AREAS Billing for CCBHC Visits In general, the same definition of billable visits should be used in billing CCBHC services under PPS as was used in the development of the PPS rates. Non-compliance frequently arises in regard to: Limitations on the number of billable visits that may be billed per day Qualifications of rendering clinician as a billable provider under state CCBHC visit definition Billing services under procedure codes inconsistent with services that qualify as a billable CCBHC visit Billing services with location codes inconsistent with limitations on location or modality for billable CCBHC visit Insufficient documentation of services by CCBHC or DCO 24

FALSE CLAIMS RISK AREAS Implied False Certification Under this theory, with every claim a provider submits, it is certifying that it has complied with all the laws, regulations and conditions of payment. If it has not complied, the provider is not entitled to payment and it should not submit the claim. False Certification could relate to: State licensure requirements Licensure of types of inpatient and outpatient facilities Licensure of specific types of health care practitioners (including supervisory requirements) State certification requirements Certification of specific programs or services Medicaid/Medicare Conditions of Payment (e.g., CCBHCs) Credentialing: MCOs require that a practitioner be credentialed Exclusion Screening 25

IMPLIED FALSE CERTIFICATION LITIGATION Whistleblower action leads to $9.25 Pennsylvania psychiatrist arrested million fraud settlement for for practicing during suspended residential substance abuse license treatment facility Unlawful prescribing controlled Providing services by substances inappropriately licensed Billing for services while license therapists was suspended Failing to meet state certification Michigan nonprofit charity faces requirements potential exclusion for fraudulent Adult day care center owner guilty billing of behavioral health services of billing fraud, conspiracy to Billing for services by pay/receive kickbacks practitioner who had lapsed Providing services by license inappropriately licensed Billing for services that did not therapists comply with supervision requirements 26

IMPLIED FALSE CERTIFICATION LITIGATION Universal Health Services, Inc. v. U.S. ex rel. Escobar, 579 U. S. (2016). Available at: https://www.supremecourt.gov/opinions/15pdf/15-7_a074.pdf. Background In 2009, a 17 year-old patient, Yarushka Rivera, died from an adverse reaction that a purported doctor prescribed for bipolar disorder. Massachusetts Medicaid ( MassHealth ) investigated and issued a report detailing violations of over a dozen Medicaid regulations related to the qualifications and supervision required for staff at mental health facilities. MassHealth requires satellite mental health facilities to have specific types of clinicians on staff; delineates licensing requirements for certain positions, including psychiatrists, social workers and nurses; and details supervision requirements for staff. MassHealth established a remediation plan and entered into consent agreements with two employees of Universal Health Services. The patient s mother and stepfather ( Escobar ) filed a qui tam suit alleging that Universal Health Services ( UHS ) violated the False Claims Act under an implied false certification theory of liability. 27

IMPLIED FALSE CERTIFICATION LITIGATION Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S.Ct. 1989 (2016). Available at: https://www.supremecourt.gov/opinions/15pdf/15-7_a074.pdf. Supreme Court Ruling Justice Thomas, writing for a unanimous U.S. Supreme Court, held that implied false certification can, in some circumstances, provide a basis for liability under the FCA. Those circumstances are when: 1. the claim does not merely request payment, but also makes specific representations about the goods or services provided; and 2. the misrepresentations (or omissions) were material to the government s payment decision. The Supreme Court remanded the case back down for further proceedings as to whether Escobar s complaint sufficiently alleged that the regulatory violations in question were material to the government's payment decision. 28

IMPLIED FALSE CERTIFICATION LITIGATION Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 14-1423 (1 st Cir. 2016). Available at: http://media.ca1.uscourts.gov/pdf.opinions/14-1423p-01a.pdf. Subsequent Rulings On remand, the First Circuit held that it had little difficulty finding that the relator s claims alleging that UHC s alleged violation of licensing standards were material to the Medicaid payments. 1. MassHealth conditioned payment on regulatory compliance with the licensing and professionalism regulations (relevant though not dispositive alone) 2. The licensing and supervision requirements in MassHealth go to the very essence of the bargain between MassHealth and its health care providers. 3. There is no evidence that MassHealth paid claims despite knowing of the violations. At the core of the MassHealth regulatory program in this area of medicine is the expectation that mental health services are to be performed by licensed professionals, not charlatans. The First Circuit remanded the case to the district court for further proceedings. 29

EXCLUSION AND DEBARMENT OIG Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs (May 2013) Overall Rule: No Federal health care program payment may be made for any items or services furnished by an excluded individual or entity (or referred by an excluded individual or entity) Applies even if excluded individual s services are not separately billed to a federal health care program Applies even if the excluded person does not receive payments from the provider for his or her services Applies even if excluded individual furnishes administrative or management services not directly related to patient care, but that are a necessary component of providing items and services to Federal program beneficiaries 30

EXCLUSION AND DEBARMENT OIG Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs (May 2013) Penalties. If a health care provider arranges or contracts (by employment or otherwise) with a person that the provider knows or should know is excluded by OIG, the provider may be subject to Civil Monetary Penalties (CMP) liability if the excluded person provides services payable, directly or indirectly, by a Federal health care program. OIG may impose CMPs of up to $10,000 for each item or service furnished by the excluded person for which Federal program payment is sought, as well as an assessment of up to three times the amount claimed, and program exclusion. 31

EXCLUSION LISTS OIG List of Excluded Individuals and Entities (LEIE) http://www.oig.hhs.gov/fraud/exclusions/exclusions_list.asp Government Services Administration (GSA) Excluded Party List System http://www.sam.gov State Exclusion Lists Check your state s exclusion list! 32

EXCLUSION CHECKS CCBHC-Related Risks Areas Failure to screen board members, employees, and practitioners (including volunteers and contracted practitioners) Failure to screen contractors and vendors, including DCOs Failure to check exclusion lists monthly Compliance Pointer: It is a good idea to review and update written policy and procedures for conducting exclusion checks. 33

PRIVACY - CARE COORDINATION ARRANGEMENTS Privacy and confidentiality. Care coordination agreements must contain privacy and confidentiality terms. Documentation of compliance with HIPAA and other federal and state patient privacy requirements HIPAA Privacy Rule applies only to protected health information ; routine communications between health care providers and a consumer s family and friends are permissible so long as consumer does not object 42 C.F.R. Part 2 contains additional protections on information about substance use disorder treatment It is advisable (though not always legally required) to obtain patient consent for release of health information pursuant to care coordination relationships 34

PRIVACY - DCO RELATIONSHIPS Privacy and confidentiality. DCO agreements must contain privacy and confidentiality terms. CCBHC must work with DCO to ensure compliance with privacy and confidentiality requirements, particularly if sharing of electronic health record (EHR) HIPAA Privacy Rule applies only to protected health information ; routine communications between health care providers and a consumer s family and friends are permissible so long as consumer does not object Document compliance with HIPAA, 42 C.F.R. Part 2, and other federal and state privacy laws CCBHC should consider modifying consumer consent to allow sharing of protected health information with DCO 35

PRIVACY AND CONFIDENTIALITY 42 CFR Part 2 Final Rule First substantive revision to Part 2 regulations since 1987 Issued: January 18, 2017 Effective Date: February 17, 2017 Purpose: To modernize Part 2 To facilitate information exchange within new health care models To protect the privacy of individuals seeking and receiving treatment for substance use disorders 36

PRIVACY AND CONFIDENTIALITY 42 CFR Part 2 Final Rule Compliance required for: Organizations that are federally assisted and that meet the definition of a Part 2 program Any individual or entity who receives information from a Part 2 program (these individuals and entities are known as lawful holders ) Unlike HIPAA, patient consent is required even for disclosures for the purposes of treatment, payment or health care operations Written patient consent forms must include an explicit description of the amount and kind of information to be released Formal written policies and procedures must be in place to protect both paper and electronic records 37

PRIVACY AND CONFIDENTIALITY CCBHC-Related Risks Areas Failure to understand how patient information can be shared under applicable federal and state laws Failure to incorporate applicable privacy and security requirements into the appropriate written agreements Failure to have appropriate patient consent forms Failure to have written policies and procedures Failure to provide training to all staff members and specialized training for staff members in high-risk roles (medical records, case managers, providers, front desk staff) 38

QUESTIONS? Adam J. Falcone, Esq. afalcone@ftlf.com FELDESMAN TUCKER LEIFER FIDELL LLP 1129 20 th Street, N.W., Suite 400 Washington, DC 20036 (202) 466-8960 39

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