Behavioral Health Advisor: The Guide to Navigating

Compliance

Quarterly WebinarApril 12, 2018

Today’s PresentersShannon MaceSenior Advisor National Council for Behavioral Health

Adam FalconePartner Feldesman Tucker Leifer Fidell LLP

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Agenda• Sign of the Times:

– Integrated Care: State of the field• In the Field:

– 42 CFR Part 2 Questions and Answers• The Upshot:

– Third party liability • Due Process:

– Compliance Issues related to Primary Care and Behavioral Health Integrated Practice

• Resources• Questions and answers

Sign of the Times

Latest updates on integrated primary

and behavioral health care from the

field.

www.integration.samhsa.gov/

Sign of the Times

In the Field

Your 42 CFR Part 2 questions

answered!

42 CFR Part 2

Dianne Pledgie, Compliance Counsel, Feldesman Tucker Leifer Fidell LLP

The Upshot

Third party HIV disclosure of 12,000 Aetna members leads to $17 million settlement following

class action lawsuit

Due Process

Compliance Issues related to Primary Care and Behavioral Health Integrated Practice

Adam Falcone, JD, MPHPartner

Feldesman Tucker Leifer Fidell LLPWashington, DC

Presenter: Adam J. Falcone

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• 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.

• Joined FTLF in 2004 after a stint serving as Public Policy Counsel for a membership association of non-profit and provider-sponsored HMOs.

• 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.

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.

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Primary Care And Behavioral Health Integrated Practice

STRUCTURAL CONSIDERATIONS

(Legal) Form Follows Function• Have a general sense of the activities likely to be performed

by the integrated practice in order to select the appropriate type of legal relationship or structure.

• Key considerations for selecting the appropriate legal structure for your integrated practice will ultimately depend upon:

– the number of legal entities involved– financial/legal risks of the integrated activities– whether the proposed activities are already being provided by one

or more of the partners or are new activities– licensure or regulatory requirements – anticipated sources for capital investments– governance considerations

Contractual Relationships• A contract is an agreement between two or more parties that

creates a legal obligation to perform (or not perform) a particular duty.

• Contractual relationships permit a broad array of partnerships between and among agencies, and can be the basis for establishing an integrated practice, including: – Referral arrangements– Co-located referral arrangements– Lease of personnel / purchase of services– Merger or acquisition arrangements

Behavioral Health Provider Primary Care Provider

Referral Arrangements

Each provider agrees to furnish services to individuals referred by the other.

Behavioral Health

ProviderPrimary Care

Provider

Referral Agreements• Each provider is financially, clinically, and legally

responsible and is solely liable for claims related to services it directly provides:– Patients are patients of the provider which directly

furnishes services– Each provider’s policies, procedures, and standards

govern its provision of services– Each provider bills and collects payment for the

services it directly renders

Referral Agreements• Each provider should furnish assurances

regarding professional qualifications, eligibility to participate in federal/state health care programs, standards of care, and compliance with state and federal confidentiality laws

• Each provider agrees to accept referred patients regardless of a patient’s or patient family’s ability to pay or insurance status

• Patient freedom of choice and independent clinical judgment should be safeguarded

Co-Located Referral Arrangements

Referral

Similar to referral relationship, but co-located partner is physically located in and provides services to its own patients (including individuals referred to it by the partner) at the partner’s facility, subject to applicable state law.

Behavioral Health

Provider

Primary Care

Provider

Primary Care

Provider

Behavioral Health

Provider

Lease of Personnel / Purchase of Services

Behavioral health provider leases or purchases clinical and/or administrative services from primary care provider for a fair market value fee.

Behavioral Health Provider

Policies & ProceduresFair Market Value Fee

Primary Care Provider

(Contractor)

Services or Capacity

Behavioral Health Patients

Merger or Acquisitions• Partial corporate consolidation:

– Both corporations continue in existence post-integration

• One corporation “acquires” certain lines of business that are currently operated by the other corporation

• Transferor may reorganize to assume related, often supportive functions

– Parent/subsidiary model• Full corporate consolidation through merger

– One corporation ceases to operate as an independent entity and one corporation is the “surviving entity”

Formation of New Legal Entity• Two or more parties may establish a new legal entity to

conduct integrated practice under shared ownership or control.

• The benefits of forming a new legal entity include:– Shielding each partner from liability for debts, obligations and

other liabilities of the network and other partners– Partners retain control over their own organizational operations

because shared control only extends to network’s joint activities– Partners maintain their independence and autonomy while

working together– Partners can pool resources to make joint investments in

information technology, clinical or financial expertise, or equipment

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Primary Care And Behavioral Health Integrated Practice

COMPLIANCE CONSIDERATIONS

Freedom Of Choice• Many federal and state programs require providers to ensure a patient’s

freedom of choice.• Purchase of Services agreements should include provisions related to

judgment and freedom of choice.• Such provisions should ensure the independent exercise of

professional judgment by any and all health care professionals providing services and the patients’ freedom to present to any provider of his or her choice (regardless of any referral).

Sample Provision:• 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.

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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

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Federal Anti-Kickback StatuteAnti-Kickback Risk Areas

• Under a purchase of service agreement, if one party purchased clinical services from the other, and the buyer received a discount based upon the number of referrals to the seller.

• Under a purchase of service agreement, if one party purchased clinical services from the other, and the seller received additional compensation based upon the number of referrals back to the purchasing provider.

• Under a referral agreement, if one party compensated the other party for each referral of a patient for services.

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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

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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

• A behavioral health provider’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.

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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

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Patient InducementsRisk Areas • Examples implicating the Beneficiary Inducement

Prohibition include, but are not limited to:• Not charging patients for services• 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 services• Free items (e.g., cell phone, video games, ipad, etc.)• Free lunch!

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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 pre-natal / post-natal well-baby services• Services described in the Guide to Clinical Preventive Services

(published by the US Preventive Services Task Force

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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

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Patient InducementsOIG 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)

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Patient InducementsOIG: 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

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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 behavioral health provider did not comply with primary care-related license, certification, other legal precondition for payment.

• Most states have equivalent state laws

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False Claims Act LiabilityRecently 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.

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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

• Credentialing: MCOs require that a practitioner be credentialed • Exclusion Screening

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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

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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.

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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!

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Exclusion Checks

Risks Areas • Failure to screen board members, employees, and practitioners

(including volunteers and contracted practitioners)• Failure to screen contractors and vendors• 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.

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Adam J. Falcone, Esq.

FELDESMAN TUCKER LEIFER FIDELL LLP1129 20th Street, N.W.Suite 401Washington, DC 20036(202) 466-8960afalcone@ftlf.com

We want to hear from you!Email us topic ideas, questions or suggestions for future editions at:

compliance@thenationalcouncil.org

Questions

Resources• SAMHSA-HRSA Center for Integrated Health

Solutions• The Integration Edge • SAMHSA Clarifies Certain Privacy Rules

Applicable to Substance Use Disorder Records

Next Behavioral Health Advisor Webinar: June 14 at 12pm ET(only open to subscribers)

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