The Issue: Compliance in a New Market

Transcription

1 Alan E. Schabes, Esq. Benesch, Friedlander, Coplan & Aronoff LLP Cleveland, OH (216) Marsha Lambert, Consultant AccentCare Inc. Dallas, TX (714) The Issue: Compliance in a New Market The health care system rewards volume and creates fragmented care. There is a move toward models that incentivize quality, efficiency, and access. Coordinating care will be key but how do we do this and stay in compliance? 2 1

2 Potential Post Acute Care Referral Sources Hospitals Accountable Care Organizations (ACOs) Physician Groups Health Plans Preferred Provider Organizations (PPOs) 3 Potential Collaborative Arrangements Discounted Fee for Service Waiver of Medicare Cost Sharing Amounts Preferred Provider Agreement Exclusive Provider Agreement Risk/Gainsharing Arrangements Management Services Organization (MSO) Co Management Arrangements Group Purchasing Arrangements Data Sales Joint Ventures Bundled Payment for Care Initiatives 4 2

3 Marketing Differentiators: How Can Entities Attract Collaborators? Data that demonstrates high quality, efficiency, and customer satisfaction Technology to track metrics, increase efficiency, and coordinate care between providers Communication between providers will be essential EHRs are key Ability to care for higher acuity patients in a shorter period of time 5 Marketing Differentiators: How Can Entities Attract Collaborators? Good reputation Willingness to take on financial risk Willingness to create joint clinical protocols Ability to provide Coordinated Care Nurses to coordinate care between providers and follow up with patients, even after they go home Creativity/Diversity Can the entity provide additional services? 6 3

4 Legal Considerations Fraud and Abuse Anti Kickback Statute (AKS) Stark Law Gainsharing CMP or the Civil Monetary Penalty Law Prohibition on Payments to Reduce or Limit Care (42 U.S.C. 1320a 7a(b)) Beneficiary Inducement CMP or the Civil Monetary Penalty Law Prohibition on Inducements to Beneficiaries (42 U.S.C. 1320a 7a(a)(5)) 7 Legal Considerations Prohibitions Against Charging or Collecting More Than the Medicare Allowable Amount (42 U.S.C. 1320a 7a(a)(2)) Contracting Issues Anti Trust Issues State Health Plan/Insurance Regulations 8 4

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6 Discounted Fee For Service AKS Safe Harbor If buyer is required to submit cost reports: Buyer must report discount on cost report Seller must report discount and notify buyer of obligation to report discount Offeror must inform buyer of obligation to report discount and not impede buyer from doing so If buyer submits for payment on a per charge basis: Buyer may either make discount immediately or via a rebate Seller must report discount or notify buyer of obligation to report discount 11 Discounted Fee For Service Offeror must inform buyer of obligation to report discount and not impede buyer from doing so If buyer is an HMO or Competitive Medical Plan: Buyer does not need to report the discount unless required under risk contract Neither Seller nor offeror are required to report the discount 12 6

7 Discounted Fee For Service OIG Guidance on Swapping: Size of discount is not determinative of whether the arrangement involves illegal swapping. Discounting goods or services below cost is an indicator of illegal swapping. It is highly suspect when a vendor offers a higher discount to a customer that is in a position to refer business to the vendor than to a similarly situated customer that is not in a position to refer business. 13 Discounted Fee For Service Discounts offered in conjunction with exclusive provider agreements are also highly suspect. Any other discount or pricing arrangement made (implicitly or explicitly) for referrals potentially creates an inference of a swapping arrangement. 14 7

8 Discounted Fee For Service Swapping Providing discounts on goods or services in exchange for referrals or other goods and services reimbursable by Medicare. Swapping violates the AKS. There should be no link, either direct or indirect or implicit or explicit, between discounts for goods or services a provider pays a vendor for and the provider s referral of business which the vendor can bill directly to Medicare or another federal health care program. 15 Waiver of Cost Sharing Amounts Generally implicates CMP for beneficiary inducement and AKS. AKS Safe Harbor A waiver of a beneficiary s obligation to pay coinsurance or deductible amounts will not implicate the AKS in the following situation: The provider is a hospital which receives Medicare payments for inpatient hospital services and: The hospital does not shift the burden of the reduction; The hospital offers the reduction or waiver without regard for the reason for admission or length of stay; and The hospital s offer of the reduction or waiver is not made as part of a price reduction agreement. 16 8

9 Waiver of Cost Sharing Amounts CMP Exception Waiver or reduction of cost sharing amounts will not violate the CMP Law if: The waiver is not offered as part of any advertisement or solicitation; Waivers are not made routinely, but are assessed on individual determination of financial need; and The determination of financial need is based solely on objective criteria. 17 Waiver of Cost Sharing Amounts OIG Advisory Opinions Common themes of waivers that are treated favorably: Unlikely to result in increased utilization or the need for additional services Unlikely to affect providers professional judgment Unlikely to result in patient steering Waiver presents minimal anti competitive risks Waiver is not routine but based on individually assessed financial need Waiver is offered in a geographically underserved location Waiver is offered to an at risk population 18 9

10 Preferred Provider Agreements Focus on coordinating care, increasing efficiency, improving the quality of care, and sharing data Fraud and Abuse Concerns: Could raise kickback concerns Avoid obligating parties to refer to one another Avoid connecting payments or any form of financial incentive to the agreement If there is no payment or incentive to refer, there is no kickback 19 Exclusive Provider Agreement Same Fraud and Abuse concerns as Preferred Provider Agreements OIG Advisory Opinions Common Themes: An arrangement involving an exclusive provider agreement that also involves one provider billing and collecting payment for services performed by the other provider and paying the other provider less than the amount collected raises several concerns for the OIG Providers engaging in these arrangements should be sure they fall into a safe harbor, such as the personal services and management contract safe harbor 20 10

11 Gainsharing Arrangements OIG Special Advisory Bulletin Gainsharing arrangements clearly violate the CMP prohibiting hospitals from directly or indirectly compensating physicians for reducing or limiting services to beneficiaries and may violate the AKS OIG Advisory Opinions Common Themes Overtime, OIG is becoming more comfortable with gainsharing arrangements 21 Gainsharing Arrangements OIG concerns Stinting on patient care Cherry picking Patient steering Disguised payment for referrals 22 11

12 Gainsharing Arrangements Recommended safeguards for CMP Transparency Credible medical evidence should support each performance measure Establish floors below which physicians cannot earn incentive Calculate cost savings based on actual out of pocket cost Amounts paid should be: Calculated based on all procedures performed, regardless of payor 23 Gainsharing Arrangements Subject to cap on payment for Federal healthcare program procedures Not disproportionately performed on Federal healthcare program beneficiaries Reasonable and limited in duration and amount Distributed to physician group as opposed to individual physicians All supplies/devices should available if needed for particular patient 24 12

13 Gainsharing Arrangements Recommended safeguards for AKS Arrangements should include pools of 5 or more physicians The physicians should be on the hospital s active medical staff The physicians should receive per capita payment from the physician group There should be limits on the amounts the physicians can earn The targets/measures should be re based if multi year The agreement should be for a limited duration (1 3 years) Admissions should be monitored for changes 25 MSOs Management Services Organizations (MSOs) Examples: Administrative, Operational, Financial; Personnel; Education; Coding, Billing and Collection; IT; Compliance; Credentialing; Strategic Planning AKS Safe Harbor Compensation paid to an agent by a principal for the services of the agent will not violate the AKS if the following conditions are met: The Agreement is: In writing; Signed by the parties; 26 13

14 MSOs For a term of not less than one (1) year; and Specific as to services, schedule, and compensation. The compensation is: Set in advance; Consistent with FMV in an arm s length transaction; and Not determined in a manner that takes into account the volume or value of referrals. The services do not involve the promotion of any illegal activity. The aggregate services are reasonably necessary to accomplish a commercially reasonable business purpose. 27 MSOs Stark Exceptions Personal Services Exception Same requirements as AKS Safe Harbor Fair Market Value Exception Same requirements as AKS Safe Harbor, except: The written agreement must specify the time frame for the arrangement, which can be for any period of time

15 Co Management Agreements An agreement between hospital and provider who agrees to assist hospital in co managing the clinical and operational activities of a hospital based service line in exchange for a management fee, which typically includes a fixed payment amount, as well as some form of performance based incentive fee Raises AKS and CMP concerns OIG has issued favorable Advisory Opinion 29 Co Management Agreements Recommended Safeguards Base compensation on FMV for a specifically defined set of services. Compensation (both fixed and performance based) does not vary by the number of patients treated or number of patient referrals. Have physician group distribute compensation on pro rata basis. Condition performance based compensation upon the physician not: (1) stinting on care of patients; (2) increasing referrals; (3) cherry picking healthy patients with desirable insurance; or (4) accelerating patient charges. Include oversight by utilization review and performance improvement committees

16 Co Management Agreements Do not limit or restrict physician s access to supplies or devices. Make performance based measures specific, objective, and, when possible, founded on national standards. Structure performance measures to incentivize improvement, not reward the status quo; establish a baseline and benchmarks or tiers for payment. Limit the duration and scope of the co management incentive agreement. If appropriate or required, disclose incentive agreements to patients prior to the delivery of care. 31 Group Purchasing Arrangements AKS Safe Harbor Payments by a vendor of goods or services to a GPO that provides goods or services to individuals or entities (for which payment may be made in whole or in part under Medicare or a state health care program) as part of a group purchasing agreement will not violate the AKS if two conditions are met: The GPO has a written agreement with each individual or entity that either: (1) states the vendor will pay the GPO a fee of 3% or less of the purchase price; or (2) specifies the amount the vendor will pay the GPO (either a fixed amount or a fixed percentage of the value of the goods or services) 32 16

17 Group Purchasing Arrangements If the entity is a health care provider, the GPO must disclose in writing to the entity, at least annually, and to the Secretary upon request, the amount received from each vendor with respect to purchases made by or on behalf of the entity The individuals or entities contracting with the GPO may not be wholly owned by the GPO nor be subsidiaries of a parent corporation that wholly owns the GPO OIG Advisory Opinion OIG has allowed arrangement where GPO and purchasers are wholly owned subsidiaries of the same parent if certain safeguards are in place 33 Data Sales Agreements Similar to MSO arrangement Beware of HIPAA and State Privacy Laws AKS Safe Harbor for EHR Donation may be useful Recently Amended Extended to December 31, 2021 Provisions updated and clarified Electronic prescribing component no longer required Laboratory companies excluded 34 17

18 Joint Ventures AKS Safe Harbor 60/40 Investor and Revenue Rules OIG Special Advisory Bulletin Common elements of Questionable Contractual Arrangements : A provider expands into a related line of business, which is dependent on referrals from the provider s existing business The provider neither operates the new business itself nor commits substantial financial, capital, or human resources to the venture 35 Joint Ventures The provider contracts with an established provider of the same services as the new line of business to essentially run the new business The two providers share in the economic benefit of the new business The aggregate payment to the established provider varies with the value or volume of referrals generated to the new provider The parties may agree to a non compete clause, barring the established provider from providing services in its own right to patients of the new provider 36 18

19 Bundled Payment Bundled Payment for Care Improvement Initiative Four Models Model 1: Acute Care Model 2: Hospitals, Physicians and Post Acute Care Model 3: Post Acute Care Model 4: Expansion of Acute Care Episode Demonstration 37 Bundled Payment Issues/Concerns with Bundled Payment Establishing adequate payment Management and governance Defining the Bundles Establishing quality and efficiency measures Designing the care model Risk Mitigating risk Allocating risk Allocating reward 38 19

20 39 Contracting Issues Contracts should support the three aims of healthcare reform: Improve quality of care Improve patient experience Reduce costs of care Issues to be Addressed in Contracts: Duties and Expectations of Parties Duration of Agreement Termination Indemnification 40 20

21 Contracting Issues Gainsharing Risk of Payment Methods Insurance Compliance Patient Choice HIPAA and State Privacy Laws Any Willing Provider Statutes Managed Care Dual Eligibility Programs

22 Anti Trust Issues Receiving attention because of high cost of care Concern aligned providers will use collective bargaining power to negotiate higher reimbursement rates from private insurers and boycott insurers that refuse to pay higher rates Naked price fixing and market allocation are per se illegal 43 Anti Trust OIG and FTC s Final Statement of Anti Trust Enforcement Policy Regarding ACOs Participating in the Medicare Shared Savings Program offers all aligning providers guidance Anti Trust review Rule of Reason Anti Trust Safety Zone 44 22

23 Anti Trust Conduct to Avoid: Sharing competitively sensitive information, such as pricing, discounting, future product offerings, operations, performance, and marketing plans Restricting payors ability to share cost, quality, efficiency, and performance information with enrollees Tying sales of services to the private payor s purchase of other services from outside providers Exclusive contracting Preventing or discouraging private payors from directing or incentivizing patients to choose outside providers through anti steering or most favored nation provisions

24 State Regulatory Issues Licensing Issues Does collaboration trigger any type of approval from respective licensing agency? Corporate Practice of Medicine Is there a CPOM statute that will dictate the legal structure? State Health Insurance Laws What qualifies as a state health insurer? What is required of state health insurers? 47 State Regulatory Issues Third Party Administrator Statutes Who is an administrator? Is a certificate of authority required? Utilization Review Laws Is a license or registration required? 48 24

25 49 Accountable Care Organizations Focus on accountability for patients, quality measures, cost efficiency, coordination of care, preventative care Similar to managed care arrangements but preserve patient choice Arrangements with Post Acute Care Providers ACOs need to coordinate with PAC providers to reduce costs Focus on coordinating care and preventative measures PAC providers should seek out alignment early in ACOs development to be in the best bargaining position 50 25

26 Accountable Care Organizations Types of ACOS Medicare Shared Savings Program ACOs If the ACOs reach certain quality measures, they share in a portion of Medicare s savings Pioneer ACOs For organizations who already have experience coordinating patient care among several types of providers Advance Payment ACOs Organizations that would like to create an ACO but do not have the necessary capital can receive up front financial support in the form of an advance on their shared savings 51 Accountable Care Organizations Fraud and Abuse Waivers Waive AKS, Stark, and CMPs Types: Pre Participation Waiver ACO Participation Waiver Shared Savings Distribution Waiver Compliance with Stark Law Waiver Waiver for Patient Incentives 52 26

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