5/30/2017 Legal Issues in New Contracting and Risk Sharing Models - What To Know Before You Sign Alexis Finkelberg Bortniker Foley & Lardner LLP 617-226-3177 Abortniker@foley.com June 2, 2017 Top 10 Issues in APM Contract Negotiations 1) Negotiations over high cost outliers – Responsibility for high cost drug therapies 2) Reinsurance – Physician Incentive Plan Rules 3) Risk pool calculations and participants – Off-cycle enrollment – Off-cycle physician enrollment/disenrollment 4) Antitrust issues – Data Access and Anti-Trust 1
5/30/2017 Top 10 Issues in APM Contract Negotiations cont… 5) Preauthorization requirements 6) Medical necessity and retrospective review – Underutilization monitoring 7) Data access – What you will get – Who will have access – Who owns the information – What will you be required to share Top 10 Issues in APM Contract Negotiations cont… 8) Downstream compliance liability 9) In-network negotiation, buy-in and compliance 10) Understanding payment parameters and potential for upside – Upside and downside potential parameters 2
5/30/2017 But first… Back to Basics Renewed importance in definition of terms – Assignment of Members – Quality metrics – Included and excluded expenses – Included and excluded services Example: definition of “Readmission” You cant forget fraud and abuse compliance… – ACO waivers and state/federal push to use APMs creates a false sense of freedom – Must assess Federal Kickback, Stark and CMP Issues when dealing with MA and potentially Medicaid or other federal healthcare programs. MA AKS rules when dealing with commercial health plans MA Medicaid regulations when dealing with Medicaid agreements. 3
5/30/2017 Other Massachusetts Compliance Issues HPC Material Change Filings – Corporate Affiliations, Contracting Affiliations, Clinical Affiliations, Discount Arrangements Registration of Provider Organizations Risk Bearing Provider Organization Risk Bearing Certificate Requirements – http://www.mass.gov/ocabr/government/oca-agencies/doi-lp/risk-certificate-application- information.html – A Provider Organization shall not be permitted to enter into an arrangement with either a Carrier or a Public Health Care Payer whereby the Provider Organization or any entity with which the Provider Organization has a Contracting Affiliation manages the treatment of a group of patients and bears Downside Risk according to the terms of an Alternative Payment Contract, or other alternative payment arrangement as part of an insured health benefit plan network, unless the Provider Organization obtains a Risk Certificate or a Risk Certificate Waiver, as applicable – Definition of Alternative Payment Methodologies or Methods: “Methods of payment that are not solely based on fee for service reimbursements; provided, however, Alternative Payment Methodologies may include, but shall not be limited to, shared savings arrangements, bundled payments, and global payments; and further provided, Alternative Payment Methodologies may include fee for service payments, which are settled or reconciled with a bundled or global payment.” 4
5/30/2017 ACO Compliance Requirements Compliance program requirements applicable to MSSP ACOs. The MSSP regulations at 42 C.F.R. § 425.300 (the “Regulations”) explicitly require that a MSSP ACO’s compliance program have the following elements: – A designated compliance officer who is not legal counsel (but who may be a lawyer) and who reports directly to the ACO’s governing body; – Mechanisms for identifying and addressing compliance problems related to the ACO’s operations and performance; – A method for employees or contractors of the ACO, ACO participants, ACO providers/suppliers and other individuals or entities performing functions or services related to the ACO to anonymously report suspected problems related to the ACO to the compliance officer; – Compliance training for the ACO, the ACO participants, and the ACO providers/suppliers; and – A requirement for the ACO to report probable violations of law to an appropriate law enforcement agency. – The ACO must also update its compliance program periodically to reflect changes in law and regulation. The RFR model agreement for the Model A ACO includes robust contractual requirements for a compliance program that incorporates the federal Managed Care Organization program integrity requirements at 42 C.F.R. § 438.608. To adhere to the contractual requirements, a MassHealth ACO’s compliance program must include: – Written policies, procedures, and standards of conduct that articulate the ACO’s commitment to comply with all applicable federal and state standards; – A designated compliance officer and compliance committee that is directly accountable to senior management as described in 42 C.F.R. § 438.608, and a designated fraud and abuse prevention coordinator (who may also be the compliance officer) that manages the fraud and abuse program and is the referral and education point for employees in conjunction with the compliance officer; – Training and education for the compliance officer and the ACO’s employees, as well as providing employees, subcontractors, and agents with information about fraud and abuse laws, false claims, and whistleblower protections including in compliance with 42 U.S.C. § 1396a(a)(68) where applicable; – Effective lines of communication between the compliance officer, fraud and abuse prevention coordinator, and the ACO employees; – Provisions for prompt responses to detected offenses and corrective action initiatives; – Enforcement standards and disciplinary guidelines for compliance violations that are well-publicized; – Provisions for internal monitoring and auditing including provider audits through sampling methods to determine whether represented services were actually delivered by provider and received by enrollees, utilization review, and a mechanism to suspend payments to providers where MassHealth has credible allegation of fraud pursuant to 42 C.F.R. § 455.23; – Communication of suspected violations of state and federal law to government agencies, including overpayments, circumstances affecting an enrollee’s MassHealth eligibility, and circumstances affecting a participating provider’s eligibility to participate in MassHealth; – A fraud and abuse program to prevent and detect program violations, investigate allegations of misconduct, protect reporting employees from retaliation, recover improper or fraudulent payments, implement corrective actions, and comply with MassHealth’s reporting and certification requirements; and – Initial and ongoing screening procedures for the ACO and providers to determine if any individuals or entities are excluded from participation in federal health care programs, and notification of any discovered exclusions to MassHealth 5
5/30/2017 Fraud and Abuse Reference Materials ACO Waiver Examples Next Generation ACO https://www.cms.gov/Medicare/Fraud-and- Abuse/PhysicianSelfReferral/Downloads/Next-Generation-ACO-Model-Waiver.pdf ACO Participation Waiver Shared Savings Distribution Waiver Stark Law Waiver Waiver for Patient Engagement Activities – MSSP Waivers https://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27599.pdf ACO Pre-participation Waiver ACO Participation Waiver Shared Savings Distribution Waiver Stark Law Waiver Waiver for Patient Engagement Activities 6
5/30/2017 Fraud and Abuse Compliance: A key question for analysis What kind of Plan is at the top of the food chain? – This will determine the applicability of AKS safe harbors, the Stark exception, and applicable MA law There are many plans, and in applying the various potential safe harbors, or exceptions, the greatest opportunity for flexibility occurs when the plan is a risk based plan such as a Medicare Advantage (MA) plan, a competitive medical plan (CMP), a prepaid health plan or another type of plan that operates under a risk based contract with CMS or a State health care program The Analysis Begins: The Anti-Kickback Statute SSA Section 1128B – Criminal penalties (42 USC 1320a-7b) --”Knowingly and willfully solicits are receives …any kickback …or rebate…directly or indirectly…” -- “…in return for referring…for the furnishing or arranging for the furnishing any item or service for which payment may be made...” -- “…in return for purchasing, leasing, ordering or arranging for or recommending …any good, facility service or item…” -- “…for which payment may be made in whole or in part under a Federal health care program…” 7
5/30/2017 The AKS Managed Care Safe Harbors 42 CFR 1001.952 [“952”][All regulatory references are to 42 CFR 1001.952 unless otherwise noted] – A statement of what is NOT remuneration for purposes of Section 1128B (42 USC 1320 a-7(b)) Discounts -- 952(h) and 42 USC 1320a-7(b)(b)(3)(A) Increased coverage, reduced cost sharing amounts or reduced premium amounts offered by health plans – 952(l) Price reductions offered to health plans – 952(m) AKS Managed Care Safe Harbors, cont. Price reductions offered to eligible managed care organizations (“EMCOs”) – 952(t) Price reductions offered by contractors with substantial financial risk (“SFR”) to managed care organizations – 952(u) 8
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