Legal Challenges and Concerns with Clinical Integration

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1 Legal Challenges and Concerns with Clinical Integration By Edward Matto and Claire Turcotte, Bricker & Eckler LLP A clear goal of health reform is to foster greater integration and collaboration among health care providers to achieve the Centers for Medicare & Medicaid Services (CMS) triple aim: better care, better health and reduced health care costs. In response, hospitals, physicians and other care providers are forming clinically integrated networks (CINs) to begin managing health care services for populations of patients. Hospitals often lead efforts to form new companies to operate CINs so they can jointly negotiate third party payer contracts with participating employed and independent physicians. Although CINs are aligned with federal health care policy goals, those involved in structuring and operating CINs should carefully consider compliance with applicable health care laws. Structuring Clinically Integrated Networks in Compliance with the Antitrust Laws For purposes of compliance with the antitrust laws, a clinically integrated entity basically must be structured such that the network of competing providers will result in a high degree of provider interdependence and cooperation to control health care costs and ensure quality health care through the CIN. The CIN must be structured such that it avoids a per se violation of the antitrust laws and avoids overriding anticompetitive effects. 1 Properly structured, the CIN will avoid a per se violation of price fixing, market allocation or agreement not to compete. The antitrust test becomes, instead, a balance of the pro-competitive benefits versus the anticompetitive effects of such collaboration (the rule of reason test). The antitrust question under the rule of reason test is whether the anticipated joint price negotiations and any competitive restrictions within the CIN are ancillary to and reasonably necessary to further the legitimate purpose of the network, i.e., are the joint negotiations and competitive restrictions necessary to achieve cost efficiencies and increased quality of care that benefit patients and payers. Another antitrust question that is considered is whether the CIN will have market power within any service line covered by the CIN. Market power is evidenced by high market shares or other indicators of market power such that the CIN can demand monopoly prices and/or eliminate competition in the particular market(s). The higher the percentage of providers participating, the less network restrictions can be placed upon such providers limiting their ability to contract directly with payers or with other networks. In other words, the percentage of providers in any of the specialties is considered high when other competing networks or plans need some of those providers to participate for the network or plan to be competitive. In such a situation, there cannot be network restrictions requiring exclusive commitment by those providers or any restriction against participating in other networks or plans. 1 The alternative to clinical integration would be financial integration. This article focuses on clinical integration. 1

2 The following is an example of key provisions in structuring a CIN. 2 The goal is for the CIN to implement an ongoing program to evaluate and modify practice patterns by the network s providers to control costs and ensure quality by including: Creation of specialty advisory groups that are responsible for developing and periodically updating clinical practice guidelines, with all physicians being required to actively participate in developing the guidelines. The network s specific evidence-based clinical practice guidelines should be developed for as many disease-specific conditions as practical, and the specific groups will periodically review, reassess and update these guidelines as appropriate. Creation of a quality assurance committee which will include participating physicians and quality assurance individuals responsible for establishing the measures for individual and group performance benchmarking, monitoring individual and group compliance with the network s standards and administering provider corrective actions as necessary. Development of measures to identify high-cost providers, inappropriate use of resources, and failures to comply with clinical practice guidelines. The network will develop a mechanism to develop recommendations for improving individual and aggregate compliance performance and to assist with risk management. The development of electronic platforms for use by the CIN and its participating providers such that the use of the electronic platforms becomes a critical component of the clinical integration program described above. The providers enter into non-exclusive contracts with the network such that the providers can engage in contracting independently or through participation in a competing network. In other words, potential customers could negotiate and contract directly with the individual providers. The providers agree to participate in all payer contracts entered into by the CIN. This increases the likelihood that the providers will actively participate in the mechanisms set up to achieve the goal of cost efficiencies and increased quality of care. The CIN provides a mechanism to avoid potential spillover effects; that is, provides mechanisms to avoid competing providers engaging in discussions and possible agreements for anticompetitive conduct outside of the legitimate business activities of the CIN. One way to assist in avoiding spillover effects is to provide antitrust counseling and training to ensure that the participating providers do not collectively reach anticompetitive agreements in dealings outside of the network. 3 Fraud and Abuse Challenges in Structuring Clinically Integrated Networks In addition to antitrust concerns, the fraud and abuse laws as they exist today may present significant legal challenges and barriers to clinical integration. The Stark Law. The federal Stark Law prohibits physicians from referring Medicare or Medicaid patients to entities for the furnishing of designated health services (DHS) if they have a financial relationship with the entity that cannot meet a Stark exception. 4 CINs should evaluate whether their 2 This summary example is taken from the favorable FTC Advisory Opinion issued to the Norman (Oklahoma) Physician Hospital Organization regarding its proposed clinical integration structure, February 13, See at 3 The actual structure and antitrust concerns will be specific to the proposed make-up of the CIN and to the character of the markets within which the CIN expects to operate USC 1395nn(a)(1)(A). 2

3 contracts with participating physicians for services may create compensation arrangements 5 that must meet an available Stark compensation exception. 6 In particular, even if the CIN itself is not furnishing and billing Medicare or Medicaid for DHS, participation contracts could potentially create an indirect compensation arrangement 7 between hospitals and referring physicians that would need to meet the indirect compensation exception. 8 A challenge for CINs is that if a Stark compensation relationship is created, it may be difficult to be certain that an available Stark exception can be met. The Stark compensation exceptions clearly permit payments for a physician s professional or administrative services using an hour s worked or work effort approach such as wrvus. 9 However, CINs often pay participating physicians for achieving quality and performance metrics, following standardized clinical protocols, or contributing to organizational goals, which are not typically measured by a physician s hours worked, wrvus or other measures of individual productivity. Also challenging is that many Stark exceptions require payments to be consistent with fair market value, but to date there is no benchmark data or other generally accepted method to determine the fair market value of payments for achieving quality and performance measures. Likewise, Stark exceptions prohibiting payments that vary based on the volume or value of DHS referrals or other business generated by physicians may be a challenge. For example, payments that vary based on services ordered, instead of based on hours worked or personal productivity, may be viewed as not meeting an 5 If a CIN is structured to include physician ownership in the CIN or other related entities, participants should also consider whether a Stark ownership interest is created that must meet a Stark ownership exception. 6 Depending on the CIN s structure, available exceptions may include: Employment (permits payments to physicians for identifiable services at fair market value and not taking into account the volume or value of referrals, and commercially reasonable; limits productivity bonuses to physicians personally performed services) Personal Services (permits payments to physicians for services if set in advance and fair market value and not taking into account the volume or value of referrals, and commercially reasonable; signed, written agreement for at least one year term; permits per-service and other formula payments) Fair Market Value (permits payments to physicians for items or services if set in advance and fair market value and not taking into account the volume or value of referrals, and commercially reasonable; signed, written agreement, for any timeframe,; permits percentage or per-service arrangements for personal services) Indirect Compensation (permits payments to physicians with an indirect compensation arrangement for items or services if fair market value and not taking into account the volume or value of referrals; signed, written agreement) Electronic Health Records Items and Services (permits donating part of the cost of qualifying EHR systems to physicians under specified conditions) Risk Sharing Arrangements (permits payments pursuant to certain risk-sharing arrangements between MCOs or IPAs and a physician) 42 CFR An indirect compensation arrangement is created if (i) there is an unbroken chain of financial relationships linking the referring physician and the DHS entity, (ii) the aggregate compensation received by the referring physician from the person or entity with a direct financial relationship with the physician varies with or takes into account the volume or value of DHS referrals or other business generated by the physician for the DHS entity (without regard to the special rules on compensation, (iii) the DHS entity has actual knowledge or acts in reckless disregard or deliberate ignorance that the referring physician receives aggregate compensation that varies with or reflects the volume or value of referrals or other business generated for the DHS entity. 42 CFR (c)(2), (d) CFR (p). 9 The physician self-referral law is premised on compensation arrangements for services rendered, an hours worked approach, that is out of sync with clinical integration, where compensation is linked to the achievement of results or use of clinical protocols or best practices. Its regulations have become a tight web of confusing and changing requirements that place hospitals at risk for serious sanctions based on inadvertent or procedural violations. Letter from American Hospital Association to The Federal Trade Commission, Department of Health and Human Services and Centers for Medicare & Medicaid Services dated September 27, 2010 Re: Workshop regarding Accountable Care Organizations and Implication Regarding Antitrust, Physician Self-Referral, Anti-Kickback, Civil Monetary Penalty (CMP) Laws. 3

4 exception. Enforcement authorities could also find that hospitals involved in CINs considered the volume of hospital services participating physicians refer when determining CIN arrangements and payments. This arguable misfit of the current Stark exceptions to the types of payments involved in CINs may place hospitals and physicians involved in CINs at risk of violating Stark. The Anti-kickback Statute. The federal anti-kickback statute prohibits making payments to induce referrals of Medicare or Medicaid patients or the ordering of goods or services reimbursable by Medicare or Medicaid. 10 The anti-kickback statute was intended to protect against financial relationships causing physicians and others to over utilize Medicare and Medicaid services by referring patients for unnecessary services or steer patients to particular providers based on financial motives versus patients best interests. CINs should be aware that rewards for physicians following best practices or evidence-based protocols could be construed as violating the anti-kickback statute. 11 For example, government regulators could view a CIN s incentive payments to participating physicians as disguised payments to induce physicians to refer to the CIN s sponsoring hospitals. Voluntary safe harbors protect certain arrangements from prosecution under the anti-kickback statute, if all requirements are met. 12 However, it may not be possible for CINs to structure certain common types of arrangements to satisfy a safe harbor. For example, at-risk payments to contracting physicians cannot meet the set in advance requirement of the personal services and management contracts safe harbor because their aggregate amount cannot be determined in advance. Particularly if a safe harbor cannot be met, available guidance suggests incorporating certain safeguards to minimize the risk of a violation including: Determining that payments are at fair market value, such as by obtaining an appraisal from an appropriately qualified appraiser familiar with CIN arrangements Ensuring that payments are for identifiable services of the physicians (versus for referrals) Avoiding compensation that varies with the number of patients, such as compensation that increases with referrals to the CIN s hospital sponsors Avoiding offering CIN participation opportunities to physicians as an incentive to switch referrals to the CIN s sponsoring hospitals Using nationally recognized standards and identifying specific actions required to achieve payments Requiring measurable improvement over the status quo to receive payments USC 1320(a)-7b. 11 According the American Hospital Association: The anti-kickback law has been stretched to cover any financial relationship between a hospital and physician. The result is that rewards for a physician following best practices or evidence-based protocols could be construed as violating the statute. See American Hospital Association letter, supra note Relevant safe harbors may include: Employment (permits payments by employers to W-2 employee physicians for furnishing items or services covered by Medicare, Medicaid or other federal health care programs) Personal Services and Management Contracts (permits payments to physicians for services if aggregate payments are set in advance and fair market value and not taking into account the volume or value of referrals and commercially reasonable; signed, written agreement for at least one year term; generally does not permit per service, or percentage payments) Risk sharing and other arrangements with managed care organizations (permits payments between managed care plans and contracts for services under specified circumstances) Electronic Health Records Items and Services (permits donating part of the cost of qualifying EHR systems to physicians under specified conditions) 42 CFR

5 Limiting the duration of participation agreements to three years or less to ensure re-evaluation of the CIN s goals, measures and compensation. 13 The Civil Monetary Penalty Law. The Civil Monetary Penalty (CMP) law prohibits a hospital from knowingly making payments directly or indirectly to a physician involved in the direct care of a Medicare or Medicaid patient to induce the physician to reduce or limit services. 14 The CMP law was intended to prevent hospitals from incentivizing physicians to reduce or provide a different level of care to Medicare or Medicaid patients versus nongovernmental patients. The CMP law has been interpreted to prohibit payments or incentives to reduce or eliminate even medically unnecessary care, as well as incentives to substitute less expensive products, limit choice of products, and other similar cost saving measures. Liability under the CMP law does not require payments to be tied to reductions in medically necessary care and can result from reductions in unnecessary care. 15 CINs may incentivize physicians to reduce costs by eliminating medically unnecessary services and standardizing or limiting product vendors or options. However, doing so may present a risk of violating the CMP law. CINs using these types of incentives should incorporate safeguards deemed favorable by available guidance including: Ensuring that incentives do not negatively impact patient care, such as by engaging an independent medical expert and monitoring cost savings measures to prevent inappropriate reductions in services Structuring benchmarks to allow physicians flexibility to use the most cost-effective clinically appropriate items and supplies and avoiding blanket prohibitions on using particular items that may be clinically appropriate for certain patients Limiting financial incentives tied to cost savings to a reasonable amount and duration, such as by including a maximum annual cap and limiting the duration to three years Conditioning incentives on not stinting on care, increasing referrals, cherry-picking healthy patients or those with desirable insurance or accelerating patient discharges 16 Parting Thoughts While health reform and recent CMS initiatives continue to fuel widespread industry consolidation and clinical integration, current healthcare laws continue to present legal challenges and concerns in structuring CINs and other similar models intended to improve the health care delivery system for the future. All indicators suggest consolidation and clinical integration will continue. Nevertheless, CIN should carefully consider the health care laws in structuring and ongoing operations of CINs to ensure compliance. Authors: Edward A. Matto Partner ematto@bricker.com Claire Turcotte Partner cturcotte@bricker.com 13 See, e.g., United States Department of Health and Human Services, Office of Inspector General, Advisory Opinion (December 31, 2012) USC 1320a-7a(b). 15 See United States Department of Health and Human Services, Office of Inspector General, supra note Id. 5