AMERICAN HEALTH LAWYERS ASSOCIATION. Year in Review

Transcription

1 AMERICAN HEALTH LAWYERS ASSOCIATION Year in Review

2 American Health Lawyers Association Year in Review Table of Contents...2 Accountable Care Organizations Antitrust...4 Arbitration/Mediation..24 Employment and Labor..39 EMTALA..44 ERISA..53 Food and Drug Law/Life Sciences..68 Fraud and Abuse.98 Healthcare Reform.177 Health Information Technology..196 HIPAA 203 Hospitals and Health Systems Individual Patient Rights..214 Insurance/Managed Care Long Term Care..232 Medical Records.238 Medicaid 242 Medical Malpractice Medicare Patient Safety..354

3 Physicians 357 Quality of Care RICO..384 Tax.389 3

4 Accountable Care Organizations CMS Issues Proposed Rule On Accountable Care Organizations The Centers for Medicare and Medicaid Services (CMS) issued March 31, 2011 the muchanticipated proposed rule on the Medicare Shared Savings Program for accountable care organizations (ACOs) pursuant to Section 3022 of the Patient Protection and Affordable Care Act (PPACA). The proposed rule, slated for publication in the April 7, 2011 Federal Register, is intended to help physicians, hospitals, and other providers form patient-centered ACOs to better coordinate care across healthcare settings. Among other things, the proposed rule details and seeks comments on various aspects of ACO formation and participation in the shared savings program, including eligibility criteria, legal and governance structures, quality measures, performance scoring, and payment models. ACOs will enter into agreements with the Department of Health and Human Services (HHS) for not less than three years under one of two tracks, discussed more below. HHS emphasized that participation in an ACO is purely voluntary. According to an analysis of the proposed regulation, Medicare could potentially save as much as $960 million over three years as a result of the shared savings program. Comments on the proposed rule are due June 6. HHS is planning a series of open door forums on the proposal during the comment period. Accountable Care Under Section 3022, ACOs agree to be accountable for the quality, cost, and overall care of the Medicare fee-for-service beneficiaries assigned to the organization. Beginning in January 2012, ACOs that meet specified quality performance standards will be eligible to receive a share of any savings if the actual per capita expenditures of their assigned Medicare beneficiaries are a sufficient percentage below benchmark amounts set by CMS. For too long, it has been too difficult for health care providers to work together to coordinate and improve the care their patients receive. That has real consequences: patients have gaps in their care, receive duplicative care, or are at increased risk of suffering from medical mistakes. Accountable Care Organizations will improve coordination and communication among doctors and hospitals, improve the quality of the care their patients receive, and help lower costs, said HHS Secretary Kathleen Sebelius. An ACO will be rewarded for providing better care and investing in the health and lives of patients, said Donald M. Berwick, M.D., CMS Administrator. ACOs are not just a new way to pay for care but a new model for the organization and delivery of care. Eligibility for Shared Savings The PPACA identifies four groups as eligible to participate in the shared savings program: ACO professionals (i.e., hospitals and physicians) in group practice arrangements, networks of individual practices of ACO professionals, partnerships or joint venture 4

5 arrangements between hospitals and ACO professionals, and hospitals employing ACO professionals. The statute also gives the Secretary the discretion to expand eligibility to other groups of providers and suppliers as appropriate. Under the proposed rule, the four statutorily identified groups, as well as critical access hospitals, would be allowed to form ACOs independently. Other Medicare-enrolled entities, like skilled nursing facilities, long term care hospitals, and federally qualified health centers, could participate in established ACOs, but not form them on their own. CMS is seeking further comments on the providers/suppliers that should be eligible to participate in ACOs for purposes of the shared savings program. State-Recognized Legal Entity Under the PPACA, an ACO must have a formal legal structure that would allow the organization to receive and distribute payments for shared savings to participating providers of services and suppliers. Each ACO would need to be a legal entity recognized and authorized to conduct business under applicable state law that is capable of receiving and distributing shared savings; repaying shared losses; establishing, reporting, and ensuring ACO participant and ACO provider/supplier compliance with program requirements, including the quality performance standards; and performing the other ACO functions identified in the statute, the rule said. Thus, under the proposal, a hospital employing ACO professionals could be eligible to participate in the shared savings program as an ACO with its current legal structure, so long as it was recognized under state law, and would not have to develop a separate new entity. CMS made clear, however, that existing ACOs will not automatically be accepted into the shared savings program. Shared Governance The proposed rule would require the ACO to demonstrate a mechanism of shared governance that provides all ACO participants with an appropriate proportionate control over the ACO s decision making process. CMS is proposing that an ACO must establish and maintain a governing body such as a board of directors or board of managers with adequate authority to execute the ACO's statutory functions. Under the proposed rule, the governing body must include representatives from ACO providers and suppliers and Medicare beneficiaries. ACO participants would have to control at least 75% of the governing body. This proposal ensures that ACOs remain provider-driven, but also leaves room for both nonproviders and small provider groups to participate in the program, CMS said. Beneficiary Assignment CMS is proposing to assign beneficiaries to an ACO based on primary care services rendered by physicians in general practice, internal medicine, family practice, and geriatric medicine. 5

6 The agency is seeking comments on other options that may better address the delivery of primary care services by specialists. According to CMS, assignment as used in the PPACA is an operational process by which Medicare will determine whether a beneficiary has chosen to receive a sufficient level of the requisite primary care services from physicians associated with a specific ACO so that the ACO may be appropriately designated as exercising basic responsibility for that beneficiary's care. CMS emphasized that the term assignment... in no way implies any limits, restrictions, or diminishment of the rights of Medicare FFS beneficiaries to exercise complete freedom of choice in the physicians and other health care practitioners and suppliers from whom they receive their services. Under the PPACA, an ACO must have a minimum of 5,000 beneficiaries assigned to it to participate in the shared savings program. CMS would issue a warning and corrective action plan to an ACO whose assigned population fell below 5,000 during the course of the three-year agreement period. The ACO would remain eligible for shared savings for the performance year for which the warning was issued. If the ACO continued to miss the 5,000 mark by the completion of the next performance year, then CMS would terminate the ACO's participation and it would not be eligible to share in savings for that year. Two-Track Payment Model Under the proposed rule, CMS would develop a performance benchmark for each ACO to assess whether it qualifies to receive shared savings, or to be held accountable for losses, according to agency fact sheets. The proposed rule would allow ACOs to opt for either a one-sided risk payment model (sharing of savings only for the first two years and sharing of savings and losses in the third year) or a two-sided risk model (sharing of savings and losses for all three years). CMS believes this approach would have the advantage of providing an entry point for organizations with less experience with risk models, such as some physician-driven organizations or smaller ACOs, to gain experience with population management before transitioning to a risk-based model, while also providing an opportunity for more experienced ACOs that are ready to share in losses to enter a sharing arrangement that provides a greater share of savings, but at the risk of repaying Medicare a portion of any losses, according to a CMS fact sheet. CMS also is proposing to establish a minimum sharing rate (MSR) that would account for normal variations in healthcare spending, so that the ACO would be entitled to shared savings only when savings exceeded the minimum sharing rate (MSR). Under the proposed rule, ACOs in the one-sided risk program that have smaller populations (and having more variation in expenditures) would have a larger MSR, while ACOs with larger populations (and having less variation in expenditures) have a smaller MSR. Under the two-sided approach, CMS is proposing a flat 2% minimum sharing rate. Once the ACO surpasses the minimum savings rate, it may share in savings if it is eligible to receive shared savings based on its quality performance score, CMS said. Under the 6

7 proposed rule, ACOs in the two-sided model would have a higher maximum sharing percentage of 60%, compared to 50% in the one-sided model. In addition, CMS explained, under the two-sided model, ACOs would receive shared savings for the first dollar after achieving the minimum savings rate, while under the one-sided model, ACOs would share in savings after a 2% threshold is met, with an exemption for small ACOs in rural or underserved communities. Under both models, shared savings would be linked to quality and performance scores. The proposed rule also provides a methodology for determining shared losses, which also would be based in part on the ACO s quality performance score. CMS is proposing a shared loss cap of 5% of the benchmark in the first year of the program, 7.5% in the second year, and 10% in the third year. Quality Measures, Performance CMS is proposing 65 quality measures for the first year in five main areas: patient/caregiver experience of care; care coordination; patient safety; preventive health; and at-risk population/frail elderly health. CMS indicated that quality measures for the remaining two years would be proposed in future rulemaking. In several fact sheets, CMS indicated that these measures are aligned with those in other programs such as those for Electronic Health Records and the Physician Quality Reporting System. CMS is proposing to define the first quality performance period as beginning January 1, 2012 and ending December 31, ACOs that do not meet the quality performance thresholds for all proposed measures would be ineligible for shared savings, regardless of how much per capita costs were reduced, CMS said in the rule. ACOs that continue to underperform, or exhibit a pattern of incomplete or inaccurate reporting, will be subject to termination from the program. In the first year of the shared savings program, CMS proposes to define the quality performance standard at the reporting level, and to define it based on measure scores in subsequent years, according to the rule. Program Integrity CMS also proposed a number of program integrity provisions to guard against fraud and abuse in the shared savings program, including requiring ACOs to have a compliance plan, to meet certain certification requirements, and to put a conflicts of interest policy in place. CMS also is considering screening ACOs during the application process for any history of program exclusions or other sanctions and affiliations with individuals or entities that have a history of program integrity issues. Legal, Tax Implications Stakeholders have raised concerns that forming ACOs may run afoul of existing antitrust, tax, and fraud and abuse laws, including the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law. 7

8 In conjunction with the proposed rule, the HHS Office of Inspector General and CMS issued a joint notice and solicitation of public comments on potential waivers of certain fraud and abuse laws with respect to the shared savings program. In addition, the Department of Justice and the Federal Trade Commission issued a proposed antitrust policy statement and the IRS requested comments on the need for additional tax guidance for tax-exempt organizations participating in the shared savings program. Federal Agencies Move To Address Antitrust, Fraud And Abuse Concerns For ACOs As the Centers for Medicare and Medicaid Services (CMS) unveiled the long-awaited proposed regulations on the Medicare Shared Savings Program, the administration also moved to address concerns that accountable care organizations (ACOs) could run afoul of federal antitrust, tax, and fraud and abuse laws. Stakeholders have said certain federal laws could pose significant barriers to ACO formation, indicating that in the absence of further guidance from the agencies, ACOs and other similar integration strategies may present too great of a regulatory risk for providers. [CMS] has worked closely with agencies across the Federal government to ensure a coordinated and aligned inter- and intra-agency effort to address these legal and tax implications, according to an agency fact sheet posted March 31, In conjunction with the proposed rule, CMS and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a joint notice seeking comments on potential fraud and abuse law waivers for ACOs participating in the shared savings program. The Federal Trade Commission (FTC) and the Department of Justice (DOJ) also released a proposed antitrust policy statement regarding ACOs. Finally, the IRS issued a notice seeking comments regarding the need for guidance on tax-exempt organizations participating in ACOs. Fraud and Abuse Law Waivers The CMS/OIG notice outlines proposals for waivers of certain fraud and abuse laws the physician self-referral law, the anti-kickback statute, and the civil monetary penalty law (CMP) for the shared savings program and solicits comments on further waiver design considerations, according to the fact sheet. At the outset, the agencies noted that a waiver is not needed for all arrangements to the extent the ACO does not implicate the fraud and abuse laws or fit within existing safe harbors and exceptions. The agencies are proposing waivers in three circumstances: The distribution of shared savings payments received by an ACO to or among qualified ACO participants and ACO providers/suppliers. 8

9 An ACO s distribution of shared savings payments to other individuals or entities for activities necessary for and directly related to the ACO s participation in the shared savings program. For the anti-kickback statute and CMP only, certain financial relationships that are necessary for and directly related to the ACO s participation in the program and fully comply with an exception to the physician self-referral law. The waivers related to the distribution of shared savings would apply to the distributions of shared savings earned by the ACO during the term of agreement with CMS to participate in the Medicare Shared Savings Program, even if the actual distributions occur after the expiration of the agreement, the notice said. The notice also seeks comments on exercising HHS' waiver authority to address start-up costs, operating expenses, and non-shared savings relationships between ACO members or outside entities, the fact sheet said. Comments on the notice are due June 6. The notice will be published in the April 7 Federal Register. Antitrust Policy The FTC s and DOJ s Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program is intended to ensure that health care providers have the antitrust clarity and guidance needed to form procompetitive ACOs that participate in both the Medicare and commercial markets. The proposed policy is applicable to collaborations, not including mergers, that were formed after March 23, 2010 for purposes of participating in the shared savings program. ACOs using the same governance structure and the same clinical and administrative processes in the commercial market as they used to participate in the program would be subject to rule of reason treatment, which will apply for the duration of their participation in the shared savings program, the agencies said. The Agencies further note that CMS s proposed regulations allow an ACO to propose alternative ways to establish clinical integration, and the Agencies are willing to consider other proposals for clinical integration as well, the policy statement said. The proposed antitrust policy provides a Safety Zone for certain ACOs that participate in the program, which would not be subject to antitrust scrutiny absent extraordinary circumstances. To fall within the Safety Zone, independent ACO participants that provide a common service must have a combined share of 30 percent or less for each common service in each participant s Primary Service Area ("PSA ), wherever two or more ACO participants provide that service to patients from that PSA, the fact sheet said. According to the policy statement, the higher the PSA share, the greater the risk the ACO will be anticompetitive. An ACO with high PSA shares may reduce quality, innovation, and choice for Medicare and commercial patients, in part by reducing the ability of competing equally or more efficient ACOs to form. High PSA shares also may allow the ACO to raise prices to commercial health plans above competitive levels. On the other hand, if there are already other competing ACOs, or sufficient suitable unaffiliated 9

10 physicians and hospitals to form competing ACOs, it is less likely that the ACO would raise significant competitive concerns. An ACO applicant with a combined share above 50% for any common service would fall outside the safety zone and will be subject to a mandatory antitrust review. To be eligible for the shared savings program, the ACO subject to the mandatory review must obtain a letter from DOJ or the FTC indicating the agency has no present intent to challenge the ACO. The agencies have pledged a 90-day expedited review of the ACO applicant. ACOs between the 30% safety zone and the 50% mandatory review threshold that do not impede competition and engage in pro-competitive activities may participate in the shared savings program without antitrust agency review. ACOs in this category may still seek agency review for added certainty, the fact sheet said. The agencies are seeking comments on the proposed policy through May 31. Issues for Tax-Exempt Organizations The IRS issued Notice asking whether additional guidance is needed for taxexempt organizations that plan to participate in the program through ACOs, the fact sheet said. A primary concern for tax-exempt organizations is whether their participation in the ACO results in prohibited inurement or impermissible private benefit. According to the fact sheet, given CMS regulation and oversight, the IRS expects that a tax-exempt organization s participation in the Shared Savings Program through an ACO generally would not result in prohibited inurement or impermissible private benefit to the private party ACO participants. The IRS also said shared savings received by tax-exempt organizations from ACOs that complies with program requirements generally would not result in unrelated business taxable income. The IRS also is soliciting comments on whether guidance is needed regarding the tax implications for tax-exempt organizations participating in activities unrelated to the program, including shared savings arrangements with commercial health insurance payors, through an ACO. Comments on the notice were due May 31, Antitrust Enforcement FTC Says Discounted Pharmaceuticals Furnished To In-Home Hospice Patients Would Not Violate Robinson-Patman A provider s proposal to provide pharmaceuticals purchased at a discount to in-home hospice patients is exempt from the Robinson-Patman Act, the Federal Trade Commission (FTC) staff said in a July 2, 2010 advisory opinion. 10

11 Community CarePartners, Inc., the opinion requestor, is a nonprofit corporation that offers a full range of post-acute care services, including inpatient rehabilitation, inpatient and in-home hospice and palliative care, home health, and adult day care services. The Robinson-Patman Act is an antitrust law that prohibits anticompetitive price discrimination, the opinion letter explained. The Non-Profit Institutions Act (NPIA) exempts from the Robinson-Patman Act purchases of their supplies for their own use by schools, colleges, universities, public libraries, churches, hospitals, and charitable institutions not operated for profit. CarePartners asked FTC if it could provide discounted pharmaceuticals available to eligible nonprofit entities to hospice patients receiving treatment in their homes and still qualify for the exemption. According to FTC staff, the discounted drugs would qualify for the exemption. First, CarePartners is an eligible institution under the NPIA, the letter said. In addition, consistent with existing case law, the use of the NPIA-discounted pharmaceuticals in connection with treatment of in-home hospice patients admitted to CarePartners Hospice Program falls within the own use requirement of the statute, FTC said. The extension of CarePartners use of the NPIA-discounted pharmaceuticals to the inhome hospice setting contributes directly to its ability to fulfill its central institutional function and is consistent with both prior case law and prior staff advisory opinions, the letter noted. DOJ, Michigan Sue Blue Cross Blue Shield Of Michigan Alleging Use Of MFN Clauses Anticompetitive The Department of Justice (DOJ), along with the state of Michigan, filed a civil antitrust lawsuit October 18, 2010 against Blue Cross Blue Shield of Michigan (BCBSM) alleging its use of most favored nation (MFN) clauses in its contracts with hospitals raises prices, prevents other insurers from entering the marketplace, and discourages discounts. According to the suit, which was filed in the U.S. District Court for the Eastern District of Michigan, the challenged provisions likely resulted in Michigan consumers paying higher prices for their healthcare services and health insurance. MFN provisions generally refer to contractual clauses between health insurance plans (buyers) and healthcare providers (sellers) that guarantee no other plan can obtain a better rate than the plan wielding the MFN. Some of the MFNs in this case guarantee the plan an even better rate than given to any other plan or purchaser. According to the complaint, BCBSM has used MFNs or similar clauses in its contracts with at least 70 of Michigan s 131 general acute care hospitals, including many major hospitals in the state. The MFNs at issue require a hospital either to charge BCBSM no more than it charges BCBSM s competitors, or to charge the competitors a specified percentage more than it charges BCBSM, in some cases between 30% and 40%, DOJ said. 11

12 DOJ alleges BCBSM s use of MFN provisions has reduced competition in the sale of health insurance in Michigan by raising hospital costs to BCBSM s competitors, which discourages other health insurers from entering into or expanding within markets throughout the state. In addition, the complaint alleges BCBSM agreed to raise the prices that it pays to hospitals to obtain the MFNs, thus buying protection from competition by increasing its own costs. BCBSM's efforts to secure the lowest rates in hospital agreements are designed to benefit the people of Michigan consistent with BCBSM's statutory obligations, the company said in a statement. "Negotiated hospital discounts are a tool that Blue Cross uses to protect the affordability of health insurance for millions of Michiganders, said Andrew Hetzel, BCBSM vice president for corporate communications. "Through this lawsuit, the federal government seeks to deny millions of Michigan residents the lowest cost possible when they visit the hospital." Hetzel said the lawsuit was "without merit" and vowed to "vigorously defend our ability to negotiate the deepest possible discounts for our members and customers with Michigan hospitals." "It does not make good business sense for Blue Cross Blue Shield of Michigan to reimburse a provider at a higher rate than we can otherwise negotiate," Hetzel added. "These kinds of low cost guarantees are widely used in a variety of contracts in a number of industries. In fact, the federal government routinely requires its own vendors to abide by these same low cost requirements." Proposed Settlement Bans Texas Hospital From Entering Into Anticompetitive Contracts With Insurers, DOJ Says The Department of Justice (DOJ) announced February 25, 2012 a proposed settlement with United Regional Health Care System of Wichita Falls, TX prohibiting the hospital from entering into contracts with health insurers that undermine competition from competing hospitals. According to DOJ, United Regional unlawfully used contracts with insurers to maintain its monopoly for hospital services in violation of Section 2 of the Sherman Act, causing consumers to pay more for healthcare services than they otherwise would have. DOJ said the lawsuit, filed in the U.S. District Court for the Northern District of Texas, is the first since 1999 that challenges a monopolist with engaging in traditional anticompetitive unilateral conduct. The proposed settlement, if approved by the court, would resolve the civil antitrust case, DOJ added. As a must have hospital in the Wichita Falls area, DOJ alleged, United Regional systematically required most commercial health insurers to enter into contracts that effectively prohibited them from contracting with United Regional s competitors. According to DOJ, because the penalty for contracting with United Regional s rivals was so significant, almost all insurers offering health insurance in Wichita Falls entered into exclusionary contracts with United Regional, DOJ contended. 12

13 The proposed settlement, which would expire in seven years, prohibits United Regional from conditioning the prices or discounts that it offers to commercial health insurers based on whether those insurers contract with other health-care providers and from inhibiting insurers from entering into agreements with United Regional s rivals. In addition, under the settlement, United Regional may not take any retaliatory actions against an insurer that enters into an agreement with a rival provider. FTC, Georgia AG Move To Block Hospital Acquisition The Federal Trade Commission (FTC) and the Georgia Attorney General (AG) filed a complaint seeking to halt Phoebe Putney Health System, Inc. s proposed acquisition of rival Palmyra Park Hospital, Inc. in Albany, GA from its owner HCA, according to an FTC press release. The complaint asks a Georgia federal district court to block the deal until the FTC concludes an administrative challenge, including appeals, to the transaction. FTC announced April 20, 2011 its administrative complaint, which alleges the transaction would violate federal law by significantly reducing competition and allowing the combined Phoebe/Palmyra to raise prices for general acute-care hospital services charged to commercial health plans. We have challenged this transaction for one very simple reason, said Richard Feinstein, FTC s Bureau of Competition Director. By eliminating vigorous competition between Phoebe and Palmyra, this merger to monopoly will cause consumers and employers in the Albany region to pay dramatically higher rates for vital health care services, and will likely reduce the quality and choice of services available in the community as well. According to the FTC complaint, the transaction is a merger to monopoly because Phoebe and Palmyra are the only two competing hospitals in the Albany, GA area. After the acquisition, FTC says, Phoebe would have a market share of more than 85%. The combination also would harm non-price competition that has spurred the two rivals to increase the quality of patient care, FTC contends. State Action FTC and the Georgia AG also have raised concerns that the proposed transaction is being structured to skirt federal antitrust scrutiny. The Hospital Authority of Albany-Dougherty holds title to the assets of Phoebe, a 443-bed hospital in Albany, which operates under a long term lease entered in Under the proposed transaction, the Authority would acquire Palmyra, which also operates in Albany, from its owner HCA and then lease it to a nonprofit corporation that Phoebe controlled. FTC says it expects Phoebe, the Authority, and HCA to assert the transaction is exempt from federal antitrust liability under the state action doctrine, which provides a narrow exception to the antitrust laws for anticompetitive conduct if it is an act of government. FTC alleges the transaction was motivated and planned exclusively by Phoebe, acting in its own independent, private interests, and not in the interest of patients. 13

14 FTC also contends that rather than acting in the State of Georgia s interests, the Authority served only as a strawman in an attempt to shield an overly anticompetitive transaction from antitrust scrutiny. Specifically, FTC alleges the Authority conducted no independent analysis of the deal, which it was only informed of at the last minute. FTC contends the state action doctrine is inapplicable because the Authority has not actively supervised Phoebe nor made any efforts to review the hospital s recent price increases. Cases Third Circuit Affirms Dismissal Of Antitrust, RICO Claims Against Orthopedic Device Makers The Third Circuit affirmed June 1, 2010 the dismissal of a lawsuit alleging five of the nation s largest manufacturers of orthopedic devices harmed competition by paying bribes and kickbacks to surgeons to use defendants products in violation of federal antitrust law. Plaintiffs Richard and Holly McCullough sued defendants Zimmer, Inc., Depuy Orthopaedics, Inc., Bioment, Inc., Smith & Nephew, Inc., and Stryker Orthopedics, Inc., under the Clayton Act for violating Section 1 of the Sherman Act and Section 2 of the Robinson-Patman Act. Plaintiffs also asserted claims under the Racketeer Influenced and Corrupt Organizations Act (RICO). Defendants are competing manufacturers of surgical orthopedic devices that together account for roughly 95% of the U.S. market in such products. According to government investigators, each defendant individually paid kickbacks and bribes to orthopedic surgeons to induce them to use its products. To avoid criminal liability, the companies agreed to implement corporate compliance plans, submit to federal monitoring, and pay a fine totaling $311 million. Plaintiffs contended they competed directly with defendants because they had exclusive contracts with defendants competitors to demonstrate, distribute, and service surgical orthopedic devices. According to plaintiffs, the bribes and kickbacks harmed their business and eventually excluded them from the surgical orthopedic device market in violation of the federal antitrust laws and RICO. The district court dismissed their antitrust and RICO claims, finding plaintiffs lacked standing because they had not suffered a cognizable antitrust injury attributable to defendants alleged conduct and failed to show a RICO enterprise. The Third Circuit affirmed in a non-precedential ruling. With respect to the antitrust standing issue, the appeals court noted the main deficiency in plaintiffs complaint was that they failed to establish they were competitors or consumers in the relevant market. According to the appeals court, plaintiffs only established they did business with defendants' competitors and consumers in the relevant market, but were not competitors or consumers themselves. 14

15 As mere intermediaries in the supply chain, the McCulloughs suffered no cognizable antitrust injury as a result of Defendants alleged anticompetitive conduct, the appeals court said. Nor did plaintiffs show any harm to their business inextricably intertwined with Defendants alleged conduct, the appeals court observed. Thus, the appeals court held the antitrust claims were properly dismissed for lack of standing. The appeals court also concluded the district court properly dismissed plaintiffs RICO claim for failing to show a RICO enterprise. Plaintiffs argued the surgeons, hospital administrators, and other entities that allegedly received bribes and kickbacks from defendants comprised the relevant enterprise for RICO purposes. Simply listing a string of individuals or entities that engaged in illegal conduct, without more, is insufficient to allege the existence of a RICO enterprise, the appeals court said. Finally, the appeals court declined to remand the action to the district court, holding that any additional amendments to plaintiffs complaint would be futile. McCullough v. Zimmer, Inc., No (3d Cir. June 1, 2010). California Supreme Court Says Pharmacies May Continue With Antitrust Suit Against Drug Makers The California Supreme Court held July 12, 2010 that a group of pharmacies could proceed with their far-reaching antitrust action under state law against major drug makers for allegedly conspiring to artificially inflate drug prices. In so holding, the high court rejected the manufacturers contention that the pharmacies suit should be barred because they were able to pass on the alleged overcharges to consumers. The high court s decision reverses an appeals court ruling that the defendant drug makers could mount a pass on defense and that such a defense entitled them to summary judgment on the price-fixing allegations. Instead, the high court opted to follow a U.S. Supreme Court decision holding antitrust violators in most instances could not assert as a defense that any illegal overcharges were passed on by a plaintiff direct purchaser to indirect purchasers. Hanover Shoe v. United Shoe Mach., 392 U.S. 481 (1968). Thus, the high court concluded that under California s Cartwright Act, as under federal law, generally no pass-on defense is permitted. In the high court s view, adopting the Hanover Shoe rule in the state context was most in accord with the legislature s overarching goals of maximizing effective deterrence of antitrust violations, enforcing the state s antitrust laws against those violations that do occur, and ensuring disgorgement of any ill-gotten proceeds. 15

16 Price-Fixing Conspiracy Plaintiff pharmacies sued a number of major drug manufacturers under Section 1 of the Cartwright Act alleging they agreed to set artificially high prices for their drugs by blocking reimportation of lower-priced drugs from abroad and limiting generic competition. According to the complaint, this concerted action allowed manufacturers to maintain prices for their drugs in California and nationally at levels 50% to 400% higher than they otherwise would have been. As a result, the pharmacies contended they were forced to pay an overcharge i.e., the differential between the inflated prices and the prices of a competitive marketplace. The pharmacies sought treble damages, restitution, and injunctive relief. The drug makers asserted an affirmative defense that the claims were barred because the pharmacies suffered no compensable injury as they passed on any alleged overcharge to consumers and third-party payors. The trial court held defendants could assert the pass-on defense to avoid liability and defeat plaintiffs claims. The appeals court affirmed, finding the defense was available to the drug makers under state law and was fatal to the suit because plaintiffs could show no damages sustained. Damages Sustained The California Supreme Court reversed, holding, on an issue of first impression, that under the Cartwright Act an antitrust defendant cannot defeat liability by asserting a pass-on defense. The Cartwright Act allows those injured in his or her business or property by actions forbidden under the law to recover three times the damages sustained. The high court rejected defendants argument that damages sustained evinced legislative intent that the pass-on defense be available to rebut claims under the Cartwright Act. The question we face is how to measure damages sustained, and nothing in the Cartwright Act s language as enacted in 1907 or thereafter amended, resolves that question, the high court said. The high court also found no evidence in the legislative history that in enacting the Cartwright Act, the legislature had any specific intent as to how to measure damages in antitrust lawsuits by direct purchasers. Hanover Shoe Rule Consistent with Legislative Intent Without any specific textual guidance or legislative history on point, the high court turned to subsequent statutory amendments to shed light on whether to adopt the Hanover Shoe rule. The high court highlighted two specific actions by the legislature indicating that given a choice, it would prefer an enforcement regime in which Hanover Shoe is the law. 16

17 First, after Congress passed the Hart-Scott-Rodino Antitrust Improvements Act, which authorizes state attorneys general to file suits on behalf of injured consumers for antitrust violations, the California legislature quickly moved to amend the Cartwright Act to incorporate the remedial framework of the Hart-Scott-Rodino Act. The Hart-Scott-Rodino Act, the high court said, reflected Congress belief that it was better to overdeter antitrust violations and maximize the likelihood violators would be required to fully disgorge price-fixing profits. The Hart-Scott-Rodino Act also expressly contemplated antitrust lawsuits by direct and indirect purchasers, with the potential for duplicative recoveries addressable by offsetting damages already paid. Second, the high court found significant the fact that the legislature repudiated a subsequent U.S. Supreme Court decision holding that, just as defendants could not raise a pass-on theory as a defense, so indirect purchasers could not use a pass-on theory to sue for overcharges arising from antitrust violations. Illinois Brick Co. v. Illinois, 431 U.S. 720 (1977). Shortly after that decision, the California legislature passed an Illinois Brick repealer bill, repudiating for purposes of the Cartwright Act any ban on indirect purchaser suits. These two actions by the legislature, the high court said, indicated acceptance of the Hanover Shoe rule and the notion that maximizing deterrence and the probability of full disgorgement of illegal gains are of paramount importance. To allow defendants universally to assert a pass-on defense, even in cases such as this that present no risk of duplicative recovery, would hamper enforcement by reducing incentives to sue and police antitrust violations, the high court wrote. In addition, [a]llowing a pass-on defense would plunge parties and courts into minitrials attempting to trace every penny of any initial overcharge, as well as seeking to measure the further ramifications that an overcharge might have in the form of lost sales and other tertiary consequences. The high court also noted that even though pharmacies may have in fact passed on overcharges, they could have been damaged in other ways such as lost profits or sales. Exceptions to Hanover Shoe The high court did single out two exceptions to the Hanover Shoe rule, namely for cost plus contracts and in instances where multiple levels of purchasers have sued. As to the latter, the high court said, if damages must be allocated among the various levels of injured purchasers, the bar on consideration of pass-on evidence must necessarily be lifted; defendants may assert a pass-on defense as needed to avoid duplication in the recovery of damages." Unfair Competition Plaintiff pharmacies also asserted claims against the manufacturers under the state s unfair competition law (UCL). The manufacturers asserted that plaintiffs lacked standing and were ineligible for relief. The lower courts also granted summary judgment to the manufacturers on this claim. 17

18 Reversing, the high court found the pharmacies had established standing, saying the manufacturers argument that the pharmacies suffered no compensable loss because they mitigated any injury by passing on the overcharges conflates the issue of standing with the issue of the remedies to which a party may be entitled. Finally, the high court noted that even if the pharmacies were not entitled to restitution, they were still entitled to seek an injunction under the UCL. Clayworth v. Pfizer, Inc., No. S (Cal. July 12, 2010). Third Circuit Allows Hospital To Proceed With Antitrust Action Alleging Conspiracy Between Hospital System And Insurer The Third Circuit reversed November 29, 2010 a federal district court decision dismissing antitrust claims brought by West Penn Allegheny Health System, Inc. alleging the University of Pittsburgh Medical Center (UPMC) and Highmark, Inc. conspired to protect one another from competition in their relevant markets to the detriment of the community s employers, consumers, and patients. The Third Circuit found West Penn adequately alleged a conspiracy between UPMC and Highmark that resulted in an unreasonable restraint of trade causing antitrust injury to West Penn. West Penn s Claims West Penn, Pittsburgh s second-largest hospital system, asserted claims against UPMC and Highmark under Sections 1 and 2 of the Sherman Act for entering into an illegal conspiracy, monopolization, and attempted monopolization. West Penn Allegheny also alleged state law claims of tortious interference and employee raiding. According to the opinion, UPMC is the dominant hospital in the Pittsburgh, PA metropolitan area, with a 55% share of the hospital services market and an over 50% market share in every tertiary and quaternary care service line. Highmark is the dominant insurer in the area with 60%-80% of the commercial market. Highmark s second-largest competitor is an affiliate of UPMC. West Penn Allegheny alleged that, beginning at least in summer 2002, UPMC agreed to protect Highmark by refusing to contract on reasonable terms with any competing health insurer or to sell its health insurance affiliate to any competing health insurer. In turn, Highmark agreed to restrict UPMC s hospital primary competitor, West Penn Allegheny, by shuttering its low-cost Community Blue product, attempting to block West Penn Allegheny s efforts to refinance its debt, and paying inflated reimbursement rates to UPMC while maintaining depressed rates for UPMC s competitors, especially West Penn Allegheny, the complaint said. West Penn also contended UPMC engaged in a ruthless and predatory campaign of physician raiding... to thwart the formation of West Penn Allegheny and to cripple, if not destroy, West Penn Allegheny as a viable competitor. According to West Penn, because of the alleged conduct, it lost millions of dollars in additional reimbursement, which has restricted its access to the necessary capital to invest in and expand its service lines. 18

19 During the years of the alleged conspiracy, the opinion said, UPMC and Highmark reaped record profits, with UPMC s net income rising from $23 million in 2002 to over $618 million in 2007, and Highmark s net income increasing from $50 million in 2001 to $398 million in UPMC s increased revenue came largely from the sweetheart reimbursements it received from Highmark, and Highmark increased its earnings by raising premiums, the opinion said. District Court Decision UPMC and Highmark moved to dismiss the action, relying on two Supreme Court decisions, Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 129 S.Ct (May 18, 2009), which allowed dismissal of a complaint if it failed to allege enough facts to state a claim to relief that is plausible on its face. The U.S. District Court for the Western District of Pennsylvania granted the dismissal motion, emphasizing its gatekeeper function under the cited Supreme Court cases to insist upon some specificity in pleading before allowing a potentially massive factual controversy to proceed. The court found West Penn had failed to adequately allege an illegal market allocation agreement between UPMC and Highmark for purposes of the conspiracy claims. In addition, the court held West Penn had not alleged an antitrust injury that the antitrust laws were designed to protect. The court also rejected the attempted monopolization claim under Section 2 based on UPMC s hiring of physicians from West Penn Allegheny. Plausibility Standard As an initial matter, the Third Circuit rejected the heightened pleading standard applied by the district court, finding it squarely at odds with Supreme Court precedent. We concluded that it is inappropriate to apply Twombly s plausibility standard with extra bite in antitrust and other complex cases, the appeals court said. Agreement to Protect Against Competition Next, the appeals court found West Penn adequately alleged direct evidence that UPMC and Highmark agreed to protect each other from competition. Specifically, the complaint alleged that in 2005 Highmark refused to refinance a loan it had made to West Penn, citing concerns that UPMC would retaliate against the insurer for violating their agreement. Similarly, the complaint alleged that in 2005 and 2006, West Penn asked Highmark to increase its reimbursement rates, which the insurer acknowledged were too low but refused to raise, again citing concerns that UPMC would retaliate. Unreasonable Restraint Likewise, the appeals court held West Penn sufficiently alleged the conspiracy unreasonably restrained trade by producing anticompetitive effects in the relevant markets. 19

20 According to the appeals court, at least at this stage of the litigation, West Penn plausibly suggested that by denying West Penn capital, the conspiracy caused West Penn to cut back on its services and to abandon expansion projects. The complaint also plausibly suggests that by shielding Highmark from competition, the conspiracy resulted in increased premiums and reduced output in the market for health insurance, the appeals court said. Antitrust Injury The appeals court also concluded that West Penn had alleged an antitrust injury in the form of artificially depressed reimbursement rates. Here, the complaint alleged Highmark had substantial monopsony power, with a 60%- 80% share of the Allegheny County market for health insurance. The complaint also alleged Highmark paid West Penn depressed reimbursement rates, not because of independent decision making, but pursuant to a conspiracy with UPMC. In these circumstances, it is certainly plausible that paying West Penn depressed reimbursement rates unreasonably restrained trade, the opinion said. Attempted Monopolization Finally, the appeals court reversed the lower court s dismissal of West Penn s attempted monopolization claim against UPMC. The complaint alleged UPMC tried to lure a number of employees away from West Penn even though UPMC could not absorb them; UPMC pressured community hospitals to stop referring oncology patients to West Penn by threatening to build competing facilities nearby; and UPMC made false statements about West Penn s financial health to potential investors, causing West Penn to pay artificially inflated financing costs on its debt. Viewed as a whole, these allegations plausibly suggest that UPMC has engaged in anticompetitive conduct, the Third Circuit held. Thus, the appeals court reversed in part and vacated in part the district court s judgment and remanded for further proceedings. West Penn Allegheny Health Sys., Inc. v. UPMC, No (3d Cir. Nov. 29, 2010). In subsequent developments, the U.S. District Court for the Western District of Pennsylvania granted motions to stay the proceedings while the defendants petitioned for writs of certiorari before the U.S. Supreme Court. The district court in granting the motion to stay noted that it must consider whether: (1) it was reasonably likely that the Supreme Court will grant Highmark and/or UPMC s petition(s), and if so, whether there is a fair prospect that a majority of the Court would decide that the Third Circuit s decision was incorrect; (2) Highmark or UPMC would suffer irreparable injury if a stay were to be denied; (3) West Penn would suffer substantial injury if a stay were to issue; and (4) a stay would be in the public interest. Regarding the first factor, the court agreed with defendants that it was at least reasonably likely that the Supreme Court would grant the defendants petitions, given that the decision of the Third Circuit appears to create a conflict between the First, Third, and Ninth Circuit Courts of Appeal on the issue of whether a plaintiff can maintain a 20