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Utah State Bar – Health Law Section – 2013 Spring Conference 1. Recent Stark & Anti-Kickback Cases 2. Note 3. Healthcare Reform Legislation • Patient Protection and Affordable Care Act, Pub. L. o. 111 – 148 • Health Care and Education Affordability Reconciliation Act 0f 2010, 4. Health Care Reform Legislation (Cont.) • Section 6402(f) — New AKS intent Standard — “With respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section.” § 1128B(h). • Overturns Hanlester Network et al. v. Shalala, 51 F.3d 1390 (9th Cir. • Same lowered intent level for health care fraud (ACA Section 5. Health Care Reform Legislation (Cont.) • Linkage to False Claims Act — Many courts have held under an express or implied certification theory that a violation of AKS is actionable under the False Claims Act. ii. Allows whistleblowers to bring actions. • ACA Section 6402(f) adds language on this issue — “In addition to the penalties provided for in this section . . ., a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim for purposes of the [False Claims Act].” § 1128B(g). 6. United States ex rel. Drakeford v. Tuomey, 675 F.3e 394 (4th Cir. 2012). 7. Stark Question • What year did CMS publish the final Stark I regulation? • Offered part-time employment agreements to physician specialists – gastroenterologists, orthopedists, and other specialists. • 10-year exclusive agreement. • Physicians acted in the capacity of employees only when performing • 2-year, 30-mile post-termination non-competition provision. i. “Tiered” based salary tied to collections of personally performed services – $5000 for each tier. ii. Full- time benefits package – health, malpractice ins., and CME iii. Productivity bonus totaling 80% of collections. iv. Up to 7% of collections for meeting certain quality measures. v. Tuomey received FMV reporting – physician compensation was justifiable so long as it did not exceed 150% of the 90th percentile – methodology rejected at trial by both party’s experts. vi. Tuomey taped conversation where executives represented that the payments functioned as “phantom ownership.” 10. Tuomey – Allegations & Arguments • Government alleged the total compensation to the physicians, including benefits, on average, was 19% higher than the professional component collections. • Parties agreed that if Stark applied, the arrangement should be analyzed as an indirect compensation arrangement. • The government argued that the arrangements did not meet the ICA exception because the compensation “took into account the volume or value of the physicians’ referrals.” i. Jury decided Tuomey violated the Stark Law but not the False ii. On post-trial motions, the district court entered $45 million Judgment for payment by mistake of fact and unjust enrichment based on Stark violation, set-aside the verdict with respect to FCA, and ordered a new trial. iii. Tuomey appeals arguing that the Stark Law does not apply because there is no “indirect compensation arrangement.” iv. Physicians were only paid for personally performed services. v. A “referral” excludes any DHS personally performed or 12. The Governments’ Arguments on Appeal • The government argued that the compensation: i. Varied with the volume & value of referrals because the physicians only earned money for work that simultaneously generated a technical component or facility fee; ii. Considered volume or value or referrals by including a portion iii. Was designed to exceed collections for the professional component, by including an amount to compensate for TC referrals. • Overturned judgment by finding a violation of Tuomey’s 7th • Addressed two Stark issues likely to recur on remand: i. Whether the TC fee of hospital outpatient services (which was billed to Medicare) performed by physicians under contract with Tuomey constituted “referrals” under the Stark Law; and ii. Whether considering the volume or value of anticipated TC referrals in calculation physician’s compensation violated the “volume or value” standard of the Stark Law. i. When a physician initiates a DHS and performs it him or herself, that action would not constitute a referral . . . However, in the context of inpatient and outpatient hospital services, there would still be a referral of any hospital service, technical component, or facility fee billed by the hospital in connection with the personally performed services. ii. The Court concluded that the TC of the physicians personally performed services constitutes a “referral.” • “We will not consider the volume or value standard implicated by otherwise acceptable compensation arrangements . . . so long as the payment is fixed in advance . . . is consistent with fair market value for the services performed (that is, the payment does not take into account the volume or value of the anticipated or required referrals). . . .” 66 Fed. Reg. 877. • Physicians should be compensated for the service they actually perform and not for their ability to generate referrals. • The fact that a physician is being paid for personally performed services does not automatically mean that Stark is a non-issue. • In the case of inpatient/outpatient hospital services, a Stark analysis will always be necessary because there will always be a referral of the TC whenever the physician provides a PC. • Anticipated referrals of DHS cannot be considered when establishing • The amount of the compensation must reflect only the FMV of the • Do not “tier” base (or bonus) compensation. • If possible, avoid part-time employment, especially in similar • Don’t give full-tie benefits to part-time employees. • If possible, keep compensation below expected professional fees. • Transaction “as a whole” should be commercially reasonable. • United States ex rel. Westmoreland v. Amgen, Inc. • United States ex rel. Jamison v. McKesson Corp., et al. • United States ex rel. Banigan et al. Organon USA, Inc. • (I chose a few of, what I believe, to be the best recent AKB cases – unfortunately I won’t be able to cover all of the relevant cases. 19. AKB v. Implied False Certification Cases based on AKB violations iii. Bundles Discounts (Swapping and pull through) • What were not talking about: Implied certification cases. (The Second, Third, Sixth, Ninth, Tenth, Eleventh and District of Columbia Circuit Courts have all recognized implied certification in some form. We don’t have enough time to cover these cases today but it would make a great CLE in the future. ) • The Anti-Kickback Statute contains and exception for: “a discount or other reduction in price obtained by a provider of services or other entity under [Medicare or Medicaid] if the reduction in price is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity under [Medicare or Medicaid].” • The committee included this provision to ensure normal business transaction discounts would not be deemed illegal. • The committee encourages providers to seek discounts that result in saving to Medicare and Medicaid. H.R. Report No. 95 – 393(II), at 53. • Established separate disclosure obligation for different types of i. Sellers - Manufacturers, that furnish goods and services to ii. Buyers - Providers that buy such goods and services and iii. Offerors - Parties that are essentially middlemen who arrange for discounts between buyers and sellers. • The safe harbor’s obligations are further differentiated depending on iii. Falls under neither of these categories. i. “Supplying one good or service without charge or at a reduced charge to induce the purchase of a different good or service.” ii. Bundled discounts often focus on a direct link or contingency of products A and B being purchased together. 1. Purchases of A, B, and C are aggregated toward a threshold for a volume discount to apply. 2. Must buy multiple products together. 3. Volume purchases of A allow free, discounted or credits 4. Disposables/equipment deals. 5. Lab scam cases – addition of ferritin to chem panel. 6. Free infusion pumps – purchase of enteral nutrition therapy product and related supplies (operation headwaters). 7. Free car (Bay State). 8. Free blood glucose meters – testing supplies. 9. Discounted Part A work to induce services payable a. Ambulance services (Klaczak), and b. Lab testing (often nursing home context). 10. Rebated, special pricing, entertainment and hunting trips, and write-offs of bad debt – ordering lab testing (Shaw). • OIG Position: two problems with bundled discounts a. Situation typically is – free or discounted good b. If a purchased good is paired with a free good, the free good might be one that cannot be measured and fully reported to Medicare. c. Bundled goods might potentially shift cost among reimbursement systems or distort the true cost of all the items. • OIG ‘s Position on Safely Applying the Safe Harbor iv. In certain circumstances where the net value can be properly reported, bundled discounts to not pose a risk of program abuse. v. Example: Where the goods and services are reimbursed by the same Federal health care program in the same manner, such as under a DRG payment. 23. Quiz Question: If you had to choose, would you choose a client who had violated the Stark Statute or the Anti-Kickback Law? Why? 24. United States ex rel. Westmoreland v. Amgen, Inc., 738 F. Supp 2d 267 On December 19, 2012 Amgen Inc. pled guilty to federal charges and will pay $762 Million to Resolve Criminal Liability and False Claims Act Allegations. They entered into a criminal plea, a civil plea, and a corporate integrity agreement. I am going to talk about one of the cases that drove the civil plea and I am going to talk about both the State issues and the Federal issues. 10 different Amgen qui tam cases were brought most of them based on Aranesp overfilling • An “overfill kickback scheme” in which D provided overfill of anemia drug Aranesp in vials to dialysis providers. • Providers did not pay for excess (overfill), but Amgen encouraged them to profit from the overfill by improperly billing Medicare for the “free doses.” • Other alleged kickbacks – free weekend retreats, lavish advisory board meetings, sham honoraria, and consulting fees. • Def. argued overfill is “part and parcel” of the product and cannot be 26. United States ex rel. Westmoreland v. Amgen, Inc., 812 F. Supp. 2d 39 • Claims that needed to be decided under Federal Law: i. Amgen artificially inflated Aranesp’s ASP by failing to include overfill as a “price concession” in violation of FCA; ii. Defendants’ theory that they are shielded from AKS liability by i. Amgen artificially inflated Aranesp’s ASP by failing to include overfill as a “price concession” in its ASP calculations and thus, claims submitted by providers based on this ASP violated the FCA. ii. Discount safe harbor doesn’t apply because the “pass through” of administrative fees paid by Amgen to other Defendants (who used the funds to provide discounts to customers) was illegal and indicate of a conspiracy to defraud Medicare. i. CMS consciously excluded “overfill” as a “price concession” included in the ASP calculation and stated that medical providers cannot seek reimbursement for it. ii. “Overfill” has no independent value apart from the rest of the dosage in the vial and, thus, cannot be illegal remuneration for purposes of the AKS; iii. However, “excess overfill” could constitute illegal remuneration (“excess overfill” above fill volume approved by FDA). Whether overfill in the Aranesp vials actually comported with the FDA-approved level at all times remains a triable issue of fact. i. “The illegality arises where drug manufacturers, like Amgen, and their affiliates . . . encourage health care providers to seek reimbursement for any independent value the overfill may have had but for which they did not pay. The fraud is in asking the government to pay a debt that it does not owe because the debt was never incurred by the provider.” 812 F. Supp. 2d at 69. 30. United States ex rel., Jamison v. McKesson Corp., et al., Civil Action No. • Beverly Enterprises, Inc. owned a chain of over 100 SNFs. • Beverly’s procurement arm CSMS negotiated a 3-year service agreement with MediNet/McKesson for enteral nutrition services contract. • Two separate contract – 2003 & 2006 • Government alleged a “Swapping arrangement” existed in violation of i. Beverly “dangled” the prospect of McKesson Obraining it DME supply business relation to enteral nutrition services with the inducement of MediNet providing Beverly with the lowest possible billing fees. ii. MediNet offered its contract billing services below FMV to induce Beverly to refer the general Medical supply contract. 1. In other words, MediNet paid remuneration to Beverly in the form of below-market billing services, purportedly in exchange for a contract to supply enteral nutrition products to residents of Beverly nursing homes. • (This tactic to get a better price initially seemed to work for Beverly.) • (In 2003 MediNet’s bid started at $75 per mo per resident and resulted in a price of $70 per month per resident.) • (In 2006 MediNet’s best and final bid was $68 but came back at $55 per patient per month to win the 3-year contract) The $75 bid was closer to what FMV was at the time. • 2003 transaction: The court stated that MediNet offered, and Beverly knowingly and willing received, remuneration in return for referrals of Medicare business. • 2006 transaction: The Discount safe harbor does not apply. As defined in the regulation, a “discount” does not include reductions in price “applicable to one payer but not to Medicare, Medicaid, or other Federal health care program” or “services provided in accordance with a personal or management services contract.” • Based on this definition, the Court determined that it would not extend the safe harbor to a purported discount where Medicare does not receive the benefit of the reduction in price offered to Beverly. 34. United States ex rel. Banigan et al. v. Organon USA, Inc., Civil Action No. • Relators filed a qui tam action against Organon, PharMerica and Omnicare, alleging AKS violations against all defendants. • Accused Organon of offering unlawful remuneration in exchange for prescribing specific antidepressants – resulting in submission of millions of dollars of fraudulent claims to Medicaid. • Paid “conversation rebate” for switching prescriptions to Remeron SolTab and a “therapeutic interchange bonus” for making Remeron a “preferred drug” and instituting a therapeutic interchange program that encourage prescription of Remeron over competitor products. • Discount kickbacks: market share rebated and discounts pursuant to written purchasing agreements as “conversation rebates” for switching prescriptions to Remeron. • Collateral kickbacks: research grants, sponsorship of annual meetings, data purchasing agreements, nominal-price transactions and partnership programs. • Relators argued that rebate amounts and discounts were not properly disclosed because contracts did not disclose complete terms and conditions. i. Stated that definition of “discount” in safe harbor is exhaustive and does not embrace collateral kickback or reductions in price that are not passed on to Medicaid. 37. Quiz Question: What year was the original Regulatory Discount Safe • United States ex rel. McDonough v. Symphony Diagnostic Services, • United States ex rel. Hutcheson v. Blackstone Medical, Inc. • United States ex rel. Wilkins v. United health Group, Inc. • Thomas S. Crane, Esq., American Health Lawyers Association Fraud and Compliance Forum: Anti-Kickback and Stark Update (Sept. 30 – Oct. 2, 2012). • Linda A. Bauman et al., Health Care Fraud and Abuse: Practical • Gary W. Herschman & Alexandra Miller Khorover, New Stark Law Guidance: Court of Appeals Decision in the Tuomey Case, Compliance Today, July 2012 at 48.

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