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FIVE COMPLIANCE ISSUES FOR PHARMACISTS TO THINK ABOUT-2013

FIVE COMPLIANCE ISSUES FOR PHARMACISTS TO THINK ABOUT-2013. PSSNY PROGRAM 9/11/2013 Jim Sheehan Chief Integrity Officer, Executive Deputy Commissioner New York City HRA sheehanj@hra.nyc.gov. HRA EFFORTS ON PRESCRIPTION DRUGS. PDF (Prescription Drug Fraud) Task Force

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FIVE COMPLIANCE ISSUES FOR PHARMACISTS TO THINK ABOUT-2013

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  1. FIVE COMPLIANCE ISSUES FOR PHARMACISTS TO THINK ABOUT-2013 PSSNY PROGRAM 9/11/2013 Jim Sheehan Chief Integrity Officer, Executive Deputy Commissioner New York City HRA sheehanj@hra.nyc.gov

  2. HRA EFFORTS ON PRESCRIPTION DRUGS • PDF (Prescription Drug Fraud) Task Force • Partners with County DA offices, Special Narcotics Prosecutor, Bureau of Narcotics Enforcement, NY AG, HHS/OIG • undercover investigations • Work with pharmacists

  3. HRA EFFORTS ON PRESCRIPTION DRUGS • Participant in NYC Oxycontin Task Force • Limitation in HHC ERs to three day supply of oxycontin, vicodin, other narcotic painkillers • No ER refills for lost or stolen scripts • Developing data on prescription drug abuse-estimated 40,000 addicted New Yorkers • RXStat-developing data on prescriptions and overdoses-focus on patients, physicians, pharmacies • Announcement January 10, 2013

  4. HRA AND LAW ENFORCEMENT PARTNERS IN PHARMACY FRAUD CASES • AleksandrIlayev, owner of the V & A Pharmacy in Williamsburg was charged with fraudulently billing Medicaid for HIV medications for customers he lured with payoffs of cash and MetroCards in exchange for their prescriptions, by Brooklyn District Attorney Charles Hynes Read more: http://www.nydailynews.com/news/crime/bklyn-pharmacy-nabbed-medicaid-scam-article-1.1440933#ixzz2eKd6VjWh (August 29, 2013)

  5. CASES FROM HRA AND LAW ENFORCEMENT PARTNERS • Sanjay Patel, Bronx pharmacist, sentenced to prison, ordered to repay $7.7 million in Medicaid fraud rap-billing for prescriptions never received. • In all, seven Bronx pharmacies were used in the scam, including Citi Care Pharmacy, 161st StreetRead more: http://www.nydailynews.com/new-york/bronx/bronx-pharmacist-sentenced-medicaid-fraud-rap-article-1.1420443#ixzz2eKePaKFg (August 7, 2013)

  6. ISSUE 1:I-STOP-effective August 27, 2013 • Internet System for Tracking Over-Prescribing (I-STOP), • real-time prescription drug database. It will enable the state to track the prescribing and dispensing of drugs. • requires physicians to review a patient’s prescription history before writing controlled substabnce prescriptions • requires pharmacists to report when prescriptions are dispensed. I-STOP requires pharmacists to file prescription information “by electronic means on a real time basis”

  7. ISSUE 2-EXCLUDED PERSONS • New HHS/OIG “Special Advisory Bulletin on excluded persons” (May 9, 2013) • Payments to excluded persons at any level now must go back to CMS Medicaid (I think) • The easy qui tam?-match the exclusion list with the MCO provider list • List of Excluded Individuals and entities(LEIE) on the OIG Web site http://oig.hhs.gov/exclusions • OMIG state Medicaid exclusion list

  8. EXCLUSIONS • Prohibited Services: • (1) by an excluded person or • (2) at the medical direction or on the prescription of an excluded person • Employment • Contracting • Ordering • No case law-all interpretation • Excluded person ordering or providing services top reason for self-disclosures to OIG/HHS

  9. SERVICES BY EXCLUDED PERSONS • “The prohibition on Federal health care program payment for items or services furnished by an excluded individual includes items and services beyond direct patient care.” • For instance, the prohibition applies to services performed by excluded individuals . . . when such services are related to, for example, preparation of surgical trays or review of treatment plans, regardless of whether such services are separately billable or are included in a bundled payment. “One . . . example is services performed by excluded pharmacists or other excluded individuals who input prescription information for pharmacy billing or who are involved in any way in filling prescriptions for drugs that are billed to a Federal health care program.” • From “Special Advisory Bulletin on Excluded Services” (OIG 2013)

  10. ORDER OR PRESCRIPTION BY EXCLUDED PERSON • Many providers that furnish items and services on the basis of orders or prescriptions, such as laboratories, imaging centers, durable medical equipment suppliers, and pharmacies, have asked whether they could be subject to liability if they furnish items or services to a Federal program beneficiary on the basis of an order or a prescription that was written by an excluded physician. Payment for such items or services is prohibited.10 To avoid liability, providers should ensure, at the point of service, that the ordering or prescribing physician is not excluded.11 • From “Special Advisory Bulletin on Excluded Services” (OIG 2013)

  11. EXCLUSION – SNEAKY FOOTNOTES • 10 “Some excluded practitioners will have valid licenses or Drug Enforcement Agency (DEA) numbers. Therefore, it is important not to assume that because a prescription contains a valid license number or DEA number, the practitioner is not excluded.” • 11 “In some cases, pharmacies and laboratories rely on Medicare Part D plans and/or State agencies to ensure that prescribers are not excluded through, for example, computer system edits. These alternative screening mechanisms may effectively identify excluded individuals and prevent the pharmacies or laboratories from submitting claims for services ordered or prescribed by excluded individuals. However, pharmacies and laboratories that rely on a third party to determine whether prescribers are excluded should be aware that they may be responsible for overpayments and CMPs relating to items or services that have been ordered or prescribed by excluded individuals. “ • From “Special Advisory Bulletin on Excluded Services” (OIG 2013)

  12. EMPLOYMENT OF EXCLUDED PERSON-CIVIL MONETARY PENALTIES • After it self-disclosed conduct to the OIG, Community General Hospital (CGH), NY, agreed to pay $248,362.78 for allegedly violating the Civil Monetary Penalties Law. The OIG alleged that CGH employed an individual that it knew or should have known was excluded from participation in Federal health care programs.

  13. HOW OFTEN SHOULD YOU CHECK THE EXCLUSION LIST • “OIG updates the LEIE monthly, so screening employees and contractors each month best minimizes potential overpayment and CMP liability. Additionally, in January 2009, CMS issued a State Medicaid Director Letter (SMDL) recommending that States require providers to screen all employees and contractors monthly.26 In 2011, CMS issued final regulations mandating States to screen all enrolled providers monthly. “ • From “Special Advisory Bulletin on Excluded Services” (OIG 2013)

  14. ISSUE 3 – CURRENT CASES AND THEORIES • Walgreens had offered government health beneficiaries $25 gift cards when they transferred a prescription from another pharmacy to Walgreens.  • Walgreens employees frequently ignored the stated exemptions on the face of the coupons and handed gift cards to customers who were beneficiaries of government health programs, in violation of federal law. • $7.9 million settlement 2012

  15. U.S. ex rel. Denk v. PharMerica Corporation, Case No. 09-cv-720. • “The government’s complaint alleges that PharMerica routinely dispensed Schedule II controlled drugs in non-emergency situations without first obtaining a written prescription from a treating physician. According to the complaint, PharMerica’s actions violated both the spirit and the letter of the Controlled Substances Act by enabling nursing home staff to order narcotics, and pharmacists to dispense narcotics, before confirming that a physician had made a medical judgment about whether these narcotics were necessary and should be used by the resident.” • DOJ release August 9, 2013

  16. U.S. ex rel. Doe v. RxAmerica, U.S. ex rel. Hauser v. CVS Caremark Corp. and RxAmerica • The United States alleged that RxAmerica (CVS subsidiary) made false submissions to CMS regarding prices for certain generic prescription drugs used for Plan Finder, despite certifying to CMS that it would submit accurate Part D pricing data for Plan Finder. • October 2012 settlement by Brooklyn US Attorney-$5 million

  17. ISSUE 4: KEEPING MONEY YOU ARE REQUIRED TO REFUND Wellcare Reporting Violations (2011 $137.5 million False Claims/ qui tam settlement) The Government’s Contentions: • “Knowingly concealed its contractual obligation to pay . . . monies back. . . .” • “[C]oncealed and retained overpayments received from state Medicaid programs in violation of its contractual obligations to pay monies back to the state Medicaid programs” • “[F]iling false and misleading fraud prevention plans” • Applies 6402 (report, refund, return) in managed care context

  18. Issue 4- FERA Overpayment Provision Congressman Berman: “Liability for all non-disclosed overpayments of the same type also should be imposed once an organization or other person is on notice that it has been employing a practice that has led to multiple instances of overpayment. For example, if a corporation learns after-the-fact that it has been violating a billing rule or a contract requirement in its billing, and it nonetheless fails to comply with a legal obligation to disclose the resulting overpayments, this amendment renders the corporation liable under the Act for all overpayments resulting from the violation of the billing rule or contract requirement, even those not specifically identified or quantified.” 155 Congressional Record E1295 (Monday, May 18, 2009) (emphasis added).

  19. FERA OVERPAYMENT PROVISION • Report, Refund, Explain Overpayments • THE AFFORDABLE CARE ACT OF 2010 (ACA) Section 6402 • MANDATORY REPORTING, REPAYMENT, AND EXPLANATION OF OVERPAYMENTS BY “PERSONS”

  20. AFFORDABLE CARE ACT PROGRAM INTEGRITY PROVISIONS “Payments made by, through, or in connection with an Exchange are subject to the False Claims Act (31 U.S.C. 3729 et seq.)” ACA Section 1313 What does this mean? No comment from CMS, no payments for insurance until 1/1/2014 Waiting for case law development, but expect argument that any claim to any health plan for patients whose coverage is obtained through the exchange are subject to FCA Use by insurors as well as whistleblowers

  21. ISSUE 5: CERTIFICATIONS • Not just the ones you sign • Applies to data you submit to plans, and contractors • Applies to contract compliance on DUR and edits

  22. ISSUE 5: Certifications Medicare Advantage Annual Attestation • MA organization must certify that risk adjustment data is accurate, complete and truthful (based on best knowledge, information, and belief). (42 C.F.R. § 422.504(l)) New York • New York State Model Managed Care Contract: • “Covered services provided by the Contractor under this Contract shall comply with all standards of the New York State Medicaid Plan established pursuant to Section 363-a of the State Social Services Law and satisfy all other applicable requirements of State Social Services and Public Health Law” • False Claims Act-liability for “causing submission of a false claim”

  23. United States of America, ex rel. Anthony R. Spay v. CVS Caremark Corp. (E.D. Pa. December 20,2012) • “[A]s a condition for receiving payment, a Part D sponsor must certify the accuracy, completeness, and truthfulness of all data, including claims data, related to the requested payment from the government. When that claims data is generated by a subcontractor of a Part D Sponsor, such as a PBM, the subcontractor must similarly certify, as a condition of payment, the truthfulness, accuracy, and completeness of the data.”

  24. United States of America, ex rel. Anthony R. Spay v. CVS Caremark Corp. (E.D. Pa. December 20,2012) • “This interpretation (i.e., that the data certification is a condition of payment) finds support in CMS's Prescription Drug Benefit Manual. Section 80.1, entitled ‘The False Claims Act,’ specifically references section 423.505(k)(3) and provides as follows: • Sponsors should devise their compliance programs so that their policies and procedures are consistent with the Federal Civil False Claims Act . . . When submitting claims data to CMS for payment, Sponsors and their subcontractors must certify that the claims data is true and accurate to the best of their knowledge and belief [footnote referencing section 423.505(k)(3)]. The False Claims Act is enforced against any individual/entity that knowingly submits (or causes another individual/entity to submit) a false claim for payment to the Federal government.

  25. Spay: Claims Data Accuracy is a Condition of Payment Based on the Prescription Drug Manual • “The plain import of this language suggests that 42 CFR 423.505(k)(3) was designed precisely to make a subcontractor's certification of the truthfulness, accuracy, and completeness of claims data a condition of payment. Further, it indicates that false certification by a subcontractor of this information, which ‘causes’ the Part D Sponsor to submit a false claim for payment to the government, is grounds for an FCA claim.”

  26. THANK YOU • New laws • New theories • New relationships • Support for patient and program protection

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