Patient Requested Restrictions: The covered entity must comply with a requested restriction if - (1) the disclosure is to a health plan for purposes of carrying out payment or health care operations (and is not for purposes of carrying out treatment); and (2) the protected health information pertains solely to a health care item or service for which the health care provider involved has been paid out of pocket in full.See Section 164.522 of title 45, Code of Federal Regulations. Accounting for Disclosures of EHR. If the covered entity uses an electronic health record, an individual shall have the right to an accounting of disclosures of PHI for a period of three (3) years, including all disclosures to carry out treatment, payment and health care operations. Currently, it is a 6-year period of accounting excluding any disclosures for T., P. and H.C.O. Copy of EHR. If the covered entity uses an electronic health record, an individual may request a copy of the record in electronic format to be transmitted to a person or entity selected by the individual and the associated charges shall be "labor only"; Use of CMPs for Enforcement. Any civil monetary penalty or settlement collected with respect to an offense for violation of the privacy or security rules is to be transferred to the Office of Civil Rights for use in enforcement.
Audits. The Secretary of HHS shall provide for periodic audits to ensure that covered entities and business associates that are subject to the Privacy and Security Regulations.
Michigan Anti-Referral Laws Apply to Physicians Regardless of Source of Payment; Federal Stark Anti-Referral Rules Applies to Physicians and Chiropractors. What is a “physician”?It is not always so easy to determine.For example, the Michigan Attorney General has determined that, in Michigan, a “chiropractor” is not a “physician and surgeon” for purposes of the Professional Services Corporation Act, see MIAG Opinion No 7151 (March 9, 2004).Therefore, medical doctors and chiropractors cannot legally form a professional corporation under Michigan law.A “physician” for purposes of the provisions of the Public Health Code, section 16221 of the Michigan Public Health Code, MCL 333.16221, which covers unprofessional conduct, such as "payments for referrals" defines “physician” to mean that term as defined in sections 17001 [Medical Doctor] and 17501 [Doctor of Osteopathic Medicine], of the Michigan Public Health Code, and does not include a Chiropractor. Because the Michigan licensing statute incorporates by reference the Stark Anti-Referral rules, a referral by a physician for a designated health service that violates section 1877 of part D of title XVIII of the social security act, 42 USC 1395nn, or a regulation promulgated thereunder, is also a violation of the Michigan statute. The physician who makes such a referral is subject to disciplinary action for such a referral regardless of the source of payment for the designated health service referred and rendered.Ironically, the Social Security Act, 42 USC Sec. 1395x(r), includes a licensed chiropractor among the list of defined "physicians" which are covered by the Subchapter XVIII, which in subchapter includes, among its provisions, the prohibition of certain referrals by a physician, 42 USC § 1395nn.Therefore, Stark anti-referral rules apply to chiropractors and medical doctors and doctors of osteopathy.This definitional exercise has become more important to Chiropractors since the adoption of the new designated health services definitions which now include “(D)Radiology services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services.”
Dismissal of former employee’s Qui Tam claimupheld by the U.S. Court of Appeals for the Sixth Circuit.
See US/Poteet v. Medtronics, Inc., Docket No.07-5262 (January 14, 2009).
In this qui tam action, the Relator, Jacqueline Kay Poteet (“Poteet”), was a former Senior Manager for Travel Services for Medtronic Sofamor Danek USA, Inc. (“MSD”), a subsidiary of Medtronic, Inc.Medtronic, Inc. (“Medtronic”), is a medical technology firm which manufactures and distributes various types of medical equipment and supplies.MSD is a manufacturer and seller of spinal implants and other surgical devices. Both Medtronic and MSD market their products to healthcare providers throughout the United States.
MSD paid large amounts of money to physicians and provided them with lavish travel and recreational opportunities—“upgraded lodging for physicians, dinners, entertainment and activities such as golf, snorkeling, sailing, fishing, shopping trips, horse-back riding, hiking,” etc.—in connection with sham consulting contracts and royalty agreements.In return, the defendant physicians and hospitals purportedly purchased MSD products for use in their patients’ surgeries.
Thereafter, according to Poteet, the individual defendants, or their employers, “actually submitted false claims for reimbursement for such devices for which payment was made in whole or in part under a federal healthcare program.”Poteet contended that these actions violated both the FCA and the Anti-Kickback statute., appealed the district court’s dismissal of her complaint, brought pursuant to the False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq. (2000), as jurisdictionally barred by the statute’s public disclosure provision, 31 U.S.C. § 3730(e)(4)(A), and first-to-file provision, 31 U.S.C. § 3730(a)(5).
On July 18, 2006, after completing its investigation into Poteet’s allegations, the government filed a motion to dismiss Poteet’s complaint, arguing that it was barred by the first-to-file provision and the public disclosure provision of the FCA. In this motion, the government also informed the district court that it recently had entered into a settlement agreement with Medtronic and MSD (the “Settlement Agreement”), under which those firms would pay $40 million to settle claims alleging that they had, between 1998 and 2003, paid illegal kickbacks to physicians to induce them to use certain MSD spinal products.Under the terms of the Settlement Agreement, dismissal of the Poteet and another qui tam suit (filed by “John Doe”, a former Medtronic attorney) was a condition of the settlement. In response, Poteet also attempted to obtain discovery regarding the settlement terms and her role in them.
On January 23, 2007, the district court granted the government’s motion to dismiss Poteet’s complaint. The district court found that Poteet’s complaint was jurisdictionally barred by the first-to-file rule as well as the public disclosure rule, and dismissed the case.
The Sixth Circuit Court of Appeals found that the Wiese wrongful discharge complaint against Medtronics was sufficient to qualify as a public disclosure of fraud and barred Poteet’s qui tam complaint. As a filing in a California civil action, the Wiese complaint clearly was a “public” disclosure.See, e.g., McKenzie, 123 F.3d at 939; Bledsoe I, 342 F.3d at 645 (“There is little doubt that [a] complaint, filed in Tennessee state court, qualifies as a public disclosure.”). Moreover, the allegations contained in the Wiese complaint were sufficient to put to the government on notice of potential fraud by MSD and its physician customers.
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