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Recruiting Physicians: Beware Stark, Anti-Kickback Statutes, and IRS Rules
/in Fraud and Abuseby Kim C. Stanger, Holland & Hart LLP
Hospitals and other entities that offer incentives to recruit physicians must ensure their arrangements comply with federal and state laws governing financial relationships with physicians, including the the Ethics in Patient Referrals Act (“Stark”), Anti-Kickback Statute (“AKS”), and the IRS’s 501(c)(3) requirements. Recruitment arrangements usually need to fit within one of the following safe harbors:
1. Employment Arrangements. If you are going to hire the physician as an employee and pay him or her no more than fair market value, you can structure the deal to fit within Stark’s bona fide employment safe harbor, which requires the following:
(42 CFR 411.357(c)). Under the employment safe harbor, you are not required to have a written agreement or establish the compensation formula in advance, but it is generally a good idea to do so to avoid misunderstandings. Complying with the foregoing Stark parameters should also satisfy the AKS and 501(c)(3) rules. (See 42 CFR 1001.952(i); IRS Healthcare Provider Reference Guide, 2004 EO CPE Text at p.18). If you need to pay more than fair market value or provide additional incentives to recruit the physician, you will likely need to structure the deal to satisfy the Stark recruitment safe harbor described below. Read more
Appellate Court Affirms $237 Million Award Against Hospital for Stark Law Violations
/in Fraud and Abuseby Teresa Locke, Holland & Hart LLP
The Fourth Circuit Court of Appeals recently issued an alarming decision affirming a $237 million judgment against Tuomey Healthcare Systems, a nonprofit hospital located in a small, largely rural South Carolina community that is a federally-designated medically underserved area. The judgment resulted from a jury’s finding that Tuomey submitted 21,730 false claims to Medicare for reimbursement knowing that the claims were generated through part-time physician employment contracts that violated the referral constraints found in the Stark Law. The decision clarifies that hospital “facility fees” associated with outpatient procedures performed by physicians constitute “referrals” under the Stark Law even when the “referring” physician is personally performing the outpatient procedure. The false claims themselves had a total value of $39 million, but with automatic treble damages and civil penalties in the minimum amount for each violation, the resulting judgment was for $237 million. Despite its affirmance of the judgment, the Fourth Circuit panel recognized “the troubling picture this case paints: An impenetrably complex set of laws and regulations that will result in a likely death sentence for a community hospital in an already medically underserved area.” U.S. ex rel. Drakeford v. Tuomey.
The part-time employment contracts at issue in Tuomey allowed the physicians to maintain their private practices, but required them to perform all outpatient surgical procedures exclusively at the hospital. The contracts had multiple compensation components, two of which proved problematic under Stark. First, each physician was paid an annual guaranteed base salary which was adjusted from year to year based on the amount the physician collected from all services rendered the previous year. Second, the bulk of the physicians’ compensation was earned in the form of a productivity bonus, which paid the physicians 80% of the amount of their collections for that year. Read more
HIPAA, E-mails, and Texts to Patients or Others
/in HIPAAby Kim C. Stanger, Holland & Hart LLP
The HIPAA Privacy and Security Rules require covered entities (including healthcare providers and health plans) and their business associates to implement certain safeguards when e-mailing or texting electronic protected health information (“e-PHI”) to patients or others.
E-mails and Texts to Patients. The HIPAA Privacy Rule not only allows but requires covered entities to communicate with patients via e-mail or text if requested by the patient. (See 45 CFR 164.522(b)). However, the Privacy Rule requires covered entities to implement appropriate safeguards when e-mailing or texting e-PHI to patients. The Office for Civil Rights (“OCR”) explained:
The Privacy Rule allows covered health care providers to communicate electronically, such as through e-mail, with their patients, provided they apply reasonable safeguards when doing so. (See 45 CFR 164.530(c)). For example, certain precautions may need to be taken when using e-mail to avoid unintentional disclosures, such as checking the e-mail address for accuracy before sending, or sending an e-mail alert to the patient for address confirmation prior to sending the message. Further, while the Privacy Rule does not prohibit the use of unencrypted e-mail for treatment-related communications between health care providers and patients, other safeguards should be applied to reasonably protect privacy, such as limiting the amount or type of information disclosed through the unencrypted e-mail. In addition, covered entities will want to ensure that any transmission of electronic protected health information is in compliance with the HIPAA Security Rule requirements at 45 CFR Part 164, Subpart C.
(OCR FAQ dated 12/15/08, available at http://www.hhs.gov/ocr/privacy/hipaa/faq/health_information_technology/570.html). Read more
Idaho Passes Direct Primary Care Act
/in Physician Practicesby Melissa Starry, Holland & Hart LLP
Direct Primary Care (“DPC”) is increasing in popularity in the United States as an alternative payment model for primary care medical services. Instead of fee-for-service insurance billing, typically a DPC medical provider enters into an agreement with its patients and charges its patients a monthly, quarterly, or annual fee that covers all or most primary care services. Given the fact that a DPC medical provider takes on a certain amount of risk in agreeing to provide primary care services to patients for a fixed amount (regardless of how often a patient is seen by the provider), there were concerns that such an arrangement could be interpreted under Idaho law as the provision of insurance. With the passage of the Idaho Direct Medical Care Act1 (the “Act”), and subsequent signing by Governor Butch Otter, Idaho is now the ninth state in the country to pass legislation to ensure that DPC medical providers are not treated as insurance products by state regulators. Read more
New OIG Guidance Emphasizes Health Care Compliance Oversight for Boards
/in Fraud and Abuseby Ellen Bonner, Holland & Hart LLP
In late April, the Office of Inspector General, U.S. Department of Health and Human Services (“OIG HHS”) issued Practical Guidance for Health Care Governing Boards on Compliance Oversight (“Compliance Guidance”)1. The Compliance Guidance assists health care organization boards (“Boards”) with compliance plan oversight obligations. Highlighted below are a few of the Compliance Guidance’s numerous practical tips for proactive compliance oversight and review of health care organizations.
As a starting point for compliance assessment, the Compliance Guidance recommends the following publically available compliance resources:
With a nod towards the “ever-changing regulatory landscape and operating environment,” the Compliance Guidance promotes the development of formal plans, including periodic updates from informed staff, to stay current with the changes in regulations and operating environments that impact the organization and its Compliance Program. The following four areas are emphasized in the Compliance Guidance: Read more