Category: Alert

HHS Office of Civil Rights has proposed changes to HIPAA’s Privacy Rule which would prohibit disclosures to law enforcement related to obtaining or providing abortions.

The current Privacy Rule permits covered entities to disclose Protected Health Information (PHI) about an individual for law enforcement purposes “pursuant to process and as otherwise required by law”, under certain conditions.

The proposed rule would prohibit covered entities from disclosing to law enforcement PHI related to abortions.

Per HHS:

After Dobbs, the Department has heard concerns that civil, criminal, or administrative investigations or proceedings have been instituted or threatened on the basis of reproductive health care that is lawful under the circumstances in which it is provided. The threat that PHI will be obtained and used in such an investigation or proceeding is likely to chill individuals’ willingness to seek lawful treatment or to provide full information to their health care providers when obtaining that treatment.

…

[T]he Department believes it is necessary to provide heightened protections for another especially sensitive category of health information—PHI sought for the purposes of conducting a criminal, civil, or administrative investigation into or proceeding against any person in connection with seeking, obtaining, providing, or facilitating reproductive health care that is lawful under the circumstances in which it is provided. These proposed modifications would provide heightened protections for individuals’ health information privacy under the defined circumstances; foster an open and honest exchange of information between the individual and health care provider, who—with that information—could employ evidence-based clinical practice guidelines; and increase access to high-quality, lawful health care.

Source: HIPAA Privacy Rule to Support Reproductive Health Care Privacy

Arrangements with referring physicians are common in healthcare, but they can be very danagerous if not structured properly. Too often they are used to obfuscate the purpose of payments to physicians.

The Department of Justice for the Eastern District of Michigan announced three civil settlements which serve as good reminders of the types of arrangements that can get providers into trouble:

• The health system had contracts with several physicians to serve as medical directors, and none of these arrangements satisfied any exceptions to the Stark Law or the AKS, such that referrals these physicians made to the health system violated the False Claims Act.
• The health system employed a physician and this financial relationship did not satisfy any exception to the Stark Law, such that referrals for designated healthcare services were prohibited and violated the False Claims Act.
• The health system rented office space to a physician and forgave rent payments, constituting remuneration paid in exchange for referrals from that physician in violation of the AKS and the False Claims Act, and creating a financial relationship that did not meet any exception to the Stark Law, also violating the False Claims Act.
• The health system permitted a group of referring physicians to secure an equipment lease through non-arm’s-length negotiations, in order to induce referrals of patients from these physicians, in violation of the AKS and the False Claims Act.

When discussing the Anti-Kickback Statute (AKS), it’s common to say that “remuneration” can be “anything of value.” That board definition has been called into question by the Sixth Circuit in United States ex rel. Martin v. Hathaway et al., No. 22-1463. In that case, a qui tam relator (physician) alleged that a small-town hospital refused to hire her in exchange for a physician group to continue to send the hospital referrals. The “value” then was the not hiring a physician in exchange for referrals. The AKS does not define “remuneration.”

The Sixth Circuit determined that a careful examination of the meaning of “remuneration” and context shows that this term is limited to “payments and other transfer of value,” not “any act that may be valuable to another.” Thus the act of not hiring the physician is not remuneration.

Further, even if remuneration was present, the court stated that False Claims Act liability “resulting from” an AKS violation requires showing but-for causation. In other words, an FCA plaintiff must show “that the referrals would not have been made without the remuneration, and that the claims would not have been submitted to the government without those referrals.” Here, the qui tam physician was unable to point to any specfic Medicare claims that would not have been submitted as a result of the hospital’s decision not to hire the physician.

OIG has used various avenues to communicate its views on various healthcare compliance issues, such as advisory opinions, contractor self-disclosures, corporate integrity agreements, and exclusions. In March, the OIG has expanded the number of topics it will consider for FAQs submitted by the healthcase stakeholders:

1. general questions regarding the Federal anti-kickback statute and the civil monetary penalty (CMP) provision prohibiting certain remuneration to Medicare and State health care program beneficiaries and OIG’s administrative enforcement authorities in connection with these statutes
2. inquiries regarding the general application of the Federal anti-kickback statute and Beneficiary Inducements CMP to a type of arrangement that may implicate these statutes,
3. questions regarding compliance considerations, and
4. OIG’s Health Care Fraud Self-Disclosure Protocol.

More information at Frequently Asked Questions | Office of Inspector General | U.S. Department of Health and Human Services.