Stark and Safe Harbor Exceptions Published for Comment
On August 1, 2006, the Secretary of HHS announced the final rules for the Federal anti-kickback statute (AKS) and the physician self-referral law (the "Stark Law). The former rules are from CMS and the latter from the Office of the Inspector General.
The following notes are my personal interpretation and should not be construed as legal advice or in any other way authoritative.
The anti-kickback statute defines criminal penalties for individuals or entities that pay or receive remuneration to foster business referrals under federal health care programs. These regulations are similar to many state laws but do not pre-empt these state laws. The definitions were extremely vague and some believe created sufficient concern that entities like hospitals or health plans could not provide legitimate services to enhance the care of individuals out of fear of prosecution under the AKS regulations. Some exceptions have been declared by the OIG, but uncertainty remains. In the current publication, the OIG states: "this final rule creates a separate new safe harbor for certain arrangements involving the provision of non-monetary remuneration in the form of electronic health records software or information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records."
There are two basic types of AKS safe harbor regulations:
Electronic prescribing safe harbor and exceptions:
Electronic health records safe harbor and exceptions
Stark
Compliance with the Stark Law is mandatory. (Compliance with the AKS is voluntary). It refers specifically to referrals by and to physicians. (AKS is much broader and refers to multiple parties).
The following notes are my personal interpretation and should not be construed as legal advice or in any other way authoritative.
- Follow this link to the 33-page PDF document from the August 8 Federal Register
- Follow this link to the 29-page OIG document from the august 8 Federal Register
- Follow this link to the PDF pages requesting comment from the August 9 Federal Register
The anti-kickback statute defines criminal penalties for individuals or entities that pay or receive remuneration to foster business referrals under federal health care programs. These regulations are similar to many state laws but do not pre-empt these state laws. The definitions were extremely vague and some believe created sufficient concern that entities like hospitals or health plans could not provide legitimate services to enhance the care of individuals out of fear of prosecution under the AKS regulations. Some exceptions have been declared by the OIG, but uncertainty remains. In the current publication, the OIG states: "this final rule creates a separate new safe harbor for certain arrangements involving the provision of non-monetary remuneration in the form of electronic health records software or information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records."
There are two basic types of AKS safe harbor regulations:
Electronic prescribing safe harbor and exceptions:
- Authority under the Medicare Modernization act
- Applies to necessary items used only for e-prescribing, including hardware, connectivity, support, training, other services
- In my view, the definition of e-Rx is broad and includes many other data items required for safe and effective e-prescribing - labs, allergies, decision-support; but the e-Rx rule did not include labs and related data but the EHR rule did
- Any amount of such goods and services can be provided 100% by appropriate donors, including hospitals providing services to their medical staffs, prescription drug plans and pharmacies, group practices
- Donors cannot select recipients in ways that directly or indirectly take into account volume or value of services of referrals. From my non-lawyer perspective, this means one can make contributions based on volume of Rx but not on where the Rx re filled.
- Commercial messaging does not appear to be allowed.
- This rule has no sunset date
Electronic health records safe harbor and exceptions
- Authority through the Safe Harbor section of the Social security act - 1128(b)(3)(E) to the OIG and 1887(b)(4) to CMS
- Applies broadly to software used for electronic health records but must include an electronic prescribing component. Includes billing and administrative functions, services, and others.
- Unlike the pure e-Rx safe harbor, hardware and software cannot be contributed
- Systems must meet HHS standards for interoperability as defined by a certification process
- Recipient must pay 15% of the donor's cost for the donation. This cost may not be financed or loaned to the recipient by the donor
- Covers those people and organizations providing covered services, health plans, and related individuals
- Protected recipients are physicians
- Donors cannot make their donations on the basis of recipient behavior that directly is related to volume or value of referrals to the donor or other related business relationships.
- This rule sunsets at the end of 2013.
Stark
Compliance with the Stark Law is mandatory. (Compliance with the AKS is voluntary). It refers specifically to referrals by and to physicians. (AKS is much broader and refers to multiple parties).
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