Today, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General of the Department of Health and Human Services (OIG) published proposed regulations for the creation of additional exceptions to the Stark prohibitions against physician self referrals and safe harbors under the federal anti-kickback statute. The goal of the proposals, if published in final form, is to further the adoption of e-prescribing and interoperable electronic health record (EHR) systems. The exceptions and safe harbors are designed to enable hospitals, group practices, and prescription drug plan sponsors and Medicare advantage organizations to provide certain technology and other non-monetary remuneration to their medical staffs, physicians members and physicians, respectively, in furtherance of this goal.
The publications actually propose regulations to provide Stark law exceptions for permitted remuneration for e-prescribing and EHR systems and an anti-kickback safe harbor for permitted remuneration for e-prescribing. However, the OIG states that it has insufficient information to propose regulations concerning an anti-kickback safe harbor in connection with remuneration for EHR systems and solicits public comments on the features it is considering including in a future proposed EHR safe harbor.
While the proposed regulations describe the permitted donors, recipients and remuneration as well as the agencies’ intent to establish safeguards against abuse, the proposals amount to a broad request for information and ideas concerning how best to structure exceptions and safe harbors for e-prescribing and EHRs. The proposals contain more than 55 requests for comments concerning the best way to permit the donation of hardware, software and other services related to e-prescribing and EHRs. This presents a real opportunity for health care providers to influence the structure of the final regulations.
Following is a chart that summarizes the proposed exceptions and safe harbors.
|
Basic Features |
E-Prescribing |
Pre-Interoperability EHR |
Post-Interoperability EHR |
|
Authority |
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 101 |
Social Security Act, §§ 1128(b)(3)(E) and 1877(b)(4) |
Social Security Act, § 1128(b)(3)(E) and 1877(b)(4) |
|
Covered Technology |
Items and services that are necessary and used solely to transmit and receive electronic drug information Includes hardware, software, internet connectivity, and training and support services |
Software used solely for the transmission, receipt or maintenance of EHRs Directly related training services Software must include an e-prescribing component |
EHR software certified by Secretary of DHHS Directly related training services Software must include e-prescribing component Could include billing and scheduling software, provided the core function of the software is EHRs |
|
Standards with which Donated Technology Must Comply |
Foundation standards for e-prescribing as adopted by the Secretary of DHHS |
E-prescribing component must comply with foundation standards for |
Product certification criteria adopted by the Secretary of DHHS E-prescribing component must comply with foundation standards for e-prescribing as adopted by the Secretary of DHHS (to the extent these standards are not fully incorporated into the product certification criteria) |
|
Permissible Donors |
Both the Stark Exception and the Safe Harbor Hospitals—to members of their medical staffs Group practices—to physician members Stark Exception PDP sponsors and Medicare advantage organizations—to physicians Anti-Kickback Safe Harbor PDP sponsors and Medicare advantage organizations—to network pharmacies and prescribing health care professionals |
Both the Stark Exception and the Safe Harbor Hospitals—to member of their medical staffs Group practices—to physician members Stark Exception PDP sponsors and Medicare advantage organizations—to physicians Anti-Kickback Safe Harbor PDP sponsors and Medicare advantage organizations—to network pharmacies and prescribing health care professionals |
Both the Stark Exception and the Safe Harbor Hospitals—to member of their medical staffs Group practices—to physician members Stark Exception PDP sponsors and Medicare advantage organizations—to physicians Anti-Kickback Safe Harbor PDP sponsors and Medicare advantage organizations—to network pharmacies and prescribing health care professionals |
|
Selection of Recipients |
Donors may not take into account the volume or value of referrals from the recipient or other business between the parties |
Donors may not take into account the volume or value of referrals from the recipient or other business between the parties |
Donors may use criteria to select recipients that are not directly related to the volume or value of referrals or other business between the parties |
|
Value of Protected Technology |
Cap proposed but no specific dollar amount stated |
Cap proposed but no specific dollar amount stated |
Cap proposed but no specific dollar amount stated May be greater than cap on pre-interoperability donations |
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