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Archive for the ‘Clinical Laboratory’ Category

EHR Donation Program Extended Through 2021 – Clinical Laboratory Companies Excluded

Monday, December 30th, 2013

Electronic Health System Donation RulesElectronic Health Record Donation – Final Rules Issued By CMS and OIG

Qualified Donations Extended Through 2021

Clinical Laboratory Companies Excluded As Donors

Just before the current rule was due to expire, the Center for Medicare and Medicaid Services released final regulations on donation of electronic health record donations.  The existing rule, which was set to expire on December 31, 2013, permitted hospitals and other providers of Stark Law “designated health services” to make donations of electronic health records software that meets certain requirements, to physicians and physician groups.  The new final rule was released on December 27, 2013.  A similar rule was released by the Office of Inspector General addressing the Anti-kickback issues presented by donation arrangements.

The final rule adopts most of the changes that were proposed in draft rules that had been previously released in April 2013.  For example, the rule extends the expiration of date of the EHR donation exception from December 31, 2013, to December 31, 2021.  The final rule also removes some of the previous requirements that qualifying software contain electronic prescribing capacity.  The proposed regulations in April raised the possibility of excluding certain types of designated health service providers from qualification to offer EHR donations to physicians.  Comments were solicited on whether providers such as clinical laboratories and durable medical equipment providers should be permitted to offer donations to referring providers.  In the final rules, only clinical laboratory companies are excluded from the ability to offer EHR donations under the exception.

The reversed rule also clarifies some issues regarding restrictions on the use, compatibility, and/or interoperability of donated items.  Since 2006, there has been an exception to the Stark Law protecting certain arrangements involving inter-operable electronic health records software or information technology and training services (the ‘‘Donation Exception”).  The Donation Exception provides an exception from the physician self referral laws for certain arrangements involving inter-operable electronic health records software or information technology and training services.  Absent such an exception, the value of qualifying technology that is donated by a hospital or other provider of “designated health services” would create a compensation arrangement that would trigger a violation of the Stark Law.

 

Anti-kickback Statutes Safe Harbor Regulations

Thursday, December 8th, 2011

Anti-kickback Statutes and Safe Harbor Regulations

Medicare Antikickback Statute Safe HarborsOverview: On the books since 1972, the federal anti-kickback law’s main purpose is to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions. Straightforward but broad, the law states that anyone who knowingly and willfully receives or pays anything of value to influence the referral of federal health care program business, including Medicare and Medicaid, can be held accountable for a felony. Violations of the law are punishable by up to five years in prison, criminal fines up to $25,000, administrative civil money penalties up to $50,000, and exclusion from participation in federal health care programs.

Because the law is broad on its face, concerns arose among health care providers that some relatively innocuous — and in some cases even beneficial — commercial arrangements are prohibited by the anti-kickback law. Responding to these concerns, Congress in 1987 authorized the Department to issue regulations designating specific “safe harbors” for various payment and business practices that, while potentially prohibited by the law, would not be prosecuted.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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