Self-Referral Rules Unveiled
[Staff Reporters]
The Centers for Medicare and Medicaid Services [CMS] recently reported changes to the Stark self-referral ban that could have a significant effect on physician-hospital relationships and Physician-Hospital-Organizations [PHOs].
Final IPPS Regulations
The new changes appeared in the final Inpatient Prospective Payment System [IPPS] regulation unveiled on July 31, and due for publication in the August 19th 2008 Federal Register [FR].
“Standing-in-the-Shoes” and other Issues
The healthcare industry will soon have to navigate new Stark rules on issues like percentage-based compensation, per-click arrangements and other “stand-in-the-shoes” legal analysis. And, it’s time to sunset “under-arrangements” with physicians because CMS finalized its revised definition of entities that provide Designated Health Services (DHS) under Stark.
But, CMS also cleared a path for returning to Stark compliance over unsigned physician contracts, and clarified how providers can end the “period of disallowance,” when a Stark violation renders Medicare claims un-payable.
Assessment
According to the Report on Medicare Compliance [8/11/08], the Stark self-referral law bans Medicare payments to entities providing DHS if patients were referred by physicians with an ownership, investment or compensation relationship with the DHS entity.
Conclusion
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Filed under: "Doctors Only", Career Development, Health Law & Policy | Tagged: Stark laws |















Stark Follow-Up
Did you know that the Medical Group Management Association [MGMA] is seeking to simplify the Stark Regulations [Rep Pete Stark D-California]?
The Group, recently asked CMS to examine the rules, saying they are too difficult to understand and execute. In fact, MGMA President William F. Jesse; MD is reported to have said, “The goal of this review should be administrative simplification.”
Can anyone shed some more insight on this rule review request?
-Ann
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New Disclosure Requirements for Imaging Services under the Stark
In-Office Ancillary Services Exception
Ann and all ME-P Readers and Subscribers,
Here are some of the key provisions in the Patient Protection and Affordable Care Act, as modified by the Health Care and Education Reconciliation Act of 2010 (collectively, the “Health Care Reform Act”). This post summarizes the new disclosure requirements for medical providers utilizing the “In-Office Ancillary Services” exception (the “IOAS Exception”) to the federal Stark law to provide certain imaging services to their patients.
• The federal Stark law generally prohibits a physician from making referrals to their own practice for the furnishing of certain designated health services (“DHS”) reimbursable by Medicare, unless an applicable exception to the law is satisfied. Generally, the IOAS Exception, if met, permits physicians to make referrals of certain DHS (including, among others, certain imaging services) within the referring physician’s own practice.
• The Health Care Reform Act requires providers utilizing the IOAS Exception for the provision of certain imaging services to provide patients with written notification, at the time of the referral, that the patient may obtain the services from someone other than the referring physician or the referring physician’s group practice. Specifically, the written notice must provide the patient with a written list of other suppliers who furnish services in the applicable service area. Currently the list of covered services includes magnetic resonance imaging (“MRI”), computed tomography (“CT”) and positron emission tomography (“PET”). This list is subject to expansion by the Centers for Medicare and Medicaid Services (“CMS”).
• While the Health Care Reform Act was signed into law on March 23, 2010, this notification requirement purports to be retroactive to January 1, 2010 and therefore applies to services furnished on or after January 1, 2010. While there is some question as to whether disclosure is required right now or after CMS issues regulations, many recommend compliance at this time as to MRIs, CTs and PET. Others expect that CMS will be issuing regulations incorporating this new requirement and addressing whether any additional requirements apply or whether additional DHS will be subject to this disclosure requirement.
Stuart
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Stark Rule and CMS Regulations
More on the Stark Rural and Whole Hospital Exceptions:
Click to access ppaca.pdf
Source: Health Capital Consultants, LLC
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Stark III Defined
Stark III became effective December 4, 2007 and implements changes and clarifications to Stark II.
The Stark laws in general regulate the referral practices of a physician and were first formed under the “Ethics in Patient Referral Act” in 1992 and became known as “Stark I” after Representative Pete Stark of California. The general provisions of Stark allow that a physician may be compensated and given direct credit for services they personally perform that are “incident to” services. In other words, services that are incidental but an integral part of the physician’s services. Stark III still allows “incident to” services such as drugs, vaccines, revenues from both the nonphysician services and the drugs themselves, and even services provided by nurse practitioners, physician assistants and physical therapists can be billed using incident-to rules and those revenues may also be allocated directly to the treating physician.
One of the biggest changes in Stark III is that the revenues generated from diagnostic testing may not be considered “incident to” the physician service. This is an important distinction as revenues from such procedures as clinical labs, imaging tests (MRI’s, CTs, PETs and ultrasounds) must now float up into a profit distribution pool for the groups and not be credited to the ordering/treating physician.
Another change in Stark III is a further refinement of the definition of “designated health services” (DHS). Under Stark II, the statue prohibits a physician from referring a Medicare patient to any entity which the physician has a financial relationship with when the referral is for a list of items defined under DHS. Under Stark III, evaluation and management services performed by a nurse practitioner, PA and clinical nurse specialist are not DHS. So even if the service is not incident to another physicians’ services, those revenues may be allocated to treating physician because they are not DHS.
Also now allowed under Stark III are Intra-family referrals if there is no alternative provider within 45 minutes of the patient. Stark II allowed for “25 miles” of the patient. In rural communities that can be a big difference for a referring physician.
These are just a few of the key changes in Stark III. Of course, the rules surrounding Stark III, as with the prior provisions of Stark, are quite complicated. Violations are punishable by a $15,000 civil penalty for each infraction, with circumvention schemes punishable by a $100,000 civil penalty.
References:
1. Gosfield, Alice G. “Stark III: Refinement not Revolution” Family Practice Management 15.3 (2008): 25-28. Web. 23 Apr. 2012.
2. “Regulatory Compliance.” American Academy of Family Physicians online. Web. 23 Apr. 2012.
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David
A cogent and currently referenced explanation.
Many thanks.
Hope
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Self-Referral Boosts Medicare Imaging Costs: GAO
It’s estimated that in 2010, providers who self-referred patients for advanced imaging made about 400,000 more referrals than they would have had they not had a financial interest in the imaging equipment and that these referrals cost the Medicare system an additional $109 million, according to a new Government Accountability Office report.
In 2010, some 6.8 million magnetic resonance imaging and computed tomography services for Medicare beneficiaries were conducted in a physician office or independent diagnostic testing facility, according to the report, and this accounted for about 23% of all such services delivered to Medicare fee-for-service beneficiaries. The GAO studied Medicare Part B claims for MRI and CT services from noninstitutional providers from 2004 through 2010 and used taxpayer identification numbers to determine whether there was a financial relationship with the provider who performed the MRI or CT service. It also identified a group of providers who began to self refer in 2009.
Source: Andis Robeznieks, Modern Healthcare [10/31/12]
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CMS Sends Message That Stark Liability Is Limited to 4 Years With Self-Disclosure
“Stark liability does not exist forever. If you are outside the four-year reopening period, you probably have no liability to CMS,” says Bob Wade, who is with Krieg DeVault in Mishawaka, IN. Wade got the good news when CMS responded to several of his hospital-clients’ applications to the self-referral disclosure protocol (SRDP). CMS turned them down, but only because the hospitals didn’t have liability under the Stark law because the claims were deemed too old.
In letters to Wade, CMS explained that it “uses the time frame established under the re-opening regulations at 42 C.F.R. 405.980(b) as a guide to determine the time frame of the SRDP. As such, the time frame of the SRDP is limited to four years from the date that the disclosing party submits the disclosure to the SRDP, unless reliable evidence of fraud or similar fault exists….Because all of the non-compliance disclosed by [reporting entity] occurred outside of the four-year time frame under the SRDP, CMS is removing [reporting entity] from the SRDP.”
Nina Youngstrom
Report on Medicare Compliance [12/15/14]
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