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Articles Posted in Stark and Anti-Kickback

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The U.S. Senate Committee on Finance released a whitepaper, which addresses proposed reforms of the Stark law (which prohibits physicians from referring Medicare beneficiaries to an entity in which they have a financial relationship for designated health services).

The whitepaper asserts that support for reform of the Stark Law has grown tremendously in recent years, especially since the enactment of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which addresses alternative payment models, in accordance with which the Stark law needs to be reformed. The Committee notes that, while the goals and effects of the Stark law were appropriate when it was initially implemented, the “huge penalties, and the breadth, complexity, and ambiguities of the Stark law” currently create a “minefield” for the healthcare industry. The spectrum of changes to the Stark law proposed in the whitepaper range from an expansion of its exceptions to the law’s repeal.

If enacted, such changes could have revolutionize the compliance efforts of healthcare agencies. Senator Orrin Hatch stated that the Committee will attempt to take action before next year.

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On July 28th, 2016, the Department of Justice released a report stating that the Lexington County Health Services District will pay $17 million for violations of the Physician Self-Referral Law (the Stark Law) and the False Claims Act.

The Department alleged that Lexington Medical Center (“LMC”) violated the Stark Law (which prohibits physicians from referring Medicare beneficiaries to an entity in which the physicians have a financial relationship for designated health services) by providing financial incentives to  28 physicians in exchange for referrals. The physicians were purportedly provided compensation in excess of fair market value, with the volume or value of referrals taken into account. The False Claims Act (which, in pertinent part, imposes penalties on healthcare providers for submitting false claims to a government program) lawsuit was filed by whistleblower Dr. David Hammett, a former employee who claims he was fired for not providing enough referrals to LMC.

This False Claims Act case is one of many since 2009, through which the government has, in total, recovered more than $18.3 billion from healthcare agencies. The countless violations of the Stark Law alleged by the government in recent years have called into question the complexity and breadth of the law.

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New rules published on June 30th, 2016 in the Federal Register could dramatically change the regulatory enforcement landscape for healthcare providers, with fraud penalties nearly doubling under the False Claims Act and the Anti-Kickback Act.

The False Claims Act (which in pertinent part imposes penalties on healthcare providers for submitting false claims to a government program) has had a penalty range of $5,500 to $11,000 per claim since 1996, but such penalties will increase to a range of $10,781 to $21,563 per claim. Penalties for violations of the Anti-Kickback Act (which prohibits physicians from referring Medicare beneficiaries to an entity in which they have a financial relationship for designated health services) will correlatively be substantially enhanced, from $11,000 per violation to $21,563 per violation.

The basis for these adjustments is the Federal Civil Monetary Penalties Inflation Adjustment Act of 1990, which requires that civil monetary penalties be adjusted regularly in order to account for inflation. These changes are set to take effect on August 1st, 2016. Public comments on the changes can be submitted to the Justice Department until August 29th, 2016.

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Please join The Health Law Partners, P.C., in congratulating Adrienne Dresevic (a Founding Shareholder), and Clinton Mikel (a Partner), for earning what has been described as the “Pulitzer Prize of Legal Writing”.

The Burton Award for Distinguished Legal Writing, which is run in association with the Library of Congress and co-sponsored by the American Bar Association, is earned each year by 35 exceptional authors nationwide.

Submissions for the Distinguished Legal Writing Award are extremely competitive. The award is generally selected by professors from Harvard Law School, Yale Law School, Stanford Law School, and Columbia Law School, among others.

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In U.S. ex rel. Wall v. Circle C. Construction, Case #14-6150, 2016 WL 423750 (6th Cir. Feb. 4, 2016), the 6th Circuit Court held that damages in false certification cases should be based on the difference between the value of the items or services the government should have received and the value of the items or services the government actually received. The holding, which arose in the non-healthcare context of a construction contract, arguably applies in healthcare matters where medically necessary items or services were furnished pursuant to referrals that violated AKS or Stark laws and thus the government did not sustain any actual damages. A court could then find that the treble damage provision under the False Claims Act is not applicable and the government’s damage recovery is limited to the $5,500-11,000 per claim penalty.
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On November 2, 2015 the President signed The Bipartisan Budget Act of 2015, requiring that civil monetary penalties must be raised to account for inflation, followed by an annual review for further increases. Providers accused of False Claims Act (FCA) violations are likely to see an increase as high as 40% over the current penalty ranging from $5,500 to $11,000. Higher penalties may add up quickly in FCA cases, which generally involve hundreds of alleged tainted claims.

This could potentially have a negative impact on providers that have earmarked monies for quality of care improvement efforts who must now spend the money on paying higher penalties. The threat of higher penalties might also influence a provider’s decision to settle FCA cases due to the risk of astronomical penalties that may be imposed.

Budget Deal Raises Stakes for False Claims, Civil Monetary Penalties [link]
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In July, we blogged about the major Stark Law provisions in the 2016 Proposed Medicare Physician Fee Schedule (the “Proposed Rule“). On October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS“) released the final 2016 Medicare Physician Fee Schedule (the “Final Rule“) (available here), with few changes between the proposed rule and final rule as it related to the Stark provisions. The Final Rule will be published in the Federal Register on November 5, 2015. These are the first major changes to the Physician Self-Referral Rule (Stark Law) since 2009.

CMS stated that the Stark Law updates are meant to accommodate health care delivery/payment system reform, reduce burdens, facilitate compliance, clarify certain applications of the Stark Law, and issue new Stark exceptions. Below is a brief summary of the provisions adopted in the Final Rule:

(a) CMS adopted the proposed Stark exception for recruitment assistance and retention payments from hospitals, federally-qualified health centers (FQHCs), and rural hospital clinics (RHCs) to physicians to assist with employing non-physician practitioners (NPPs) in their geographical area. The only change from the Proposed Rule is the addition of a definition for the geographical area serviced by the FQHCs and RHCs, which is:

The “geographic area served” by a federally qualified health center or a rural health clinic is the area composed of the lowest number of contiguous or noncontiguous zip codes from which the federally qualified health center or rural health clinic draws at least 90 percent of its patients, as determined on an encounter basis. The geographic area served by the federally qualified health center or rural health clinic may include one or more zip codes from which the federally qualified health center or rural health clinic draws no patients, provided that such zip codes are entirely surrounded by zip codes in the geographic area described above from which the federally qualified health center or rural health clinic draws at least 90 percent of its patients.

(b) CMS standardized the various terms used for the principle of “takes into account” referrals (e.g., variations include “based on” or “without regard to”). CMS settled on standardizing the language to “takes into account” the volume or value of referrals.

(c) CMS clarified that the regulations in 42 CFR 411.357(t) regarding retention payments in underserved areas is correct. The Final Rule clarifies that the retention payment must not exceed the lesser of an amount equal to 25 percent of the physician’s current annual income averaged over the previous 24 months.

(d) CMS clarified that the Stark exception requiring that a lease arrangement be set out in writing does not require a single formal contract, but a collection of documents may satisfy the “writing” requirement. CMS did so by replacing the term “agreement” with the term “lease arrangement” throughout the regulation.

(e) CMS extended the “holdover” lease arrangement provision from six months to indefinitely (as opposed to a definite, but longer than six-month period as contemplated in the Proposed Rule). The new holdover lease language is applicable so long as the lease arrangement met the conditions of the exception prior to its expiration, the holdover is on the same terms and conditions as the immediately preceding arrangement, and that the holdover continues to satisfy the requirements of the exception.

(f) CMS revised the language of the exception to the definition of “remuneration” for items/devices/supplies that are used solely for one or more of the six purposes (i.e., collection, transportation, processing, storing, ordering, or communicating the specimen/results). The revision clarifies that the item can be used for more than one of the six purposes, so long as it is used solely for one or more of those purposes.

(g) CMS adopted the language in the Proposed Rule with regard to the clarification that employees or independent contractors do not “stand in the shoes” of their physician organization’s arrangements “unless they voluntarily stand in the shoes of the physician organization as permitted under 42 CFR 411.354(c)(1)(iii) or (c)(2)(iv)(B).

(h) CMS expanded the exception for ownership of publicly traded securities with the language from the Proposed Rule to include protection for “trading on an electronic stock market or over-the-counter quotation system in which quotations are published on a daily basis and trades are standardized and publicly transparent.”

(i) CMS added a new exception for timeshare lease arrangements between a physician and a hospital or unrelated physician organization for the use of premises, equipment, personnel, items, supplies, or services if certain conditions are met. The exception does not apply to advanced imaging, radiation therapy, or clinical/pathology laboratory equipment (other than equipment used to perform CLIA-waived laboratory testing).

(j) CMS added language to clarify that the physician-owned hospital disclosure requirements are not met by posting the ownership interest disclosure on a social media website, electronic patient payment portal, electronic patient care portal, or an electronic health information exchange.
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On August 6, 2015, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 15-12 (available here) regarding a home health provider (the “Requester”) offering free introductory visits to patients who have chosen it for home health care. The OIG concluded that this arrangement does not violate the federal Anti-Kickback Statute (“AKS”).
Under the proposed arrangement, the Requester does not have any involvement in the patient’s home health selection process. Instead, a physician, another health care professional, or discharge planner/case manager presents the patient with a list of home health providers from which to choose. If the patient selects the Requester as its home health provider, then the Requester contacts the patient to schedule a free introductory visit with one of its liaisons. The purpose of the introductory visit is to provide the patient with: (1) an overview of the home health experience; (2) contact lists for the Requester’s administrative and clinical staff; and (3) pictures of the patient’s care team.
In reaching the conclusion that the arrangement does not generate prohibited remuneration under the AKS, the OIG considered the following facts:
• The Requester does not pay or offer any remuneration to the physicians or other individuals involved in the patient’s provider selection process;
• The introductory visit does not involve any diagnostic or therapeutic services reimbursed by federal health care programs or by third-party payors, and the services provided by the liaison during the introductory visit do not require clinical training;
• The liaison does not contact the patient until after receiving notice that the patient has chosen the Requester as his or her home health provider; and • The Requestor does not submit claims for or claim costs associated with the introductory visit.
The OIG reasoned that any benefits received by the patient during the introductory visit were for the primary purpose of facilitating the patient’s transition to home health care, and the intangible worth to patients does not implicate the AKS. The OIG emphasized that when analyzing whether a service has economic value to patients, “the absence of a paying market for such service is not dispositive.” According to the OIG, such an absence may be the result of factors other than the service having little or no value, including because: (1) the service is still new and emerging in the marketplace; or (2) the market has been distorted by the availability of free services. The key takeaway here is that AKS liability is not avoided simply because the service is not reimbursable.
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On July 8, 2015, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule containing major provisions relating to the Physician Self-Referral Law (i.e., the Stark Law) and its exceptions. CMS states that the purpose of the Stark proposals is: “to accommodate delivery and payment system reform, to reduce burden, and to facilitate compliance,” as well as to “expand access to needed health care services.” CMS also states that it realizes that “additional clarification” of Stark would help.

Below is a brief summary of the proposals affecting the Stark Law:

a) Proposes new Stark exception for recruitment assistance and retention payments from hospitals, federally-qualified health centers (FQHCs), and rural hospital clinics (RHCs to physicians to assist them in employing non-physician practitioners (NPPs) in the geographical area served by the hospital, FQHC, or RHC providing the remuneration.
• The exception would not apply to remuneration flowing to a group practice or other type of physician practice (i.e., physician organizations). But, the exception would protect physicians from being considered to be “standing in the shoes of the physician organization” when determining a direct compensation arrangement.
• The exception would only apply where the NPP is a bona fide employee of the physician (or physician’s practice).
• The exception would only apply to NPP services that are primary care services (i.e., family practice, internal medicine, pediatrics, geriatrics, and OB-GYN).
• Additional proposals seek to limit or “cap” the remuneration allowed under this exception.

b) Proposes adding a definition of the geographical area served by FQHs and RHCs under 42 CFR 411.357(e).

c) Proposes to standardize the various terms (e.g., “based on” or “without regard to”) used for the principle of “takes into account” referrals to clarify that there are not different volume or value of referral standards in the Stark exceptions.

d) Proposes revisions to clarify that the policy stated in the Stark Phase III regulations regarding retention payments in underserved areas (42 CFR 411.357(t)) is correct and remains CMS’s policy.

e) Proposes revisions to clarify that the Stark exceptions requiring that a lease or arrangement be set out in writing do not require a single formal contract. Rather, “a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement.” Additionally, the proposed rule clarifies that the one-year term requirement is satisfied “as long as the arrangement clearly establishes a business relationship that will last for at least 1 year.”

f) Proposes to extend the “holdover” arrangements permitted by 42 CFR 411.357(a), (b) and (d) from six months to indefinitely (or, alternatively, a longer but definite period), provided that the holdover continues on the same terms and conditions and that it meets the fair market value requirements. Additionally, CMS proposes to revise the fair market value compensation exception “to permit renewals of arrangements of any length of time, including arrangements for 1 year or greater.”

g) Proposes to revise the definition of remuneration to clarify that if one of the six statutory exceptions to remuneration applies, then the term “used solely” does not mean that the exception does not apply if the item, device or supply is used for more than one of the six statutorily allowed purposes.

h) CMS clarifies that employees or independent contractors do not “stand in the shoes” of their physician organization’s arrangements “unless they voluntarily stand in the shoes of the physician organization as permitted under 42 CFR 411.354(c)(1)(iii) or (c)(2)(iv)(B). Additionally, CMS proposes to remove the phrase “stands in the shoes” from the definition of “locum tenens physician.”

i) Proposes to expand the exception for ownership of publicly traded securities to include protection for “trading on an electronic stock market or OTC quotation system in which quotations are published on a daily basis and trades are standardized and publicly transparent.”

j) Proposes a new exception for timeshare leasing “that would protect timeshare arrangements that meet certain criteria,” including, but not limited to, that “the arrangement is between a hospital or physician organization (licensor) and a physician (licensee) for the use of the licensor’s premises, equipment, personnel, items, supplies, or services…used predominantly to furnish evaluation and management services.” This exception would not apply to independent diagnostic testing facilities or clinical laboratories.

k) CMS provides further guidance to physician-owned hospitals on the disclosure of its ownership interests, including that social media websites are not considered to be public websites for the hospital.

l) CMS also solicits comments on the affect that the Stark Law may have on Accountable Care Organizations.

In addition to the above-noted Stark provisions, the proposed rule contains a number of other proposals, including provisions on appropriate use criteria for advanced imaging services, telehealth, self-referral disclosure protocol, and more. More information on these provisions will be coming soon.
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On Thursday, August 1, 2013, Congresswoman Jackie Speier (D-CA-14) introduced the “Promoting Integrity in Medicare Act of 2013 (PIMA) in the United States House of Representatives. As the law stands, Stark Law prohibits physicians from referring Medicare patients for certain health care services in which they have a financial interest. However, there is an in-office ancillary service exception included in the Stark Law, which according to two recent reports issued by the United States Government Accountability Office (GAO), has led to the overutilization of self-referrals. The reports estimate that in 2010 alone, Medicare could have saved $109 million on advanced imaging and $69 million on anatomic pathology if self-referring physicians had referred the same number of procedures as non-self-referring physicians.

According to Congresswoman Speier’s press release, the proposed bill would eliminate diagnostic MRI, CT, PET, and other advanced diagnostic imaging services, anatomic pathology, radiation oncology, and physical therapy from the in-office exception because they are services that are rarely provided on the same day as the initial office visit. According to the release, “the goal of PIMA is to cut spending in Medicare by hundreds of millions annually without reducing the essential care that seniors rely on.”

On the same day that the bill was introduced in Congress, the Alliance for Integrity in Medicare (AIM) issued a joint statement that applauded the strong leadership of Congresswoman Speier and showed its support for PIMA. The statement explained that if PIMA is enacted, the ability of collaborative group practices to operate as they do today will be preserved and physicians will continue to be allowed to order x-rays and other routine clinical laboratory tests in order to diagnose and treat patients during office visits. The AIM reiterated that reforming the in-office exception through the passing of PIMA will ensure that Medicare patients will “receive the highest quality and safest health care most appropriate to their needs, and Medicare policy incentives are properly aligned saving billions of dollars, which is in the best interests of beneficiaries, providers, and our nation’s health system overall.”

To see the full text of the Promoting Integrity in Medicare Act of 2013, click here.

To see the full text of the two GAO reports analyzing the in-office exception, click here and here.

To see the full text of the AIM’s statement in support of the bill, click here.
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