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Articles Posted in Stark and Anti-Kickback

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In its recent Advisory Opinion No. 17-05, OIG stated that the Proposed Arrangement (“Arrangement”) would not violate the anti-kickback statute (“AKS”) nor would it prompt administrative sanctions under the Civil Monetary Penalties (“CMP”) provision of the Social Security Act, prohibiting inducements to beneficiaries.

The Proposed Arrangement discussed in the Opinion centers around a retail pharmacy chain offering a voluntary membership program to Federal healthcare program beneficiaries that includes discounts on certain prescriptions and clinic services.

OIG further noted that Program Members receiving discounts would also be eligible to earn rewards in the form of credits when certain merchandise in-store photo-finishing services were purchased. On its face, the Arrangement would appear to invoke prohibitions of the CMP and AKS, since the discounted items and services and earned credits could induce a beneficiary to select the retail pharmacy chain as his or her supplier for federally reimbursable items or services.

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On December 7, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) released a final rule (“Final Rule”) codifying new safe harbors to the Anti-Kickback Statute (“AKS”) and new exceptions to the beneficiary inducement provisions of the Civil Monetary Penalties law (“CMP”). The Final Rule will go into effect on January 6, 2017. The final rule can be found using the following link, https://www.gpo.gov/fdsys/pkg/FR-2016-12-07/pdf/2016-28297.pdf.

The Final Rule creates several new safe harbors to the AKS and new exceptions to the beneficiary inducement provisions of the CMP. Below is a summary of the newly codified Local Transportation Safe Harbor to the AKS.

The Local Transportation Safe Harbor that protects free or discounted local transportation made available by an “eligible entity” to federal health care program beneficiaries as long as the following conditions are met:

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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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