Archive for the ‘Stark Law and Anti-Kickback Issues’ Category

Whistleblower Settlements Increase Compliance Risk for Providers

Thursday, April 23rd, 2020

By Fisher, JD, CHC, CCEP

Dermatology Risk Areas Fraud and Abuse

Recent Fraud Settlements Emphasize Risk of Whisttleblowers

One of the reasons why compliance officers and health care attorneys read fraud settlements is to identify the issues that the government is focused on.  The cases that the government decides to pursue are very indicative of the areas of fraud enforcement that they feel are important.  These are not the only issues that should be considered, but government enforcement actions certainly tell us what types of arrangements the government considers important.

The misfortune of the defendants involved in these cases hold a potential learning experience for everyone else.  Others have an opportunity to focus on their own operations to identify whether they are at risk in any of the areas involved in these cases.

An ancillary lesson that these settlements hold is that each was initially raised by a whistleblower.  The False Claims Act gives whistleblowers a portion of the settlement in cases where the government decides to intervene.  This in effect creates a universe of potential claimants that can include almost anyone with original knowledge of the alleged practice.

Common whistleblowers include former or disgruntled employees.  It really does not matter of the employee is or was the worst employee in the world, they can

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When is a Referral Mandate for Employed Physicians Permitted under the Stark Law?

Thursday, April 23rd, 2020

By Fisher, JD, CHC, CCEP

Referral Requirements Employed Physicians

When Employed Physicians be Required to Make Referrals for Designated Health Services

The Stark Law Regulations include a provision that dictates the conditions under which an employer of a physician may mandate referrals for designated health services. Certain specific conditions must be met if an employer wishes to require its employed physicians to make referrals to the employer’s designated health services. Many institutions assume that an employer may always require an employed physician to make referrals to its ancillary services. That assumption is not correct.

The Stark regulations provides that a physician’s compensation from a bona fide employer or under a managed care contract or other contract for personal services may be conditioned on the physician’s referrals to a particular provider, practitioner, or supplier. There are a number of specific requirements that must be present to permit referral requirements including:

  1. The required referrals can only relate to the physician’s services covered by the scope of the employment or the contract.
  2. The referral requirement must be reasonably necessary to effectuate the legitimate business purposes of the compensation arrangement.
  3. The physician’s compensation must be set in advance for the term of the agreement requiring referrals.
  4. The physician’s compensation must beRead more here: Health Law Blog

      

Investment Interest in Radiation Therapy Anti-kickback Statute Settlement

Thursday, April 16th, 2020

By Fisher, JD, CHC, CCEP

Anti-kickback Statute Radiation Therapy Investments

Radiation Therapy Referral Kickback Arrangements with Investors.

A national operator of radiation therapy centers, has agreed to settle a False Claims Act action alleging that it submitted claims violated the Anti‑Kickback Statute by paying of $11.5 million and entering into a 5 year Corporate Integrity Agreement with the Office of Inspector General.  The arrangement involved payments to investors who were allegedly targeted because of their referral potential to the therapy centers.  The challenged arrangement involved a series of leasing companies that accepted investments from referring physicians.  The investment interests resulted in the payment of investment returns that the government considered to be remuneration for referrals in violation of the Anti-Kickback Statute.  The whistleblower who originally raised the issue will receive up to $1.725 million.

This case involves a garden variety claim of a kickback by investment interest.  The typical investment case involves targeting potential investors who are in a professional position to make referrals to the company in which they are asked to invest.  The referral source has a financial incentive to increase referrals.  This might be an excellent financial investment scenario, but the problem is that the investment return might well be an illegal kickback; which is potentially a federal felony.

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Treatment Center Plead Guilty to Anti-kickback Statute Violations Involving Alcohol and Drug Addiction Treatment Centers

Thursday, April 16th, 2020

By Fisher, JD, CHC, CCEP

Treatment Center Fraud Plea

Substance Abuse Treatment Center Fraud Scheme Results in Guilty Plea

The Department of Justice recently announced the guilty plea of two individual alcohol and substance abuse treatment center owners for their participation in what DOJ labeled a “multi-million dollar health care fraud and money laundering scheme.”  The two individuals owned a licensed substance abuse service provider (or treatment center) offering clinical treatment services for persons suffering from alcohol and drug addiction. The treatment center also offered medication-based treatment for opioid addiction.

The government had accused the two owners of paying illegal kickbacks/bribes to “sober homes” in exchange for the referral of the sober homes’ insured residents to treatment program. The sober homes provided safe and drug-free residences for individuals suffering from drug and alcohol addiction. This made them a prime source of potential referrals to the treatment program.

The accusations against these defendants read like a laundry list of thinly veiled kickback schemes.  Some of the specific accusations included:

  1. Providing funds used to purchase or rent several sober home properties under purchase agreements or leases that were in the names of other parties so as to disguise the source of funds.
  2. Paying remuneration for referrals in the form of free or reduced rent, insurance premiumRead more here: Health Law Blog

      

When is a Referral Mandate for Employed Physicians Permitted under the Stark Law?

Thursday, April 16th, 2020

By Fisher, JD, CHC, CCEP

Referral Requirements Employed Physicians

When Employed Physicians be Required to Make Referrals for Designated Health Services

The Stark Law Regulations include a provision that dictates the conditions under which an employer of a physician may mandate referrals for designated health services.  Certain specific conditions must be met if an employer wishes to require its employed physicians to make referrals to the employer’s designated health services.  Many institutions assume that an employer may always require an employed physician to make referrals to its ancillary services.  That assumption is not correct.

The Stark regulations provides that a physician’s compensation from a bona fide employer or under a managed care contract or other contract for personal services may be conditioned on the physician’s referrals to a particular provider, practitioner, or supplier.    There are a number of specific requirements that must be present to permit referral requirements including:

  1.  The required referrals can only relate to the physician’s services covered by the scope of the employment or the contract.
  2. The referral requirement must be reasonably necessary to effectuate the legitimate business purposes of the compensation arrangement.
  3. The physician’s compensation must be set in advance for the term of the agreement requiring referrals.
  4.  The physician’s compensation must be consistent with fair market value for servicesRead more here: Health Law Blog

      

Telemedicine IT Donations and the Anti-kickback Statute – OIG Opinion 18-03

Thursday, April 16th, 2020

By Fisher, JD, CHC, CCEP

telemedicine donation it

IT Donation to Facilitate Telemedicine Consultations – Low Risk of Fraud says OIG

The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 in support of an arrangement where a federally qualified health center look-alike (the “Provider”) would donate free information technology-related equipment and services to a county health clinic (the “County Clinic”) to facilitate telemedicine encounters with the County Clinic’s patients (the “Proposed Arrangement”).  The OIG concluded that although the Proposed Arrangement could potentially generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMPL”) with the requisite intent to induce or reward referrals of federal health care programs, the OIG would exercise its discretion and not sanction the Provider or the County Clinic (collectively the “Requestors”).

The OIG’s analysis and conclusion of the Proposed Arrangement provides new insight into the government’s position on these type of donations that facilitate telemedicine encounters.  Specifically, how the government views these type of donations with the continued expansion of coverage and reimbursement of telemedicine services under federal health care programs.  The Advisory Opinion indicates support for the development of collaborative telemedicine affiliations and that the potential remuneration from the future

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Using Self-Disclosure Protocols – CMS and OIG Self Disclosure Process

Tuesday, April 11th, 2017

By Fisher, JD, CHC, CCEP

Self-Disclosure Has Become a Normal Part of the Compliance Process

As the OIG and CMS make self-disclosure easier for providers, we have noticed an increase in the rate of cases that are being filed.  Assisting providers in making decisions whether to self-disclose, conducting internal investigations, and guiding the self-disclosure process when appropriate has become a large part of our compliance practice.  Here are just a few of the articles and other resources that we have released regarding self-disclosure issues:

Exercising Reasonable Care to Identify and Address Potential Overpayments

Criminal Exposure for Failing to Repay Known Overpayment

When to Use the OIG’s Self Disclosure Protocols

Excluded Party Cases Dominate OIG Published Self Disclosure Settlements

Self-Disclosure Process – Voluntary Self Disclosure Decisions are not Always Easy

When Does An Overpayment Become Fraud? How Simple Inattention Can Expose You to Penalties for Fraudulent Activities

Provider Self-Disclosure Decisions – Voluntary Disclosure Process

Provider Self Disclosure Process

For more information on the self-disclosure process and legal updates impacting the process, watch this space.

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6 Year Lookback Period Under Self Disclosure Protocol

Tuesday, April 11th, 2017

Look-back Period for Self-Disclosures Increased from 4 Years to 6 Years

6 year lookback Self disclosureOn February 12, 2016, CMS published a final rule for the reporting and returning of overpayments (the “final overpayment rule”). See 81 FR 7653. The effective date for this rule was March 14, 2016. Among other things, the final overpayment rule established a 6-year lookback period for the reporting and returning of overpayments under regulations at 42 CFR 401.305(f). Prior to March 14, 2016, CMS used the time frame established under the reopening regulations at 42 CFR 405.980(b) as a guide to determine the time frame of the SRDP. As such, the time frame of the SRDP was limited to 4 years from the date that the disclosing party submitted the disclosure to the SRDP, unless reliable evidence of fraud or similar fault existed.

Self-referral overpayments reported to CMS in accordance with the SRDP prior to March 14, 2016 are not governed by the 6-year lookback period specified in the final overpayment rule. This includes both overpayments reported and returned (via compromise and settlement) as well as those reported and still in the process of being reviewed through the SRDP. Providers and suppliers that reported self-referral overpayments to the SRDP prior to March 14, 2016 are not expected to return overpayments from the fifth and sixth years. Providers and suppliers reporting overpayments to the SRDP on or after March 14, 2016 are subject to the 6-year lookback period specified in the final overpayment rule.

Anti-kickback Statutes – Free Transportation Services to Patients – Safe Harbor Regulations

Wednesday, March 22nd, 2017

Free Patient Transportation Services

Factors to Consider When the Transportation Safe Harbor is Not Satisfied

Health Attorney Wisconsin Health LawHere are some factors pulled from various OIG Advisory Opinions on free patient transportation.  The safe harbors for patient transportation should also be consulted, but these factors may be relevant in cases where not all safe harbor elements can be met.  Some factors identify criteria that makes an arrangement suspect.

  • Offering out of state patients free transportation to receive services.
  • Compensating drivers of vans or other vehicles on a per patient basis for patients that are brought to the facility.
  • Offering free luxury transportation.
  • Offering free transportation to the patients of physicians or other referral sources in order to induce them to refer to the facility.
  • Free ambulance services without making any determination of financial need.
  • Offering free transportation to nursing home residents to a facility,especially for services of questionable necessity.
  • The costs of the free transportation must be borne by the facility and should not be passed on to any Federal health care program.
  • Higher levels of advertising and marketing of the transportation service will raise more concern.
  • Transportation from one provider to another raise a higher level of concern than transportation directly to the facility. In other words, where the transportation is from the place of business of a potential referral source (i.e. physician or other health care provider) the fraud and abuse risk is higher.
  • Whether there are other methods of affordable transportation in the area. If affordable transportation options are not readily available, the arrangement will raise less concern.
  • Whether the services are offered and/or marketed outside of the facilities normal service area. The OIG looks with disfavor on “leap-frog” arrangements that induce patients to bypass other closer providers due to the free or low cost transportation arrangement.
  • The OIG also raised general concerns about the provider who uses free transportation to gain access to patients, potentially for unnecessary or questionable services.

OIG Releases Annual Work Plan for 2017

Monday, January 23rd, 2017

OIG Annual Work Plan for 2017 – Topics Covered

The Health and Human services Office of Inspector General (OIG) recently released its 2017 Annual Work Plan.  Work planning is an ongoing project within the OIG.  Every year, the OIG publishes a work plan that consolidates the OIG audits and evaluations that are being conducted or planned within the organization.  The annual work plan has become a source that compliance officers look to as a tool for the identification of potential risk areas or areas of emphasis within their organization.  It is obviously not the only source for identifying compliance risk areas, but is certainly one reliable source that providers can draw on when setting their annual compliance priorities.

The 2017 OIG Work Plan can be download through the OIG site.

Ruder Ware’s health care group will continue to put out blogs and articles on various issues identified in the 2017 Annual Work Plan.  We will focus primarily on issues that were introduced for the first time in this year’s plan.