Investment Interest in Radiation Therapy Anti-kickback Statute Settlement

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

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?

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

      

Faxing Patient Health Information to Wrong Number – Compliance Risk Area

April 16th, 2020

By Fisher, JD, CHC, CCEP

faxing phi wrong number

Physician Revises Faxing Procedures to Safeguard PHI After Faxing PHI to Employer  by Mistake

A medical office recently settled with OCR after it allegedly disclosed a patient’s HIV status when the office mistakenly faxed medical records to the patient’s place of employment instead of to the patient’s new health care provider.  The employee responsible for the disclosure received a written disciplinary warning, and both the employee and the physician apologized to the patient.  To resolve this matter, OCR also required the practice to revise the office’s fax cover page to underscore a confidential communication for the intended recipient. The office informed all its employees of the incident and counseled staff on proper faxing procedures.

Two things pop about about this instance.  First, this was clearly a privacy violation.  The patient’s protected health information, which incidentally revealed his or her HIV status, we sent to the employer.  Secondly, it was evident from the facts that this was a mistake.  We aren’t told exactly how this mistake was made.  Was the fax number written down in the wrong box on the patient’s records?  Did the employee who faxed the records put the incorrect number on the fax cover sheet?  We may never know.  But

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Ruder Ware Health Care and Compliance Attorney Receives Top Award

April 16th, 2020

By Fisher, JD, CHC, CCEP

Ruder Ware health care and compliance attorney John Fisher has received top recognition from JDSupra, a leading national legal blogging platform and resource site.  Mr. Fisher received the 2018 Reader’s Choice Award from JDSupra in two separate categories, Health Care and Compliance.  Mr. Fisher joins some of the top legal authors in the country receiving this award.

Mr. Fisher ranked #5 in Health Care and #7 in Compliance.

You can view the JDSupra 2018 Reader’s Choice recipient pages at the following links: Health Care Compliance

Mr. Fisher blogs on the Ruder Ware Blue Ink Blog, the Health Law Blog,  Wisconsin Health Lawyer in addition to other various blog sites and is syndicated through JDSupra.

 

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

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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RCS-1 Model Worksheet Gives a Glimpse of a World Without RUG

March 12th, 2018

By Fisher, JD, CHC, CCEP

RCS-1 Sample Worksheet

RUG System for Skilled Nursing Facility Reimbursement – Time is Running Out

It is currently anticipated that the RUG system, which is currently used to calculate reimbursement for Medicare Part A skilled nursing services, will be changed over the next year.  CMS is currently considering a new Resident Classification System that will completely change the way SNFs are reimbursed for their services.

Providers are getting glimpses of what may be included in the new calculation system.  CMS issued a draft sample worksheet using the RCS-1 system.  The stated purpose is to give providers a description of how the new system would work.  The worksheet gives a description of how a manual calculation would take place using the RCS-I methodology.

The sample draft worksheet that was issued by CMS is available here.  RCS_I_Logic-508_Final

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Providing Protected Health Information in Response to Subpoena

March 12th, 2018

By Fisher, JD, CHC, CCEP

unauthorized release phi subpoena

OCR Citation for Improper Disclosure of PHI in Response to a Subpoena

A health care provider or other covered entity under HIPAA is permitted to disclose protected health information if it receives a lawful order from a court or administrative tribunal.  this does not mean that a provider can simply release everything it has in a patient record when it receives a court order.  Some records, such as mental health or substance abuse records might have special protections or limitations that apply.  Additionally a provider should closely review the relevant order and only disclose the information that is specifically required by the order.

The ability to release information in response to a subpoena, as opposed to an order of a court, is subject to different rules.  Patient information can only be provided under subpoena if certain notification requirements of the Privacy Rule are met. The notification requirements require the provider who received the subpoena to obtain evidence that there were reasonable efforts to notify the person who is the subject of the information about the request.  This is intended to give the individual an opportunity to object to the disclosure, or obtain a protective order from the court.

The application of these rules are

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Medical Alerts – HIPAA Implications of Flagging Patient Records

March 7th, 2018

By Fisher, JD, CHC, CCEP

AIDS identification external alert HIPAA

Identification of AIDS Status Through Medical Alert System

Dentist Revises Process to Safeguard Medical Alert PHI

A recent OCR investigation of a dental practice’s flagging of patients records highlights a potential HIPAA violation.  The OCR investigation confirmed allegations that the dental practice flagged some of its medical records with a red sticker with the word “AIDS” on the outside cover.   Records were handled so that other patients and staff without need to know could read the sticker.  A patient complaint commenced an OCR investigation into whether the practice potentially identified the AIDS status of patients within the office.

When notified of the complaint filed with OCR, the dental practice immediately removed the red AIDS sticker from the complainant’s file. To resolve this matter, OCR also required the practice to revise its policies and operating procedures and to move medical alert stickers to the inside cover of the records. Further, the covered entity’s Privacy Officer and other representatives met with the patient and apologized, and followed the meeting with a written apology.

The lesson here is not to place special medical alerts on the outside of physical patient records.  This is a particularly bad practice in a dental office where the typical office setup can

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Applying Section 1557 Discrimination Rules to Employer Sponsored Health Plans

February 11th, 2018

By Fisher, JD, CHC, CCEP

Health Plan 1557 Compliance

Section 1557 Covered Entities and Employer Sponsored Health Plans

Section 1557 of the Affordable Care Act (ACA) prohibits “covered entities” discrimination in health programs that receive federal financial assistance from the Department of Human and Health Services.  Regulations were issued in 2016 that define the details of compliance with Section 1557 which prohibits discrimination based on race, color, national origin, age, disability and sex.  (including discrimination based on pregnancy, gender identity and sex stereotyping).  The stated purpose for the rules is to expand access and eliminate barriers to the ability to obtain health care coverage.

The definition of “covered entities” to which Section 1557 apply is extremely broad.  Through the broad definition, the requirements of Section 1557 apply to any health program or activity that received federal financial assistance through the Department of Health and Human Service.  This definition includes most health care providers, such as hospitals, nursing homes, and physician, who receive Medicare or Medicaid reimbursement, insurance marketplace and exchanges and participating health plans.

The Section 1557 rules extend to some (but not all) employers that are group health plan sponsors.  Determining whether Section 1557 applies to a specific employer can be quite complicated and is based on several factors such as

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