Archive for April, 2020

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

      

Complying with HIPAA and Beyond during COVID-19

Thursday, April 23rd, 2020

By John Fisher, JD, CHC, CCEP

Safeguarding Patient Health Information in an Emergency Situation

Even in an emergency situation such as that presented by the COVID-19 pandemic, covered entities must continue to meet their obligations under federal and state laws protecting confidentiality of patient health care information, to implement reasonable safeguards to protect patient information against intentional or unintentional impermissible uses and disclosures. They must continue to comply with the administrative, physical, and technical safeguards of the security rule and privacy rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Covered Entities must continue to comply with HIPAA and other confidentiality laws during the COVID-19 pandemic. Certain emergency provisions may apply in applicable state and federal regulations.

The obligation to conduct periodic HIPAA security assessments continues, even during the existence of an emergency or natural disaster. The obligation to meet the requirements of state laws protecting special status health information such as mental health records and drug and alcohol rehabilitation records, also continues through a pandemic.

Each of the bodies of regulations that apply to patient health information contain certain specific provisions that can apply during a pandemic. For example, HIPAA permits disclosures to public health authorities and others

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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

      

Faxing Patient Health Information to Wrong Number – Compliance Risk Area

Thursday, 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

Thursday, 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.

 

Read 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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