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

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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Read more here: Health Law Blog

  

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.

Employment Exceptions From Anti-kickback Statute

Tuesday, May 20th, 2014

By John Fisher, JD, CHC, CCEP

employment exception safe harbor regulations

How Broad is the Employee Exception 

Parameters of the Stark Law and Anti-kickback Statute Exception

Both the Anti-Kickback Statute and the Stark Law contain exceptions that apply to employer/employee relationships.  Recent developments in the health law area indicate that there may be limits on the employment exception that were not previously contemplated.  I posted an article on the Health Law Blog that discussed possible limited to compensation structures for employed physicians.

Read more here: Health Law Blog

  

Physician Owned Hospital Expansion – CMS Approval Process

Tuesday, May 20th, 2014

By John Fisher, JD, CHC, CCEP

physician owned hospitals

Expanding Physician Owned Hospitals – Stark Law Approval Process

The Stark Law prohibits physicians from owning interests or having financial relationships with entities that provide “designated health services,” including hospital services, unless an exception exists.  The Stark Law contained an exception that permitted investment in a “whole hospital” but that exception was seriously limited under the Affordable Care Act.  Physician-owned hospitals must now obtain CMS approval of any expansion projects.  CMS regulations define the process and requirements for obtaining CMS approval of expansion projects.

I posted an article on the Health Law Blog that summarizes some of the requirements for obtaining approval for expansion of a physician-owned hospital.

Read more here: Health Law Blog