201 posts categorized "Regulatory"

January 03, 2012

OIG Posts Video & Audio Podcast on Stark Law

Today the OIG posted a video and an audio podcast about the Physician Self-Referral Law, also called the Stark law. This video and audio podcast includes a general introduction to the Physician Self-Referral Law, an important fraud and abuse law administered by the Centers for Medicare & Medicaid Services and enforced, in part, by OIG.

You can access all of the Provider Compliance Training videos and audio podcasts at http://go.usa.gov/5no%20.

October 19, 2011

Medical staff incidental benefits and nonmonetary compensation

Are the Stark law compensation exceptions for medical staff incidental benefits and nonmonetary compensation interrelated, or are they mutually exclusive? Said another way, does a DHS entity need to add up the value of medical staff benefits provided to a physician that are protected under the Stark law medical staff incidental benefits compensation section and aggregate this with benefits provided to that same physician that meet the nonmonetary compensation exception, to ensure that the nonmonetary compensation exception cap is not exceeded? Or are they two separate and distinct categories?

Note the non-monetary compensation exception and incidental medical staff benefits exception are not interrelated. The tracking for the non-monetary compensation is separate from the incidental medical staff benefits exception. If a benefit to a physician (e.g. lab coat or modest food/beverages in physician lounge) fits within the incidental medical staff benefit exception, it does not have to be tracked as non-monetary compensation.

October 17, 2011

2012 OIG Work Plan - Looking at physicians

Physicians: Incident-To Services. OIG will review physician billing for incident-to services to determine whether payment for such services had a higher error rate than non-incident-to services. Assess CMS’s ability to monitor incident-to services.

Evaluation and Management Services: Use of Modifiers During the Global Surgery Period. OIG will review the appropriateness of the use of certain modifier codes during the global surgery period and whether Medicare payments for claims with such modifiers used during the global surgery period were in accordance with Medicare requirements.

Diagnostic Radiology: Excessive Payments. OIG will review of Medicare payments for high-cost diagnostic radiology tests to determine whether they were medically necessary and to determine the extent to which the same tests were ordered for a beneficiary by both a primary care physician and a specialist.

Providers and Suppliers: High Cumulative Part B Payments. OIG will review what controls are in place to identify high cumulative Medicare Part B payments to individual physicians and suppliers, or on behalf of an individual beneficiary, over a specified time period.

August 09, 2011

Update on Recent Physician Prosecutions

From the American Health Lawyers Association (www.healthlawyers.org) authored by Judd Harwood, Esquire (Balch & Bingham LLP, Birmingham, AL), and David Ivers, Esquire (Mitchell Blackstock Ivers & Sneddon PLLC, Little Rock, AR)

Maryland Cardiologist Convicted for Inserting Unnecessary Cardiac Stents

A federal jury in Baltimore, MD, convicted cardiologist, John McLean, MD, fifty-nine years old, on six healthcare fraud offenses on July 26, 2011, for inserting unnecessary cardiac stents, ordering unnecessary follow-up tests, and falsifying medical records to justify the stents.

From at least 2003 to May 2007, McLean performed cardiac cathertizations and implanted unnecessary stents in more than 100 patients at Peninsula Regional Medical Center, according to the U.S. Department of Justice (DOJ). He then falsely recorded the existence of lesions observed during the procedures to justify the stents and the claims he submitted to Medicare and Medicaid. In addition, McLean ordered his cardiac patients to undergo medically unnecessary follow-up tests, including cardiolite stress tests, echocardiograms, and EKGs.

McLean faces a maximum sentence of ten years in prison for healthcare fraud and five years in prison for each of five counts of making false statements related to healthcare matters. Sentencing is scheduled for November 10, 2011. The government is also seeking forfeiture of $711,583 in proceeds from the billings.

The case was investigated by DOJ and Office of Inspector General. The case was tried by the U.S. Attorney's Office for the District of Maryland.

California Oncologist Sentenced to Prison for Billing for Cancer Medications That Were Never Provided

An Orange County, CA, oncologist was sentenced on July 25, 2011, to eighteen months in federal prison for submitting bills for cancer medications that were never provided.

U.S. District Judge Cormac J. Carney sentenced Glen R. Justice, MD, sixty-six years old, of Corona del Mar, after Justice pleaded guilty to five counts of healthcare fraud. Justice operated the Pacific Coast Hematology/Oncology Medical Group in Fountain Valley, CA. He billed for injectable cancer medications when patients never received them. In some cases where patients did receive medications, Justice upcoded claims by billing for more expensive injectable medications than were actually provided.

The medications involved were Neulasta, Neupogen, Procrit/Epogen/Aranesp, and Neumega. According to the U.S. Attorney's Office, the fraudulent billing occurred between 2004 through October 2009, despite Justice being advised about thee issue and subjected to a search warrant at his office in November 2006.

Improper billings amounted to between $400,000-$1 million. Insurers he billed included Medicare, Tricare, the Federal Employees Health Benefit Program, and Blue Cross and Blue Shield of California. The judge ordered Justice to pay $1 million in restitution.

The prosecution resulted from an investigation by the Federal Bureau of Investigation, U.S. Department of Health and Human Services Office of Inspector General, Internal Revenue Service Criminal Investigation Division, and U.S. Department of Defense Office of Inspector General.

Washington Oncologist and Wife Indicted for Twenty Counts of Healthcare Fraud

Alfred Hongleung Chan, MD, sixty-three years old, and his wife, Judy Yuan Chan, sixty-two years old, both of Lakewood, WA, were indicted by a federal grand jury for twenty counts of healthcare fraud, obstruction of justice, and money laundering. Alfred Chan was also indicted on two counts of making false statements. The indictment was unsealed in July.

According to the indictment and the civil litigation, Alfred Chan would make patient treatment notes on individual slips of paper that were given to his nurse. The notes specified the amount of drugs to be provided to a specific patient. After the nurse provided the drugs to patients by injection or infusion, the slips of paper were returned to Alfred Chan who shredded them. The doctor then made entries into a "superbill" form, ostensibly recording the amount of medications the patients had received. However, he allegedly recorded more medication administered than actually received by the patient, and inflated the time spent administering the medication. Judy Chan allegedly prepared the bills for Medicare and other government and private healthcare programs using the inflated amounts, which substantially increased the amount of money paid to the Chan clinic for medication. The government alleges the scheme resulted in inflated payments to the clinic in the amount of $1.7 million.

June 08, 2011

OIG offers online videos on healthcare compliance

The U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG's) Healthcare Fraud Prevention and Enforcement Action Team has hosted a series of compliance trainings throughout the country for compliance professionals, healthcare businesses, and in-house counsel. The OIG posted a video of the Washington, DC, training on HEAT's website. In addition to the three-hour and forty-five-minute training video, OIG will release a series of shorter videos, broken down into discrete subject areas so viewers can choose which segments to watch. Presentation slides for the training and eleven related handouts are also available on HEAT's website. These materials offer a valuable tool for developing or delivering internal compliance trainings, and for raising awareness about compliance within healthcare organizations. Compliance professionals will want to ensure that annual and effectiveness review efforts acknowledge these OIG materials as part of any effective review.

February 03, 2011

OIG Offers Free Compliance Training Seminar

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services is offering a series of free, half-day compliance training sessions for local health care providers, compliance professionals, and their legal counsel. The first one is on February 16 in Houston at the Houston InterContinental near the Galleria.

The sessions will feature experts from OIG, the Centers for Medicare and Medicaid Services, United States Attorneys’ Offices, and State Medicaid Fraud Control Units. They will talk about the realities of health care fraud and the importance of implementing an effective compliance program.

Space is limited!  For information regarding the training and additional dates and cities, visit http://compliance.oig.hhs.gov

December 23, 2010

Physician practices can say bye bye to red flag rules

Physicians and other professionals and service providers get some relief from proposed identity theft compliance obligations. On December 18, President Obama signed the "Red Flag Program Clarification Act of 2010" into law [Text, PDF].  Under the measure, physicianswill no longer be defined as "creditors" under the controversial "Red Flag Rules."  The changes were passed by the Senate in November and the House last week after months of lobbying and litigation by professional societies.

The brief clarifying statute redefines "creditor" to exclude service providers that advance funds on behalf of a person for expenses incidental to a service they provide to that person. The Red Flag Rule was designed to require creditors such as banks, credit card companies and other lenders, to implement various safeguards to protect their clients from identity theft.  

The original statute defined "creditor" broadly, and the FTC initially interpreted it to apply to physicians and other professionals who bill their clients for services, believing that they were obligated to do so by the statutory language. After being bombarded with complaints, FTC chairman Jon Liebowitz assured physicians that his agency was pushing Congress to work quickly to fix the Red Flag Rule that he said had "unintentionally swept up countless small businesses – including every doctor, dentist, lawyer, gardener, plumber, and housekeeper who bill customers on a monthly basis."

The effective date of the Red Flag rules has been postponed several times, most recently in June, and will take effect for other creditors on January 1, 2011.  The American Bar Association and other professional societies had sued the FTC earlier this year and the federal agency had agreed to delay enforcement for attorneys, physicians and accountants until the appeal of that ruling was heard - it remains pending but will be rendered moot by this legislation. 

December 22, 2010

Hospital Pays $22M Settlement for Allegedly Improper Physician Professional Service Agreements

The United States Attorney’s Office for the District of Maryland has announced that St. Joseph Medical Center in Towson Maryland will pay $22 million to settle allegations that it violated the federal False Claims Act, the federal anti-kickback statute and Stark by entering into several improper professional services contracts with a cardiology group, MidAtlantic Cardiovascular Associates that involved the payment of illegal remuneration.

The DOJ alleged that St. Joseph paid kickbacks to the cardiology group through sham professional services agreements between 1996 and 2006. Specifically, the parties had entered into 11 professional services agreements which involved payments above fair market value, and/or payments for services that were either not rendered or not commercially reasonable.

Importantly, the settlement was the result of a qui tam whistleblower lawsuit brought by a group of cardiac surgeons who alleged that the service agreements were in violation of federal law. 

This settlement underscores the importance of ensuring that all financial relationships between physicians and hospitals to which they refer, including medical directorships, call coverage arrangements, rental arrangements and the like are for legitimate and necessary items/services and that payments are consistent with fair market value. 

November 29, 2010

tark In-Office Ancillary Services Exception Disclosure Requirements Effective January 1, 2011

Effective January 1, 2011, the new Stark In-Office Ancillary Services Exception (the "IOASE") provisions will require physicians or group practices relying upon the IOASE (collectively, "Physician Practices") to furnish the following notice/disclosure to patients receiving MRI, CT, and PET (as identified on the Stark CPT/HCPCS Code list):

• Written notice at the time of the referral (not the time of the service)that the Medicare patient may receive the same services from another person or other supplier.

• The written notice must include a list of at least 5 (this was reduced from the original list of 10) suppliers that provide such services and which are located within a 25-mile radius of the referring physician's office location (depending upon the various office locations, a Physician Practice may be required to have different lists) at the time of the referral. (Note that so long as the requisite number of suppliers is listed, you can now also include a list of providers on the notice (e.g., hospitals) this was previously prohibited under the proposed rule).

• The notice must be written as to be understood by all patients and should include at a minimum, for each listed supplier the supplier's name, address, and telephone number. (Note that CMS removed the requirement that the practice obtain the patient's signature on the notice and maintain a copy in the patient's medical record. Also, note that CMS is no longer requiring the practice to list the mile radius for each listed supplier.) NOTE that although Physician Practices are no longer required to obtain and maintain the patient's signature, it may be prudent to otherwise document that the disclosure requirement was met such as having a physician in the Physician Practice document in the chart that the notice was given.

All Physician Practices nonetheless should begin working to identify the alternative list of suppliers that they will provide (including the name, address and number of each) on the notice. Physician Practices should also ensure that they have their notices ready by January 1, 2011 and have procedures established to ensure that their office staff is providing the notice to Medicare patients at the time the MR/CT/PET is ORDERED. Physician Practices should be mindful of the fact that the notice can be simple and only needs to merely provide notice. A Physician Practice is permitted to identify its own services on the notice and according to CMS, a Physician Practice can also include language on the notice which informs patients that the inclusion of the alternate suppliers is not intended to endorse or recommend those suppliers.

November 23, 2010

DOJ: Record-Breaking Year for False Claims Act Recoveries

The U.S. Justice Department recovered more than $5 billion under the False Claims Act since the beginning of 2009, the largest amount in any two-year period in history, a DOJ official said today.

In that time, health care fraud recovery accounted for $4.6 billion, Assistant Attorney General Tony West of the Civil Division told reporters. Most of the cases that resulted in a recovery of taxpayer money were brought through the whistleblower provision of the False Claims Act.