Compliance Update

IFPMA Releases Revised Code for Interactions with Health Care Professionals and Other Stakeholders Print E-mail
Written by   
Friday, 30 March 2012 10:37

On March 1, 2012, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) issued a Code of Practice relating to interactions with the health care community, which replaces and expands upon its 2006 Code of Pharmaceutical Marketing Practices. In this newsletter, we summarize some of the key changes between the new IFPMA code and its 2006 predecessor, and discuss certain implications of these revisions for pharmaceutical companies, including those with significant operations in the United States.

Read the full article here.
The Impact of Medical Device Fraud on Physicians' Practices Print E-mail
Written by Dave Restaino   
Friday, 16 March 2012 08:53
A recent U.S. Department of Justice (DOJ) settlement with a medical device manufacturer highlights the need for physicians to pay close attention to their dealings with medical device companies. The settlement, announced in December, calls for the payment of $23.5 million to resolve allegations that a medical device manufacturer was manipulating post-market studies to improve the results and to encourage doctors to increase usage of the company's products.  

Click HERE to see DOJ Press Release.

Click HERE to see Medtronic Press Release.

Specifically, the company was allegedly paying per-patient kickbacks of $1,000 to $2,000 to doctors in order to encourage the use of company medical devices in lieu of competitors' devices. Because the fees were payable only when the company's devices were used, the DOJ was concerned that the ultimate goal was to discourage the use of other devices.

Because the law imposes criminal liability upon both sides of a situation involving illegal kickbacks [See Section 1128B of the Social Security Act, 42 U.S.C.1320a-7b], the consequences are enormous, and can include:

-A felony conviction;
-Criminal fines and civil penalties;
-Prison; and
-Exclusion from federal health care programs.

Although there are regulatory "safe harbors" that specify certain acceptable situations, it is nevertheless imperative that medical professionals monitor their practice to ensure that all physicians avoid situations where the use of medical devices is essentially conducted on a "pay-to-play" basis.

Finally, keep in mind that the DOJ investigation was triggered by company whistleblowers, which serves as an ever-present reminder that internal compliance programs are an essential tool in the fight against fraud.

 Dave Restaino is a partner at Fox Rothschild, LLP in Princeton, NJ.
Last Updated on Monday, 19 March 2012 08:06
CMS Confirms Admitting Hospitals' EMTALA Obligations, Seeks Comments on Specialized Hospitals' EMTALA Obligations Print E-mail
Written by   
Friday, 09 March 2012 17:33

The U.S. Centers for Medicare & Medicaid Services recently affirmed Emergency Medical Treatment and Labor Act (EMTALA) obligations end upon inpatient admission to an admitting hospital, but left open for comment the issue of EMTALA obligations of hospitals with specialized capabilities to accept inpatient transfers.

Read the full article here.
OIG Slams Trusting Doctors Who Let Others Bill for their Services Print E-mail
Written by Jeffrey L. Cohen   
Friday, 09 March 2012 10:02

Physicians who allow other people or entities to bill for their services are taking a risk. Settlements with eight physicians whose provider numbers were used unlawfully by entities they worked for prompted the OIG to issue an Alert on February 8th. The Alert basically says that physicians who assign to others (e.g. 855R) the right to bill for the services of the physicians will be responsible for the wrongful actions of those using the doctors' provider numbers. Ignorance will likely not be a good excuse any longer.

What does all this mean to doctors? Simple: VERIFY REGULARLY.  If you assign to any person or entity the right to bill for your services, you MUST routinely check to see if they are billing correctly. The fact that some person or entity may bill wrongfully, even fraudulently, without your direct knowledge, will not protect you from liability. Make sure (1) you have written agreements for all arrangements that involve any person or entity billing for your services, and (2) those contracts contain indemnification provisions in case you have to hire a lawyer or pay anything to the government for their wrongdoing.

With almost 25 years of healthcare law experience following his experience as legal counsel for the Florida Medical Association, Mr. Cohen is board certified by The Florida Bar as a specialist in healthcare law. With a strong background and expertise in transactional healthcare and corporate matters, particularly as they relate to physicians, Mr. Cohen's practice involves him in regulatory, contract, corporate, compliance and other healthcare law related matters. As Founder of the Florida Healthcare Law Firm, Mr. Cohen can be reached at 888-455-7702 or online at 
Last Updated on Friday, 16 March 2012 09:18
"Incident To" Services Under Medicare Print E-mail
Written by Troy A. Kishbaugh & Sarah L. Mancebo   
Friday, 02 March 2012 11:22

Medicare Part B allows for services to be billed by a physician even though the services are actually performed by non-physicians. These types of services are known as "incident to" services and are provided under the Medicare "incident to" rule. Services billed under the "incident to" rule are paid at 100% of the Medicare Physician Fee Schedule amount.   

"Incident to" services are provided incident to a physician's or other practitioner's (physician assistant, nurse practitioner, clinical nurse specialist, nurse midwife and clinical psychologist) professional service and must be:

  • an integral, although incidental, part of the physician's professional service;
  • commonly rendered without charge or included in the physician's bill;
  • of a type that are commonly furnished in the physician's offices or clinics;
  • furnished by the physician or by auxiliary personnel under the physician's "direct supervision."

"Incident to" services must be billed under the physician's provider number and must meet specific criteria to fall within the parameters of the Centers for Medicare & Medicaid Services ("CMS") guidelines. Generally, (i) the physician must first see the patient to establish a physician-patient plan of care, (ii) the services provided by the non-physician should be provided in the physician's office, (iii) the physician must be present in the office suite and readily available when the services are provided (direct supervision) and (iv) the physician must be involved in the patient's treatment of care on an ongoing basis.   

Services provided under the "incident to" rule are coming under new focus by the federal government. The Health and Human Services, Office of the Inspector General ("OIG") 2012 Work Plan lists "incident to" services as a new review for the agency to examine billing error rates and assess CMS's capability to monitor services billed as "incident to." The OIG intends to prevent unqualified personnel from providing services to Medicare beneficiaries and will be seeking to recover overpayments made if individuals have been incorrectly billing "incident to" services.   

Billing "incident to" services is attractive to physicians because it allows the physician to generate additional revenue from the services that are provided by non-physicians. However, before engaging in "incident to" services, the physician and non-physician providing the services must ensure they are strictly complying with the "incident to" rules. Failure to do so can result in harsh penalties, including without limitation, a comprehensive CMS investigation into billing practices, recoupment of Medicare overpayments, and/or criminal charges from filing and submitting false claims to Medicare.  

For more information about "incident to" services under Medicare, please contact Troy A. Kishbaugh and Sarah L. Mancebo with GrayRobinson's Health Law Team.

Last Updated on Friday, 09 March 2012 10:30
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