Archive for the ‘Health care compliance’ Category

Compliance Officers Are Funny People!

Tuesday, June 14th, 2011

A Wall Street Journal article today called, “If You Think Accountants are Hilarious, Try These Guys”, discusses America’s search for the funniest compliance officer.  As a partner in a law firm that practices healthcare compliance, I found this article wonderful!  Imagine my delight to also find the article located on the front page!

Congratulations are in order for Michael Shaw, from GlaxoSmithCline, the funniest compliance officer in America!  Next year’s profession appears to be lawyers…should be exciting!

Here’s a video that was attached to the WSJ article, which shows some of the stand-up routines!  Enjoy!


Thursday, June 9th, 2011

Physician-owned distributorships (POD’s), are rapidly growing across the country, and already exist in at least 20 states.  However, there are growing concerns over their legality, primarily in the context of anti-kickback regulations.  Just this month, Sen. Orrin Hatch, Ranking Member of the Senate Finance Committee, has called for an investigation into the structure of POD’s and their potential adverse impact on the Medicare program and its beneficiaries.

What Are POD’s and How Do They Work?

POD’s are business arrangements involving physician ownership of medical device companies.  At its most basic level, medical device companies are formed by physician-owners.  These physician-owners then have control over medical devices they implant in patients, and are given a share of the profits generated by the sale of the medical devices.  To put it more simply, Surgeon A is a physician-owner of a medical device company.  When patients come to Surgeon A, he implants the medical device in the patient during surgery.  Surgeon A profits from the sale and utilization of the medical device.

POD’s have been popular among surgeons and we are now seeing more orthopedic POD’s in the context of joint-replacement devices.

Potential Legal Problems with POD’s

There are several different concerns over the legality of POD’s.  One such concern is whether physician-owners are performing medically unnecessary procedures in order to profit off the sale of the medical device.  There are some statistics to back up this claim.  An article in the Wall Street Journal (“Senators Request Probe of Surgeons”, June 9, 2011) maintains that the spread of POD’s has coincided with an explosion in spinal fusion surgery.  A 2010 study in the Journal of of the American Medical Association found that complex spinal fusions increased 15-times among Medicare patients with spinal stenosis between 2002 and 2007.  According to a Wall Street Journal analysis, spinal infusion went from costing Medicare $343 million in 1997 to costing $2.4 billion in 2008.

Another legal concern involves the ant-kickback statute.  Some have argued POD’s may violate anti-kickback statutes and other federal fraud and abuse laws by creating financial incentives for physician investors to use devices that steer business back to themselves.  Unfortunately, there has been no clear guidance by the OIG on this topic.  While the OIG has acknowledged the risks of abuse POD’s pose, the lack of any specific rules from the government appears to be contributing to the potential for abuse and has allowed these entities to flourish.

Attention on this matter has made it up to Congress, where five senators have called for an investigation.  The five senators requesting an investigation are: Sen. Orrin Hatch (R-Utah), Senate Finance Committee Chairman Max Baucus (D-Mont.) and Sens. Herb Kohl (D-Wis.), Charles Grassley (R-Iowa) and Bob Corker (R-Tenn.). The senators have requested the Inspector General submit an initial report on his findings by Aug. 1

With all the uncertainty and potential liability, POD’s will continue to be a hot-topic in the area of healthcare compliance until the legality question is answered.



ACO Test Pilot Programs

Wednesday, May 4th, 2011

While doing some ACO research, I compiled quite a few helpful resources on ACO test pilot programs.  Here are a few links describing some of these programs.  This is not intended to be an exhaustive list of each and every ACO test pilot program.  However, these are the links I found most informative.  Enjoy!

The Vermont Accountable Care Organization Pilot: A Community Health System to Control Total Medical Costs and Improve Population Health

New Jersey Prepares to Launch Accountable Care Organization

On the Road to Better Value: State Roles in Promoting Accountable Care Organizations (includes a state-by-state summary)

Successful Pilot Tests Clear the Way for July Debut of ACO Standards

A Guide to Accountable Care Organizations, and Their Role in the Senate’s Health Reform Bill (Seton Hall School of Law Web Log, lots of information about ACO’s in general)

Accountable Care Organizations: Can They Rein In Health Care Spending for States? (pertinent section begins at page 13)

Creating Accountable Care Organizations in Massachusetts

The ACO Toolkit (a comprehensive ACO implementation guide)

The Brookings-Dartmouth ACO Test Pilot Implementation Sites

(Disclaimer: This post does not constitute legal advice and should not be considered as such.)

Matthews Law Firm, P.A., practicing health law in Polk County, Florida.

Patient Access to Medical Records

Tuesday, April 19th, 2011

In Florida and under HIPAA, a patient is entitled to have access to his or her medical records.  Sounds easy enough, right?  It can be.  But for some patients, gaining access to their medical records can take some time.  For example, some medical offices require the request to be in writing.  Some offices even have a specific request form to use.

Typically, a health care provider has 30 days to respond to a patient’s request for records.  Under certain conditions, the provider can get an extension.  For example, some records may be kept off-site and they may require additional time to secure the records.  However, in most instances, a health care provider must furnish the records within 60-90 days of the request.

Will you be charged for a copy of your records?  Probably.  Health care providers are allowed to charge for the copy fees.  Under Florida law, most doctors are allowed to charge $1 for the first page and up to 25 cents for each additional page.  For example, 100 pages of records would cost $25.75.  {First page = $1.00 + (99 pages x .25).  $1.00 + $24.75 = $25.75}  Note: The maximum copy fees for hospitals and various types of doctors may be different.

Is a health care provider allowed to deny a patient’s request for medical records?  Yes, but only under limited circumstances.  Also, if a provider is denying access to records, they must give notice in writing, explaining why access was denied.

For more information on access to medical records in Florida, go here.

(As always, the content in this blog is not legal advice.  If you are having issues obtaining your medical records, please contact an attorney.  Depending on the health care provider or type of doctor, different strategies may apply.)




Monday, April 18th, 2011

Physician agreements often prohibit a doctor from establishing a practice or accepting other employment within a certain area for a certain period of time following termination of employment.  Additionally, there may also be restrictions against recruiting the employer’s staff members.  These types of restrictions are sometimes referred to as “covenants not to compete” or “non-compete clauses”.  These types of covenants will be enforced only to the extent that enforcement is necessary to afford reasonable protection to an employer’s legitimate interests (like patient lists, trade secrets and confidential information).  A covenant must be reasonable in time and in geographic area.  (In some states, geographic covenants are illegal.)

For example, an agreement providing that after termination, a doctor may not practice within 50 miles of the employer for 6 months may be deemed reasonable by a court.  However, an agreement that states a doctor may not practice within 1000 miles of the employer for 10 years may be ruled to be unreasonable and therefore unenforceable.

For more general information on non-compete clauses, go here.

Although not related to Physician Agreements, non-compete clauses recently made the news when Conan O’Brien left NBC.


Compliance Now Newsletter

Tuesday, March 29th, 2011

To read our firm’s latest edition of Compliance Now, go here.  This issue focuses on judging the effectiveness of a health care compliance program.


Thursday, March 24th, 2011

In the context of health care compliance, attorneys are often hired to assist with Physician Agreements.  Physician Agreements are basically employment contracts between an organization and the newly-employed physician.

Fundamentals of contract law, labor law, Stark law, anti-kickback law, and arbitration issues can arise out of a poorly drafted Physician Agreement.  Here are some common problem areas (though not an exhaustive list) that both the organization and the physician will want clearly set forth in the Physician Agreement:

  • Who are the parties?
  • What is the term of the contract? (Start date, termination date)
  • What are the physician’s job duties? (Schedule, job description)
  • What are the employer’s responsibilities?
  • How will the physician be compensated?
  • Benefits? (Time off, vacation)
  • Who pays for CME?
  • Who pays for Malpractice insurance and “tail coverage”?
  • Is there a Non-Compete, Non-Solicitation or Confidentiality Agreement?
  • Is outside employment permitted?
  • How can the Agreement be terminated?
  • Will the physician have continuing access to records?
  • Who controls the physician’s research and writing results?
  • Recruitment incentives (Moving allowances, etc.)
  • How will disputes be resolved, and who will pay the costs and attorney’s fees?
  • Miscellaneous boilerplate provisions

When dealing with Physician Agreements, newly-hired physicians should seek legal advice to be sure that a particular contract complies with the law and is in their best interests.


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