Feds Plan to Crackdown on Kickbacks Involving Consulting Fees

An article from the New York Times on March 3, 2009 discusses statements by federal prosecutors that they plan to crack down on physicians who receive consulting fees from drug companies or device manufacturers.

Lewis Morris, the Chief Inspector of the OIG for HHS stated that "what we need to do is make examples of a couple of doctors so that their colleagues see that this isn't worth it."

Not all consulting agreements are illegal. It is possible to draft agreements in a manner that would meet the safe harbors contained in the anti-kickback statute. If you would like our assistance with reviewing or drafting compliant agreements, or if you need compliance policies addressing this issue please contact us.

To read the full story click here.

HIPAA Violation Costs CVS Pharmacy $2.5 Million

According to a press release today on HHS.gov, the CVS Pharmacy chain paid $2.5 million and entered into a corrective action plan to settle HIPAA violations discovered during an investigation conducted by the Office of Civil Rights (OCR) of HHS and the FTC.

The OCR and FTC reported that some of the chain's stores were disposing of protected health information in trash dumpsters that were accessible to the public.

To read the full press release including links to the corrective action plan and resolution agreement, please click here.

For information on drafting HIPAA compliant policies and procedures for disposal of protected health information, please contact us.

FEMA Issues Fact Sheet on Ambulance Reimbursement

In January, FEMA released a fact sheet on ambulance reimbursement for disaster response.

The fact sheet reiterates the importance for private for-profit ambulance services to enter into MOUs with state or local government entities in order to receive reimbursement, since these entities cannot receive reimbursement directly from FEMA. The fact sheet reaffirms, however, that for-profit ambulance companies can receive funds indirectly through contracts with state or local entities.

The fact sheet further states that ambulance companies can be reimbursed for the costs of activation and staging, if part of a state or regional evacuation plan.

Rickard & Associates, P.C.'s attorneys are nationally known for our work in drafting disaster planning documents. If you need assistance in this area, please contact us.

You may read the FEMA fact sheet in its entirety on the American Ambulance Association's website: http://www.the-aaa.org/capitol_hill/FINAL%20DAP9580.104%20Ambulance%20Fact%20Sheet%20Signed.pdf

Lori-Ann Rickard Quoted in Article Regarding Restrictive Covenants

Lori-Ann Rickard was recently quoted in Image, a national publication for radiology professionals, on the topic of restrictive covenants.
As discussed in the article, restrictive covenants are becoming more prevalent in provider contracts and providers should carefully consider the ramifications before signing these agreements. If you need advice regarding restrictive covenants in Michigan, please contact Rickard & Associates.
To read the full article in Image, please click here.

OIG Report Could Increase Review of Financial Interests in Clinical Trials

A recent report issued by the OIG calls into question the adequacy of the FDA's oversight of financial interests of clinical investigators.
The OIG recommends that the FDA should ensure that sponsors submit complete financial information for all clinical investigators, ensure that reviewers consistently review financial information and take action in response to the disclosed financial interests, and require sponsors to submit financial information for clinical investigators as part of the pretrial process.

To read the full report and recommendations, as well as the FDA's response, please click here.

Revised Family and Medical Leave Act Rules Take Effect January 16, 2009

The final rule published by the Department of Labor on November 17, 2008 will take effect on January 16, 2008.

The rule creates two new leave entitlements for military families, including:

(1) Military Caregiver Leave - which will allow eligible family members of covered service members to take up to 26 work weeks of leave in a 12 month period to care for a covered service member with a serious injury or illness incurred in the line of duty. In addition to extending the normal leave from 12 to 26 work weeks, this new provision broadens the definition of family members who are permitted to take leave to include "next of kin".

(2) Qualifying Exigency Leave - which will allow family members of the National Guard or Reserves to take time off to manage their affairs when the family member is called to active duty, including time off for: short notice deployment, military events and related activities, childcare and school activities, financial and legal arrangements, counseling, rest and recuperation, post-deployment activities and additional activities agreed to by employer and employee.

In addition to these new categories of leave for military families, the Final Rule clarifies many provisions of the regulations and incorporates recent court rulings. A few of the changes are as follows:

(1) Light duty - an employee who voluntarily takes a light duty position while eligible for FMLA leave retains the right to restoration for the full 12 month FMLA leave year.

(2) Waiver of rights - FMLA rights may be waived retrospectively (e.g., to settle a lawsuit), but not prospectively.

(3) Substitution of paid time off - if an employee wants to use other forms of paid time off during a family medical leave (e.g., vacation or sick time) the employer may impose restrictions that are applicable to all employees (e.g., vacation may only be taken during certain time periods).

(4) Perfect attendance awards - Employers can deny "perfect attendance" awards to employees who are on FMLA so long as employees on other types of leave are treated the same.

(5) Employee notice - Absent unusual circumstances, employees must follow the employer's usual and customary call-in procedures to report FMLA absences.

(6) Medical Certification/Contact with health care providers - only certain employer representatives may contact a health care provider regarding an employee's FMLA request. The employee's direct supervisor may not make such contact.

(7) Fitness for Duty - Employers may require fitness for duty examinations even when employees are just on intermittent leave if there are reasonable job safety concerns. Also the the employer may require that the fitness for duty certification specifically address the essential functions of the employer's job.

(8) Tracking leave in increments - FMLA leave must be tracked in increments no greater than the shortest period of time the employer uses for other types of leave. For example, an employer's policy may say that sick leave can only be taken in increments of one hour and could also require FMLA to be taken in one hour increments.

For more information on the new regulations, as well as revised forms and notice poster, go to the Department of Labor's FMLA Final Rule compliance page here.

Effective January 1: Revised Medicare Beneficiary Signature Regulations

The newly revised Medicare Beneficiary Signature requirements as published in the 2009 Medicare Physician Fee Schedule became effective January 1.

The revisions should ease some of the burden on ambulance suppliers by providing for the following:

1. The alternative method of fulfilling the rule by obtaining a signature from transporting personnel and documentation from the receiving facility has been extended to nonemergency transports.

2. The word "facility" has been added so that the alternative method of compliance can be used for any authorized facility (e.g., SNF) rather than just hospitals.

3. HHS clarified that the signature on the "claim form" does not actually mean the form that will be submitted for payment, but can be any form that contains adequate notice to the beneficiary or authorized individual who is signing that the purpose of the form is for the provider to submit the claim to Medicare for payment for the services.

To read the actual text of the Medicare Physician Fee Schedule, please click here. (Note that pages 136-139 of the document are applicable to the final signature requirements.)