Florida physicians are being approached to become owners of pharmacies to which they may refer, often compounding pharmacies, but may be unaware of the regulatory issues involved. Physicians need to be aware of the core laws that apply, which include the Florida Patient Self Referral Act (FPSRA), the Florida Anti Kickback Statute, the Patient Brokering Act and the Federal Investment Interest Safe Harbor.Continue reading
Florida Clinical Labs Must Now Give Patients Direct Access to Their Laboratory Test Results
By: David Hirshfeld
In an effort to help individuals access their health information so that they can become more actively involved in managing their own health care, several agencies within the Department of Health and Human Services promulgated a rule that modifies the Clinical Laboratory Improvement Amendments (“CLIA”) and the Health Insurance Portability and Accountability Act (“HIPAA”) in a way that supersedes Florida State laws governing the disclosure of laboratory test results directly to patients.
HIPAA Stings Dermatology Practice
The US Department of Health and Human Services, Office of Civil Rights is the chief enforcer of HIPAA. The Office’s recent enforcement of HIPAA with respect to a Massachusetts derm practice is illustrative of how the government views HIPAA and how vulnerable medical practices are. Continue reading
Blue Cross Lawsuit Against Avee Attacks Point of Care Testing
A recent lawsuit by Horizon Blue Cross/Blue Shield of New Jersey has the potential to cripple point of care testing arrangements often employed by drug and alcohol treatment centers. At risk is not only the roughly $36 Million sought to be recouped by BC/BS, but also perhaps the many millions more which may be claimed by other payers as well.
BC/BS is making serious allegations against Avee Laboratories, Alere, Inc., and a number of recovery centers. The factual allegations include:Continue reading
Board of Medicine: New Rule Regarding Adequacy of Medical Records for Compounded Medication
 The Florida Board of Medicine reviewed Rule 64B8-9.003, Florida Administrative Code which provides standards for the adequacy of medical records. The underlined portions below are the new standards required for medical records as it relates to compounded medications. These standards are effective September 9, 2013.Continue reading |
Is The End of Stark (and IOAS) Near?
Background
Since its passage in 1989, the now ubiquitous federal law known as the Stark Law has driven the business behavior of health care providers of many kinds. Recent developments, however, make us wonder whether the end of Stark is near, and if so, whether that’s a good thing.
By way of background, the Stark law has two components: part one, a self referral prohibition, generally forbids physicians from referring to a provider of any “designated health service” (DHS) (e.g. MRI, PT, clinical lab) if the physician or his/her immediate family member has a financial relationship (including ownership interest) with the provider of the service. Part two mandates that certain compensation arrangements between healthcare providers meet certain requirements. Things like medical director agreements, management agreements, employment and independent contractor arrangements have been regulated by the law since its inception. Most notably, for purposes of this article, one provision (the “In Office Ancillary Services” exception or “IOAS”, also known as the “Group Practice Exception”) has allowed medical practices to provide all sorts of “ancillary services” to their own patients. That is the key aspect of the law that is lately coming under serious attack.Continue reading
The Cost of Inaccurate Medical Records
On July 8, 2013 the United States Attorney’s Office for the Southern District of Florida issued a Press Release with the headline “Supervisor of $63 Million Health Care Fraud Scheme Sentenced in Florida To 10 Years in Prison”. The Defendant, a 51 year old employee of the Healthcare Provider was the director of medical records. The employee was a certified medical records technician and was found to have overseen the alteration, fabrication and forgery of documents that were used to support claims submitted to Medicare and Medicaid. In addition, the employee was found to have directed therapists to fabricate documents and forged signatures on documents. The defective medical records were used to support claims to Medicare and Medicaid in excess of 63 million dollars.Continue reading
The Effect of being excluded from Participation in Federal Healthcare Programs
The Government recently clarified six areas related the effect of exclusion from participation in Federal Healthcare Programs.
- Switching professions during a period of exclusion does not change the exclusion and payment prohibitions.
- You can accept a referral from an excluded provider as long as the excluded provider does not provide any services to the referred patient.
- Being excluded along with the payment prohibitions extends beyond just direct patient care.
- If you are excluded you cannot provide either administrative or management services to non excluded provider.
- Excluded providers cannot even provide volunteer services, and
- Excluded providers can work for non excluded providers as long as the services they provide are furnished to non-federal healthcare program patients.
Providers need to screen every professional, employee and contractor they do business with to insure they are not on the Exclusion list. It is always best to check the list of Excluded Individuals/Entities (LEIE) for anybody you work with.
Why Compliance Plans Make Sense
Has your practice implemented a compliance program or considered improving an existing one? Is it really necessary? Prior to the Patient Protection and Affordable Care Act (ACA), the necessity for physician practices to develop compliance plans was merely voluntary. However, the ACA will now require physician practices to have a fraud and abuse compliance plan in place as a condition of continuing to participate in Medicare or Medicaid programs. Because the government first published guidelines in the year 2000 for the voluntary use of compliance plans in physician practices and has subsequently enacted a mandate in the ACA for compliance plans, many physician practices are proactively implementing them. While this compliance plan mandate may be viewed by physicians as yet another administrative burden and expense to the practice, it can have many benefits as well. Implementing an effective compliance program can have the result of not only reducing liability risks, but can also allow a practice to reap monetary benefits. In fact, it could be more costly for the practice not to have one!Continue reading
Gift Giving and the Anti Kickback Law
Even though the holiday season is long gone Healthcare Providers need to pay attention to the value of gifts they give or receive to avoid violating the Anti Kickback Laws. Providers may not accept any one gift with a value of more than approximately $30.00 or gifts worth more than $350.00 annually. The Government is concerned that gifts may cause billing for unnecessary services or may affect the referral of patients. Providers as well as their employees must not solicit gifts either. When a gift is given or received it must not be based upon either the volume or value of any referrals. Gifts that are given frequently after referrals or after any specific successful referral are red flags for violations of the law. In fact the Sunshine Act now requires pharmaceutical companies and durable medical equipment companies to report gifts to providers with a value over $25.00.Continue reading