Covered Entities and Business Associates may be ringing in the New Year with the prospect of responding to on-site HIPAA audits by federal regulators. The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has announced that a certain number of comprehensive on-site HIPAA compliance reviews will be done over the first quarter of next year. Details … Continue Reading
Category Archives: Physicians
Subscribe to Physicians RSS FeedWhen a Discount May be a Kickback
Healthcare providers of all kinds, as well as medical equipment suppliers, have traditionally relied upon discounts as a legitimate means of attracting patients and commercial clients without running afoul of the federal anti-kickback statute (AKS). Congress specifically created the discount “safe harbor” to the AKS years ago based on its policy of encouraging discounts that are properly disclosed as a … Continue Reading
Attention Employers: Action Required Before Having Employees or Contractors Sign Non-Disclosure Agreements
In May, President Obama signed the federal Defend Trade Secrets Act of 2016 into law, the details of which we reported in a recent Akerman Practice Update. The Act allows companies for the first time to bring trade secret theft claims under federal law. One of the many important provisions of the law that employers should not overlook is … Continue Reading
Prepare for the Unexpected with Data Storage and Retrieval
Last week, a federal court in Illinois encountered another example of unexpected events causing problematic privacy and data storage implications for a healthcare company. The non-profit organization responsible for maintaining the MetroChicago Health Information Exchange (the HIE) filed suit against its information technology support contractor and the contractor’s owner to prevent the contractor’s plan to destroy all client data after … Continue Reading
Shhh….OCR Releases New HIPAA Audit Protocol
Just in time for the Phase 2 audits, the Department of Health and Human Services Office for Civil Rights (OCR) quietly posted the updated HIPAA Audit Protocol on its website. The new audit protocol has been updated to include business associates who became subject to HIPAA following the 2013 HIPAA Omnibus Final Rule. The protocol covers Privacy Rule, Security Rule … Continue Reading
Fighting Prescription Drug Abuse Gets a Little Easier for Florida Providers, Pharmacists
Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements.… Continue Reading
CMS Updates Two-Midnight Rule
The Centers for Medicare and Medicaid Services (CMS) has revised the two-midnight rule to create an exception that will allow payment under Medicare Part A for certain medically necessary hospital stays that do not extend across two midnights. The new rule is effective for admissions after January 1, 2016, and permits payment on a case-by-case basis, supported by the admitting … Continue Reading
Culture of Safety Wins: Federal Patient Safety Law Preempts Amendment 7
Florida’s First District Court of Appeal issued its opinion in the highly watched case of Southern Baptist Hospital of Florida, Inc. v. Charles et al. The First District Court ruled that the federal Patient Safety and Quality Improvement Act of 2005 (PSQIA):
- Expressly preempts any broad discovery rights afforded under Florida’s Amendment 7 for documents meeting the definition of Patient
CMS Publishes Notice of Proposed Rule Making Regarding Stark Law Amendments and Seeks Comment on the Issue of Stark Acting as a Barrier to Healthcare Reform
In early July, the Centers for Medicare and Medicaid Services (CMS) published a notice of proposed rulemaking, amending the Physician Self-Referral Prohibitions, or Stark law. 80 Fed. Reg. 41,909-930 (July 15, 2015). The proposed rule introduces two exceptions to Stark. The first new exception, 42 C.F.R. §411.357(x), allows financial assistance to medical practices so they may be able to recruit … Continue Reading
Illinois Appellate Court Holds No Standing to Sue for Medical Information Data Breach Where Injury is Speculative
On June 2, 2015, the Second District Illinois Appellate Court affirmed the decisions of two lower courts, which had dismissed breach of privacy cases for lack of standing. The cases were consolidated for the purposes of the appeal. Both cases were brought against Advocate Health and Hospitals Corporation d/b/a Advocate Medical Group (Advocate), an Illinois network of affiliated physicians and … Continue Reading
OIG Now Targeting Physician Compensation Arrangements
In a Fraud Alert issued on June 9, 2015, the U.S. Department of Health and Human Services Office of Inspector General (OIG) notified the healthcare community that physician compensation arrangements are on the OIG’s radar screen. While many physician compensation arrangements may be legitimate, the OIG has noted that “a compensation arrangement may violate the anti-kickback statute if even one … Continue Reading
Divestiture of St. Luke’s Acquisition Upheld Despite Transaction’s “Laudable” Goals
On February 10, 2015, the Federal Trade Commission (FTC) achieved a historic victory when a U.S. Court of Appeals ruled that a hospital’s acquisition of a physician’s group – the transaction challenged by the FTC – ran afoul of federal antitrust laws, despite the likelihood that the acquisition would result in greater efficiencies and quality of care. This decision marks … Continue Reading
CMS Announces Enforcement of EHR Payment Adjustments in 2015
On December 17, 2014, the Centers for Medicare and Medicaid Services (“CMS”) announced that there would be reductions in Medicare reimbursement for health care providers who do not meet the CMS electronic health record (“EHR”) incentive program’s meaningful use requirements. This announcement comes in the wake of CMS’ decision in October to extend the hardship exception deadline – an exception … Continue Reading
Reimbursement Changes, Shift to Consumerism Discussed at Akerman Healthcare Briefing
Changing reimbursement models and a shift to consumerism were two of the hot topics discussed at Akerman LLP’s recent Healthcare Briefing event titled “Financial and Corporate Implications of the Affordable Care Act: A Look at the Past, Present, and Future”. Health care and financial industry leaders gathered Friday, November 21 in Tampa for the interactive discussion. Panelists leading the discussion … Continue Reading
Talk Amongst Yourselves: HIPAA Does Not Preempt Florida Med Mal Presuit Authorization Law
A federal appellate court recently concluded that the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) does not preempt a Florida law that requires aggrieved patients to authorize the release of their protected health information as a presuit condition to suing a medical provider for negligence. See Murphy v. Dulay (11th Cir. Oct. 10, 2014) (opinion available here).… Continue Reading
CMS launches database of manufacturer and GPO payments to physicians
The Affordable Care Act contains a provision known as the Physician Payments Sunshine Act, which requires the Centers for Medicare and Medicaid Services (CMS) to establish a national databank containing information on the financial relationships between physicians (which includes dentists, chiropractors, and other physician specialties) and teaching hospitals, applicable manufacturers, and group purchasing organizations (GPOs). CMS launched its Open … Continue Reading
Florida Board of Medicine Clarifies That Common Cardiac Procedures Can Be Performed In Office Surgical Setting.
The Florida Board of Medicine recently amended its office surgery rules to clarify that many common cardiac procedures already being performed in office surgical settings around the state may, in fact, be performed legally in those settings. Rule 64B8-9.009, Fla. Admin. Code, sets forth the standard of care for office surgery. The rule previously defined office surgery, in part, as … Continue Reading
Physicians and Photography Don’t Mix
A gynecologist who secretly photographed and videotaped women’s bodies in the examining room will cost one of the world’s leading medical institutions $190 million. In a damaging blow to its reputation, Johns Hopkins Hospital has agreed to a settlement with more than 8,000 patients of Dr. Nikita Levy, who wore a pen-like camera around his neck to secretly record videos … Continue Reading
New OIG Special Fraud Alert Aimed at Laboratory Payments to Referring Physicians
On June 25, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert entitled “Laboratory Payments to Referring Physicians.” While the Alert breaks no new ground (see, e.g., its 1994 Special Fraud Alert), it demonstrates the OIG’s continuing concerns about clinical laboratories’ offering inducements to referring physicians.
The … Continue Reading
Patient Records: Increasing Exposure for Privacy Breaches
Healthcare providers and businesses that store or process protected health information (“PHI”) face increased scrutiny and significant fines for data privacy breaches and security lapses in the coming months. In the past 12 months, the U.S. Department for Health and Human Services Office for Civil Rights (“OCR”) has recovered more than $10 million in fines for alleged violations of HIPAA. … Continue Reading
HHS Proposes Extension of Deadline for EHR Compliance
According to the federal government, over 370,000 providers have participated in the Medicare and Medicaid Electronic Health Record (“EHR”) incentive program since its inception in 2011. However, providers nationwide continue to grapple with the challenges of complying with federal EHR requirements, and many such providers have voiced their displeasure to the federal government regarding the tight compliance timeframes. On Tuesday, … Continue Reading
Florida Board of Pharmacy Clarifies that Pharmacies Can’t Compound Sterile Human Drugs for “Office Use”
The Florida Board of Pharmacy rules allow pharmacies to engage in office-use compounding. Rule 64B16-27.700, FAC. This allows pharmacies to compound drugs for physicians to use in treating their patients in the office without writing a patient-specific prescription. It does not allow the physician to dispense the office-use drugs to their patients (i.e. give the patient a supply to take … Continue Reading
The Downside to Sharing – Two Hospitals to Pay Largest HIPAA Fine Yet
On May 7, 2014, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced the largest settlement to date under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). New York and Presbyterian Hospital (“NYP”) and Columbia University (“Columbia”) agreed to pay $4.8 million and enter into resolution agreements as the result of a breach … Continue Reading
Florida Says Can Do To Medical Cannabis
In the waning days of the 2014 legislative session, the Florida Legislature passed the Compassionate Medical Cannabis Act of 2014. It is a very limited medical marijuana bill with very strict restrictions and conditions on use. The bill allows access to only low-THC (tetrahydrocannabinol) cannabis (so-called “Charlotte’s Web”) for persons with cancer or another condition that produces seizures or … Continue Reading
