February 2012 Health Law Summaries

The following are brief summaries prepared by section volunteers of new developments in Florida health care law that may be of interest to members of the Health Law Section. The summaries are presented for general information only as a courtesy to section members and do not constitute legal advice from The Florida Bar or its Health Law Section.

Fraud and Abuse

In United States v. Villaspring Health Care Center, Inc., No. 3:11-43-DCR (E.D. Ky. Dec. 19, 2011).

A federal district court in Kentucky refused to dismiss the federal government’s civil  False Claims Act (FCA) against a nursing home that it is alleged submitted claims to Medicare and Medicaid for “worthless services”.

The complaint alleged that a nursing home in Erlanger, KY operated by Villaspring Health Care Center, Inc. defrauded the federal and state government by “seeking, and receiving substantial reimbursement from Medicare and Kentucky Medicaid programs for care provided to the residents despite knowing that such ‘care’ was either non-existent or so inadequate as to be worthless.”

The Defendants argued that the government could not base a FCA claim on a “worthless services” theory because services to residents are billed on a per diem basis and Villaspring provided room, board and at least some patient care.

The U.S. District Court for the Central District of Kentucky commented that it “is not necessary to show that the services were completely lacking; rather, it is also sufficient to show that patients were not provided the quality of care which meets the statutory standard.”  The Court found that the federal government could move forward under an “implied certification” theory of recovery based on allegations that the nursing home violated its provider agreement.  The Court found the certification statement signed by the nursing home’s CEO when the nursing home enrolled in Medicare and conditioned payment of its claims on “complying with such laws, regulations and program instructions…and on a provider/supplier being in compliance with any applicable conditions of participating in any federal healthcare program”, was sufficient to support the implied certification theory.

Reported by Karina P. Gonzalez, Esq.

Health Information Technology & Privacy

HITECH –HIPAA Final Rules Publication

On January 20, 2012, the federal Department of Health and Human Services ("HHS") issued its semiannual regulatory agenda.  The agenda's timetable lists two dates relating to pending rules implementing portions of the Health Information Technology for Economic and Clinical Health Act ("HITECH Act"). The HITECH Act makes several significant changes to HIPAA.  The agenda states that HHS will issue final rules to modify the HIPAA Privacy, Security, Enforcement and Breach Notification Rules.  The timetable lists "03/00/2012" as the date for "Final Action" on these rules.  Additionally, "06/00/2012" is listed as the date for a "Final Rule" relating to modifications to the HIPAA Privacy Rule Accounting of Disclosures under the HITECH Act.  Neither of these final rules have been sent to the Office of Management and Budget, so the actual publication dates are unknown at this time.

The agenda is available at Regulations.gov.

Reported By: Shannon Hartsfield Salimone

Life Sciences

First Drug Wholesale Distributor Advisory Council Meeting at DBPR

On December 6, 2011, Florida's Drug Wholesale Distributor Advisory Council held its first meeting since responsibility for regulation of drugs, devices and cosmetics was transferred to the Department of Business and Professional Regulation ("DBPR") from the Department of Health on October 1, 2011.  Chair Gary Cacciatore had council members introduce themselves.  Ken Lawson, Secretary of DBPR, addressed the council and indicated that DPBR wants to "send a message that, in the state of Florida, we are partners in protecting the drug supply and making sure the rules are clear."  Section 499.01211, Florida Statutes, requires the council to meet once per quarter.  The council's duties include providing input on proposed rules, as well as making recommendations regarding improving the protection of prescription drugs and public health; improving coordination with other regulatory agencies concerning wholesale distribution of drugs; and minimizing the impact of regulation of the wholesale distribution industry while ensuring the protection of public health.  During its meeting, the council discussed recent drug shortage issues, housekeeping items relating to the transition to DBPR, possible rule changes, and controlled substance reporting.  More information on the Council, as well as future meetings, can be found at this site:  http://www.myfloridalicense.com/dbpr/ddc/index.html


Florida's Drug Wholesale Distributor Advisory Council

At the February 16, 2012 meeting of Florida's Drug Wholesale Distributor Advisory Council, Reggie Dixon, the Executive Director of the Drugs, Devices and Cosmetics Program discussed the program's main goals for 2012.  These goals are to increase the program's efficiency and effectiveness.  The Department of Business and Professional Regulation plans to accomplish these goals through a variety of mechanisms, including:

  • Conducting targeted employee training to reduce processing times for applications and inspections;
  • Implementing risk-based inspections;
  • Revising licensing applications by reducing processing time and deficiency notices;
  • Employing industry-oriented outreach efforts; and
  • Increasing compliance with controlled substance reporting requirements.

Reported By: Shannon Hartsfield Salimone

Professional Licensure

Expedited Investigation of Some Violations by Department of Health

The Department of Health is expediting the investigations of every complaint alleging sexual misconduct or pain management violations. The Department's investigators are instructed to personally serve the subject of the complaint in every case where the allegations include sexual misconduct or pain management violations.  The Department's investigators are also required to personally serve the practitioner with a voluntary relinquishment of licensure form at the same time the complaint is served.  The Department of Health investigators are required to personally serve the practitioner within two hours of the investigator's receipt of the complaint and voluntary relinquishment form in the field office.  

Challenge of AHCA Fines and Application of Fraud and Abuse Reporting Requirements

Humana Medical Plan, Inc. is challenging nearly $3.4 million in fines that the Agency for Health Care Administration (AHCA) has tried to impose in a dispute about reporting suspected Medicaid fraud.  According to pleadings filed in Division of Administrative Hearings (DOAH) case number 11-6451MPI, AHCA issued the fines in August, contending that the Humana HMO did not report suspected fraud by Medicaid providers within 15 days of becoming aware of the possible wrongdoing. The suspected fraud involved such things as doctors providing excessive services.  Humana is asserting that it properly reported the alleged erroneous billing within 15 days of determining that fraud or abuse may have occurred and that AHCA has misinterpreted the reporting requirements of §409.91212, F.S. Humana also asks DOAH to find that Humana has a "vested interest" in rooting out fraud because it is at full financial risk for the services provided to Medicaid enrollees.  In conjunction with the challenge to the intended fines, Humana has filed a challenge to the validity of AHCA’s position on the statutory reporting requirement as an unpromulgated rule and seeks attorneys fees and costs pursuant to §57.111, F.S.  An administrative hearing at DOAH has been scheduled for May 2012.

Reported By:: Allen R. Grossman and Michael L. Smith

Public Health

Model Aquatic Health Code

The Regulatory Program Administration module of the Model Aquatic Health Code (MAHC) is now available for public comment. CDC, through an initial grant from the National Swimming Pool Foundation, is working with public health and industry representatives across the United States to stem the rising number of recreational water illness outbreaks, pool associated chemical incidents, drownings, and injuries at public swimming pools and spas. The MAHC will serve as a tool for local and state agencies interested in implementing or updating existing laws governing the design, construction, operation, and maintenance of swimming pools, spas, hot tubs, and other treated or disinfected aquatic facilities. The MAHC is being developed as a set of modules on specific topics with multiple opportunities for review and comment by the public and other stakeholders. The current MAHC module is available for comment until February 5, 2012.  Find more information about MAHC module status and content.

Report: "Ready or Not? 2011."

The Trust for America's Health has published "Ready or Not? 2011: Protecting the Public from Diseases, Disasters, and Bioterrorism." The report, which was published December 2011 and was supported by the Robert Wood Johnson Foundation, identifies key programs which are at risk because of continued cuts to federal public health emergency preparedness funds. Find more information and read the report.

Reported by: Rodney M. Johnson


Palms West Hospital Limited Partnership d/b/a/ Palms West Hospital v. Charles H. Burns, as Personal Representative of the Estate of Enrique Casasnovas, 2011 WL 5964360 (Fla.App. 4 Dist. November 30, 2011), focused on negligent retention/credentialing claims against a hospital.  An indigent patient was admitted to Palms West’s emergency room with complaints of abdominal pain, nausea and vomiting blood and required consultation by a gastroenterologist.  The gastroenterologists on-call refused to come to the hospital to treat the patient allegedly because he was uninsured.  The patient died after being transferred to another facility.  The personal representative of the estate filed suit against Palms West for negligently retaining physicians who it knew would not treat patients without insurance.           

After dismissing the majority of the Plaintiff’s claims for failure to comply with the pre-suit screening procedure, the trial court found that the claims for negligent retention of physicians and the hospital’s duty to assure competent staff members were not medical negligence claims.   The Fourth District Court overturned the trial court’s ruling on these two claims holding that Palms West’s alleged negligent retention of doctors who fail to treat patients and the hospital’s continued staffing of these doctors are claims arising under the Medical Malpractice Act.  

West Florida Regional Medical Center, Inc. v. See, 2012 WL 87282 (Fla.), Hospital petitioned for writ of certiorari, challenging discovery orders entered in medical malpractice action. The Supreme Court held that:1.   A blank application for medical staff privileges is a record of an adverse medical incident and therefore not protected from discovery under sections 766.101(5) and 395.0191(8) and is discoverable under Amendment 7,2.   Section 381.028(7)(b)1, Florida Statutes, is invalid because the Amendment 7 disclosure requirements are not limited to only those incident reports such as Code 15 reports and AHCA annual reports listed in sections 395.0197(5) and (7), Florida Statutes,  and3.  The federal Health Care Quality Improvement Act of 1986 ("HCQIA") does not preempt Amendment 7 because HCQIA and Amendment 7 each address different concerns and do not conflict with each other.

Reported by:  Malinda R. Lugo

CMS Issues Proposed Overpayment Rule

On February 16, the Centers for Medicare and Medicaid Services ("CMS") issued a proposed rule regarding mandatory return of overpayments.  Section 6402(a) of the Affordable Care Act requires a person to return a Medicare or Medicaid overpayment within 60 days after the date on which the overpayment is identified or the date any corresponding cost report is due.  The proposed rules would relate only to Medicare Part A and B overpayments.  Medicaid requirements will be proposed later.  Though the rules have not been finalized, CMS stated that, even without a final regulation, entities that bill Medicare are still subject to the statute's mandate, "and could face potential False Claims Act liability, Civil Monetary Penalties Law liability, and exclusion from Federal health care programs for failure to report and return an overpayment."  Under the proposed rule, an overpayment would be sufficiently "identified" if a person "has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the existence of the overpayment."  Reports of overpayments must contain specific information set forth in the rule.

Interested parties wishing to provide input on the proposed rules must submit comments by 5 p.m. on April 16, 2012.  The full text of the proposed rule is available at this link: http://www.gpo.gov/fdsys/pkg/FR-2012-02-16/pdf/2012-3642.pdf.

Reported By: Shannon Hartsfield Salimone

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