November 2017 Health Law Update

Dear Health Law Section Members:

The Section website has been updated with articles on significant developments in the health law arena that may be of interest to you in your practice. These summaries are presented to Section members for general information only and do not constitute legal advice from The Florida Bar or its Health Law Section. HLS thanks the following volunteers who have generously donated their time to prepare these summaries for our members:

Rodney Johnson, Esq.

Yesenia Fatima Lara, Esq.

Christian Perez-Font, Esq.

Elizabeth Scarola, Esq.

Michael Smith, Esq.

Thank you.

Jamie Gelfman, Esq.

Patricia Huie, Esq.

COMPLIANCE

Tampa-based provider of managed care services pays $31.7MM to settle FCA allegations

On May 30, 2017, Freedom Health, Inc., a Tampa-based provider of managed care services, agreed to pay $31.7 million to resolve allegations that it violated the False Claims Act by engaging in illegal schemes to maximize payments from the federal Government regarding Medicare Advantage plans. According to the Government, from 2008 through 2013, Freedom Health used unsupported diagnosis codes in its submissions to CMS, resulting in inflated reimbursements from two of its Florida Medicare Advantage plans. The Government also claimed that in its 2008 CMS application, Freedom Health materially misrepresented to CMS, the scope and content of its provider network (physicians, specialists and hospitals) to expand into new counties in Florida and in other states in 2009. The Government further announced that the former Freedom Health Chief Operating Officer agreed to pay $750,000 to resolve his alleged role in these schemes.

A copy of the Department of Justice’s press release is available at https://www.justice.gov/opa/pr/medicare-advantage-organization-and-former-chief-operating-%20officer-pay-325-million-settle.

Reported by: Christian Pérez Font, Esq.

Allergan settlement sends important message in whistleblower litigation

On June 30, 2017, pharmaceutical powerhouse Allergan announced that it had agreed to pay $13 million to the Government and 19 states to resolve a whistleblower lawsuit alleging multiple federal and state anti-kickback violations. According to the Government, Allergan knowingly provided business consulting arrangements, continuing medical education, and other valuable services to eye care providers to induce the providers to prescribe its products. Notably, this case was filed in 2009 by two ophthalmologists under the qui tam provisions of the False Claims Act, but in 2010, the Government declined to intervene, although it remained an interested party. As a result, the case was entirely pursued by the whistleblowers, who will also share in the recovery. This case signals that even in the absence of direct government intervention, relators may successfully pursue these types of cases.

The lawsuit is United States of America ex rel. Herbert J. Nevyas, M.D. and Anita Nevyas-Wallace, v. Allergan, Inc., Civil Action No. 09-CV-00432 (E.D. Pa.) (United States District Court Judge Mark A. Kearney).

Reported by: Christian Pérez Font, Esq.


FACILITY & PROFESSIONAL LICENSURE

Soliciting Loan from Patient Violates Minimum Standard of Professional Activity

An Administrative Law Judge from the Division of Administrative Hearings recently ruled that a licensed mental health counselor violated the minimum standards of professional activity by

soliciting and accepting a loan from a patient. Department of Health, Board of Clinical Social Work, Marriage and Family Therapy, and Mental Health Counseling v. Friedman, LMHC, DOAH Case No. 16-6322PL (June 19, 2017). The mental health counselor, who had a long-standing professional relationship with a patient, asked her patient to cosign for a loan, but really obtained loans in the name of the patient. The mental health counselor made several false representations to the patient about making payments on the loans, but no loan payments were ever made.

The allegations in the Administrative Complaint show a violation of professional boundaries. The Administrative Law Judge concluded that the even if the mental health counselor had not solicited the loan, it would have been below professional standards for her to accept the loan.

The Florida Board of Clinical Social Work, Marriage & Family Therapy, and Mental Health Counseling was set to consider the Recommended Order on August 10, 2017, but the case was continued.

Reported by: Michael L. Smith, Esq.


HEALTHCARE FRAUD

Healthcare Fraud Taking Center Stage

On July 13, 2017, Attorney General Jeff Sessions announced that the Medicare Fraud Strike Force had charged 412 defendants in numerous health care fraud schemes. Specifically, over 120 of the defendants were charged for prescribing and distributing opioids. As part of a kickback scheme, opioid addicted individuals were recruited to seek treatment from certain providers in return for gift cards, free airline travel, gambling money, trips to strip clubs, and even drugs. The providers would then fraudulently bill for pharmaceuticals and services which were either not provided or overcharged. Jointly, these defendants were responsible for $1.3 billion in fraud losses.

From the 41 participating federal districts, Florida led the nation with 34 cases resulting from this initiative. In 2016, there were 301 defendants charged in healthcare fraud schemes from 36 participating federal districts. The efforts to curb healthcare fraud are increasing in resources and intensity. This healthcare fraud takedown was focused on schemes where individuals were improperly and fraudulently billing Medicare, Medicaid, and TRICARE.

These enforcement efforts are key in preserving the integrity of federal funds meant to facilitate healthcare services to the elderly and those in need. For more information click on the link below: https://www.justice.gov/opa/documents-and-resources-july-13-2017-national-health-care-fraud-takedown-press-conference

Reported by: Yesenia Fatima Lara, Esq.


HEALTH INFORMATION TECHNOLOGY AND PRIVACY

Failure to Adequately Monitor Activity on Health Information System Contributes to HIPAA Breach

The South Broward Hospital District d/b/a Memorial Healthcare System recently agreed to a $5.5 million settlement with the Department of Health and Human Services (“HHS”) due to a HIPAA breach. The breach, involving the protected health information (“PHI”) of more than 100,000 patients, was attributed in part to the lack of proper audit controls to monitor the activity of individuals provided access to Memorial Healthcare's health information system.

Memorial Healthcare discovered that two employees had inappropriately accessed PHI using the login and password of a former employee. Upon further investigation, Memorial Healthcare discovered an additional 12 individuals associated with the offices of affiliated physicians were also impermissibly accessing the health information system using the former employee's login and password. Some of the inappropriately accessed information was sold and subsequently used to file fraudulent tax returns.

According to HHS, Memorial Healthcare failed to regularly monitor its health information system activity, and it failed to prevent inappropriate access to its system by not disabling the login and password of its former employee. Memorial Healthcare previously identified the misuse of access granted to its health information system as a potential risk, but failed to monitor activity on its health information system, thus resulting in the breach.

Reported by: Michael L. Smith, Esq.


PUBLIC HEALTH

Feedback Needed on Competencies for the Emerging Field of Legal Epidemiology.

To support public health practitioners, lawyers, and policy experts working in the emerging field of epidemiology, the Center for Disease Control’s (CDC) Public Health Law Program (“PHLP”) is leading an effort to develop a set of competencies outlining the research and translation knowledge and skills needed to develop, implement, and oversee legal epidemiology studies. In collaboration with a multidisciplinary expert review workgroup, a Legal Epidemiology Competency Model (“LECM”) has been drafted and is ready for public review and comment. Feedback is needed from the broad public health community, as well as from those engaged directly in legal epidemiology work, to refine this draft. More information about legal epidemiology, the draft LECM, and providing feedback is available in the archive of a recent town hall meeting or the related PHF Pulse blog post.

Updated Criminal and Epidemiological Investigations Handbook.

The CDC recently released an updated Criminal and Epidemiological Investigations Handbook. This latest version provides an overview of criminal and epidemiological investigation procedures involving interactions between law enforcement and public health, as well as educates public

health and law enforcement about how to work together to identify a biological agent, prevent the spread of the disease, avoid public panic, and apprehend those responsible. The Handbook is also available in French and Spanish.

Action, Not Rhetoric, Needed to Reverse the Opioid Overdose Epidemic – Q&A

According to the CDC, there were over 33,000 opioid overdose-related deaths reported across the United States in 2015. Corey Davis, deputy director at the Network’s Southeastern Region Office, co-authored the article, “Action, Not Rhetoric, Needed to Reverse Opioid Epidemic.” In the Q&A, linked below, Davis discusses his article and how changes to law and policy could dramatically decrease the number of Americans who die each year from opioid addiction and overdose.

Link: https://www.networkforphl.org/the_network_blog/2017/06/19/902/action_not_rhetoric_needed_to_reverse_the_opioid_overdose_epidemic_-_qa/?utm_source=Network+Report+6-22-17&utm_campaign=network+report+6-22-17&utm_medium=email&utm_content=308

Legal Interventions to Reduce Overdose Mortality

Opioids (both prescription painkillers and illegal drugs such as heroin and illicitly manufactured fentanyl) were responsible for over 33,000 overdose deaths in 2015 alone. Overdoses can be reversible through the timely administration of naloxone and emergency care. However, access to naloxone has historically been limited by various laws. However, all 50 states have, over time, amended their laws to increase access to naloxone. The resource linked below summarizes laws designed to increase naloxone access, as well as Good Samaritan laws, which encourage people to call for emergency care.

Link: https://www.networkforphl.org/resources_collection/2017/06/08/396/resource_legal_interventio ns_to_reduce_overdose_mortality/?utm_source=Network+Report+6-22-17&utm_campaign=network+report+6-22-17&utm_medium=email&utm_content=308

Primer: Emergency Legal Preparedness Concerning Zika Virus

Zika virus infection remains a public health threat both in the United States and internationally, with tens of thousands of cases confirmed across the United States alone. Microcephaly (a condition that causes babies to be born with small skulls and brains) and multiple other disabilities have been linked to pregnant mothers infected with the mosquito-borne virus. This updated primer, linked below, outlines major public health concerns regarding Zika and discusses legal preparedness and response issues.

Link: https://www.networkforphl.org/resources_collection/2017/06/05/738/primer_emergency_legal_preparedness_concerning_zika_virus/?utm_source=Network+Report+6-22-17&utm_campaign=network+report+6-22-17&utm_medium=email&utm_content=308

Cybersecurity Preparedness in Healthcare Organizations

According to the Department of Health and Human Services, the health care industry is now the number one target for cyber-attacks, where such attacks result in unauthorized access to health information, which significantly impedes public health efforts. Understanding the role of cybersecurity is central to managing risks to both the health and public health sector.

Link to cybersecurity preparedness: https://www.networkforphl.org/the_network_blog/2017/07/05/906/cybersecurity_preparedness_in_healthcare_organizations/?utm_source=Network+Report+7-6-17&utm_campaign=Network+Report+7-6-17&utm_medium=email&utm_content=309

The Fifty Nifty

For public health law news from every state in the nation, see the below link. Link: https://www.cdc.gov/phlp/news/current.html#fifty

Menu of State Healthcare Facility Hepatitis B Vaccination Laws

The Centers for Disease Control has published a menu about hepatitis B vaccination requirements for patients and workers in healthcare facilities. This resource, linked below, can be used by researchers or practitioners interested in comparing specific hepatitis B vaccination requirements across the states.

Link: https://www.cdc.gov/phlp/publications/topic/menus/hepatitisb/index.html

Reported by: Rodney Johnson, Esq.

Florida Department of Health Table of Reportable Diseases or Conditions to Be Reported

The Florida Department of Health (“DOH”) has updated the Table of Reportable Diseases or Conditions to Be Reported, Rule 64D-3.029, Florida Administrative Code, and section 381.985, Florida Statutes, related to reporting elevated blood lead levels and screening results to DOH. These revisions were made in 2016 and 2017 to reflect current public health needs for disease reporting and to align with national public health priorities. A summary of updates to reportable disease and condition requirements is included below. The full text of the revised rule is posted on the Disease Reporting Information for Health Care Providers and Laboratories website (http://www.FloridaHealth.gov/DiseaseReporting).

Summary of changes to general reportable disease and condition requirements:

  1. Added Zika fever as explicitly reportable (previously reportable under other arboviral infections) and that notification should occur upon initial suspicion (i.e., clinical suspicion or laboratory test order), but after-hours reporting is not required.
  2. Updated reporting timeframe for dengue fever to be upon initial suspicion (i.e., clinical suspicion or laboratory test order), but after-hours reporting is not required.

  3. Updated reporting timeframe for arboviral infections not otherwise listed in the Table of Reportable Diseases or Conditions to Be Reported from next business day to suspect immediately (i.e., laboratories and health care providers should call DOH immediately, 24 hours a day, seven days a week, by phone upon initial clinical suspicion or laboratory test order).

  4. Added babesiosis as a reportable disease.

  5. Expanded leptospirosis to include all species of Leptospira, not just interrogans.

  6. Lowered the blood lead level considered as lead poisoning from ≥10 µg/dL to ≥5µg/dL. Note that all blood lead level results should be submitted to DOH, but results ≥5 µg/dL should be reported on the next business day. Results <5 µg/dL should be submitted to DOH within 10 business days.

  7. Added requirement that all Salmonella isolates or specimens be forwarded to DOH for confirmation.

  8. Specified that isolates or specimens required to be submitted to DOH for confirmation must be submitted within two weeks from the time the isolate or specimen is received by a laboratory, unless otherwise noted by DOH.

Reported by: Rodney Johnson, Esq.


THIRD-PARTY PAYORS

CMS Proposes Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Changes for 2018

On July 13, 2017, the Centers of Medicare and Medicaid Services (“CMS”) released a proposed rule that would update the 2018 Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System.

Although hospitals would see a two percent (2%) Medicare reimbursement increase in 2018 for services paid under the OPPS, the proposed rule would change how Medicare pays hospitals for drugs that are acquired under the 340B Drug Discount Program and could potentially add certain procedures to be reimbursed on the ASC payable list.

Under the 340B Drug Discount Program, hospitals would be reimbursed separately for administering payable, non-pass-through drugs bought at a discount through the program at average sales price less 22.5% rather than the program’s average sales price plus 6%.

Additionally, two new spine procedures would be added to the ASC center payable list: cervical artificial disc arthroplasty and second-level cervical discectomy. As stated in the proposed rule, CMS is also soliciting comments regarding whether total knee arthroplasty, partial hip arthroplasty and total hip arthroplasty surgeries should take place at ASCs. This request for information has drawn speculation regarding CMS’ intentions to continue its mandatory, bundled-payment Comprehensive Care for Joint Replacement (“CJR”) program.

CMS will accept comments on the proposed rule and the request for information until September 11, 2017.

Reported by: Elizabeth Scarola, Esq.

CMS Releases 2014 Health Care Spending Data by State

On June 14, 2017, the Centers for Medicare and Medicaid Services (“CMS”)’ Office of the Actuary (“OACT”) released data detailing health care spending by state for the years 1991 through 2014. The data provides estimates for spending on goods and services (e.g., hospital services or retail prescription drugs) as well as categorizing such spending by major payor (including Medicare, Medicaid, and other private health insurers).

The data validates considerable regional variation in personal healthcare spending. For the year 2014, New England had the highest level of total per capita personal health care spending of roughly $10,000.00 per person and the Southwest region of the United States U.S. had the lowest per capital health care spend of roughly $6,800.00 per person. The national average per capita personal health care spending was roughly $8,000.00 per person.

The state with the highest 2014 per enrollee Medicare spending was New Jersey ($12,614.00 per person) and the lowest was Montana ($8,238.00 per preson). Interestingly, per capita health spending in Medicaid expansion (4.4%) and non-expansion states (4.5%) grew at similar rates.

Reported by: Elizabeth Scarola, Esq.

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