January - April 2018 Health Law Updates

The Health Law Section (“HLS”) website has been updated with January through April 2018 articles on significant developments in the health law arena that may be of interest to you in your practice. These summaries are presented to HLS 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:

  • Trish Calhoun, Esq., Carlton Fields
  • Jocelyn Ezratty, Esq., Di Pietro Partners, LLP
  • Christian Perez Font, Esq., Chief Compliance Officer, OPKO Health, Inc. 
  • Angelina Gonzalez, Esq., Panza, Maurer & Maynard, P.A.
  • Jan Gorrie, Esq., Of Counsel, Panza, Maurer & Maynard, P.A.
  • Caycee Hampton Esq., Carlton Fields
  • Jeanne E. Helton, Esq., Smith, Hulsey & Busey
  • Anne Kelley, J.D. Candidate, University of Florida
  • Michael D. Lessne, Esq., Broad and Cassel, LLP
  • Erica Mallon, Esq., Carlton Fields
  • Juan Carlos (“JC”) Palacio, Esq., CHC, Associate Director, Health Information Privacy, Jackson Health System
  • Danielle Scheer, MPH, CPH, J.D. Candidate, University of Florida
  • Paul Thompson, Esq., MPH, Contract Attorney, Raymond James Financial, Inc. 
  • Timothy S. Wombles, Esq., Broad and Cassel, LLP

Thank you,

Jamie Gelfman, Esq., Broad and Cassel LLP, HLS Editor in Chief

Trish Huie, Esq., Patricia A. Huie, PLLC, HLS Team Editor

Ashley Brevda, Oncology Analytics, Inc., HLS Team Editor  

Download the Updates at the Following Links

http://www.flabarhls.org/resources-menu/document-library/health-law-updates

document April 2018 HLS Updates DOCX (47 KB)

pdf April 2018 HLS Updates PDF (259 KB)

Table of Contents in This Edition

ADMINISTRATIVE LAW UPDATES

CHALLENGE TO FLORIDA BOARD OF OPTOMETRY’S AUTHORITY

FIFTH CIRCUIT REVERSES DISMISSAL OF COMPLAINT SEEKING INJUNCTION TO PREVENT MEDICARE RECOUPMENT PRIOR TO CONCLUSION OF ADMINISTRATIVE APPEAL BASED ON VIOLATION OF PROCEDURAL DUE PROCESS

ANTITRUST UPDATES

CONSIDERATION OF EFFICIENCIES IN ANTITRUST MERGER ANALYSIS UNDER § 7 OF THE CLAYTON ACT

COMPLIANCE UPDATES

OIG AUDITS THE ACCURACY OF HOSPITAL CREDIT REPORTING IN CLAIMS

FRAUD AND ABUSE UPDATES

FLORIDA OPHTHALMOLOGIST SENTENCED TO 17 YEARS FOR MEDICARE FRAUD

HEALTHCARE PROVIDERS EMPOWERED BY DOJ MEMO IN HEALTHCARE FRAUD ACTIONS

MIDDLE DISTRICT CONTINUES TO REFINE THE APPLICATION OF STANDARDS SET FORTH IN ESCOBAR

Q1/2018: AN ACTIVE MONTH FOR HEALTHCARE FRAUD ENFORCEMENT IN FLORIDA

PRIVACY AND SECURITY UPDATES

EU’S NEW PRIVACY LAW, THE GDPR – THE BAR IS SET HIGH

HIPAA – LESSONS TO LEARN FROM THE FRESENIUS SETTLEMENT

LEGISLATIVE UPDATES

2018 LEGISLATIVE SESSION – HEALTH LAW MATTERS

LICENSING & SCOPE OF PRACTICE UPDATES

GOVERNOR RICK SCOTT SIGNS HOUSE BILL 21 (HB 21), IMPOSING NEW REQUIREMENTS AND RESTRICTIONS ON PRESCRIBING CONTROLLED SUBSTANCES IN FLORIDA

REGULATORY UPDATES

DEPARTMENT OF JUSTICE RAISES PENALTIES FOR FALSE CLAIM AND ANTI-KICKBACK VIOLATIONS

CMS FINALIZES COVERAGE FOR NEXT-GENERATION SEQUENCING TESTS

FDA PROPOSES RULE TO LOWER NICOTINE IN CIGARETTES

TRANSACTIONS UPDATES

NEED A LYFT? NON-EMERGENCY MEDICAL TRANSPORTATION RIDESHARING: UBER HELPFUL AND UBER RISKY

 

 

December 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:

  • Christian Pérez Font, Esq

  • Rodney Johnson, Esq.

  • Shantal L. Henriquez, Esq.     

  • Elizabeth Scarola, Esq.

  • Erica C. Mallon, Esq.

  • Rodney Johnson

Thank you,

Malinda Lugo, Esq.

Kimberly Sullivan, Esq.


Fraud and Abuse

Owner of Florida Pharmacy pleads Guilty in $100MM Compounding Pharmacy Scheme

On November 6th, 2017, the Department of Justice announced that the president and owner of Florida-based A to Z Pharmacy had plead guilty to one count of conspiracy to commit health care fraud and one count of conspiracy to engage in monetary transactions involving criminally derived property as part of a large scheme to defraud private insurance companies, Medicare and Tricare. According to the admissions made as part of the plea agreement, the defendant caused the submission of fraudulent reimbursement claims for prescription compounded medications by using billing codes that included ingredients that were never used. The defendant and his seven co-conspirators also admitted to paying kickbacks and bribes in exchange for prescriptions and patient identifying information used to further the scheme. Sentencing will be scheduled before U.S. District Judge James S. Moody Jr of the Middle District of Florida.  

A copy of the Department of Justice’s press release in this case is available at: https://www.justice.gov/opa/pr/owner-florida-pharmacy-pleads-guilty-100-million-compounding-pharmacy-fraud-scheme-real.

Reported by: Christian Pérez Font, Esq

Competitors Can be Whistleblowers Too

On August 18, 2017 the Department of Justice announced that pharmaceutical giant Mylan had agreed to pay $465MM to resolve claims that it violated the False Claims Act by knowingly misclassifying its EpiPen as a generic drug despite the absence of any therapeutically equivalent drugs. This misclassification allowed Mylan to demand massive price increases in the private market (around 400% between 2010 and 2016) while avoiding the payment of rebates to the Medicaid program. Aside from the magnitude of the settlement itself, it is notable that the whistleblower in this case was not an individual but rather Sanofi Aventis, a competitor, who received $ 38.7MM as its share of the total settlement. This is yet another example, that strong healthcare fraud and abuse enforcement is here to stay.

A copy of the settlement agreement is available at the Department of Justice’s website at https://www.justice.gov/opa/press-release/file/990736/download.

Reported by: Christian Pérez Font, Esq

Life Sciences

Update on Medical Marijuana

In June, the Florida Legislature codified the laws implementing Amendment 2 (Fla. Const. Art. X, § 29), which expands the licensure, sale, use, etc. of medical marijuana in Florida. The implementing regulations created the Office of Medical Marijuana Use within the Florida Department of Health, which is charged with overseeing the writing and implementation of the rules, licensing businesses and physicians to grow, dispense, and “order” medical marijuana, as well as issuing licenses for patient use. The law, codified at F.S. § 381.986 et seq. allows for the licensure of 10 additional growers to the already seven licenses in existence. It also provides for the opening of an initial 25 dispensaries. The law sets into place specific provisions regarding how counties and municipalities can regulate dispensaries: (1) regulate like retail pharmacies, (2) ban from opening altogether, or (3) issue a temporary moratorium on opening dispensaries. As a result of these options, many local governments have banned or put into place moratoriums on the opening of dispensaries in cities and counties throughout the state, many of which are in effect until early 2018. The law also requires the medical marijuana to be tested by certified testing laboratories before being dispensed to users. In addition, the law sets forth the prohibitions regarding the financial interests between ordering physicians, testing laboratories, and dispensaries.

Reported by: Shantal L. Henriquez, Esq.

DISCLAIMER:  The views expressed herein do not represent the views of the Social Security Administration or the United States Government.  They are solely the views of Shantal L. Henriquez, in my personal capacity or as representative of The Florida Bar Health Law Section.  I am not acting as an agent or representative of the Social Security Administration or the United States Government in this activity. There is no expressed or implied endorsement of views or activities of The Florida Bar Health Law Section by either the Social Security Administration or the United States.

Third Party Payors

CMS Innovation Center Requests Stakeholder Input

On September 20, 2017, the Centers of Medicare and Medicaid Services (CMS) issued a Request for Information soliciting stakeholder with regards to innovative programs it could offer to improve quality, reduce costs, and improve outcomes. The RFI states requests suggestions in the following eight focus areas: (i) increased participation in Advanced Alternative Payment Models; (ii) consumer-directed care and market-based innovation models; (iii) physician specialty models; (iv) prescription drug models; (v) Medicare Advantage Innovation Models; (vi) state based and local innovation, including Medicaid models; (vii) Mental and Behavioral Health Models and (viii) Program Integrity.

The RFI was released just a month after CMS proposed changes to the Comprehensive Care for Joint Replacement Model, cancellation of the mandatory episode payment models and cardiac rehabilitation incentive payment model.

CMS Administrator Seema Verma explained, “Stakeholders have asked for more input on the design of [Innovation Center] models. These changes make this possible and give CMS maximum flexibility to test other episode-based models that will bring about innovation and provide better care for Medicare beneficiaries.”

Interested stakeholders can submit comments online or e-mail them to CMMI_NewDirection@cms.hhs.gov through November 20, 2017.

Reported by: Elizabeth Scarola, Esq.

CMS Cancels Two Bundled Payment Models & Announces More Voluntary Bundles

On November 30, 2017, the Centers for Medicare and Medicaid Services (“CMS”) canceled mandatory hip fracture and cardiac bundled payment models and implemented changes to the Comprehensive Care for Joint Replacement (“CJR”) model.

The number of mandatory geographic areas participating in CJR has been reduced from sixty-seven (67) to thirty-four (34) areas. CMS is also making participation in the CJR model voluntary for all low volume and rural hospitals within the 34 mandatory geographic areas.

In the CMS announcement, CMS Administrator, Seema Verma indicated that CMS would be announcing new voluntary payment bundles in the future. Ms. Verma stated, “[w]hile CMS continues to believe that bundled payment models offer opportunities to improve quality and care coordination while lowering spending, [CMS] believe[s] that focusing on developing different bundled payment models and engaging more providers is the best way to drive health system change while minimizing burden and maintaining access to care.”

Reported by: Elizabeth A. Scarola, Esq.

CMS Proposes  Next Generation Sequencing Coverage for Medicare Beneficiaries with Advanced Cancer

Last month, the U.S. Food and Drug Administration (“FDA”) approved the FoundationOne CDx, a next generation sequencing device (“F1CDx™”). Shortly after announcing FDA approval, CMS received a formal request (See: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id290.pdf)   to establish coverage for comprehensive genomic profile testing for the management of cancer patients with solid, metastatic tumors (including Stage IV and recurrent turmors) with F1CDx™.

Next generation sequencing provides detailed information on multiple types of genetic alternations simultaneously, providing a more comprehensive genetic profile of cancer and information relevant to potential cancer treatments. Providers and patients believe the technology holds potential for personalized cancer therapy.

CMS is soliciting public comment relevant to the request through December 29, 2017.

Reported by: Elizabeth A. Scarola, Esq.

Health Care Transactions

Update on Healthcare Transactions

The business of providing health care has shifted dramatically in recent years, and continues to transform at a rapid pace. As companies face uncertain impacts of health care reform (or potentially an unwind of existing health care reform), a tumultuous political climate, and potential reimbursement cuts, large players in one healthcare industry have been entering the market in other healthcare industries. 

Two recent transactions that have garnered significant attention are the $69 billion CVS-Aetna deal and the $4.9 billion UnitedHealth Group-DaVita Medical Group deal. The CVS-Aetna transaction combines a pharmacy, benefits manager, insurer, and retailer with more than 1,000 walk-in clinics across 33 states into one entity. The UnitedHealth-DaVita transaction brings UnitedHealth deeper into the delivery of medical care as it acquires dialysis giant DaVita's primary care division entity, which operates nearly 300 clinics across six states.

Health insurers believe that they can cut medical costs by playing a more direct role in the delivery of medical care, shifting patients to cheaper, more accessible locations for routine, non-life-threatening medical care, potentially at facilities that they themselves own.

It is anticipated that even more innovative transactions and strategic affiliations will take place as non-traditional players like Amazon enter the healthcare market.  Existing players are scrambling to compete and maintain market share when new companies develop inventive offerings and relationships.

Reported by: Erica C. Mallon, Esq.

Public Health

The Aftermath of the Hurricane: Emergency Preparedness Rules

CMS’ 2016 final Emergency Preparedness Rule requires Medicare and Medicaid participating providers and suppliers to plan for natural and man-made disasters in collaboration with federal, state, regional and local emergency preparedness organizations. Participating providers must conduct a risk assessment, develop an emergency plan, implement policies and procedures, communicate the plan, develop training and testing programs and update the plan annually. Providers should revisit the final rule and their existing emergency preparation plans to ensure compliance, as the rule takes effect November of this year.

In light of Hurricane Irma and the related nursing home deaths, Florida Governor Rick Scott enacted a Florida emergency rule related to emergency operations of assisted living facilities six days after the storm. The Emergency Rule requires nursing homes and assisted living facilities to maintain generators to run air conditioners in the event of a loss of power.

On September 27, 2017, the Emergency Rule was challenged by LeadingAgeFlorida, an organization that represents more than one hundred nursing homes and assisted living facilities. LeadingAgeFlorida argues that it is unrealistic to expect facilities throughout the state to install generators within sixty days, as the Emergency Rule required.

Reported by: Elizabeth Scarola, Esq.

Youth Sports Concussion Laws

A recent study published by the American Journal of Public Health looking at youth sports concussion laws passed between 2009 and 2014 found that the laws have led to a "significant decline" in repeated concussions among young athletes. To-date, these laws have been passed in all 50 states and the District of Columbia. The Network’s resource on youth sports concussion laws outlines specific aspects of the laws, including which states require return-to-play protocols for student athletes, which type of provider can issue a return-to-play clearance, and whether or not the law applies to recreational sports.     

Link:

https://www.networkforphl.org/resources_collection/2017/08/23/472/table_youth_sports_concussion_laws/?utm_source=Network+Report+10-26-17&utm_campaign=Network+Report+10-26-17&utm_medium=email&utm_content=336

Reported by: Rodney Johnson

2018 Public Health Law Conference: Save-the-Date and Call for Abstracts

The Network and ASLME are excited to announce the 2018 Public Health Law Conference will take place October 4 – 6 in Phoenix, Arizona. We are now accepting abstracts for proposed panels and individual presentations. We encourage submission of abstracts related to this year's Conference theme, Health Justice: Empowering Public Health and Advancing Health Equity, as well as abstracts on other timely public health law topics. Deadline for abstract submission is December 15, 2017.

Link:

https://www.networkforphl.org/2018_conference/phlc18/?utm_source=Network+Report+10-26-17&utm_campaign=Network+Report+10-26-17&utm_medium=email&utm_content=336

Reported by: Rodney Johnson  

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.

Read More

March-April 2017 Health Law Updates

Dear Health Law Section Members:

The following articles involve 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, its Health Law Section, or the authors of these summaries.

HLS thanks the following volunteers who have generously donated their time to prepare these summaries for our members:

  • Elizabeth Scarola, Esq.

  • Yesenia Fatima Lara, Esq.

  • Christian Pérez Font, Esq

  • Rodney Johnson, Esq.

Thank you.

Malinda Lugo, Esq.

Kimberly Sullivan, Esq.

You may download a copy of the summaries as well as read them, below.

document March April Heath Law Updates 2017 (DOCX) (23 KB)

pdf March April Health Law Updates 2017 (PDF) (153 KB)


COMPLIANCE

Owner of South Florida Home Healthcare Owner indicted in $15MM Medicare Fraud Scheme

On March 14th, 2017, the Department of Justice announced that it had indicted the owner of Elite Home Care, LLC, a Miami-based home healthcare provider, with one count of conspiracy to commit health care fraud and wire fraud, two counts of health care fraud and one count of conspiracy to defraud the United States and pay health care kickbacks. According to the indictment, aside from filing documents in an effort to conceal his ownership of the home healthcare provider, the defendant engaged in other illegal practices that included the payment of kickbacks to Medicare beneficiaries and patient recruiters in exchange for referrals. As a consequence of this scheme, Medicare paid approximately $ 15MM in false claims. The case is still ongoing and the defendant is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

A copy of the Department of Justice’s press release is available at https://www.justice.gov/opa/pr/south-florida-home-health-owner-charged-role-15-million-medicare-fraud-scheme.

Christian Pérez Font, Esq

Two Defendants plead guilty to $20MM Medicare Fraud Scheme at Seven Miami Area Home Health Agencies

 On March 2nd, 2017, the owners and operators of seven home healthcare agencies in the Miami area plead guilty to charges of conspiracy to commit healthcare fraud, healthcare fraud and wire fraud. As part of their pleas, the defendants admitted that they recruited nominees to conceal their ownership interest in these agencies and that they also engaged in a scheme to pay bribes and kickbacks to healthcare professionals in return for the provision of prescriptions for home healthcare services and referrals of Medicare beneficiaries many of which did not even these services. According to the Department of Justice’s press release, Medicare improperly paid approximately $ 20MM to these seven agencies.

A copy of the Department of Justice’s press release is available at https://www.justice.gov/opa/pr/two-women-plead-guilty-orchestrating-20-million-medicare-fraud-scheme-seven-miami-area-home

Christian Pérez Font, Esq


FRAUD AND ABUSE

Developments in Medicare Secondary Payer Law

Two recent legal decisions out of the Eleventh Judicial Circuit in and for Miami Dade County indicate that Medicare Advantage Organizations (MAOs) may be able to obtain reimbursement from no-fault liability carriers pursuant to Medicare Secondary Payer law on a class-wide basis. On April 20, 2017, the Honorable Judge Antonio Arzola entered a 56-page order granting class certification to a class of approximately 37 Florida MAOs. MSPA Claims 1, LLC v. IDS Property Cas. Ins. Co., No. 2015-27940 (Fla. 11th Cir. Ct. Apr. 20, 2017). The allegations are mainly that IDS Property Casualty Insurance Company: 1) failed to properly pay the personal injury protection benefits for their insureds who were also Medicare beneficiary; and 2) failed to provide appropriate reimbursement for conditional payments provided by the MAOs on behalf of Medicare enrollees.

This is only the second time in the United States where class certification has been obtained for Medicare Advantage Organizations based on the principles of Medicare Secondary Payer law. The first class certification came on February 3, 2017, from the Honorable Judge Samantha Ruiz Cohen. See MSPA Claims 1, LLC v. Ocean Harbor Cas. Ins., No. 2015-1946 (Fla. 11th Cir. Ct. Feb. 3, 2017). The order can be located at: http://msprecoverylawfirm.com/wp-content/uploads/2017/02/15-1946plfordergranting20Signed20Order.pdf.

Both state and federal courts are recognizing that Medicare Advantage Organizations are paying for health benefits for which no-fault carriers are primarily responsible. The Medicare Secondary Payer law provides MAOs with the same recovery rights as CMS and is meant to counteract rising healthcare costs. There are several similar nationwide putative class actions being pursued on behalf of MAOs against large insurers such as Allstate and State Farm. The road ahead in these class action cases may be long and winding, but certainly these cases are shaping the world of Medicare Secondary Payer law and MAOs.

Yesenia Fatima Lara, Esq.

 


PUBLIC HEALTH

Updated Criminal and Epidemiological Investigations Handbook.

CDC has released an updated version of to the 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. The handbook will teach public health and law enforcement how to work together to identify the biological agent, prevent the spread of the disease, avoid public panic, and apprehend those responsible. It is also available in French and Spanish. The updated handbook can be found at:

https://www.cdc.gov/phlp/docs/crimepihandbook2016.pdf

Rodney Johnson, Esq.

 

CMS Requires Participating Providers to Prepare for Emergencies

On March 24, 2017, the Centers for Medicare & Medicaid Services (CMS) released a memorandum encouraging participating providers to “seek out and participate in a full-scale, community-based exercise with their local and/or state emergency agencies and health care coalitions and to have completed a tabletop exercise by [November, 2017].”

The memo is intended to assist providers and suppliers with meeting the testing and training requirements of the September 2016 emergency preparedness final rule.

The final rule requires participating providers to plan for natural and man-made disasters, train for disaster preparedness and test emergency plans.

The memo clarified that participating providers are expected to meet the requirements of the final rule by November 15, 2017, or face citations for non-compliance.

Facilities that are unable to complete a full-scale emergency preparedness exercise by November 15, 2017 are encouraged to undergo an individual facility-based exercise and document the circumstances as to why a full-scale, community-based exercise was not completed.. More information is available at:

https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertemergprep/emergency-prep-rule.html

Elizabeth Scarola, Esq.


 

THIRD PARTY PAYORS

Mandatory Bundled Payments Delayed, CMS seeking comments

CMS Administrator, Seema Verma, and Secretary of Health and Human Services Secretary, Tom Price delayed implementation of the Comprehensive Care for Joint Replacement (“CJR”) program via an interim final rule. See CMS – 5519 – IFC

The effective date of CJR model implementation originally set for March 21, 2017 was delayed until May 20, 2017. Accordingly, the applicability of the CJR regulations at 42 C.F.R. part 512 are now set to begin on October 1, 2017.

This interim final rule also delays the implementation of other mandatory bundled payment models, including the Cardiac Rehabilitation Incentive Payment Model.

CMS is seeking comment on the appropriateness of the possibility of further delaying the start of these mandatory models until January 1, 2018.

CMS reasons,

… delay is necessary to … ensure that the agency has adequate time to undertake notice and comment rulemaking to modify the policy if modifications are arranged, and to ensure that in such a case participants have a clear understanding of the governing rules and are not required to take needless compliance steps.

Many have speculated about the future of bundled payments under the Trump Administration.

While serving as a member of Congress, HHS Secretary Tom Price publicly opposed CMS’ mandatory initiatives, like CJR. Then Rep. Price urged CMS via a signed letter to “cease all current and future planned mandatory initiatives.” Last year, he also introduced a bill (H.R. 4848) co-sponsored by Rep. David Scott (D-GA) that would have delayed the implementation date of the CJR model until January 1, 2018.

Providers concerned with the feasibility of implementing the CJR model and other mandatory bundled payment initiatives within the current year are urged to submit comments to CMS.

Questions regarding the interim final rule may be submitted to CMS via email at CJR@cms.hhs.gov

Elizabeth Scarola, Esq.

January - February 2017 Health Law Updates

Dear Health Law Section Members:

The Section website has been updated with the January – February 2017 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:

  • Matthew J. Friendly, Esq.

  • Jamie Gelfman, Esq.

  •  Rodney Johnson, Esq.

  •  Yesenia Fatima Lara, Esq.

  •  Monica McNulty, Esq.

  •  Anu Sagi-Nakkana, Esq.

Thank you.

Jamie Gelfman, HLS Team Editor  

Patricia Huie, HLS Team Editor

 Download a copy of the updates at the following link.

http://flabarhls.org/resources-menu/document-library/health-law-updates?sort=created_on&direction=desc


COMPLIANCE

DHHS and DOJ Release Fiscal Year 2016 Fraud and Abuse Control Program Annual Report

Under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Care Fraud and Abuse Control Program (“HCFAC”) was established under the joint direction of the Attorney General and the Secretary of the Department of Health and Human Services (“DHHS”), acting through the Inspector General. The stated purpose of HCFAC is to coordinate federal, state and local law enforcement activities with respect to health care fraud and abuse. Annually, the HCFAC releases a report detailing the prior fiscal year’s fraud and abuse enforcement activities and monetary results.

During Fiscal Year 2016, the Department of Justice (“DOJ”) opened 930 new civil and 975 new criminal health care fraud investigations, resulting in 658 defendants convicted of health care fraud-related crimes. Further, the FBI successfully dismantled more than 128 health care fraud criminal enterprises. Additionally, investigations initiated by the HHS’ Office of Inspector General (“HHS-OIG”) resulted in 765 criminal actions against individuals or entities that engaged in crimes related to Medicare and Medicaid, as well as 690 civil actions, which included false claims and unjust enrichment lawsuits, civil monetary penalties (“CMP”) settlements, and administrative recoveries related to provider self-disclosure matters. HHS-OIG also excluded 3,635 individuals and entities from participation in Medicare, Medicaid and other federal health care programs based upon criminal convictions for crimes related to Medicare and Medicaid or to other health care programs, for patient abuse or neglect, or for a result of licensure revocations.

Because of these activities, in addition to amounts collected from preceding years, a total of $3.3 billion was returned to the Federal Government in FY 2016, with approximately $1.7 billion of this transferred to the Medicare Trust Funds and $235.2 million in Federal Medicaid money transferred to the Treasury. Since the Program’s inception in 1997, the HCFAC reports that over $31 billion has been returned to the Medicare Trust Funds, with over $17.9 billion of this from the 2009 through 2016. Source: https://oig.hhs.gov/publications/docs/hcfac/FY2016-hcfac.pdf

Reported by: Jamie Gelfman, Esq.

FACILITY & PROFESSIONAL LICENSURE

Repeal of Certificate of Need Requirement for Nursing Homes and Hospitals Advances in Florida Legislature

Currently, Florida’s Agency for Health Care Administration must issue a certificate of need (“CON”) before a health care provider builds or converts hospitals, nursing homes, or hospices. However, Florida House Representative Alex Miller, R-Sarasota, recently sponsored House Bill 7 (“H.B. 7”) to repeal the requirement to obtain a CON “to build a new hospital or nursing home or add beds in an existing facility.” On February 15, 2017, H.B. 7 advanced in the Florida House of Representatives subcommittee with an 11-5 vote. Governor Rick Scott supports H.B. 7, but large segments of the hospice and hospital industry oppose the legislation. State Senator Rob Bradley, R-Fleming Island, recently proposed a similar piece of legislation, Senate Bill 676, which the Florida Senate will consider during the 2017 legislative session. .

If repealed, Florida, which has maintained some form of CON requirements for nearly 45 years, would join 14 other states that have eliminated CON requirements. While arguments exist on both sides regarding the merits of the Florida CON system, its repeal will have a significant impact on the hospital, hospice, and nursing home industries in Florida.

Reported by: Matt Friendly, Esq.

FRAUD & ABUSE

The Final Rule on the HRSA’s 340B Drug Pricing Program: Providing Ceiling Prices and Manufacturer Civil Monetary Penalties

On January 5, 2017, the Health Resources and Services Administration (“HRSA”), under the Department of Health and Human Services (“HHS”), published its final rule on the 340B Drug Pricing Program (“340B program”), creating drug ceiling prices, allowing 340B participating health care providers to obtain certain covered outpatient drugs at discounted prices, and imposing fines on drug manufacturers that overcharge these participating providers.

According to the HRSA, the intent of the 340B program, which was originally created in 1992, is to aid enrolled hospitals and health providers (“covered entities”) to stretch “scarce federal resources” as far as possible. Drug manufacturers, who are incentivized to participate in the 340B program by HHS’ requirement that they participate to have their drugs covered under Medicaid, must sell covered entities drugs at a discounted rate and cannot distribute drugs in a manner that discriminates against a covered entity. The 340B program applies to prescription drugs and biologics other than vaccines (“covered outpatient drugs”). The covered outpatient drugs do not include inpatient drugs or drugs bundled with other services, and, for critical access hospitals (“CAH’s”), orphan drugs are also excluded.

To participate in the 340B program and be eligible to purchase drugs at reduced prices, the hospital or other health care provider must register and be enrolled in the 340B Drug Pricing Program as a covered entity. Hospitals eligible to be classified as a covered entity primarily include disproportionate share hospitals (“DSH”) hospitals and critical access hospitals (“CAH”). In addition to DSH and CAH providers, however, rural referral centers, sole community hospitals, children’s hospitals, and freestanding cancer hospitals will also be eligible with some restrictions. Each hospital wishing to be considered a covered entity must either be a nonprofit hospital delegated by the government or under government contract to provide health care services to low-income patients, or, alternatively, be owned by a state or local government. HRSA will be accepting new registrations October 1-15, January 1-15, April 1-15, and July 1-15.

In addition to offering covered entities reduced drug pricing, the final rule also includes regulations on calculating maximum drug prices (“ceiling prices”), and imposes civil monetary penalties (“CMP’s”) on those drug manufacturers who knowingly and intentionally overcharge 340B covered entities. Under the final rule, drug manufacturers will be required to calculate drug ceiling prices quarterly. The methods for making these calculations are also laid out in the rule, which includes subtracting the drug’s “Unit Rebate Amount” from the “Average Manufacturer Price.” If the ceiling price calculation results in a $0.00 charge, the manufacturer must charge $0.01 per unit (referred to as “penny pricing”). Drug manufacturers have been charged with the duty of ensuring covered entities receive covered outpatient drugs at or below the ceiling price, and to resolve most instances of overcharging with the covered entity.

The final rule is effective March 6, 2017; with HRSA enforcing the 340B Drug Pricing Program as of April 1, 2017. The full final rule can be found here.

Reported by: Anushree ("Anu") Sagi Nakkana, Esq., CHC

Special thanks to: Allyson M. Paige, UF Law Class of 2018

PUBLIC HEALTH

State Laws Requiring Hand Sanitation Stations at Animal Contact Exhibits. This article summarizes the results of a 50-state legal assessment that collected and analyzed state statutes and regulations requiring hand sanitation stations at animal contact exhibits, such as petting zoos and agricultural fairs.

The article can be located at: https://www.cdc.gov/phlp/publications/topic/zoonotic.html.

Advancing the Right to Health: The Vital Role of Law. This report, published by the World Health Organization, discusses the role that the reform of public health laws can play to advance the right to health and create conditions for people to live healthy lives. The report provides guidance about issues and requirements to be addressed during the process of developing public health laws. It also includes case studies and examples of legislation from various countries to illustrate effective law reform practices and some features of successful public health legislation.

This report can be located at: http://www.who.int/healthsystems/topics/health-law/health_law-report/en/.

WHO Health Law Website: The World Health Organization (WHO), supported by the European Union-Luxembourg-WHO Universal Health Coverage Partnership, has created a new website containing guidance and information about universal health coverage law reform.

The website can be located at: http://www.who.int/nationalpolicies/eu-lux-who-call/en/.

Reported by: Rodney Johnson, Esq.

THIRD PARTY PAYORS

Executive Order Addressing the Pending Repeal of ACA

On January 20, 2017, President Donald J. Trump signed Executive Order 13765, “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal” (“Order”). Within the text of the Order, President Trump reaffirmed his commitment to repealing the Affordable Care Act (“ACA”) and granting the individual States more control over the healthcare industry. One of the most anticipated portions of the Order requires the heads of all executive departments and agencies to exercise all their power and discretion to “waive, defer, grant exemptions from, or delay” the implementation of any ACA provision that imposes a fiscal burden on health insurers, patients, and healthcare providers, among others. It remains to be seen if the executive agencies, such as the IRS, will comply with the mandate. The first indication of the Order’s impacts will potentially come as the federal tax return deadlines approach.

Currently, under the ACA, the penalty for not having health insurance in 2016 is calculated as a percentage of household income and on a per-person basis. Of the two yielded amounts, the highest figure must be paid by the uninsured individual. The percentage of income method makes the penalty 2.5% of the household income, with the maximum penalty being equal to the total yearly premium for the national average price of a Bronze plan sold through the ACA Marketplace. The per-person basis sets a penalty of $695 per adult, $347.50 per child under 18, with the maximum amount not to exceed $2,085. For many individuals, if this Order is strictly followed, they will avoid significant penalties. The healthcare plans, on the other hand, may experience lower enrollment numbers. The next few months will be crucial in assessing the Order’s practical application and impact.

Reported by: Yesenia Fatima Lara, Esq.

Proposed Legislation Would Prohibit Certain Retroactive Claim Denials

Parallel bills pending in the Florida legislature would prohibit health insurers from retroactively denying claims under specified circumstances. Senate Bill 102, filed on December 5, 2016, and identical House Bill 579, filed on January 30, 2017, would amend sections 627.6131 (11) and 641.3155 (10), Florida Statutes.

The bills would prohibit insurers from retroactively denying claims because of insured ineligibility if the insurer “verified the eligibility of an insured at the time of treatment and provided an authorization number.”

H.B. 579 has been referred to the Health Innovation Subcommittee, the Insurance and Banking Subcommittee, and the Health and Human Services Committee. S.B. 102 has been referred to the Committees on Banking and Insurance, Health Policy, and Rules.

Reported by: Monica M. McNulty, Esq.

Upcoming CLE Events

14Sep
09.14.2018 8:00 am - 5:00 pm
Master Class Legal Emergencies in Health Care

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13Jun
06.13.2018 - 06.18.2018
2018 Annual Convention
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