In Reach Web Audio Seminars Announced for 2017

Pricing for Each Course

$20 Section Member

$50 Non-Section Member

Course Dates and Descriptions

January 10, 2017

Course Number 2482

CLE Credits General 1.0; Certification: Health Law 1.0

Topic Trending Issues and Practical Solutions to Hospital Privileges Problems from the Physician and the Hospital Perspective

Speaker Kelly Zarzycki Andrews

Description This presentation generally addresses: (i) strategies for safer physician and provider privileging for hospitals; (ii) strategies for avoiding and resolving problems with obtaining or modifying hospital privileges for providers; and (iii) the disciplinary impact on privileges for both hospitals and providers

http://tinyurl.com/floridabarcle2482R

February 14, 2017

Course Number 2483

CLE Credits General 1.0; Certification: Health Law 1.0

Topic Meaningful Use Audits- Lessons Learned and What’s Coming

Speakers Shannon Salimone and Jim Tate

Description With the phasing out of Meaningful Use incentive payments, audits of hospitals and physicians will continue, perhaps for several more years. The OIG is also auditing hospitals and eligible professionals. State Medicaid agencies and Medicare Administrative Contractors may also scrutinize incentive payments and cost reports. With mandatory overpayment refund requirements, and potential criminal penalties for false compliance attestation, health care entities using electronic health records must ensure that they maintain accurate documentation. This webinar will discuss the audits and steps providers should take to verify that they are ready in the event the government comes knocking.

http://tinyurl.com/floridabarcle2483R

March 14, 2017

Course Number 2484

CLE Credits General 1.0; Certification: Health Law 1.0

Topic Movement of Compliance from Reactive to Proactive

Speaker T. Cole Peterson

Description This presentation will address the process of taking a compliance program and moving it from a reactive firefighting type program to a proactive partnership model, the challenges and the rewards for the journey, how the team partners with both in house and outside counsel and what such compliance professionals are looking for in a legal partner.

http://tinyurl.com/floridabarcle2484R

April 11, 2017

Course Number 2485

CLE Credits General 1.0; Certification: Health Law 1.0

Topic Regulatory Considerations for Physicians Regarding the “Off-Label” Use of Drugs and Medical Devices

Speaker Kevin Rudolph

Description This presentation will address a variety of considerations regarding the “off-label” use of drugs and medical devices, including FDA rules and regulations, IRB issues, laws governing the practice of medicine, and potential billing and coding issues.

http://tinyurl.com/floridabarcle2485R

May 9, 2017

Course Number 2371

CLE Credits General 1.0; Certification: Health Law 1.0

Topic EMTALA and Florida Statute Section 395.1041

Speakers Grant Dearborn and Karen Bolton

Description The presenters will discuss EMTALA and its Florida version which is set forth in Florida Statutes section 395.1041. The speakers will address facility obligations and requirements. Specifically, assessment and access will be discussed. The speakers will also address current cases

http://tinyurl.com/floridabarcle2371

Legislative Bills Filed February 28, 2012

The following bills were filed on February 27 and 28, 2012.

HB 7133 Relating to Quality Improvement Initiatives for Entities Regulated by the Agency for Health Care Administration (Health & Human Services Committee)

Quality Improvement Initiatives for Entities Regulated by the Agency for Health Care Administration: Provides responsibilities of DCFS & mental health service providers for me ntal health residents who reside in ALFs; provides for imposition of contract penalties on Medicaid prepaid health plans & mental health service providers; provides for interagency agreement between DCFS & AHCA; requires specified information regarding confidentiality of complaints to State Long-Term Care Ombudsman Program to be provided to residents of long-term care facilities upon admission; directs agency to establish & implement methodologies to adjust Medicaid rates for hospitals, nursing homes, & managed care plans; provides criteria for & limits on amount of Medicaid payment rate adjustments; directs agency to seek federal approval to implement performance payment system; provides applicability of performance payment system to general hospitals, skilled nursing facilities, & managed care plans; provides that specified persons who have regulatory responsibilities over or provide services to persons residing in ALFs must report suspected incidents of abuse to central a buse hotline; requires ALFs to be under management of licensed administrator; provides training & licensure requirements for administrators; authorizes agency to issue temporary license to administrator; provides additional requirements for limited mental health license; provides fines & penalties for specified violations by ALF; directs DEA to create advisory council to review circumstances of unexpected deaths in ALFs & of elopements; provides schedule for inspection of ALFs; provides that AHCA, DEA, DCFS, & APD shall develop or modify electronic information systems. Effective Date: July 1, 2012

SB 2134 Relating to Share Your Spare Act/Kidney Transplant (Smith (C))

Share Your Spare Act/Kidney Transplant; Urging Congress to pass the Share Your Spare Act, H.R. 2755, and the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patie nts Act, H.R. 2969 and S. 1454, etc.

Legislative Bills Filed February 17, 2012

SB 1990 - Relating to Developmental Disabilities (Budget)

Developmental Disabilities; Requiring that the Agency for Persons with Disabilities review a waiver support coordinator’s performance to ensure that the support coordinator meets or exceeds criteria established by the agency; requiring that the area office review the amount of funding needed to address the each client’s extraordinary needs in order to determine the medical necessity for each service in the amount, duration, frequency, intensity, and scope that meets the client’s needs; authorizing the agency to consult with the Department of Health, the Agency for Health Care Administration, the Department of Business and Professional Regulation, and the Department of Agriculture and Consumer Services concerning procedures related to the storage, preparation, serving, or display of food and procedures related to the detection and prevention of diseases caused by certain factors in the environment, etc. Effective Date: July 1, 2012

SB 1988 - Relating to Medicaid (Budget)

Medicaid; Deleting a prohibition preventing children who are eligible for coverage under a state health benefit plan from being eligible for services provided through the subsidized program; requiring a completed application, including a clinical screening, for enrollment in the Children’s Medical Services Network; updating references to data used for calculations in the disproportionate share program; providing an additional site in Broward County for the Program of All-Inclusive Care for the Elderly, etc. Effective Date: except as otherwise expressly provided in this act and except for section 23, which shall take effect upon this act becoming a law, this act shall take effect July 1, 2012

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.

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