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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