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.

October-November Health Law Updates

Dear Health Law Section Members:

The Section website has been updated with the October / November 2016 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, 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:

Christian Perez Font, Esq.

Jason Mehta, Esq.

Mitchell Blum, Esq.

Jeff Mustari, Esq.

Shantal Henriquez, Esq.

Rodney Johnson, Esq.

Ashley Brevda, Esq.

Elizabeth Scarola, Esq.

Matthew Friendly, Esq.

Thank you.

Malinda Lugo, Esq.BREAKKimberly Sullivan, Esq.BREAKAnushree Sagi Nakkana, Esq.

Download a copy of the updates using the following link: pdf Health Law Updates October - November 2016 (PDF) (157 KB)

COMPLIANCE

Draft Guidance by the FDA on the Clinical Evaluation of Software as a Medical Device (SAMD)

On October 14th, 2016, the FDA issued a draft guidance on the standards for clinical evaluation of software as a medical device (SaMD). The guidance, originally prepared by the International Medical Device Regulators Forum (IMDRF), seeks to establish “a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness and performance of software intended for medical purposes.” But, what is SaMD you may ask? To put it in simple terms, SaMD is software that utilizes an algorithm (logic, set of rules, or a model) that uses data input to produce medically valuable information intended to be used to: (i) treat or diagnose a disease, (ii) drive the clinical management of a disease, or (iii) provide relevant clinical information to assist in the management of a disease. Examples of SaMD include software that uses data from individuals to predict risk scores for developing a particular disease in order to create prevention or treatment strategies or software that performs an analysis of bodily fluids to diagnose a particular disease. The FDA has long recognized (at least since 1989) that in some cases software alone can be considered a medical device and, therefore, has exercised regulatory authority in this area. The draft guidance recognizes that the risks and benefits of SaMD are closely related to the intended use of the SaMD and, therefore, sets different standards for clinical evaluation depending on intended use. Specifically, the guidance states that “this statement of intention is the most important starting point for considering the level of evidence necessary and in the choices made to perform appropriate clinical evaluation.” The draft guidance also addresses the standards for clinical evaluation throughout the entire SaMD life-cycle and not just during development and launch.

The complete text of the draft guidance, can be viewed at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev- gen/documents/document/ucm524904.pdf

Submitted by: Christian Perez Font, Esq.

Ten Florida Assisted Living Facility Owners Indicted on Health Care Fraud and Abuse Charges

On October 25th, 2016, after a joint investigation by the FBI, HHS-OIG and Florida’s Medicaid Fraud Control Unit, the U.S. Attorney’s Office for the Southern District of Florida charged the owners of ten assisted living facilities in Miami-Dade County with participating in a healthcare fraud scheme in violation of the federal Anti-Kickback Statute and False Claims Act. The 30- count complaint alleges that the ten individuals received cash kickbacks and bribes in return for referring individuals residing in their assisted living facilities to the former owner of Florida Pharmacy Inc., a Miami-Dade company, for prescription medications and durable medical equipment reimbursed by Medicare and Florida Medicaid. The complaint further alleges that the ten individuals violated the False Claims Act by submitting Non-Institutional Medicaid Provider Agreements representing to Medicaid that they would comply with state and federal laws and all agency rules contained in the Florida Medicaid Provider Handbook which prohibits the solicitation and receipt of kickbacks. The U.S. Attorney’s office has stated that based on these alleged false representations Medicare renewed their provider numbers which allowed them to continue to submit claims and request reimbursement.

More information about this case, including the full indictments can be found on the website of the District Court for the Southern District of Florida at www.flsd.uscourts.gov or at http://pacer.flsd.uscourts.gov.

Submitted by: Christian Perez Font, Esq.

FRAUD & ABUSE

Government’s Increased Focus on Soaring Hospice Expenses

An increasing area of focus for government regulators in the healthcare fraud, waste, and abuse arena is hospice care. Hospice was originally intended solely for those patients with a terminal diagnosis. By regulation, that has been defined to mean patients whose doctors certify that they are likely to die within six months, or about 180 days. Today, however, care is routinely being extended to other types of patients such as those with non-specific, but debilitating illnesses including dementia and other mental ailments who often stay in hospice for well over 180 days.

In Florida, recent settlements reflect the government’s increased scrutiny of this issue. For example, the United States Attorney’s Office for the Middle District of Florida settled two hospice cases last year with both hospice companies paying over $3 million to resolve allegations that it provided medically unnecessary hospice care. In one such case – the matter of Hospice of Citrus County – the government contended that, in a six-year stretch, the company treated at least 52 patients with lengths of stay in excess of 1,000 days. The government alleged that for those 52 patients, Hospice of Citrus County either knowingly or recklessly failed to document a valid basis for the initial start of hospice care and/or subsequent hospice coverage. The failure in documentation included no support for the length of hospice services; patient files that failed to document basic patient characteristics; and patient records that were either unsigned or signed with inconsistent practitioner information. The government agreed to accept $3,022,000 to resolve these allegations.

Submitted by: Mitchell Blum and Jason Mehta¹

PROFESSIONAL AND FACILITY LICENSURE

AHCA Active in October Licensure Actions

Florida’s Agency for Health Care Administration (AHCA) announced that it issued final orders in October to ten (10) facilities and/or providers in Florida for failing to meet certain licensure requirements. Included in these ten orders were seven (7) orders to revoke existing licenses, two final orders to deny certain renewals, and one (1) order that resulted in a provider surrendering their license. AHCA announced that among those that were terminated or non- renewed were providers that were enrolled in the Medicaid program and that AHCA, as a result, has subsequently terminated or is in the process of terminating their participation in the program.

More information on such AHCA licensure actions can be found here: http://ahca.myflorida.com/Executive/Communications/Press_Releases/pdf/OctoberMonthlyActionsPressRelease.pdf

Submitted by: Matthew J. Friendly, Esq.

HEALTH INFORMATION TECHNOLOGY AND PRIVACY

Post-Election Potential Impact on Health Information and Privacy

During his presidential campaign, Donald Trump promised to repeal the Affordable Care Act (‘ACA”). The repeal of the ACA could impact certain aspects of the Health Insurance Portability Act of 1996 (“HIPAA”), which was expanded by the ACA. The ACA expanded HIPAA in several ways by (1) requiring the U.S. Department of Health and Human Services (“HHS”) to issue operating rules for HIPAA standard transactions, (2) making information and transmission formats more uniform, and (3) reducing the role of plan-specific companion guides.

Healthcare providers may have to adjust some of their policies and procedures implemented post ACA. If the ACA is repealed, the Operating Rules required under the ACA may change as well. The Operating Rules adopted by HHS are considered the necessary business rules and guidelines for the electronic exchange of information that are not defined by a standard or its implementation specifications. The Operating Rules also specify the information that must be included when conducting standard transactions, which makes it simpler for providers to use electronic methods to handle administrative transactions covered under HIPAA.

In addition to some of the specific potential impacts discussed above, we are facing significant uncertainty of what new healthcare related laws and regulations might be forthcoming. The “repeal and replace” mantra is well known to all of us, but what “replace” actually means remains a moving target. Previously proposed Republican backed healthcare legislation could impact health information and privacy as follows:

Sections of a larger mental health bill would allow caregivers and family members more information about a mentally ill person’s care through changes to HIPAA;
Increasing research collaboration into the discovery, development, and delivery of new treatments and cures by breaking down regulatory barriers to sharing and analyzing health data;
Advancing the use of electronic health records by spurring innovation and breaking down unnecessary legal and regulatory barriers; and
Adjusting the meaningful use program to allow partnerships between technology and health care that will drive toward interoperability and exchange of information.

It is important to note that some of the above measures have not been specifically detailed in full legislation, but statements like “breaking down regulatory barriers to sharing and analyzing health data” would almost certainly implicate changes to HIPAA. It appears that health information and privacy rules and regulations are headed for at least some level of change in the upcoming legislative sessions. Overall, we are in a wait and see position given the various positions lawmakers have been put forth in the past.

Submitted by: Jeffrey Mustari, Esq.

LIFE SCIENCES

Florida Medical Marijuana Constitutional Amendment 2 Passes in General Election

On November 8, 2016, Florida voters approved the medical marijuana constitutional ballot initiative known as Amendment 2. The text of the ballot petition approved in Florida Supreme Court Advisory Opinion No. 15-1796 states that the new amendment will create Article X, Section 29 to the Florida Constitution, titled “Medical marijuana production, possession and use.” The amendment expands the use of medical marijuana to patients suffering from a “debilitating medical condition,” which is defined as cancer, epilepsy, glaucoma, HIV positive- status, AIDS, PTSD, ALS, Crohn's disease, Parkinson's disease, MS, or “other debilitating medical conditions of the same kind or class as or comparable to those enumerated, and for which a physician believes that the medical use of marijuana would likely outweigh the potential health risks for a patient.”

Under the amendment, the term “marijuana” is defined by the same meaning given to “cannabis” in Section 893.02(3), Florida Statutes, the “Florida Comprehensive Drug Abuse Prevention and Control Act” and to “low‐THC cannabis” in Section 381.986(1)(b), Florida Statutes, for the “Compassionate use of low-THC and medical cannabis.” Only a physician that is licensed to practice medicine and who is certified by the Department of Health (“DOH”) may certify a patient as eligible to qualify for the medical use of marijuana by the DOH.

The amendment allows for the administration of medical marijuana by food, tinctures, aerosols, oils, ointments, or related products. The text specifically states that the amendment does not legalize any other use or possession of marijuana, does not require accommodations for patients to use medical marijuana at work, school, or in public places, nor does it require any private or government third-party payer to reimburse a patient for medical marijuana-related expenses.

For the full text of the amendment created by the new Section 29 to Article X of the Florida Constitution, please see Advisory Opinion SC 15-1796 or the approved Constitutional Amendment Petition Form.

Submitted by: Shantal L. Henriquez, Esq.

PUBLIC HEALTH

Report About Opioid Addiction

The Department of Health and Human Services (HHS) has stated that addressing opioid abuse is a high priority, and is promoting access to medication- assisted treatment (MAT)–an approach that combines behavioral therapy and the use of medications–to combat the problem. This study by the US Government Accountability Office (GAO) examines 1) how federal laws and regulations apply when using medications to treat opioid addiction compared to using the same medications for pain management and 2) key factors that can affect access to MAT for opioid addiction.

Online Legal Technical Assistance Knowledge Base. The Network for Public Health Law has released the beta version of a new online tool, the Legal Technical Assistance Knowledge Base, which allows users to access a limited number of records from the Network’s extensive database of legal technical assistance. The Network invites users to explore the Knowledge Base and to provide feedback through an online survey.

The end of AIDS’ Patient Zero myth shows that history is never complete

Sydney Morning Herald (10/31/2016) Joel Meares

Researchers at the University of Arizona recently published a study concluding that Gaétan Dugas, infamously and erroneously dubbed “Patient Zero” of the AIDS epidemic during the 1980s, could not have been the source of HIV in the United States. The researchers studied HIV genome sequences in blood samples from early HIV/AIDS patients in the United States. When they studied Dugas’s blood sample, they found a strain of HIV known to be present in New York years before he visited the city.

This new biological evidence prompts a second look at how the gay community has been portrayed in history. The United Kingdom recently took a step in this direction with the Turing Law, allowing thousands of living and deceased gay and bisexual men to be posthumously pardoned for previously criminalized private, consensual sex acts.

Submitted by: Rodney M. Johnson, Esq.

THIRD PARTY PAYORS

Subsidies in Florida Offset the Rise of ACA Premiums for 2017

Under the Affordable Care Act (ACA) the number of uninsured Americans fell to 8.6% in the first quarter of 2016, the lowest in U.S. history. As of March 2016, 1.5 million people had coverage through Florida’s exchange, accounting for approximately 14% of the entire country’s ACA enrollment. While the number of uninsured Americans has steadily decreased with the enactment of ACA, marketplace premiums continue to rise. The Department of Health and Human Services (HHS) announced that marketplace premiums across states using the Healthcare.gov platform will increase an average of 25% in 2017.

Price hikes for premiums vary widely across the states. In Florida, the average premium increase for 2017 is 19%. However, over 90% of Floridians who enroll in the marketplace will receive subsidies that may offset the premium increase or even lower monthly costs. This is true for both family and individual plans depending on which county the participant resides in. In 2016 over 93% of Florida’s enrollees received subsidies. The average pre-subsidy premium was $386 per month. After subsidies, the premium average was just $84 per month. Nationally, 85% of enrollees will receive a tax credit limiting the premium an enrollee will pay.

Florida utilizes the federally-run exchange where open enrollment for 2017 runs from November 1, 2016 to January 31, 2017. Seven carriers, Florida Blue (BCBS of Florida), Florida Blue HMO (Health Option), Florida Health Care Plan, Inc., Humana, Ambetter, Molina and Health First Health Plans are offering coverage in the Florida exchange for 2017.

Submitted by: Ashley Brevda, Esq.

TRANSACTIONS / MISCELLANEOUS

The MACRA Final Rule: 10 Things You Need to Know

The Centers of Medicare and Medicaid Services (CMS) released the much-anticipated Medicare Access and CHIP Reauthorization Act (MACRA) final rule this month. The rule makes extensive changes to traditional Medicare Part B reimbursement. MACRA moves Medicare away from a primarily volume based fee-for-service system to a value-based system as part of an overarching strategy to transform how health care is delivered in America by rewarding quality improvement, focusing on patient health outcomes, and reducing unnecessary costs.

The final rule eases the administrative burden for provider transition to MACRA, broadens opportunities for participation in advanced alternative models (APMs) and sets aside funding to provide technical assistance to Merit-Based Incentive Payment System (MIPS) participating clinicians in areas with a shortage of health professionals.

Below are answers to ten frequently asked questions:

1. Who is affected?

Physicians, physician assistants, nurse practitioners, clinical nurse specialists and certified registered nurse anesthetists who participate in Medicare Part B, bill Medicare more than
$30,000/year and provide care for more than 100 Medicare patients a year. Note the proposed rule had set the threshold at $10,000/year.

2. What is the Quality Payment Program?

MACRA’s Quality Payment Program (QPP) replaces the sustainable growth rate and continues the agency’s shift toward value-based care reimbursement reform. Medicare Part B participating providers must choose between two tracks: APMs or MIPS.

If providers choose to participate in an Advanced APM through Medicare Part B, they will earn an incentive payment. If, instead, a provider chooses to participate in traditional Medicare Part B, he or she will participate in MIPS, and will earn a performance-based payment adjustment.

Providers may participate as an individual (single National Provider Identifier (NPI)) or a group (sharing a common Tax Identification Number).

3. When does the Quality Payment Program start?

The first performance year starts January 1, 2017 and ends December 31, 2017.

If already participating in an Advanced APM, a clinician can provide care during the year through that model and will be eligible for a 5% incentive payment. If not participating in an Advanced APM, clinicians must participate in MIPS, or will receive a negative payment adjustment.
In the first year of the program, 2017, clinicians can pick the pace of participation in MIPS. Clinicians can begin collecting performance data anytime between the first of the year and October 2nd. To earn a positive payment adjustment, data must be submitted to CMS by March 31, 2018.

Medicare will provide feedback to providers after data submission. If a positive MIPS payment adjustment or Advanced APM incentive payment is earned, clinicians will receive the money beginning January 1, 2019.

4. How will my Medicare payments change?

Depending on the data submitted by March 31, 2018, 2019 Medicare payments will be adjusted up, down, or not at all.

• If clinicians choose not to participate, and do not send any data to CMS in 2017, they will receive a negative 4% payment adjustment;

• If clinicians submit some data, they avoid a negative payment adjustment, but will not receive a positive adjustment;

• If clinicians submit 90 days of 2017 data, they can earn a neutral or small positive payment adjustment;

• If clinicians submit a full year of 2017 data, they may earn a moderate positive payment adjustment;

• If clinicians participate in the Advanced APM path (i.e., they receive 25% of payments from Medicare and 20% of Medicare patients are seen through an Advanced APM in 2017), they will earn a 5% incentive payment.

Note: each year of the program, CMS changes the rates of payment adjustments.

5. How does the final rule affect MIPS?

MIPS streamlines prior CMS initiatives (PQRS, Meaningful Use and Value Based Modifier) with four categories: Quality, Improvement Activities, Advancing Care Information and Cost.

In 2017, CMS will not use the Cost category to determine payment adjustments. Instead, the agency will calculate payment adjustments solely based on the Quality (60% of weighted score), Improvement Activities (15% of weighted score) and Advancing Care Information (25% of weighted score) categories.

6. How does the final rule affect APMs?

Advanced APMs allow practices to earn incentive payments for taking on financial risk related to patient outcomes. CMS will announce 2017 qualifying Advanced APMs by January 1, 2017. As of now, the agency has announced 2017 qualifying advanced APMs include:

Comprehensive ESRD Care (two sided risk model);
Comprehensive Primary Care Plus (CPC+);
Next Generation ACO Model;
Shared Savings Program – Track 2;
Shared Savings Program – Track 3.

7. How does the final rule impact small practices?

The final rule eases the burden on small practices. In 2017, many small practices are excluded from new requirements, because they see less than or equal to $30,000 in Medicare Part B charges or less than or equal to 100 Medicare patients per year. Although it does not apply in 2017, in future years, MACRA will allow solo and small practices to combine and submit MIPS reporting together as virtual groups of no more than 10 clinicians.

8. How do I know if I’m ready to participate in MIPS?

Determine if you will submit data individually or as a group. Then, consider which measures you will submit to CMS in each of the three categories: quality, improvement activities and advancing care information. Use the QPP Website to explore the MIPS data your practice can choose to submit. Choose quality, advancing care information and improvement activities measures which best fit your practice.

Next, consider how you will submit data: via qualified data registry, registry, CMS web interface (for groups) or electronic health record. If you choose to submit via electronic health record (HER), verify that your EHR is certified by the Office of the National Coordinator for Health Information Technology. If so, CMS indicates your EHR is ready to capture information for the MIPS advancing care information category as well as certain quality category measures.

9. Where can I read the final rule?

The final rule is available here: https://www.federalregister.gov/documents/2016/11/04/2016- 25240/medicare-program-merit-based-incentive-payment-system-mips-and-alternative-payment-model- apm.

10. How can I learn more?

On Friday, CMS launched the Quality Payment Program website. The Agency will continue to host listening and learning sessions throughout the country. Additionally, CMS will continue to accept comments on the final rule through December 17, 2016, sixty days after the final rule release date. Comments may be submitted here.

If you have additional questions about how MACRA will affect you and your practice, you should contact a qualified health care attorney or your billing provider.

Submitted By: Elizabeth Scarola M.A., J.D., M.H.S.A.

August - September 2016 Health Law updates

Dear Health Law Section Members:

The Section website has been updated with the August – September 2016 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, its Health Law Section, or Section members. HLS thanks the following volunteers who have generously donated their time to prepare these summaries for our members: 

Shantal L. Henriquez, Esq. 

Rodney Johnson, Esq. 

Monica McNulty, Esq. 

Anu Sagi-Nakkana, Esq. 

Michael Smith, Esq. 

Thank you. 

Patricia Huie, Esq., HLS Team Editor 

Jamie Gelfman, Esq., HLS Team Editor 

Download copies of the August-September 2016 Updates at the following link:

pdf August - September 2016 Health Law Updates (PDF) (73 KB)

FACILITY & PROFESSIONAL LICENSURE 

Rule Changes for Community Pharmacies 

The Board of Pharmacy recently revised the rules for community pharmacies. Fla. Admin. Code R. 64B16-28.1081. Under the revised rule, the prescription department of a community pharmacy must be open for a minimum of 20 hours per week, compared to the previous 40 hours per week minimum; but the Board of Pharmacy could approve shorter hours on a case-by-case basis. Any pharmacy that is not open for 40 hours per week is required to post the days and hours that the pharmacy is open, information for after-hours access, and have a written policy and procedure for transferring prescriptions in compliance with Section 465.026, Florida Statutes, or receiving an emergency dose pursuant to Section 465.0275, Florida Statutes. 

The revised rule also allows a community pharmacy to delay commencing operations once the pharmacy permit has been granted but it must notify the Board office within 14days of receiving the permit of its election to delay operation commencement. The pharmacy also must notify the Board office within two business days of when it does commence operations. A community pharmacy that does not commence operations within six months of receiving the permit must provide a written statement to the Board office explaining why the pharmacy has not commenced operations, the efforts the pharmacy took to commence operations, and the date the pharmacy expects to commence operations. 

Reported by: Michael L. Smith, Esq. 

Hefty Penalty for Area of Critical Need (ACN) Licensee Practicing Outside ACN Facility 

The Board of Medicine imposed a reprimand, a one-month suspension, and a $15,000 fine on a practitioner with an ACN license for multiple instances of practice outside of an ACN facility. DOH v. Alliance, M.D., DOH Case Nos. 2014-3707 and 2014-11390. Additionally, the practitioner must complete the Florida Medical Association course "Legal and Ethical Implications in Medicine: Physician's Survival Guide-Laws and Rules," five hours of continuing medical education in ethics, five hours of continuing education in risk management, and pay the Department of Health's investigative costs. 

A physician practicing under an ACN license may only practice in a county health department; a correctional facility; a Department of Veterans’ Affairs clinic; some community health centers funded by the United States Public Health Services Act; or an agency or institution that is approved by the State Surgeon General. The ACN licensee must also notify the Department within 30 days of accepting employment with a facility. 

Reported by: Michael Smith, Esq.

LIFE SCIENCES 

DEA Denies Petition to Reschedule Marijuana but Authorizes More Manufacturers to Expand Medical Research 

On August 12, 2016, the Drug Enforcement Administration (“DEA”) denied two separate petitions to remove marijuana from the Schedule I classification of the Controlled Substances Act (“CSA”). The first petition requested the DEA to reschedule marijuana as a Schedule II drug, whereas the second petition requested to reschedule marijuana under any schedule except under the Schedule I classification.

In reviewing the petitions, the DEA consulted with the Department of Health and Human Services (“HHS”), the Food and Drug Administration (“FDA”), and the National Institute on Drug Abuse (“NIDA”) to conduct an evaluation on marijuana to determine its efficacy and safety as a medical drug. After the evaluation, the DEA determined that marijuana does not meet the standards for currently accepted medical treatment in the United States. This determination, coupled with marijuana’s high potential for abuse, lead the DEA to deny the petitions at this time. The DEA’s response to the petitions state that the DEA and FDA continue to believe that the best of course action regarding marijuana is to conduct clinical trials under the FDA’s Investigational New Drug (“IND”) application process rather than to reschedule marijuana, and to allow the FDA to determine whether marijuana is safe and effective for medical use. 

In line with its decision that clinical research is the best course of action to determine whether marijuana can be nationally classified as a medical drug, the DEA issued a new rule adopting a policy to authorize more manufacturers to grow marijuana for scientific and medical research. For the past 50 years, the DEA has had only one manufacturer registered under the CSA to grow marijuana for federal research, the University of Mississippi. Now, the DEA seeks more applicants to supply the FDA with a more diverse selection of “cannabinoids” to allow the FDA to research the various types of cannabinoids that can be used to treat various ailments. Cannabinoids are the chemical compounds found in the marijuana plant that researchers isolate and use in medical treatment and research. 

These decisions follow only a few weeks after the first licensed, medical marijuana dispensary opened in Florida on July 22, 2016, Trulieve, which offers medical marijuana for state-wide sale in the form of low-THC (tetrahydracannabinol) and medical cannabis. The DEA’s decision to expand medical marijuana research can affect the variety of products to which licensed Florida medical marijuana patients will have access now that it is currently available to treat patients diagnosed with severe seizure disorders or a terminal illness. Florida authorized the cultivation, sale, and use of low-THC and medical cannabis to treat those patients under the Compassionate Medical Cannabis Act of 2014, as amended by the Right to Try Act. 

Reported by: Shantal L. Henriquez, Esq.

PUBLIC HEALTH 

Public Health Law and Policy and Perspectives 

Preemption and Public Health – Lessons from the Federal GMO Disclosure Law 

In July, Congress passed a bill requiring that foods containing genetically modified organisms (GMOs) display a federally-mandated disclosure. The bill, recently signed into law by President Obama, includes a provision expressly preempting all state and local GMO labeling regulations that are not identical to the new federal standard. 

Resources 

Medical Marijuana – State Regulatory Statutes Governing Use 

https://www.networkforphl.org/resources_collection/2016/08/17/810/survey_medical_marijuana_state_regulatory_statutes_governing_use/?utm_source=Network+Report+8-18-16&utm_campaign=Network+Report+8-18-16&utm_medium=email&utm_content=248 

This resource outlines conditions related to the use of medical marijuana, including patient qualifications, insurance coverage, use restrictions, and includes provisions for minors’ use of medical marijuana. 

Medical Marijuana – State Regulatory Statutes Governing Distribution and Consumption

This resource details state-specific regulations related to permitted forms of consumption, dispensing, cultivating, packaging, and taxation of medical marijuana, and summarizes cities’, towns’ and counties’ powers to regulate the production of medical marijuana. 

Career Opportunities 

NHeLP Health Law Fellowships: http://www.healthlaw.org/about/job-opportunities 

The National Health Law Program has two new temporary full-time positions for health law fellows, based in its Los Angeles, CA office and Carrboro, NC office. Both positions are immediately available and are funded through June 30, 2017. Ideal candidates will have strong research and writing skills, familiarity with the Medicaid program and public health law, the ability to work individually and in teams, and a demonstrated interest in using law to reduce disparities and improve health. 

Judge won't block strict child vaccination law in California – CBS News 

A U.S. District Court judge in San Diego ruled last week to uphold California’s vaccination law. The law, which went into effect July 1, 2016, requires all children, except those with medical exemptions, to be vaccinated for certain infectious diseases before attending private or public schools or day care facilities. The law did not allow religious or personal belief exemptions. 

FDA Calls for Zika Testing of All Blood Donations – Wall Street Journal 

On August 26, 2016, the FDA recommended that all blood banks screen blood donations in the U.S. for the Zika virus. The agency advised that blood banks in these states begin testing in the next four weeks: Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas; and that blood banks in all other states test within 12 weeks. 

Pregnant Women Advised to Avoid Travel to Active Zika Zone in Miami Beach– NY Times 

In mid-August, local Zika virus transmissions were reported in Florida, prompting the CDC to issue travel advisories for two areas in the state: a one-square mile area in a neighborhood north of downtown Miami, and a 20-block stretch in Miami Beach. The CDC generally must defer to state officials when determining boundaries for areas of disease transmission and related travel warnings. 

U.S. Affirms Its Prohibition on Medical Marijuana – Washington Post 

On August 11, 2016, the DEA announced that marijuana will remain a Schedule 1 substance under the Controlled Substances Act, meaning it is illegal for any purpose, including medical use. Advocates for marijuana legalization hoped that the increase in states’ legalization of medical marijuana would soften the federal government’s stance on the drug. At least eight states will consider marijuana issues in this year’s November election. 

Grand Rounds: Preventing Suicide through a Comprehensive Public Health Approach 

CDC Media Relations: (404) 639-3286 

Suicide is a serious, but preventable, public health problem in the United States, with over 42,000 suicides among persons over the age of 10 in 2014. The overall suicide rate has increased by 27 percent since 2000. We, however, can work to reduce the number of people who consider suicide, the number who attempt suicide, and the number who die from suicide. Suicide is preventable by complementing mental health treatment with public health prevention strategies. A public health approach uses data to understand suicide; addresses the individual, family and community factors that contribute to suicide; reaches a broader segment of the population; and implements the best available prevention strategies. The risk for suicide can further be decreased by providing safe and appropriate communication to reduce the stigma associated with seeking help from others and using support systems, such as the National Suicide Prevention Lifeline (1-800-273-TALK). 

Reported by: Rodney Johnson, Esq.

THIRD PARTY PAYORS 

FLOIR Announces 2017 Premium Increase for Individual Major Medical Plans 

On September 6, 2016, the Florida Office of Insurance Regulation (“FLOIR”) released approved premium changes for the fifteen health insurance companies submitting rate filings for FLOIR’s review. The rate filings were for plans to be sold both on and off the Exchange. On average, premiums will increase by 19% beginning January 1, 2017. 

FLOIR noted that the approved percentages were approximately two percentage points higher than the increases requested by the insurers in their May 2016 rate filings. According to FLOIR, this increase is partly due to several insurers writing only off-Exchange policies in Florida for 2017. Insurers’ decreased participation in the Exchange impacted risk pool estimates. 

The rate information is subject to change until final approval from the Department of Health and Human Services. 

Reported by: Monica M. McNulty, Esq. 

Florida Telehealth Advisory Council Appointed 

In April 2016, Governor Scott signed HB 7087, which is designed to pave the way for future telehealth reimbursement legislation. The new law created a Telehealth Advisory Council within the Agency for Health Care Administration (“AHCA”). On July 27, 2016, AHCA announced the names of the 13 individuals who have been appointed to the Council. 

The Council is charged with examining the types of telehealth services that are available in the state and existing coverage for such services. By October 31, 2017, the Council must make recommendations to increase the use and accessibility of telehealth services, including identification of any barriers to access, in a report to the Governor, the President of the Senate, and the Speaker of the House of Representatives. 

The Council is chaired by AHCA Secretary Elizabeth Dudek, and is composed of the Florida Surgeon General Celeste Philip and the following appointees: 

• Elizabeth Miller, CRNP. Chief Operation Officer of WellCare Health Plans. 

• Dr. Ernest Bertha. Medical Director of Sunshine Health. 

• William Manzie. Administrative Director of Telehealth Strategy for Memorial Healthcare. 

• Matthew Stanton. Senior Director of Distance Health for the Cleveland Clinic. 

• Dr. Steven Selznick. CEO/president for Selznick Consulting. 

• Darren Hay. Senior Vice President of Ideal Life. 

• Monica Stynchula. CEO of REUNIONCare and acting state president of AARP.

• Leslee Gross. Assistant Vice President of Operations for Baptist Health South Florida. 

• Dr. Kevin O’Neil. Chief Medical Officer of Brooksdale Senior Living, Inc. 

• Dr. Kim Landry. EMS Medical Director and Chief Medical Officer for Leon County EMS and Lifeguard Ambulance Service, Inc. 

• Dr. Sarvam Terkonda. Site Medical Director for Connected Care in Florida for the Mayo Clinic. 

• Dr. Anne Burdick. Professor of Dermatology, Leprosy Program Director and Associate Dean for Telehealth and Community Outreach for the University of Miami, Miller School of Medicine. 

• Mike Smith. Telemedicine Program Development Director for Florida State University, College of Medicine. 

Reported by: Monica M. McNulty, Esq.

TRANSACTIONS 

Aetna Exits Majority of ACA Markets: Reaction to DOJ’s Lawsuit to Thwart the Aetna-Humana Merger? 

Aetna, Inc. recently announced that it would stop selling individual Affordable Care Act (“ACA”) (also known as “Obamacare”) plans in most major markets next year. Aetna plans to stop selling these plans in 11 of the 15 states where it was participating in the program, including Florida. However, Aetna will continue to sell plans on state exchanges in Iowa, Delaware, Nebraska and Virginia. Earlier this year, Aetna said it expected to lose over $300M on the plans. Both Humana Inc. and UnitedHealth Group Inc. have also stated that they plan to pull out of the ACA marketplaces. 

Earlier this year, Florida regulators had conditionally approved Aetna’s acquisition of Humana’s Florida-based Affiliates (February 15, 2016). That conditional approval included a requirement that Aetna expand its offerings on the state exchange to include five additional counties by 2018 and extend its reach even further by 2020. Florida regulators had also conditionally approved Anthem’s acquisition of Cigna’s Florida-based affiliates (April 1, 2016). 

However, the conditional approvals occurred before the U.S. Department of Justice (DOJ) sued to block both Aetna’s plan to purchase Humana ($37 billion) and Anthem’s plan to purchase Cigna ($54 billion) because “the transactions would increase concentration and harm competition across the country, reducing from five to three large, national health insurers in the nation.” The DOJ and state attorneys general filed two merger challenges in the U.S. District Court for the District of Columbia alleging that the mergers “would harm seniors, working families and individuals, employers and doctors and other healthcare providers by limiting price competition, reducing benefits, decreasing incentives to provide innovative wellness programs and lowering the quality of care.” Dept. of Justice Press Release, July 21, 2016. 

In a July 5, 2016 letter from Aetna CEO, Mark Bertolini, to the DOJ, Aetna suggested that if the government blocked the merger then Aetna would begin withdrawing from the health insurance exchanges; and on August 15, 2016, Aetna announced that it would withdraw from most major markets. 

Reported by: Anu Sagi-Nakkana, Esq.

June - July 2016 Health Law updates

Dear Health Law Section Members:

The Section website has been updated with the June-July 2016 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, its Health Law Section, or the authors of these summaries. You will note that there are two summaries regarding the U.S. Supreme Court opinion in United Health Services v. United States ex rel. Escobar, No. 157, slip op. (U.S. June 16, 2016). Considering the significance of this opinion, we have chosen to publish both summaries.

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

Lindsay Dosen, Esq.

Jaime B. Gelfman, Esq.

Matt Henderson, Esq.

Rodney Johnson, Esq.

Jeffrey Mustari, Esq.

Anelia Shaheed, Esq.

Michael L. Smith, Esq

Thank you.

Malinda Lugo, Esq.

Kimberly Sullivan, Esq.

Download copies of the June-July 2016 Updates at the following link:

pdf June July 2016 Updates (PDF) (270 KB)

document June July 2016 Updates (DOCX) (31 KB)

COMPLIANCE

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