Category Archives: Government Affairs, Licensure & Regulatory

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State Releases Medicaid Managed Care Invitation to Negotiate

Last Friday, July 14, 2017, the Florida Agency for Health Care Administration (AHCA) released its long awaited Invitation to Negotiate (ITN) for State Wide Medicaid Managed Care services. The ITN, one for each of the 11 regions within the state, may be found on the state Vendor Bid System (VBS), the link for which is provided here. This ITN … Continue Reading

Senate Healthcare Bill Released for Public Review

Just over four weeks after the Congressional Budget Office (CBO) released its score of the American Healthcare Act (AHCA), the bill passed by a narrow margin in the U.S. House of Representatives, the U.S. Senate released ‘The Better Care Reconciliation Act of 2017’. Upon initial review, we are providing a quick overview of this proposed legislation. … Continue Reading

Repeal of the Affordable Care Act Will Not Include Changes to Tax Exempt Hospitals’ 501(r) Charitable Care Obligations

While the Senate Budget Committee works to draft legislation to reconcile the American Health Care Act, the repeal and replace bill passed by the House, there is no expectation of a repeal of the charitable care obligations imposed on tax exempt hospitals under Section 501(r) of the Internal Revenue Code as part of the Affordable Care Act.… Continue Reading

The American Health Care Act, the Sequel Receives Its CBO Grade

Perhaps the high fives in the Rose Garden of the White House a few weeks ago may have been a bit premature. On Wednesday, May 24, 2017, the non-partisan Congressional Budget Office (CBO) released its analysis of the revised American Health Care Act (AHCA), and the review contained positive budgetary news, but the overall impact of the bill on health … Continue Reading

The American Health Care Act: Now What Happens?

To great fanfare by both the leadership of the Republican caucus in the House of Representatives (the House) and President Trump, on May 4, 2017, the American Health Care Act (AHCA), the proposed successor/replacement to the Affordable Care Act (ACA), passed the House by a narrow vote of 217-213. Unsurprisingly, no member of the Democratic Party in the House voted … Continue Reading

Potential Implications to the ACA Under the Incoming Republican Administration – Part I: the Insurance Industry

In the uncertain atmosphere surrounding the process of ‘repealing’ and replacing the Affordable Care Act (ACA), there are some clues as to what we can expect to come next, at least with regard with the health insurance industry. Obviously, one place to look is to President-Elect Trump himself. During his campaign, then-candidate Trump published a seven-point position statement on healthcare … Continue Reading

Former Home Health Agency Owner Sentenced to 20 Years for $57MM Medicare Fraud

The US Department of Justice announced that Khaled Elbeblaswy, the former owner and manager three Miami-area home health agencies, was sentenced to 20 years in prison and ordered to pay $36.4 million in restitution for his role in a $57 million Medicare fraud scheme.… Continue Reading

The Board of Pharmacy’s 40 Hour Rule is Dead! Long live the 20 Hour Rule! Community Pharmacy Ownership Rule Change Creates new Opportunities

The Florida Board of Pharmacy (BOP) recently amended the rules regarding community pharmacy hours of operation to reduce required daily operating hours from 40 to 20 hours per week. As before, the hours have to be posted and the pharmacy must have a policy and procedure for transferring prescriptions and addressing emergency doses.… Continue Reading

Insurers Challenge Retroactive Application of New Florida Law that Requires Comparison of Names of Accounts to Death Master File

Amendments to the Florida Disposition of Unclaimed Property Act in 2016 made significant changes to unclaimed property presumptions and insurance company obligations. See § 717.107, Fla. Stat. (2016) (the Act). Among other things, the Act: (a) revises conditions of when certain insurance policies or annuity contracts are deemed matured and the proceeds are due and payable; (b) requires  insurance companies … Continue Reading

Medical Marijuana’s Florida Debut: A Process Fraught with Constraints

Florida’s limited medical marijuana program is finally almost ready to go live. For those who have been sitting on the sidelines waiting for the right moment to learn about the program, now is that moment. Recently, the Florida Department of Health (DOH) hosted a webinar highlighting some of the key features, as well as limitations of the program. The smoking … Continue Reading

Surprise Medical Bills? The Florida Legislature Offers Some Relief!

With House Bill 221, the last bill to pass during the 2016 legislative session, the Florida legislature took a significant step towards reducing uncertainty for medical costs for persons with Preferred Provider Organization (“PPO”) health insurance by limiting unanticipated, balance billing.  “Balance billing” is the practice of providers charging patients for a bill, or any remainder of a bill, … Continue Reading

Protecting the Blood Supply During a Future Ebola Outbreak

It has been more than a year and a half since the Ebola outbreak began racing across western Africa. According to the U.S. Centers for Disease Control & Prevention (CDC), more than 28,000 people have been infected. Although the United States had very few Ebola patients, the Food and Drug Administration (FDA) recently released guidance for the collection of blood … Continue Reading

Culture of Safety Wins: Federal Patient Safety Law Preempts Amendment 7

Florida’s First District Court of Appeal issued its opinion in the highly watched case of Southern Baptist Hospital of Florida, Inc. v. Charles et al. The First District Court ruled that the federal Patient Safety and Quality Improvement Act of 2005 (PSQIA):

  • Expressly preempts any broad discovery rights afforded under Florida’s Amendment 7 for documents meeting the definition of Patient
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Two-Midnight Rule Update

The Centers for Medicare and Medicaid Services (CMS) announced a further delay, through December 31, 2015, of the Recovery Auditors’ (RA) audits of the “Two-Midnight” Rule. Congress previously passed a law delaying enforcement Recovery Audits for the Two Midnight Rule through September 30, 2015. This has now been extended through December 31, 2015 with enforcement audits of suspect non-compliant … Continue Reading

CMS Extends Enrollment Moratorium on Home Health Agencies

The Centers for Medicare and Medicaid Services (CMS) announced that it will once again extend the moratorium on the enrollment of new home health agencies, branch locations and subunits in certain metropolitan areas of Florida, Texas, Illinois, Michigan, New Jersey and Pennsylvania. In Florida, the moratorium continues in effect in Miami-Dade, Broward, and Monroe counties. The table below identifies the … Continue Reading

Legislature Reins in Addiction Recovery Residences

Florida law makers have decided it is high time to stop allowing addiction recovery residences to operate without regulatory oversight. In its last session, the Florida Legislature passed a new law (CS/CS/HB 21) requiring that the Department of Children and Families (DCF) create a voluntary certification program for substance abuse recovery residences, as well as requiring certification of residence administrators … Continue Reading

Recent Legislative Developments Affecting Florida Pharmacies

Florida’s 2015 Legislative Session ushered in two new laws affecting pharmacies: One addressing pharmacist immunizations (HB 279) and the second clarifies that veterinarians are authorized to dispense compounded drugs and regulates “maximum allowable cost” pricing (HB 1049). In addition, the FDA has delayed enforcement of certain provisions of the federal Drug Quality and Security Act (DQSA) that went into effect … Continue Reading

King v. Burwell: An Answer Arrives

Thursday’s Supreme Court decision in the King v. Burwell case can be seen as a major victory for the Obama Administration, resolving, at least for the time being, the continued implementation of the Affordable Care Act by upholding insurance subsidies for about 6.4 million consumers in over 34 states. Once again, Chief Justice John Roberts, came to the rescue of … Continue Reading

What Is Your Fraud Rank?

On June 2, 2015, Center for Medicare & Medicaid Services (CMS), provided direction to state Medicaid Directors on the implementation of Section 6401 of the Affordable Care Act, Provider Screening and Other Enrollment Requirements under Medicare, Medicaid and the Children’s Health Insurance Program (CHIP).… Continue Reading

The Top 10 Patient Safety Concerns for Healthcare Organizations in 2015

The Emergency Care Research Institute, (ECRI) Patient Safety Organization (PSO) has issued its 2015 “top 10 list” of safety concerns for multiple healthcare settings, such as hospitals, ambulatory care centers, doctor’s offices and nursing homes.[i] This year’s list is as follows:… Continue Reading

Charitable Hospitals: Financial Assistance Policies

The Internal Revenue Service (IRS) has issued the final section 501(r) regulations, implementing the amendments to the Internal Revenue Code under the Affordable Care Act and providing regulatory guidance for tax-exempt hospitals. This post describes the guidance for financial assistance policies, limitation on charges, and billing and collection practices and highlights the changes made between the proposed and final rules. … Continue Reading

Efforts to Stop Health Insurance Fraud Through Use of Contractors Under Fire

In recent reports, from June 25, 2014 and August 13, 2014, the Government Accountability Office (GAO) highlights the mixed results achieved by the federal government’s increased efforts to crack down on health insurance fraud through the use of contractors. The government has spent upwards of $600 million a year to uncover and punish health care fraud and overpayments, but  some … Continue Reading

Florida Information Protection Act of 2014 – Florida Means Business When It Comes to Protecting Customers’ Personal Information

On June 20, 2014, Governor Rick Scott signed into law the Florida Information Protection Act of 2014 (“FIPA”), which became effective July 1, 2014. FIPA expands the obligations of businesses and government entities that maintain data containing personal information of individuals to safeguard and provide notice of breaches of such information. As a result, Florida now has one of, if … Continue Reading

FDA Issues Draft Guidance for Drug and Device Information on Social Media

The Food and Drug Administration (“FDA”) recently issued two draft guidance documents relating to the use of Twitter and other social media by drug and medical device companies. Emphasizing that companies must give a balanced presentation of their products, the Agency stated that companies must provide risk information along with any benefit information within a tweet or similar promotional message.… Continue Reading

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