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FDA Releases Draft Guidance to Revamp Drug Indication and Usage Labels

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On July 6, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance outlining its recommendations for how drug companies should word the indications and usage sections on a drug’s label. The new guidance aims to increase readability and reduce redundant information on indications and usage.

Drug Indication Label.

Prescribers can expect to see revamped drug labels with clearer descriptions of the conditions and patient populations for which an FDA-approved drug is indicated. Also, described in the guidance are circumstances when it might […]

By The Health Law Firm|2024-03-14T10:00:24-04:00July 12, 2018|The Health Law Firm Blog|

Texas Doctor Charged With Faking Diagnoses in $240 Million Health Care Fraud Scheme

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On May 14, 2018, a Texas doctor was arrested on charges he led a $240 million health care fraud and money laundering scheme. He allegedly falsely diagnosed at least 16 patients with degenerative diseases and gave them unneeded chemotherapy and other treatments.

Fake Diagnoses and Treatments.

The doctor allegedly bilked Medicare, Medicaid, TRICARE, Blue Cross Blue Shield and others through a scheme in which he would falsely diagnose patients with diseases like rheumatoid arthritis. According to the indictment, he would then give them treatments […]

By The Health Law Firm|2024-03-14T10:00:24-04:00July 5, 2018|The Health Law Firm Blog|

First Year Pioneer ACO Results: Medicare Money Saved But Some Physicians Leave Program

By Lance O. Leider, J.D., The Health Law Firm

On July 16, 2013, the Centers for Medicare and Medicaid Services (CMS) issued a press release summarizing the performance results for the first year of the Pioneer Accountable Care Organization (ACO) Model. Made possible by the Patient Protection and Affordable Care Act (PPACA), the Pioneer ACO Model encourages providers and care givers to deliver more coordinated care ans services for Medicare beneficiaries. ACOs, including the Pioneer ACO Model and the Medicare Shared Savings Program, are one way CMS is providing options to providers looking to better coordinate care for patients and use health care dollars more wisely, according to CMS.

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By The Health Law Firm|2024-03-14T10:00:51-04:00June 1, 2018|ACO, In the Know, The Health Law Firm Blog|

MedPAC Wants to Hold Accountable Care Organizations More Accountable

By Lance O. Leider, J.D., The Health Law Firm

As the Centers for Medicare and Medicaid Services (CMS) prepares to designate the next class of accountable care organizations (ACOs), the agency sought the advice and input of the Medicare Payment Advisory Commission (MedPAC) on how to proceed. MedPAC is an independent Congressional Agency established to advise the U.S. Congress on issues affecting Medicare.

Click here to read our previous blog on the background and purpose of ACOs.

MedPAC Suggests All Medicare Shared Savings Program ACOs Join the Two-Sided Risk Model.

In response to the request from the CMS, MedPAC reiterated its previous position that it would like to see […]

By The Health Law Firm|2024-03-14T10:00:53-04:00June 1, 2018|ACO, Health Care Industry, In the Know, Medicare, The Health Law Firm Blog|

CMS Extends Waivers under the ACO Shared Savings Program

By Lance O. Leider, J.D., The Health Law Firm

On November 2, 2011, the Centers for Medicare and Medicaid Services (CMS) promulgated the interim final rule on fraud and abuse waivers for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program. The interim rule can be found at 76 Fed. Reg. 67801. The waiver was granted pursuant to the agency’s authority under the Affordable Care Act, specifically, 42 U.S.C. § 1899(f).

You can read our prior blog postings on the ACO waiver programs here.

Normally, interim final rules are only permitted to remain in effect for a maximum of three years […]

By The Health Law Firm|2024-03-14T10:00:58-04:00June 1, 2018|ACO, Affordable Care Act, The Health Law Firm Blog|

Burden of Proof in Administrative Cases Involving Discipline of a Health Professional’s License – Part 1

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

I am often asked about the burden of proof that must be met by the state Department of Health (DOH) in professional licensing disciplinary cases. This could be a complaint against a physician, dentists, mental health counselor, nurse, psychologist, pharmacist or anyone else. It also includes, for example, engineers, general contractors, school teachers, architects, cosmetologists, or any other professional holding a professional license in Florida. However, since we routinely represent health professionals, I will concentrate on those licenses by the state DOH in this blog.

Overview.

What few people (even […]

By The Health Law Firm|2024-03-14T10:00:43-04:00June 1, 2018|Administrative law, Department of Health, Licensing issues, The Health Law Firm Blog|

Burden of Proof in Administrative Cases Involving Discipline of a Health Professional’s License – Part 2

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

I am often asked about the burden of proof that must be met by the state Department of Health (DOH) in professional licensing disciplinary cases. This could be a complaint against a physician, dentists, mental health counselor, nurse, psychologist, pharmacist or anyone else. It also includes, for example, engineers, general contractors, school teachers, architects, cosmetologists, or any other professional holding a professional license in Florida. However, since we routinely represent health professionals, I will continue to concentrate on those licenses by the state DOH in this blog. Click here to read part one.

Fifth […]

By The Health Law Firm|2024-03-14T10:00:43-04:00June 1, 2018|Administrative law, Licensing issues, The Health Law Firm Blog|

Massage Therapists Needs Good Professional Liability Insurance, Too

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Whether you’re an independent contractor, an employee of a chiropractor, physician or spa, or you travel to clients’ homes, insurance is essential for all massage therapists. Not only can professional liability insurance protect you in the event of a lawsuit, but it may also pay your legal defenses in the event of a complaint against your license to practice or for other legal problems. In Florida, it is not mandatory for a massage therapist to have professional liability insurance. However, since it is so cheap, we always recommend buying coverage. It’s a […]

By The Health Law Firm|2024-03-14T10:00:43-04:00June 1, 2018|Administrative law, Insurance, Massage Therapy, The Health Law Firm Blog|

Locating a Healthcare Providers Service Organization (HPSO) Insurance Defense Attorney in Florida

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

We are sometimes told by the health professionals we represent especially pharmacists, licensed mental health counselors (LMHCs), advanced registered nurse practitioners (ARNPs), massage therapists and physical therapists that after they received a complaint regarding their license from the Florida Department of Health (DOH) they had difficulty finding an experienced attorney in Florida who would accept their professional liability insurance. In this case, I am speaking specifically about Healthcare Providers Service Organization (HPSO) Insurance.

Benefits of HPSO Insurance.

The professionals who are covered by HPSO Insurance have excellent insurance coverage. HPSO Insurance […]

By The Health Law Firm|2024-03-14T10:00:44-04:00June 1, 2018|Administrative law, Insurance, The Health Law Firm Blog|

Hydrocodone Combination Drugs Could Be Reclassified to Schedule II Category of Controlled Substances

By Lance O. Leider, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Food and Drug Administration (FDA) advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs from schedule III into the more restrictive schedule II category of controlled substances. According to a number of different sources, on January 25, 2013, the committee presented this recommendation to the FDA. If approved, hydrocodone combination drugs, such as Vicodin, will be harder for physicians to prescribe.

The advisory committee met because the Drug Enforcement Administration (DEA) is requesting the FDA to […]

By The Health Law Firm|2024-03-14T10:00:45-04:00June 1, 2018|Administrative law, Department of Health, In the Know, Pain Management, The Health Law Firm Blog|