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Stem Cell Litigation Update: FDA Granted an Injunction

June 7th, 2019 by

stem cell litigationBy: Matt Fischer

In a decision expected to cause waves through the rapidly-expanding regenerative medicine industry, a U.S. District Court Judge ruled on June 3rd that the U.S. Food and Drug Administration (FDA) is entitled to an injunction in a lawsuit filed against U.S. Stem Cell Clinic, LLC (US Stem Cell) based in Sunrise, Florida.  In her decision, U.S. District Court Judge Ursula Ungaro agreed that the FDA has the authority to regulate the popular stem cell procedure known as stromal vascular fraction (SVF) – administering processed stem cells derived from adipose tissue (i.e. fat tissue) – and that US Stem Cell is not exempt from regulation.

To recap, in May 2018, the U.S. Department of Justice (DOJ) filed complaints against US Stem Cell and a California stem cell clinic seeking permanent injunctions to prevent the marketing and administration of the SVF procedures without FDA approval.  Prior to the filing of these actions, both companies received warning letters from the FDA.  The letters also addressed the results of inspections and the need to resolve significant deviations from manufacturing practice requirements.  read more

House and Senate Agree on New Florida Telehealth Bill

May 7th, 2019 by

florida telehealth lawMonday, April 29, 2019, the Florida House and Senate came to agreement on a new Telehealth bill (HB 23). If signed by Governor DeSantis, the bill will become effective July 1, 2019.

The bill creates two new statutes: Section 456.47 and Section 627.42396, and amends Section 641.31.

Telehealth Services

Section 456.47 sets forth the standards of practice for telehealth providers, authorizes the use of telehealth encounters for patient evaluations, and allows certain providers to prescribe certain controlled substances in limited circumstances. The bill also allows non-physician providers to use telehealth without being deemed to be practicing medicine without a license. Further, the bill sets forth record keeping requirements and registration for out-of-state telehealth providers. It authorizes the Department of Health to establish rules for telehealth, including exemptions from registration requirements, and to set up disciplinary action against telehealth providers that violate the law or rules. read more

Physician Employment Contracts: Hidden Terms

January 11th, 2019 by

physician employment contractBy: David Davidson

Over the past few years, it seems like physician employment agreements are getting shorter and shorter.  While I applaud all efforts towards efficiency and economy, you should not always take those documents at face value.  For example, I recently reviewed a one page employment contract for a client.  That single page basically said, “We are hiring you as our employee for a term of one year, with an annual salary of $$$.”

At first glance, the simplicity of that document might seem refreshing.  That’s especially true if you’re worried about how much time it’s going to take for your lawyer to get through it!  My client’s second glance revealed a multitude of unanswered (and essential) questions.  There was no mention of expected duties, schedules, standards, renewals, terminations, insurance, benefits, vacation time, sick leave, CME, etc. in the employment contract  However, when we reviewed the contract together, we discovered that although those points were not even referenced on that single page, they were still legally, “in there.” read more

Healthcare Transactions Today: Selling a Medical Practice to Private Equity Buyers

November 12th, 2018 by

private equityBy: Jeff Cohen

Private money (e.g. private equity) is in full swing purchasing medical practices with large profit margins (e.g. dermatology). This is NOT the same thing as when physician practice management companies (PPMCs) bought practices the 90s.  Back then, the stimulus for the seller was (a) uncertainty re practice profits in the future, and (b) the stock price.  Selling practices got some or all of the purchase price in stock, with the hopes the purchasing company stock would far exceed the multiplier applied to practice “earnings” (the “multiple”).  Buyers promised to stabilize and even enhance revenues with better management and better payer contracting.  If the optimism of the acquiring company and selling doctors was on target, everyone won because the large stock price made money for both the buyer and seller. The private equity “play” today is a little different.

Today’s sellers are approaching the private equity opportunity the same way they did with PPMCs, except for the stock focus since most private equity purchases don’t involve selling doctors obtaining stock.  Sellers hope their current practice earnings will equate to a large “purchase price.”  And they hope the buyer have better front and back office management that will result in more stable and even enhanced earnings.  And for this, the private equity buyer takes a “management fee,” which they typically promise (though not in writing) to offset with enhanced practice earnings.     read more

PHI Breach Penalty Dollars Rolling in for Healthcare Enforcement

November 1st, 2018 by

PHI BreachBy: Dave Davidson

It has been a busy autumn for the enforcement of health care privacy rights.  Recent activities range from settling the claim for the largest HIPAA violation in US history, to penalties imposed for filming TV shows, to actions initiated by state governments.  All of these actions confirm the serious position taken by regulators nationwide to protect the privacy of protected health information (PHI).

The Big One

On October 15, 2018, Anthem, Inc., an independent licensee of Blue Cross, paid $16 million to settle its claim with the HHS Office of Civil Rights (OCR), for a breach that compromised the PHI of 79 million people.  This was the largest reported breach in history.  The PHI breach occurred in 2015, when hackers initiated a “spearfishing” attack via fraudulent emails.  The government found that Anthem lacked appropriate information system procedures to identify and respond to security breaches, and minimum access controls to stop these kinds of attacks.

In addition to the financial penalty, Anthem agreed to a corrective action plan, in which it agreed to perform a risk analysis, and incorporate the results of the analysis into its existing processes, in order to achieve a “reasonable and appropriate level” of HIPAA compliance.

This settlement is in addition to the $115 million settlement Anthem reached last year with the victims of the breach. read more

A New Perspective from CMS? Medicare, Stark Law and Whistleblower Changes on Deck

October 2nd, 2018 by

medicare stark lawBy: Dave Davidson

Over the past several months, the Centers for Medicare & Medicaid Services (CMS) has taken a number of steps that show an awareness of the regulatory burden placed upon participants in the government’s health care programs, and even some willingness to consider reducing those burdens.  While it remains to be seen whether the recent proposals will have measurable results, the following actions can still be viewed with guarded optimism.

Proposed Changes to Medicare

In July, 2018, CMS proposed significant changes to Medicare, to be included in rules that take effect in 2019.  These changes cover physician fee schedules, streamlining Evaluation & Management (E&M) billing, advancing “virtual care,” decreasing drug costs, revising the MIPS program and establishing the MAQI demonstration project.  The agency also asked for comments on price transparency issues. read more

Behavioral Analysis Medicaid Providers: Florida’s Latest Enforcement Target

July 20th, 2018 by

behavioral analysis medicaidBy: Matt Fischer

Florida’s Agency for Health Care Administration (“AHCA”) is the state’s chief health policy and planning organization.  AHCA is also responsible for the state’s Medicaid program.  One of the agency’s latest targets are behavioral analysis providers who treat children with autism.  Recently, AHCA imposed a temporary six-month moratorium on enrollment of new providers due to newly discovered fraud and abuse.  AHCA states that the temporary moratorium will allow the agency the time to complete a full assessment of the current provider population.  In other words, all behavioral analysis providers will experience heightened scrutiny in the coming months if not already.  This can include in-person interviews and requests for records.  Given this increased regulatory action, it is important for behavioral analysis business owners to be aware of the audit process and to prepare for likely future reviews.

Here are a few of the notable findings cited by AHCA regarding the identified fraud and abuse: read more

Medicare Opt Out: Part II

July 10th, 2018 by

medicare opt outBy: Susan St. John

As noted in Opting Out of Medicare Part I, opting out of Medicare may be an option for some physicians and practitioners. After determining whether you are eligible for opt-out or if it is financially feasible, there are a few other considerations. Part I discussed the Private Contract a physician must enter into with each Medicare beneficiary he or she treats; here, we will address the opt-out affidavit and other nuances of opting out. Let’s get started!

The Medicare Opt Out Affidavit

Provisions in an Opt Out Affidavit are similar to provisions that must be included in the opted out physician’s or practitioner’s private contract with Medicare beneficiaries. The opt-out affidavit must state that the physician or practitioner will only provide services to Medicare beneficiaries with whom they have a written and signed private contract and that the physician or practitioner will not submit claims to Medicare on behalf of Medicare beneficiaries. Medicare does allow for an exception here, but that is only when an opted out physician or practitioner treats a Medicare beneficiary who is not under private contract, and that beneficiary presents with a medical emergency or urgent care problem. Keep in mind, that if a Medicare beneficiary presents with a medical emergency or urgent care problem, the physician or practitioner cannot require that patient to sign a private contract at that time. read more

Complicated Relationships: Medical Director Contract, Marketing Agreement, Healthcare Consulting

May 16th, 2018 by

medical director contractBy: Jacqueline Bain

Healthcare providers often have more than one relationship with each other. For instance, a physician may be employed by a hospital and also provide that hospital with medical director services. Or a healthcare consultant may also be a healthcare provider’s landlord. Oftentimes, these types of relationships are each memorialized in one or several contracts between the parties. And while, on their face, these contracts may seem to be compliant with applicable healthcare laws, when examined together, compliance and other contract issues may arise. read more

Opt Out of Medicare: What Physicians & Practitioners Need to Know

May 14th, 2018 by

opt out of medicareBy: Susan St. John

Physicians and practitioners are ordinarily required to submit claims on behalf of Medicare beneficiaries when payment may be made for items and services provided by the physician or practitioner. However, in today’s health care environment, more and more physicians and practitioners are considering opting out of Medicare. For those professionals facing this decision, there are a few things to consider.

Is the Physician or Practitioner Eligible to Opt-Out?

First, determine if you are eligible to opt out of providing services to Medicare patients. Not every physician or practitioner is eligible to opt out of Medicare. For purposes of opting out of Medicare, “physician” is limited to: doctors of medicine; doctors of osteopathy; doctors of dental surgery or medicine; podiatrists; and optometrists; licensed by the state in which they practice (this could be multiple states).  The term practitioner, for opt-out purposes, is limited to: PAs, ARNPs, Clinical Nurse Specialists, CRNAs, Certified Nurse Midwife, Clinical Psychologist, Clinical Social Worker, Registered Dietitian and Nutrition Professional. What is omitted from the definition of physician and practitioner are chiropractors, and physician therapists and occupational therapists in independent practice. Consequently, a chiropractor may not opt out of Medicare; neither may PTs or OTs in independent practice, but it seems PTs or OTs working in a physician’s office may be eligible to opt out. read more