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Medical Practices & MedSpa Startups: Corporate Considerations

August 27th, 2019 by

medspa startupsBy: Chase Howard

Deciding you want to open your own medspa or start a medical practice is the first and most important step in creating something unique and building a brand. Understanding how to properly “start” that business from a legal perspective, and doing so correctly can be the difference between success and failure.

As a physician in a private, solo-practice, or the business owner of a medspa startup, proper strategy is key. Understanding your corporate structure, developing a business plan, and compliance with the laws will help eliminate pesky obstacles that will slow your growth.

When working with start-ups the following steps should be given plenty of time and attention. read more

Time out! Keeping Healthcare Lead Generation in Check

December 7th, 2018 by

healthcare lead generationBy: Michael Silverman

There are perfectly compliant ways to engage with healthcare marketers, and then there’s this; here are some of the latest real-life examples:

“DME BRACE CAMPAIGN – $40 to $150 PER LEAD PER BRACE”

“DME DIABETIC LEADS $40 PER LEAD, INSURANCE AND DOC INFO INCLUDED”

“PAIN CREAM/LIDOCANE LEADS FOR SALE, RX INCLUDED”

These marketers are seemingly holding auctions for the sale of federally protected patient health information out to the highest bidder! Couldn’t make this stuff up – if you’re in this industry, a quick gander at your (business) social media platforms will quickly confirm it. read more

OIG Unveils Latest Tool for Evaluating Fraud Risk

November 12th, 2018 by
OIG fraud risk

https://oig.hhs.gov/compliance/corporate-integrity-agreements/risk.asp

By: Karina Gonzalez

The Office of Inspector General (OIG) announced the launch of a new tool on its website titled the “Fraud Risk Indicator”.  The OIG has stated that the purpose for the tool is to provide guidance on how it has evaluated risk in settling False Claims Act (FCA) cases and to publicize information about where FCA defendants fall on the OIG’s risk spectrum.  This tool can benefit patients, healthcare industry professionals and other individuals who may find this information relevant.   This tool will also benefit the public with information about providers charged under the FCA that are at high risk for committing healthcare fraud. The Indicator shows the Risk Spectrum from Highest Risk to Lower Risk. read more

Pharmacy or DME: The Time is Ripe to Become Both

August 13th, 2018 by

pharmacy dmeBy: Michael Silverman

People looking to enter the direct-to-consumer medical supply business often question whether becoming a pharmacy or durable medical equipment provider (DME) is a “better” endeavor.

Now, more than ever, due to industry changes and because of the synergies between the two, the answer is “ become both.”

Think about it. read more

The Case Against Cloning (Medical Records)

August 10th, 2018 by

medical records cloningBy: Jacqueline Bain

The transition from paper medical records to electronic medical records has brought with it many conveniences and some unintended consequences. One example of an unintended consequence is cloning in the medical record. Cloning is copying and pasting previously recorded information from a prior patient note into a new patient note.

Providing quality medical care is only one part of the job. Appropriately documenting that care in order to be paid for your efforts is another. And while medical professionals are trained at length to provide care, hardly any are aware of the potential pitfalls associated with improper documentation.

In late 2015, CMS advised that cloning “is a problem in health care institutions that is not broadly addressed.” CMS specified that cloning records may indicate fraud, waste and abuse in inquiries and audits and that each part of a “medical record must contain documentation showing the differences and the needs of the patient for each visit or encounter.” read more

Med Spa Compliance: Are you Operating Within the Law?

July 9th, 2018 by

med spa complianceBy: Jacqueline Bain

On May 19, 2018, Delray Beach medical spa owner Jennifer Aspen was booked into the Palm Beach County Jail and charged with practicing medicine without a license. Ms. Aspen is the manager of Mermaid’s Skin & Wellness, a medical spa located in Delray Beach, Florida. The charges against Ms. Aspen stem from the fact that a Delray Beach police officer presented to Mermaid’s Skin & Wellness for a testosterone shot. Ms. Aspen stated to the officer that she would perform the injection. Ms. Aspen is a certified nursing assistant in the State of Florida. Her license is currently listed as “delinquent” on the Department of Health’s website, meaning that (as of today) she failed to renew her license after its May 30, 2018 expiration date. Certified nursing assistants are not generally allowed to administer testosterone in the State of Florida.

One of the legal issues that presents frequently in our office is med spa compliance; who can open and operate a medical spa if it is just a cash business, meaning that it does not submit claims for reimbursement to any government or commercial payor. Misunderstandings run rampant in the medical spa industry and many times patients are administered treatment from persons who are not supposed to be providing it. read more

GDPR Compliance: Has Your Company Prepared for the Heightened Data Privacy Regulations?

June 6th, 2018 by

“Protecting someone else’s data protects all of us.” Tim Cook, CEO of Apple

General Data Protection Regulation

By: Shobha Lizaso

We are in the age of electronic data and heightened data privacy. New laws to strengthen individuals’ privacy rights and to strengthen data protection are evolving worldwide. The General Data Protection Regulation (GDPR) establishes protections for the privacy and security of personal data about residents of the European Union. This new law affects US healthcare providers and organizations that provide services to residents of any of the EU countries, that collect data from EU residents or monitors EU residents through the use of cookies and the like, and practitioners involved in medical tourism programs and other clinical activities. GDPR imposes more restrictions on the collection, use, processing, storage, disclosure, and disposition of patient data than HIPAA.

GDPR became effective on May 25, 2018, and there will not be a compliance grace period, so healthcare providers should meet with their healthcare technology attorney to determine whether they are subject to the GDPR, to update their online Terms of Use & Privacy Policies, and to audit internal data handling procedures to prevent any violations. read more

Clinical Laboratory Licensure: Florida Repeals State Licensure

June 5th, 2018 by

clinical laboratory lawBy: Karina Gonzalez

Effective July 1, 2018, Florida’s recent legislation SB 622 repeals the entirety of Chapter 483, Part I of the Florida statutes, and removes the state licensure requirement for clinical laboratories operating in-state and out-of-state. Section 97 of SB 622, approved by the Governor on March 19, 2018, repeals the entirety of Chapter 483, Part I of the Florida statutes, and so eliminates section 59A-7.024(1). read more

Telemarketing Compliance: Legal Considerations Before You Call

May 15th, 2018 by

telemarketing complianceBy: Michael Silverman

Miami resident Adrian Abramovich certainly wasn’t laughing on Thursday May 10th, 2018 when the Federal Communications Commission (“FCC”) levied a $120 MILLION dollar fine on him for his alleged involvement in an illegal robodialing campaign. FCC Chairman Ajit Pai stated that Abramovich did not dispute that he had placed more than 96 million telemarketing robocalls over a three month period in 2016 without the recipient’s consent. Furthermore, Chairman Pai stated that Abramovich’s telemarketing campaign utilized caller ID “spoofing” which masks the calling party’s true phone number and causes the recipient’s caller ID to indicate that the call was being made by a local number. Abramovich’s telemarketing activities allegedly violated a variety of state and federal regulations; caller ID spoofing, for example, is expressly prohibited by the Florida Telemarketing Act, § 501.616(7).

With the record-breaking fine imposed on Abramovich, the FCC is sending a loud and clear message that it will not tolerate those individuals or entities that violate telemarketing laws. Any person or business engaged in telemarketing (be it a healthcare provider with a single telephonic sales representative or a business devoted to telemarketing with a 100 person call center) must heed the FCC’s unsubtle hint that enforcement activity of telemarketing laws is only heating up. read more

FDA Stem Cell Clinic Legal Issues: Stepped Up Enforcement

May 11th, 2018 by

By: Matthew Fischer

With the rapid growth of the regenerative medicine field, the U.S. Food and Drug Administration (FDA) is trying to strike the right balance between preventing harm to the public and fostering innovation of new treatments.  In an effort to prevent potential harm, the FDA stepped up enforcement this week.  In two complaints filed by the U.S. Department of Justice (DOJ) on behalf of the FDA, the FDA has sought permanent injunctions against a California and Florida stem cell clinic along with their owners and officers to prevent the marketing of stem cell products without FDA approval and for failure to correct deviations from manufacturing practice requirements. read more