Pharmacy or DME: The Time is Ripe to Become Both

pharmacy dme

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.Continue reading

Behavioral Analysis Medicaid Providers: Florida’s Latest Enforcement Target

behavioral analysis medicaid

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:Continue reading

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

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“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.Continue reading

DME Compliance Alert for Telehealth Doctors

By: Karina Gonzalez

Many DME suppliers purchase leads from marketing companies. The patients who respond to the marketing advertisements are generally not interested in travelling to their doctor’s office to obtain an order for braces, for example. This type of arrangement is seen often enough and so starts a potentially problematic arrangement with the DME company paying the marketing company.  The marketing company may then use some of these dollars to pay a telehealth company.  The telehealth company may then pay a telehealth physician for “telemedicine visit” with the patient. Ultimately, the telehealth/telemedicine physician issues and order for the braces or other supplies.The DME brace supplier then gets paid by Medicare Part C, or other healthcare plan for providing the supply to the patient.

The problem with this arrangement is that the sole source of the telehealth doctor’s reimbursement for the visit comes indirectly from the DME company.   Essentially, the DME supplier is paying the ordering physician through the marketing company for the visit with the patient.  This creates a prohibited kickback arrangement because the supplier is essentially paying the Teledoctor for the referral for braces. The telehealth company is acting as a virtual unregulated physician practice.  Providers engaged in this type of practice are not in compliance with either Federal or Florida law.

So, You Want to Be in the Pharmacy Business? Building from scratch, acquisitions & other considerations.

pharmacy businessBy: Michael Silverman

Like many entrepreneurial endeavors, owning a pharmacy requires careful planning and an astute risk versus reward analysis. However, unlike other industries, venturing into a healthcare business brings with it an entire new world of regulations, and rightly so. Pharmacies don’t sell widgets they sell prescription drugs, and to people whose well-being depends on it being done correctly. As such, there’s a host of state and federal laws a pharmacy must abide by, intended to safeguard patients and the healthcare system as a whole. Don’t let regulatory hurdles alone serve as an insurmountable deterrent from entering into what can be a profitable and fulfilling profession; proactive compliance is the key to success! Here’s an overview of the general steps necessary to become a pharmacy owner, be it from scratch or by acquiring an existing practice. For the purposes of this article, let’s assume it’s a community/retail pharmacy that will be located in Florida.

So what’s better – building from scratch or buying something that’s already out there? Typical lawyer answer – it depends! But I won’t stop there; here are some considerations that must be taken into account to make a proper decision: (1) how quickly does the business need to be up and running? It’s typically a faster process to commence business by acquiring an existing pharmacy rather than buying one, but that depends on (2) what is out there in the current marketplace? If a stock acquisition, all of the known and unknown liabilities will be inherited by the new owner; proper due diligence on the pharmacy’s past is essential.Continue reading

Healthcare Marketing Lesson: Compound Pharmacy Kickback Scheme

healthcare marketingBy: Jacqueline Bain

Monty Ray Grow was a defensive back on the Florida Gators’ football team from 1990 until 1993. He contracted to play for the Kansas City Chiefs in 1994 and then for the Jacksonville Jaguars in 1995 and 1996. On February 5, 2018, he was convicted by a federal jury in Miami for his chief role in a massive healthcare marketing scheme designed to defraud Tricare.

Tricare is a health benefit program that provides civilian benefits for U.S Armed Forces military personnel, retirees, their dependents, and some military reservists. Tricare is a Department of Defense Program.

In September 2014, Grow entered into an agreement with a compounding pharmacy in Pompano Beach, Florida, wherein the pharmacy would pay Grow’s marketing company a commission equal to fifty percent (50%) of what the pharmacy netted in Tricare reimbursement from Grow’s referral of Tricare beneficiaries to the pharmacy. (Later on, Grow became an employee of the pharmacy.) Grow then used his commission to offer and pay recruiters to convince Tricare beneficiaries to use this pharmacy. Additionally, Grow offered and paid Tricare beneficiaries themselves to use this pharmacy.Continue reading

Medicare Audit and Appeal Process from A to Z: Challenging Extrapolated Overpayments

ZPIC audit

Medicare claims are processed by organizations (i.e. Medicare Administrative Contractors (“MACs”)) that contract with the Centers for Medicare & Medicaid Services (“CMS”) to act as liaisons between the Medicare program and providers and suppliers.  As CMS continues to evolve its Medicare audit enforcement strategies to reduce fraud and abuse in the system, post payment reviews utilizing statistical sampling still remain as one of its key methods. 

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Healthcare Compliance: Providers Must Use Plans They Have in Place

medical practice complianceBy: Jacqueline Bain

In 2015, Assistant Attorney General Leslie Caldwell spoke publicly about the importance for every healthcare provider to not only have a compliance program on its shelf, but also being sure that the compliance program is “tailored to the unique needs, risks and structure of each business or industry.” Assistant Attorney General Caldwell explained, “the adequacy of a compliance program is a factor when [the DOJ] decide[s] how and whether to prosecute a company.  The lack or insufficiency of a compliance program can have real consequences for a company when a violation of law is discovered.”Continue reading

Telehealth Law Florida: Delivery System for Substance Abuse Services

telemedicine lawBy: Karina Gonzalez

Telehealth law Florida is constantly evolving The latest example is found with Florida’s Department of Children and Families (DCF) recent proposed rule change which now includes a definition of Telehealth as a delivery system in substance abuse.  Telehealth can be used in treatment or prevention services through electronic communications from one site to another.  However, it does not include delivery of services using only the audio on a telephone, or e-mails, text messages, fax transmissions, US mail or other parcel service. Proposed Rule 65D-30.0031 (83) Definitions.

Telehealth services can be used in intensive outpatient, day or night treatment, day or night treatment with community housing, outpatient, interventions, aftercare, and prevention.   If a substance abuse provider plans on including telehealth services it must submit to DCF detailed procedures outlining which services it intends to provide. The provider will be responsible for the quality of the equipment and technology used in the telehealth service. Proposed Rule 65D-30.004 (20) Common Licensing Standards.Continue reading

Medicare Enforcement by Civil Monetary Penalty: A Guide for Medicare Plan Sponsors

medicare civil monetary penaltyBy: Matthew Fischer

The Centers for Medicare & Medicaid Services (CMS) contracts with private companies also known as sponsors to provide Medicare services and benefits under Parts C and D. However, when a sponsor fails to comply with program and/or contract requirements, sponsors are subject to a wide range of enforcement action by CMS. Enforcement and contract actions available to CMS include intermediate type sanctions (i.e., suspension of payment, marketing or enrollment), termination, and most notably, civil monetary penalties (CMPs). Historically, the majority of enforcement action taken involve the imposition of CMPs. Thus, plan sponsors are strongly encouraged to adopt an aggressive compliance plan that includes mock periodic audits in order to prevent potential deficiency findings by CMS.Continue reading