With the 2021 competitive bidding round on the horizon for durable medical equipment (DME) providers, both those that are established as well as those fairly new to the industry must take note of the potential pitfalls that may be encountered when competing to become a Medicare contract supplier.
The durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program was first established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Under this program, DMEPOS suppliers submit bids (i.e. applications) and compete to furnish specific items in competitive bidding areas commonly referred to as CBAs. Additionally, suppliers are not just bidding for the rights to a particular CBA but also for a single payment amount that will replace the current Medicare fee schedule payment. The payment will be determined by using the bids submitted. As of December 31, 2018, all contacts have expired. As a result, there is currently a temporary gap period. The upcoming bidding process is loaded with requirements. Therefore, compliance with each requirement is crucial. Here are a few pitfalls to watch out for:
Not tomorrow, but relatively soon. And with a vengeance! We knew the current Competitive Bidding Program moratorium wouldn’t last forever, and that the floodgates that opened as of the first of this year would eventually be reined in.
Indeed, on March 7, 2019 the Centers for Medicare and Medicaid Services (“CMS”) announced a new round of Competitive Bidding, which will commence on January 1, 2021 and last through December 31, 2023.
The largest changes from previous rounds of Competitive Bidding that immediately stand out are:
Attorney Michael Silverman will present this live lunch n’ learn webinar for those considering starting a DME business startup or wanting to reconsider some of the legal issues involved in the DME business. He will review the laws, options and risks, and share information regarding state licensure requirements, product offerings and enrolling in Medicare as a Part B supplier.
Regulatory compliance is a mandatory investment for any healthcare business owner looking to stay out of serious and personal legal peril, let alone one hoping to keep their company viable.
Yet there is seemingly an onslaught of providers that blatantly run afoul of many of these regulations, knowingly or not, or those that believe they may have found a loophole.
Concerning the latter, there is an important mantra that such DME and pharmacy providers should remember and live by: “[W]hat a provider cannot do directly, it cannot do indirectly through an intermediary.”
Marketing for DME – What exactly am I talking about?
DME providers enrolled with CMS (should) know they cannot solicit or ‘cold call’ Medicare Part B beneficiaries, per the Federal Anti-Solicitation Statute, and that they cannot offer anything of value to a potential patient that could induce them to utilize them as a provider, in accordance with the Beneficiary Inducement Statute.
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.
Providers need to comply with all the Medicare ‘red tape’ but need not let fear of non-compliance inhibit their practice from offering Durable Medical Equipment Prosthetics & Orthotics Supplies (“DMEPOS”) to Medicare beneficiaries.
Here’s an overview of the steps providers need to take to enroll as a supplier of DMEPOS with Medicare to be eligible for Part B coverage and reimbursement:
In the age of heightened regulatory scrutiny, physicians and other health care providers often question whether “Consignment Closet” relationships are legal. If properly structured these arrangements are not only legal but are of great benefit to patients needing valuable medical devices. A properly structured relationship will, in all probability, withstand a regulatory challenge by the Office of Inspector General or from other regulatory authorities.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.