The regenerative medicine arena consists of a wide range of innovative products. Congress, acknowledging the importance of this field, has established a new program via the 21st Century Cures Act to help spur development and provide for accelerated approval for regenerative medicine products similar to the FDA’s fast track and breakthrough therapy designations. This new approval is the Regenerative Medicine Advanced Therapy (RMAT) Designation.
The RMAT Designation includes all the benefits of the FDA’s other accelerated designations including early agency engagement and priority review; however, unlike the other designations, the RMAT Designation does not require evidence that the product offers substantial improvement over other therapies. For a drug to be eligible for the RMAT Designation, it must meet the following:
Ever since the Centers for Medicare & Medicaid Services (“CMS”) announced its DMEPOS Competitive Bidding Program there has been outcry from both providers and consumers. Particularly with respect to Competitive Bidding for the National Mail-Order Diabetic Testing Supplies Program (“National Mail-Order Program” or “Program”), which took effect on July 1, 2013, there has been a concern about the Program’s sustainability and potential for negative implications to beneficiaries. This is largely due to the low reimbursement rates, as set by the bid winning providers, and the possible spillover effect to the Medicare Part B beneficiaries’ access to quality supplies and services. While CMS had safeguards in place when the Program was implemented, many of the regulations have gone largely unenforced. Change is on the horizon as CMS strives to better police its own Program, but is it too little, too late?
In 2011, prior to the implementation of the National Mail-Order Program, CMS tested Competitive Bidding for diabetic testing supplies in nine geographical regions. In these test markets, the payment rates for a vial of test strips were reduced from $34 to $14. CMS’ goal with Competitive Bidding is to reduce costs to the Medicare Trust Fund and beneficiaries, as well as to curb fraud, waste and abuse in the industry. Wanting to ensure that the intentions of the Program were being fulfilled without repercussions, CMS conducted a study on the nine geographical test regions. In its 2012 report CMS stated that there were no negative consequences to the beneficiaries as a result of the Competitive Bidding Program.
Pharmacy Benefit Managers (“PBMs”) act as the intermediary between insurance companies and pharmacies. PBMs contract with insurance companies on one hand and with pharmacies on the other, connecting the two so that an insured’s pharmaceutical claims may be processed at the rates set forth in the agreement between the PBM and supplying pharmacy. PBMs are paid on both sides of this transaction – by the insurance company for managing their insureds’ benefits – and by the pharmacy for processing the claims that are submitted. Processing claims for private, state, and federally funded insurance programs, PBMs play an integral role in vast majority of prescription drugs dispensed in the United States.
Part of a PBMs function is to audit a pharmacy’s claims to ensure that the claims submitted are in compliance with the PBM and insurance companies’ requirements.
Typical audits come primarily in two forms (1) desktop audit; and (2) field/on-site audit. A selected pharmacy usually will receive a letter or fax from the PBM informing an audit will be taking place.
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:
Through two public channels this month, the FDA further solidified its stance on the innovative field of regenerative medicine. First, in an article published in the New England Journal of Medicine (NEJM), Dr. Scott Gottlieb, FDA Commissioner, and Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), co-wrote a new paper entitled “Balancing Safety and Innovation for Cell-Based Regenerative Medicine.” On the same day of this publication, the FDA hosted a “Grand Rounds” webcast with Dr. Steven Bauer, Chief of the Cellular and Tissues Therapy Branch within CBER. Taken together, these actions suggest a continued effort by the FDA to take a strong position against predatory clinics touting unapproved therapies while extending an open invitation to industry developers for expedited treatment to encourage innovation.
Adding Durable Medical Equipment Prosthetics & Orthotics Supplies (“DMEPOS”) to a Chiropractic Practice is a great way to not only increase revenues, but most importantly it is a great way to increase overall patient satisfaction and care.
Providing patients with easy access to DMEPOS allows for more comprehensive care, enabling providers to help further stabilize injuries, maximize patient recoveries, and minimize patient down time. Many existing patients are already buying and utilizing DMEPOS such as back braces, so there is an opportunity to provide that additional supervision and care through an existing practice.
Examples of DMEPOS that would complement a Chiropractic Practice and which patients are likely already using:
Providers licensed or regulated by the Agency for Health Care Administration must make certain that their employees and/or contracted personnel have had Level 2 Background Screening (criminal history background check) pursuant to Florida Statutes and Administrative Code within 10 business days of being hired. Also, if a potential employee or contractor has not been employed within the previous 90 days, even if that individual previously had level 2 background screening, the individual will need to go through submitting fingerprints again. Further, each employee or contracted individual that is subject to Level 2 Background Screening must renew the background screening every 5 years to be eligible for employment or continued employment with an AHCA licensed or regulated provider.
Fingerprint Retention Period
The 5 year expiration from the date of retention of fingerprints is the date that the Florida Department of Law Enforcement (“FDLE”) will purge fingerprints from storage, meaning if fingerprint retention renewal has not occurred prior to this date, the whole screening process, that is fingerprinting, etc., starts over. There is no “grace period” if fingerprints have been purged, which means the individual is no longer “technically” eligible for employment with an AHCA licensed provider (and perhaps other providers licensed and regulated by other state agencies such as Department of Health, Department of Children and Families, or Department of Elder Affairs). Further if the provider is in the process of an AHCA survey, accreditation survey, or renewal licensure application, not having a current Level 2 Background Screening for an employee or contractor might subject the provider to a statement of deficiency, assessment of administrative fines or fees, or denial of a licensure renewal application.
Healthcare practitioners are excited about the expansive geographic scope of practice in Telemedicine. A licensed Florida physician can provide services in other states provided the physician is also licensed in the state where the patient is receiving the services. There are no geographical limitations if the delivery platform of technology provides voice and vision and where necessary videos for the Telemedicine/Telehealth visit.
As more and more physicians practice and contract to provide Telemedicine visits, one of the legal challenges we are facing is how to draft a restrictive covenant. The traditional reasonableness standards used to evaluate non-compete agreements just do not apply. What are you trying to restrict when the physician lives in Florida but has telemedicine practice with patients 500 miles away?
The concept of gainsharing in the health care industry has been around for decades. Under a typical gainsharing program, a hospital and participating physicians will develop a cost-savings plan in relation to a specific procedure or service line. As the savings are realized, the hospital will then share a portion of the measurable savings with those physicians. The goal of gainsharing has always been to align physician and hospital interests, in order to improve the quality and efficiency of clinical care.
Gainsharing has not always been viewed favorably by the government. In fact, in a 1999 Special Advisory Bulletin, the Office of Inspector General (OIG) took the position that gainsharing arrangements violated the law, and that the payments could even constitute kickbacks to the participating physicians. Since then, the government has not backed off its position that gainsharing programs might violate the law. However, the OIG has also determined that it would not seek sanctions in a growing number of gainsharing arrangements.
Not too long ago, when something would go wrong in a hospital, a patient’s medical record might note the facts of what had happened (“Mrs. Jones was found on the floor of her hospital room with a swollen wrist. An x-ray revealed a wrist fracture.”), while the hospital’s incident report would analyze why it happened in order to prevent further harm (“Orderly Green forgot to raise the guardrails on Mrs. Jones’ bed. Mrs. Jones fell out of her bed as a result of the displaced guardrail. Let’s put in place a policy that all guardrails must be raised if an orderly steps more than three feet from a patient’s bed.”). Should Mrs. Jones decide to sue the hospital, she and her attorney would have access to the medical record, but not necessarily the incident report.
Incident reports like the one mentioned above have long been meant as a learning tool for facilities to analyze unfortunate occurrences on their premises and learn from their mistakes to prevent future harm. However, these reports often contain admissions of fault, or near admissions of fault. So how can a hospital balance its need to improve on past practices without opening itself to a mountain of liability? Florida’s state laws seemingly contrast with Federal laws.
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.