Matthew M. Fischer

Attorney

About me

“Being a lawyer is not just a vocation. I love practicing law because it’s a public trust and I feel I have an obligation to protect my community.”

Background highlights

Worked at the FBI,
Justice Department,
and Medicare

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Recent articles

Stem Cell Business

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The United States Department of Justice (DOJ) has the power to issue civil investigative demand (CIDs) when the DOJ has reason to believe that a person may be in possession of information relevant to a false claims investigation.  The DOJ is empowered to serve CIDs by the False Claims Act (FCA).  A CID is similar to a grand jury subpoena; however, it provides greater versatility in the use of the information obtained.  In addition to requiring the production of documents similar to a grand jury subpoena, CIDs demand other types of discovery responses and the information gathered may be shared between the civil and criminal sides of an investigation.  Given this flexibility and with the passage of the Fraud Enforcement and Recovery Act of 2009 (which changed the law to allow issuance of a CID without the personal signature of the Attorney General), the DOJ has substantially increased its use of CIDs in the realm of healthcare law enforcement.

CIDs, similar to a subpoena, permit the DOJ to gather documents and obtain information through other discovery tools such as interrogatories and depositions.  Justifiably, the receipt of a CID can cause serious unease because this indicates the initiation of a federal investigation of potential false claims.  To add to these concerns are the potential financial costs incurred in formulating a response and the possibility that company employees will be targeted.  In order to deal with this uncertainty, it is important to know what steps to take to lessen the impact of a CID.

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The Drug Enforcement Administration (DEA) is responsible for monitoring the supply and distribution of all controlled substances.  All medical providers, pharmacies, manufacturers of pharmaceuticals, and distributors of pharmaceuticals must be registered with the DEA.  DEA registrants are governed by an ever-growing web of federal laws and regulations which if violated may result in revocation of registration, fines, and/or criminal prosecution.  Therefore, it is important when starting a business or purchasing an existing business requiring DEA registration to be proactive and prepared for periodic administrative inspections or audits.

The Diversion Control Unit is tasked with monitoring compliance and empowered to conduct inspections by the Controlled Substances Act (CSA).  Under the CSA, diversion investigators have the authority to (1) inspect, copy, and verify records required to be kept (e.g., prescription and inventory records); (2) inspect equipment; (3) make a physical inventory of controlled substances; (4) collect samples of controlled substances; and/or (5) inspect any other records appropriate for verification under the CSA.  However, there are limits to what can be inspected (unless an owner or agent of the owner consents).  Inspections do not extend to financial data, sales data (other than shipping data), or pricing data.

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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 enforcement strategies to reduce fraud and abuse in the system, post payment reviews utilizing statistical sampling still remain as one of its key methods.  These reviews are conducted not just by MACs but also by Zone Program Integrity Contractors (“ZPICs”).  When a review is completed, providers and suppliers often face large extrapolated overpayment amounts based on the analysis of a small sample of claims.  Therefore, providers and suppliers need to understand the process and most importantly, how to effectively navigate the system.

ZPICs are a part of Medicare’s integrity program and took the place of Program Safeguard Contractors (“PSCs”) that operated with the same goal in the past.  ZPIC reviews initiate in various ways such as from whistleblower complaints, through ZPIC investigations (e.g. using data mining), and from referral from the Office of Inspector General (“OIG”).

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In November 2017, the U.S. Food and Drug Administration (FDA) issued new guidance regarding its current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271(a) and the agency’s view on the same surgical procedure exception under 21 CFR 1271.15(b).  Additionally, the FDA issued a notice to all interested stakeholders that the agency intends to initiate increased discretionary enforcement over the next 36 months for HCT/P businesses.  Based on the agency’s latest position, it is important for HCT/P manufacturers and providers to understand the inspection process and be prepared to respond accordingly in this heightened regulatory environment.

The FDA is tasked with regulating HCT/Ps under the authority of Section 361 of the Public Health Service Act (PHS).  Within the FDA, the Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety of these products and promoting corrective action.  In order to reach this goal, CBER is armed with an array of administrative actions to address violations of regulatory significance.

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There are no off the shelf solutions when it comes to starting a new stem cell business or adding a new component to a practice. Between navigating regulations, receiving training, and marketing the service, there’s a lot to address in a short time.  Trying to do it all yourself?  You may be a highly trained clinician, but given healthcare’s ever-changing regulatory environment, seeking out experienced counsel at the outset will save lots of time and money in the long run.  To get started, here is a short summary of what to expect.

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Platelet-Rich Plasma (“PRP”) has become a popular treatment for various conditions from sports injuries to hair rejuvenation so it makes sense that PRP regulation must keep up.  With PRP, both the device used to separate platelets and the subsequent use of the PRP product fall under the scope of the U.S. Food and Drug Administration (“FDA”).  The common question is: what is approved by the FDA with regards to PRP?  Given the increased use, it is important for health care providers to understand the FDA’s standpoint on PRP regulation.

MEDICAL DEVICE REGULATION

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VIA HFMA: ANOTHER CMS SETTLEMENT OFFER COMING IN APRIL WILL APPLY TO CLAIMS FROM $9,000 TO $100,000.

 

Feb. 6—A new settlement offer to resolve outstanding Medicare claims that have been denied on appeal is available for a limited time from the Centers for Medicare & Medicaid Services (CMS). The offer guarantees 62 cents on the dollar for claimed payment and payable on a faster timetable than previously available.

Hospitals and other providers seeking to resolve pending Medicare appeals first must meet tight eligibility standards, according to a CMS summary.

In November, CMS introduced the Low Volume Appeals Settlement Option (LVASO), which took effect Feb. 5. The initiative aimed at clear a huge backlog of Medicare Part A and Part B only claims. To qualify, hospitals, physicians, and other narrowly defined providers must have fewer than 500 already-denied appeals claims pending either before the Office of Medicare Hearings and Appeals (OMHA, the third stage of the Medicare appeals process) or the Medical Appeals Council (the fourth appeals level) as of Nov. 3, 2017, with no appeals seeking more than $9,000 in individual claim amounts.

In 2014, the American Hospital Association (AHA) and three hospitals filed a lawsuit against CMS to force it to reduce the Medicare appeals backlog at the Administrative Law Judge (ALJ) level, alleging that CMS was violating the Medicare Act that set a 90-day limit for appeal resolution.

While CMS agreed the delays were excessive, it pointed out that ALJ workloads had dramatically increased and would require more funding to cut the backlog. A U.S. district court judge in Washington, D.C., ordered CMS to clear the backlog by 2021. CMS appealed, protesting the timetable would be impossible to achieve. The U.S. Court of Appeals for Washington issued a decision agreeing with CMS, but remanded the case back to the district court.

Assessing the Option

Matthew Fischer, a former CMS attorney now in private practice in Delray Beach, Fla., said qualifying hospitals will get 62 percent return on their claims quickly, “as opposed to waiting, perhaps for years, for an appeals decision that could potentially give even less.”

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