Donald H. Romano

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No Fraud Waivers Contemplated On February 14, 2019, CMS’ Innovation Center announced its Emergency Triage, Treat, and Transport (ET3) Model for EMS / ambulance suppliers to partner with other health care providers such as telehealth entities and urgent care centers in order to triage and treat Medicare beneficiaries more effectively.  In response to a recent inquiry, the ET3 Model Help Center clarified that at this time, CMS does not plan to issue fraud and abuse…
As noted in previous Health Care Law Today blog posts, we have seen an uptick in private equity recapitalization transactions in orthopedics. We expect this trend to continue, and to pick up pace, as the economy remains robust and the appetite for the most lucrative physician practices increases. When coupled with an increasing maturation of orthopedic practices, the volume of deals is almost certain to increase.…
Practitioners in the Medicare or Medicaid managed care space place heavy reliance on the protection of the Anti-Kickback Statute (AKS) Safe Harbor found at 42 C.F.R. § 1001.952(t), generally known as the “EMCO [eligible managed care organization] Safe Harbor,” as they look at incentive arrangements between providers and managed care plans. Although the language of the regulation is generally understood, there has not been any guidance from HHS’s Office of the Inspector General (OIG) since…
Just what is reasonable compensation in the Medicare world is not a clearly defined, black and white concept. Instead, it is somewhat in the eye of the beholder, with the parties to each situation where that is an issue seeking to reach out for third party support for their conclusions. But sometimes when the government gets a chance to look at the conclusions, it is a “bridge too far.”…
There are many health care financial arrangements where one entity has a financial obligation to another, with whom it either does business directly, or to which it makes referrals, and that obligation is either past due or for one reason or another cannot be paid. This may come up, for example, in the context of leases to physicians in a hospital owned medical office building (MOB), a loan made to a physician by a supplier…
On January 9, 2018, The Centers for Medicare & Medicaid Services (CMS) announced a new voluntary bundled payment model program – Bundled Payment for Care Improvement Advanced (BPCI Advanced). The episode payment model, which is a second generation version of the BPCI program, will qualify as an Advanced Alternative Payment Model (APM) under the Quality Payment Program adopted as part of MACRA, which means that physicians, because they take on financial risk, may earn the…
Summary of AHA v. Price, 2017 U.S. App. LEXIS 14887 (D.C. Cir. Aug. 11, 2017)   On August 11, 2017, the D.C. Circuit reversed the district court and held that the district court abused its discretion by ordering the Secretary of HHS to clear the backlog of administrative appeals of denied Medicare reimbursement claims within four years, because it failed to seriously test the Secretary’s assertion that this result was impossible. The underlying action demanded…
Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights the SFC’s concerns that certain POD structures may violate fraud and abuse statutes, including the Anti-Kickback Statute, Stark Law, as well as the Sunshine Act. According to the SFC Report, PODs are “physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable…
In the Fiscal Year (FY) 2014 Inpatient Prospective Payment System (IPPS) final rule, the Centers for Medicare & Medicaid Services (CMS) revised its Medicare policy for determining whether hospital encounters will be considered appropriately inpatient or outpatient. The status distinction has important consequences for both the provider and the beneficiary, including differences in co-insurance and deductibles, and what items and services are billable and the level of reimbursement paid to providers.…