Another genetic testing lab settles with DOJ for violating the False Claims Act (FCA) and Anti-Kickback Statue (AKS) [https://www.justice.gov/usao-wdwi/pr/autogenomics-inc-agrees-pay-over-25-million-allegedly-paying-kickbacks].California-based PersonalizeDx, a genetic testing laboratory, entered into an agreement with a third-party “healthcare marketing company”. According to the agreement, the genetic testing lab paid the health care marketing company a specified monetary kickback for each test that was reimbursed by Medicare. The particular structure of the marketing agreement violates the AKS and further implicates the False Claims Act once such tests are filed for … [Read more...]
Modernization of the Stark Law – An Appraiser’s Perspective
Part II: Commercially Reasonable
As I continue to skim over the anticipated revisions to the Stark Law and AKS I’ve analyzed the new definition for commercially reasonable (“CR”) from an appraiser/consultant’s perspective. However, first I believe it’s important to identify the existing CR definitions/meanings that the healthcare compliance community has been following.In 63 F.R. 1700 (Jan. 9, 1998) CMS identifies CR as an arrangement which appears to be “a sensible, prudent business agreement, from the perspective of the particular parties involved, even in the absence of any potential referrals.”[1] In the Stark Law, an arrangement will be considered “commercially reasonable in the absence of … [Read more...]
Modernization of Stark Law – An Appraiser’s Perspective Part I: Fair Market Value Re-Defined
I’ve been skimming over the 600+ pages of this most pleasurable reading and trying to identify the changes/revisions to the fair market value (FMV) and commercial reasonableness (CR) definitions. The proposed ruling identifies CMS’ “dramatic changes” to what it calls “The Big Three” definitions in the Stark Law: Fair Market Value (FMV)Commercial Reasonableness (CR), andProhibition on taking into account “the volume or value of physician referrals.” This FMV QuickRead will focus just on FMV. Although CMS added some additional specific language, the new language doesn’t really “move the needle” from an appraiser’s standpoint. CMS added language and specifics that the … [Read more...]
Speaker Programs & FMV Compensation for HCPs
I’m sure many of you healthcare compliance attorneys who represent pharmaceutical companies are familiar with the most recent OIG Fraud Alert related to Speaker Programs and their potential to violate the anti-kickback statute. The recent OIG alert highlights some of the inherent fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to company-sponsored speaker programs. One the standard requirements (but not necessarily listed in the recent Fraud Alert) is that healthcare professionals (“HCPs”) be paid an amount equal to (or not to exceed) fair market value for their speaking services. Many pharmaceutical companies might just look at … [Read more...]
Calculation of Lost Hospital Revenues Related to COVID-19
Part 1 The Coronavirus Aid, Relief and Economic Security Act (CARES Act) has designated $100 billion to reimburse eligible providers for health care–related expenses or lost revenue attributable to COVID-19. This includes lost revenues/profits attributed to lost or cancelled elective procedures as well as extraordinary expenses related to COVID19 responses. The law contemplates funding not only losses as of this date but future expenses as well. Presently, this fund is administered by the Assistant Secretary for Preparedness and Response (ASPR) under the U.S. Department of Health and Human Services (HHS). Currently, there is little or no guidance on whether the funds are to be … [Read more...]
CMS Waivers for Stark Law & FMV Requirements for COVID-19 Purposes
On March 30, 2020, CMS issued blanket waivers of several Stark Law requirements related to COVID-19 physician arrangements. The Stark waivers can be relied upon retroactively to March 1, 2020, until the expiration or termination of the declared public health emergency. The Stark waivers can be relied upon for financial arrangements that relate ONLY to a “COVID-19 Purpose.” CMS identified the following COVID-19 Purposes: Scope of the Stark Waivers Related to Fair Market Value Compliance The Stark waivers exempt providers from sanctions for noncompliance with the Stark Law related to the following types of arrangements, absent the government’s determination of fraud or … [Read more...]
Telehealth FMV & the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020
I’m sure many of you are aware of the recently passed Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. This new law relaxes many of the current Medicare criteria in order to rapidly expand the use of telehealth as a resource against COVID-19. Pursuant to this law, the Secretary of HHS has the authority to waive the “site” requirements for telehealth services provided to Medicare beneficiaries who are located in an identified “Emergency Area” during an “Emergency Period.” Since the whole country is currently experiencing a public health emergency, the Emergency Period and Emergency Area requirements are met on a nation-wide basis. Prior to this … [Read more...]
Fair Market Value of Telemedicine Call Coverage
With staffing shortages around the country, many healthcare facilities are calling on retired physicians and mid-levels to take telehealth shifts. In addition, many ER physicians and other specialists are being asked to work additional hours and take telehealth call. Needless to say, the demands of healthcare workers are increasing and the correct fair market value of their time and services is being called into question. The most common telemedicine arrangement is referred to as a “hub-and-spoke” arrangement. This involves an originating site (usually a rural hospital) with patients in need of care and a distant site (usually a larger health system) employing or … [Read more...]
Post-Op Co-Management: Fair Market Value & Commercial Reasonableness
Upon completion of cataract or refractive (i.e. LASIK) eye surgery, a series of post-operative exams, evaluations and tests are required. This post-operative care can be performed by the ophthalmologist who performed the surgery or it can be sub-contracted to the patient’s optometrist or another provider. This type of arrangement is most commonly referred to as clinical “co-management”. Co-management is the planned transfer of care during the global period from the operating surgeon to another qualified provider when clinically appropriate. Normally, the operating ophthalmologist makes arrangements before surgery to refer the patient to another ophthalmologist or optometrist for … [Read more...]
What Every Healthcare Attorney Should Know About Appraisals
When attorneys contract with appraisers to issue valuation opinions, there are 5 very important elements that the attorney must know and understand to ensure its proper and effective use. These may sound elementary, but I find that these elements are commonly misunderstood which can ultimately affect the transaction or the purpose of the appraisal. Subject of Valuation – The attorney, client, and appraiser need to have a clear understanding and agree on the actual subject of the appraisal. Are we valuing a specific service? If so, is it clearly defined, detailed and documented? Are we valuing a specific entity? If so, are we valuing the invested capital of a business or the … [Read more...]
