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On January 25, 2018, the U.S. Department of Justice (DOJ) issued a memorandum limiting the use of agency guidance documents in affirmative civil enforcement (ACE) cases.  Stating that “[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation,” the memorandum strongly discourages DOJ litigators from using noncompliance with agency guidance documents as a basis for suit or as evidentiary proof in ongoing litigation.…
Following a public hearing last month, the Wisconsin Medical Examining Board approved new rules for the practice of telemedicine.  The rules differ notably from its first set of rules proposed in 2015 and considered at a public hearing in January 2016.  After receiving criticism on its first set of rules, the Board withdrew them for reconsideration and redrafting. The new rules are a notable improvement and refinement, constituting a more streamlined set of rules…
Effective September 12, 2016, the Centers for Medicare & Medicaid Services (CMS) lifted the temporary ban on patient status reviews of hospital short stays for Medicare beneficiaries. Those reviews are currently conducted by the Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs).1 As of October 1, 2015, the responsibilities of the BFCC-QIOs include conducting the first-line medical reviews of short-stay inpatient hospital claims by acute care inpatient hospitals, long term care hospitals, and…
At its annual meeting on June 13, the American Medical Association (AMA) adopted ethical guidelines for the use of telemedicine, affirming the organization’s support of the use of telemedicine technologies within the confines of certain ethical principles. The guidelines were adopted after several years of debate and solidify AMA’s support for providing medical care via telehealth technologies. At an AMA meeting in November 2015, during which the proposed guidelines were discussed, AMA Chief Executive Officer…
The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration (FDA) and the Brookings Center for Health Policy, the Planning Board emerged out of an FDA action plan in 2012 seeking to strengthen the medical device post-market surveillance system by…
The U.S. Food and Drug Administration (“FDA”) recently announced a “far-reaching action plan” to evaluate and improve the agency’s prescription opioid policies. The announcement came amidst public criticism and mounting political pressure on the FDA to address the country’s “opioid abuse epidemic,” including a hold placed by Senate Democrat Edward J. Markey on President Obama’s nominee to lead the FDA, Dr. Robert M. Califf. In a December 21, 2015 letter to U.S. Department of…
The State of Wisconsin Medical Examining Board recently held a hearing to consider a proposed rule that, if enacted, would provide the first administrative requirements around the use of telemedicine services in Wisconsin. Wisconsin’s current administrative code is silent as to telemedicine practice. Some of the provisions in the proposed rules would impose operational, business, and clinical restrictions on the use of telemedicine in the Dairy State. The proposed rules address the establishment of a…
As U.S. health care providers continue to use telehealth, telemedicine, and virtual care services to expand their services and geographic footprint overseas, they are beginning to ask whether or not Medicare will cover telehealth services provided to Puerto Rico. Not only is Puerto Rico classified as a Medicare coverage location, but Puerto Rico contains geographic areas that can qualify as originating sites for Medicare telehealth service purposes. Moreover, with the health care access challenges in…
Regulations proposed by the Massachusetts Department of Public Health (“DPH”) may significantly change the procedure for state approval of nursing home sales and closures. Following public scrutiny around state inspection problems in some nursing facilities purchased by corporate chains, which have been expanding their presence in the Commonwealth, DPH expressed its intent to revise the process for sales and closures of long-term care facilities.…
In United States of America ex rel. Marc Osheroff v. Humana, Inc. et al., No. 13-15278 (11th Cir., Jan. 16, 2015), the Eleventh Circuit affirmed dismissal of a relator’s complaint under the public disclosure bar of the False Claims Act (FCA). The Court addressed several notable issues and provided insight as to how courts may apply the public disclosure bar as amended by the Patient Protection and Affordable Care Act (ACA). Relator Marc Osheroff alleged…