On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015.  A common thread ran through the testimony of the three testifying witnesses:  Erin Bliss, Assistant Inspector General with HHS-OIG; Dr. Debra Draper, Director of Health Care at the GAO; and, Captain Krista Pedley, Director of the Office of Pharmacy Affairs at HRSA:  Congress needs to legislatively grant HRSA more administrative authority over the 340B Drug Discount Program.  Continue Reading Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration (see here and here). However, since taking office, President Trump has followed through on his campaign promise to significantly roll back Federal regulations and has taken several actions aimed at slowing and reversing agency regulatory processes, including processes at the DHHS sub-agencies CMS and FDA. These executive actions are creating a climate of uncertainty for regulated industries and their stakeholders. Continue Reading Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

Cybersecurity is of increasing importance to health care organizations, given the growing trend of enforcement and increasing penalties.  President Obama’s Executive Order 13636: Improving Critical Infrastructure Cybersecurity included “the incapacity or destruction of [] systems and assets [that] would have a debilitating impact on . . . national public health or safety” as part of the “critical infrastructure” of the United States.   On the anniversary of this Executive Order, the U.S. Commerce Department’s National Institute of Standards and Technology (NIST) released a Framework for Improving Critical Infrastructure Cybersecurity (Framework) that provides a structure that organizations, regulators and customers engaged in the nation’s critical infrastructure can use to create, guide, assess or improve comprehensive cybersecurity programs.

On March 25th, Mintz Levin’s Privacy & Security Practice is hosting a panel discussion in the firm’s Boston office that will examine the NIST Framework in depth and provide insights into how organizations, including health care and life sciences companies,  can use it to assess and improve their security procedures.  Topics will include:

  • An update on cybersecurity legislative policies;
  • The NIST Framework and federal regulatory initiatives affecting government and private sector suppliers;
  • Recent developments in the U.S. Securities and Exchange Commission’s approach to disclosure of cybersecurity threats for public companies; and
  • The current state of the market for cybersecurity insurance and considerations for potential insureds.

To register and get more details about the panel, click here.

After withdrawing nearly identical proposed legislation one day earlier, on January 18, 2012, New York Governor Andrew Cuomo issued an Executive Order directing certain New York State agencies, including the Department of Health, to promulgate regulations that limit the compensation of executives of entities that receive state funding or payments from the state. Such regulations must be promulgated within ninety days of the date of the Executive Order.

The Executive Order calls for an overall compensation limit of $199,999 per executive, but that limit may be adjusted by each agency with the approval of the Director of the Budget, provided that the compensation does not exceed Level I of the Federal government executive compensation guidelines promulgated by the U.S. Office of Personnel Management (“OPM”). Further, the operative sentence calling for a compensation limit is qualified by the phrase “to the extent practicable.”

Continue Reading Cuomo Issues Executive Order Regarding Limits on Executive Compensation