The Daily Scan

July 25, 2018

Last Updated: 10:00 AM EST

Litigation

  • Two California residents have been indicted by a federal grand jury in Pittsburgh, Pennsylvania, on charges of conspiracy to distribute fentanyl, methadone, and oxycodone; distribution of oxycodone; conspiracy to commit health care fraud, and conspiracy to launder money. According to the indictment, from March 26, 2015 to June 22, 2018, in the Western District of Pennsylvania and elsewhere, Dr. Paul Hoover and his assistant Marcia Arthurs conspired to distribute fentanyl, methadone, and oxycodone. The indictment also alleges that from January 9, 2018, to June 22, 2018, Hoover and Arthurs distributed oxycodone on multiple occasions. Further, the indictment alleges that from March 26, 2015, to June 22, 2018, Hoover and Arthurs conspired to commit health care fraud. Lastly, the indictment alleges that during that same time, Hoover and Arthurs conspired to launder money. (Justice.gov)

Medicare & Medicaid

  • Yesterday, the Centers for Medicare and Medicaid Services (CMS) announced several new additions to the agency’s leadership team, as well as changes to the portfolios of senior staff in the Office of the Administrator. Administrator Seema Verma welcomes Paul Mango as CMS’s Chief Principal Deputy Administrator and Chief of Staff and Chris Traylor as the agency’s Deputy Administrator for Strategic Initiatives. In addition, the Administrator promoted Deputy Chief of Staff Brady Brookes to Deputy Administrator and Deputy Chief of Staff. Administrator Verma commented: “President Trump and Secretary Azar have laid out an ambitious agenda to strengthen the Medicare and Medicaid programs for the millions of Americans they serve. This is a big responsibility and my team will have a critical role to play to help accomplish these goals. That is why I am pleased to welcome two distinguished and experienced leaders that not only have a wealth of knowledge managing complex healthcare issues, but also have hands-on experience at the local level in the practice and implementation of policy. These new additions will further strengthen our executive team and will help deliver on the promises made by the Trump Administration to better serve the American people.” (CMS.gov)

 

  • Yesterday, the Centers for Medicare and Medicaid Services (CMS) posted a final rule that reissues, with additional explanation, the risk adjustment methodology that CMS previously established for transfers related to the 2017 benefit year. This important step fills a void created by a federal district court’s vacating of the previously issued methodology, and enables the agency to resume the CMS-operated risk adjustment program in the individual and small group markets. CMS Administrator Seema Verma commented: “Issuers that had expressed concerns about having to withdraw from markets or becoming insolvent should be assured by our actions today.  Alleviating concerns in the market helps to protect consumer choices.” (CMS.gov)

 

  • CMS contracted with Mathematica Policy Research and Provider Resources, Inc. (PRI), to conduct an evaluation of CMS’s prior authorization model for non-emergent HBO therapy in Illinois, Michigan, and New Jersey, and released the report to the public on Monday. The goal of the evaluation was to rigorously assess prior authorization as a means of reducing payments for medically unnecessary services, thereby reducing costs and improper payments while maintaining or improving the quality of care provided to beneficiaries. Despite findings that suggest that the model was effective in reducing HBO utilization and cost, the model ended on February 28, 2018, and there are no current plans for it to be extended or expanded. (Innovation.CMS.gov)

Legislation

  • The House of Representatives yesterday approved bipartisan legislation authored by Rep. Erik Paulsen (MN-03) that permanently repeals the Affordable Care Act’s excise tax on medical devices. The bill, called the Protect Medical Innovation Act, was passed by a vote of 283-132, including 57 Democrat supporters. (Press Release: Paulsen.House.gov , Bill: Congress.gov

Regulation

  • Yesterday the U.S. Food and Drug Administration approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal. “Sentinel lymph node biopsies are crucial for determining whether a patient’s breast cancer has spread and helping the provider determine the most appropriate course of treatment,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health (CDRH). “Currently, a sentinel lymph node biopsy is performed after injection of radioactive materials and/or blue dye. This magnetic system we’re approving today will offer patients undergoing mastectomy an option for their sentinel lymph biopsy procedure that does not require the injection of radioactive materials.” (FDA.gov)

Private Sector

  • During yesterday's Q2 earnings call, Eli Lilly CEO David Ricks was asked about the Trump administration's recently released drug pricing blueprint, and made the following comment on drug importation: "You also saw the administration move on putting a task force together related to addressing off-patents, brands, who take super inflationary price increases. In the absence of IP this is really a regulator failure from our perspective, the administration is talking about importation. We think that’s the wrong road to go down, but rather to fix the regulatory system to begin with. Nonetheless, clearly, that is a hot-button issue, and we agree it should be solved." (SeekingAlpha.com)

 

 

 

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