The Daily Scan

August 7, 2018

Last Updated: 8:50 AM EST

Regulation 

  • Seema Verma, administrator of the Centers for Medicare and Medicaid, spoke at the interoperability forum in Washington D.C., giving remarks about medical technology and health care information technology. The speech points out that the federal government has spent over $35 billion on the efforts to get doctors to use Electronic Health Records, which has caused burden and burnout. Seema Verma commented, "recognizing we must transform Health IT as we have all other sectors of the economy, The White House Office of American Innovation, led by Jared Kushner, launched the MyHealthEData initiative this past March. The MyHealthEData initiative is based on the premise that information is power, and patients should be fully informed and empowered to make the best decisions for their own health. But, MyHealthEData, is more than just patients and doctors getting health care records. It’s about driving a new era of digital health, one that will unleash data to trigger innovation, and advance research to cure diseases and provide more evidence-based treatment guidelines that ultimately will drive down costs and improve health outcomes." (CMS.gov

  • The U.S. Food and Drug Administration (FDA) has refused to approve the opioid painkiller Remoxy ER, said Pain Therapeutics Inc. and Durect Corp. Remoxy is an abuse deterrent, extended-release form of oxycodone. Remi Barbier, President & CEO of Pain Therapeutics, Inc. commented, “this is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction, we have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe REMOXY received an ideological judgement call that is vague in nature but conclusive in its damaging effects.” (PainTrials.com

  • Yesterday, the U.S. Food and Drug Administration (FDA) issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). HHS Secretary Alex Azar commented, “The Trump Administration is pursuing every opportunity to address our country’s opioid epidemic and support patients struggling with opioid use disorder. This work at HHS includes placing a special priority on ensuring access to a full range of safe and effective options for medication-assisted treatment, the evidence is clear: medication-assisted treatment works, and it is a key piece of defeating the drug crisis facing our country. The FDA’s new guidances have the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better chance at recovery.” (FDA.gov

  • The U.S. Food and Drug Administration (FDA) believes that as a public health agency, there is no greater impact than for the health of the nation to reduce the rate of tobacco-related disease and even death. Through the U.S. Food and Drug Administration’s comprehensive framework for regulating nicotine and tobacco, the FDA is developing policies that support the possibility of a world where combustible cigarettes could no longer create or sustain addiction. A key part of this framework are steps to pave the way for products that help currently addicted smokers move away from the deadliest form of nicotine delivery. FDA Commissioner Scott Gottlieb wrote, "these guidances are one part of larger policy efforts to address the public health crisis of tobacco usage in this country. Given some of these products are relatively new technologies, or innovations that haven’t yet been through the product development and evaluation process, we’ll be seeking input on these draft guidances and welcome feedback on whether we’ve struck the right balance between innovation and safety; and set the right framework to encourage companies to use the new drug pathway to bring novel NRT products to market, with our public health mission leading the charge." (FDA.gov

Litigation 

  • Grenada Lakes Medical Center (GLMC) has agreed to pay more than $1.1 million to resolve False Claims Act allegations that the hospital sought and received reimbursement from Medicare for services that were not medically reasonable or necessary. The settlement resolves allegations that, beginning in January 2005 and continuing until April 2013, the hospital submitted claims for Intensive Outpatient Psychotherapy (IOP) services that did not qualify for Medicare reimbursement. Acting Assistant Attorney General Chad A. Readler for the Civil Division commented, “hospitals that participate in the Medicare program are responsible for ensuring that the services performed at their facilities or on their behalf reflect the medical needs of patients rather than the desire to maximize profit." (Justice.gov)

  • A Georgia based professional corporation, Northwest ENT Associates, P.C., has agreed to pay $1,195,361 to resolve allegations that it violated the False Claims Act by submitting claims for sinus dilation procedures in which it re-used balloon catheters that were intended for single use only. Northwest ENT has five office locations, operates a single specialty surgery center, and provides services at four hospitals in Georgia. The physicians at Northwest ENT specialize in the medical field of otolaryngology and are commonly referred to as “ear nose and throat” or “ENT” physicians. U. S. Attorney Byung J. “BJay” Pak commented, “when healthcare providers take shortcuts in order to increase their financial bottom line, their patients are put at risk and federal funds are diverted from legitimate medical procedures." (Justice.gov

 

 

 

 

 

 

 

 

 

 

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