The Daily Scan

July 12, 2018

Last Updated: 11:25 AM EST

Medicare

  • CMS filed a new proposed rule yesterday titled: "Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments to Correct Existing Regulations Related to the CBP for Certain DMEPOS." This proposed rule would update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019, among other changes. (FederalRegister.gov)

Regulation

  • The Department of Justice yesterday announced the finalization of an April proposal to improve the Drug Enforcement Administration’s ability to control the diversion of dangerous drugs in the midst of the national opioid crisis. The final rule sent yesterday for publication establishes that DEA will take into consideration the extent that a drug is diverted for abuse when it sets annual opioid production limits. Attorney General Sessions commented "The opioid epidemic that we are facing today is the worst drug crisis in American history, to help end it, DEA must make sure that we prevent diversion and abuse of prescription opioids. Today's new rule, by taking diversion of these opioids into account, will allow the DEA to be more responsive to the facts on the ground. More importantly, it will help us stop and even prevent diversion from taking place. The American people can be confident that we are now better equipped to protect them from dangerous drugs and that this rule brings us one step closer to finally ending this unprecedented crisis." (Justice.gov)

 

  • The Government Accountability Office released a new report titled "Drug Discount Program: Improvements Needed in Federal Oversight of Compliance at 340B Contract Pharmacies." Among other things, this report: 1) describes financial arrangements selected covered entities have with contract pharmacies; 2) describes the extent that selected covered entities provide discounts on 340B drugs dispensed by contract pharmacies to low-income, uninsured patients; and 3) examines HRSA’s efforts to ensure compliance with 340B Program requirements at contract pharmacies. (GAO.gov)

Legislation

  • The House Appropriations Committee approved the draft fiscal year 2019 Labor, Health and Human Services, and Education (LHHS) funding bill yesterday on a vote of 30-22. The legislation includes funding for programs within the Department of Labor, the Department of Health and Human Services, the Department of Education, and other related agencies. In total, the draft bill includes $177.1 billion in discretionary funding, essentially the same as the 2018 enacted level. The bill targets investments in medical research, public health, biodefense, education, and important activities that help promote job readiness. The legislation also includes several provisions to rein in unnecessary regulations and to protect the sanctity of life. (Appropriations.House.gov)

Litigation

  • U.S. Attorney William M. McSwain announced that Arthur Miriana, the owner of a Philadelphia pain management clinic, pled guilty on Tuesday to conspiracy to distribute and distribution of oxycodone and alprazolam, commonly known as Xanax. Miriana owned and operated Life-Line Health and Wellness, in Philadelphia, PA. Miriana recruited drug dealers and drug addicts to visit his pain management clinic. These drug dealers and drug addicts paid $260 to $360 in cash for prescriptions for commonly abused controlled substances such as oxycodone and Xanax. Miriana was not a physician, so he hired Dr. Barbara Schneider to sign these prescriptions. Dr. Schneider did not perform medical examinations as required to lawfully prescribe controlled substances. She typically met with “patients” only as long as it took for her to sign the prescriptions. Additionally, Dr. Schneider gave pre-signed blank prescriptions to Miriana for use when she was not in the office. Dr. Schneider previously pled guilty to conspiracy to distribute oxycodone and alprazolam, and she is scheduled to be sentenced in September. (Justice.gov)

 

  • After a multiple-year investigation and the government’s intervention into a whistleblower suit in 2015, the United States announces a $1.2 million settlement with Liberty Ambulance. In reaching this settlement, the parties have resolved allegations that, from June 29, 2005, to January 2016, Liberty Ambulance knowingly up-coded claims for life support services from “Basic” to “Advanced” without justification, unnecessarily transported patients, and unnecessarily transported patients to their homes in an emergent fashion. “The United States Attorney’s Office is committed to taking the steps necessary to protect Medicare, TRICARE, and other federal healthcare programs from fraud and abuse,” said U.S. Attorney Maria Chapa Lopez. “Whenever founded, our Office will vigorously pursue these cases and recover taxpayers’ money.” (Justice.gov)

Private Sector

  • Pfizer Inc. announced yesterday it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. These changes will be effective at the beginning of the company’s 2019 fiscal year. (Pfizer.com)

 

  • President Trump tweeted on Tuesday: "Just talked with Pfizer CEO and @SecAzar on our drug pricing blueprint. Pfizer is rolling back price hikes, so American patients don’t pay more. We applaud Pfizer for this decision and hope other companies do the same. Great news for the American people!" (Twitter.com)

 

 

 

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