Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 31, 2017.  This week’s preview focuses on the fallout from the failed vote to repeal the Affordable Care Act (ACA), including the issue of whether the federal government will continue to pay cost-sharing reduction subsidies (CSRs), as well a new proposal by Senators Lindsey Graham (SC), Bill Cassidy (LA) and Dean Heller (NV).

Last week, the HHS Office for Civil Rights (OCR) launched an improved version of their HIPAA Breach Reporting Tool (HBRT), commonly referred to by OCR and regulated entities alike as the HIPAA “Wall of Shame.” OCR has also made minor changes to the interface for breach reporting.

The HBRT now makes it easy to navigate and mine information on all reported data breaches (breaches must be reported when they involve the protected health information of 500 or more people). Continue Reading The HIPAA “Wall of Shame” is Now Easier to Navigate

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

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 24, 2017.  This week’s preview focuses on the Better Care Reconciliation Act and Senate parliamentary rules.  The preview also addresses Wednesday’s House Energy & Commerce Health Subcommittee’s hearing on Special Needs Plans, FDA User Fee Reauthorizations, and the health care minibus.

Stay tuned for additional updates from ML Strategies!

While we continue to follow the recreational marijuana legalization saga and the Massachusetts Department of Public Health’s Medical Marijuana Program, our colleagues on the employment law side of the equation are monitoring decisions regarding the ability of employers to take disciplinary action against employees for using marijuana at work.  This blog post discusses an important new decision issued by the Massachusetts Supreme Judicial Court, Barbuto v. Advantage Sales and Marketing, LLC, in which the Court concluded that, under the circumstances in that case, employers must accommodate medical marijuana users in the normal course to avoid violating the state’s antidiscrimination laws when it fires an employee because of a failed drug test based on the employee’s use of medical marijuana. It’s a must read for employers grappling with this emerging area of employment law.

 

Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force.  As part of the national health care fraud takedown, the government charged 412 defendants with approximately $1.3 billion in alleged fraud. In addition to these charges, HHS Office of Inspector General (“OIG”) is in the process of excluding 295 health care providers from participating in federal health care programs.

Continue Reading DOJ and OIG Announce Largest Ever National Health Care Fraud Takedown; Focus on Opioids

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes the Better Care Reconciliation Act (BCRA), the User Fee Acts (UFAs), the National Defense Authorization Act (NDAA), and the health care Minibus.

Stay tuned for additional updates and analysis from ML Strategies.

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government safety net programs share in 340B savings.”

I reasoned that CMS already knew that “Medicare pays more for 340B drugs than the covered entities’ acquisitions cost.”   Continue Reading Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain, with phased-in obligations for the various trading partners over 10 years, beginning with the law’s passage in November 2013. Covered trading partners include manufacturers, repackagers, wholesale distributors, and dispensers, whose upcoming compliance obligations under the DSCSA are all addressed by FDA in the recently issued Compliance Policy guidance documentContinue Reading FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes the ongoing wrangling in the Senate over health care reform as well as highlighting the upcoming need to address FDA User Fees and the health care minibus

Stay tuned for additional updates and analysis from ML Strategies.