Health Care

It has been some time since we provided a detailed update on the status of FDA's user fee legislation making its way through Congress, so that's what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.

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.

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)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).

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.

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. 

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.

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.

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.”

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.

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).

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.

It appears that - at least for now - the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch's efforts to tackle the increasingly contentious debate about prescription drug prices.

Earlier this month, two states – Maryland and Nevada – passed legislation aimed at controlling drug prices.The two laws are being touted by proponents as decisive action against pharmaceutical manufacturers.

The Massachusetts legislature has targeted July 1, 2017 as the date by which it will have legislation on Governor Charlie Baker’s desk regarding the commercial cultivation, processing, and sale of non-medicinal cannabis products for adult use.

The Senate bill to repeal the Affordable Care Act is currently being poured over by Senate Republicans and their staff, but the early prognosis for a vote this week is not good. Senate leadership had set a goal of voting on this legislation – known as the Better Care Reconciliation Act (BCRA) – before the Fourth of July recess, which means by this Friday.

Children in United States receive their health insurance from multiple sources: the Children’s Health Insurance Program (CHIP), Medicaid, employer-sponsored insurance, or a qualified health plan on the Marketplace.

Whistleblowers remain a steady source of False Claim Act (FCA) suits against health care and life science companies each year.  Join our upcoming webinar - “Qui Tam Relators: What You Need to Know” on July 12 at 1pm ET.

On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016.  Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of July 31, 2017.  As explained in our earlier post, CMS publishes Part D DIR Reporting requirements each year and sets the deadline for DIR submissions.

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion.

A New Jersey district court recently denied a motion to dismiss Talone, et. al. v. The American Osteopathic Association, an antitrust class action. The suit alleges that the physician association violated the Sherman Act by illegally tying osteopaths’ board certification to association membership.