HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
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Top Takeaways: New Steps for Compliance: A Closer Look at the DOJ’s Revised Corporate Compliance Program

The US Department of Justice’s (DOJ) revised compliance program document “The Evaluation of Corporate Compliance Programs,” released June 1, 2020, helps organizations understand how DOJ evaluates compliance programs for effectiveness. Below are the the top takeaways from this revision that you should be aware of. For a deeper dive into this revision, listen to our webinar recording.

  1. Three questions the DOJ looks to answer are:
    • Is the corporation’s program well designed?
    • Is the program being applied earnestly and in good faith? (In other words, is the program adequately resourced and empowered to function effectively?)
    • Does the corporation’s program work in practice?
  2. Under the June 2020 updates, the DOJ will increase its focus on evaluating how effectively compliance programs are tailored to the organization’s risk profile, including the company’s size, industry, geographic footprint, regulatory landscape and other factors.
  3. Compliance programs should continuously evolve to pass muster under the DOJ’s updated guidance. Programs are expected to adapt based on review of new data, as well as lessons learned from the company’s own experiences and the experiences of similar companies.
  4. The design of compliance programs will be even more closely scrutinized. The DOJ has added more detailed questions on program design, including, among others, have the policies and procedures been published in a searchable format?; how do employees ask questions during on-line trainings; and does the company take measures to test whether employees are aware of the compliance hotline and feel comfortable using it?
  5. The importance [...]

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Five Questions with a Health Lawyer: Nicholas Alarif

Nicholas Alarif
Office: Washington, DC
Years at Firm:  3

What is your favorite part about practicing healthcare law at McDermott? 

I hate to sound like a broken record, but the best part about practicing at McDermott is the innovative and collaborative culture. I have found that McDermott fosters a team-based approach to solving client issues. The opportunity to interact with experts in so many disciplines and sub-disciplines to achieve common goals for our clients has been fantastic. Further, I have found that my colleagues are open to new approaches to tackle client issues and are always happy to streamline internal processes. Innovation is not what you typically think of in a law firm environment, and McDermott’s embrace of change makes for an exciting and fun place to practice.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

The biggest opportunity and greatest challenge may actually be the same—a shifting regulatory landscape. For instance, the Centers for Medicare and Medicaid Services and the Office of Inspector General recently published proposed revisions to the physician self-referral law (Stark Law) and the Anti-Kickback Statute (AKS) regulations, which, among other things, are attempting to foster transitions from fee-for-service medicine to value-based care. These proposed changes will potentially allow providers broader flexibility when engaging in financial relationships with a value-based goal. The proposed changes present [...]

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Five Questions with a Health Lawyer: James A. Cannatti III

Name: James A. Cannatti III
Practice Focus Area: Healthcare Fraud & Abuse
Office: Washington, DC
Years at Firm: 1

What is your favorite part about practicing healthcare law at McDermott?

My favorite part of working in the McDermott Health practice, and at the Firm generally, is the team approach to advising clients. Each of us has unique subject matter knowledge and experience in different areas of law. Very often, our clients require advice that cuts across multiple areas and issues. By working together across different disciplines within the Firm and within the Health practice we can provide comprehensive advice and counsel to our clients – not just advice on one discrete issue – and approach things from a broader, strategic perspective to help meet their needs.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

I work in the healthcare regulatory space, focusing on federal and state fraud and abuse issues. As the healthcare industry has evolved and focused more on delivering value, many fraud and abuse laws, which were written decades ago, have not kept pace and have been seen as barriers to innovation. Over the last few years regulators have signaled a willingness to rethink how some of the laws should be applied to novel arrangements and approaches to care. The evolving regulatory landscape and the potential removal of some of [...]

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ONC Expected to Release Proposed Information Blocking Rule Soon

It has now been one month since the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) sent its proposed information blocking rule to the Office of Management and Budget (OMB) for required review.

We expect OMB to approve the much-anticipated proposed rule and ONC to release it soon with the usual opportunity for public comment. While we wait, there are some things that health information technology developers, health information exchanges, health information networks and health care providers who may be subject to the information blocking prohibition and enforcement actions can do to prepare for the upcoming comment period. But before we get to comments, let’s remind ourselves about how we got to this point.

By way of background, Congress asked ONC to produce a report describing the extent of information blocking and a strategy to address it. ONC submitted that report to Congress in 2015 (the 2015 Report) noting, among other things, enforcement authority gaps and indicating that successful information blocking prevention strategies would likely require congressional intervention. In the 21st Century Cures Act, which became law in 2016, Congress granted the HHS Office of Inspector General investigative and enforcement authorities for prohibited information blocking conduct. The Cures Act defined information blocking as a practice that “except as required by law or specified by the Secretary…, is likely to interfere with, prevent, or materially discourage access, exchange, or [...]

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Medicare Hearings and Appeals: Litigation, New Initiatives, and Opportunities to Exit the Backlog

Providers continue to face a massive Medicare appeals backlog before the Office of Medicare Hearing and Appeals (OMHA). Pending appeals number in the hundreds of thousands and the current average processing time for an appeal is over three years, with newly filed appeals likely to reach closer to five. While OMHA and Medicare reimbursement appeals face endemic issues, new developments and alternative programs may present strategic opportunities for providers and chip away at the backlog.

Regulatory changes from the U.S. Department of Health and Human Services (HHS) have come into play and are designed to provide clarity, reduce delays, and streamline the appeal process.  For example, HHS has recently revamped the OMHA case processing manual, “deputized” OMHA attorney adjudicators, and determined that some decisions from the Departmental Appeals Board (the appellate level above OMHA) will now be precedential.

Additionally, OMHA and the Centers for Medicare & Medicaid Services (CMS) have initiated new programs that provide alternatives to the traditional appeals procedure with the goal of reducing the backlog. These include 1) the OMHA Settlement Conference Facilitation alternative dispute resolution process; 2) the Statistical Sampling Initiative; 3) CMS’s Low Volume Appeals settlement options, and 4) CMS’s Formal Telephone Discussion Demonstration for Durable Medical Equipment providers. Further, recent Federal Circuit court cases, including American Hospital Association, et al v. Thomas Price, may significantly impact the Medicare appeals process.

During the AHLA Annual Meeting on Monday, June 25, McDermott lawyer and former OMHA attorney advisor, Nicholas Alarif, and Amanda Axeen, the [...]

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