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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340B in 2021: What Covered Entities and Their Partners Need to Know Now

Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of Health & Human Services (HHS) and Health Resources & Services Administration (HRSA) leadership may lead to changes in 340B Program policy, but the ongoing conflicts, particularly around contract pharmacies, will not likely be resolved quickly.

In this webinar, we discussed the current issues affecting 340B Program stakeholders, the tools (and their limitations) that may be employed by stakeholders and government agencies to resolve those issues, and what covered entities can expect in future developments affecting the 340B Program.

  1. Covered entities will likely be unable to resolve contract pharmacy issues quickly through either the current litigation or the ADR panels. While there are a number of pending cases related to the 340B Program, litigation can be inherently slow process. The Administrative Dispute Resolution (ADR) Final Rule that was published in December 2020 was recently enjoined and additional injunctions may follow. While HHS appears to be moving forward with operationalizing the ADR process, the ADR Panel members who would hear the disputes remain under review by the Biden Administration. If and when the ADR panels are finally implemented, decisions of those panels may be litigated too.
  2. Covered entities should review and monitor their state Medicaid program’s billing requirements for 340B drugs. State Medicaid programs must have a mechanism to identify 340B drugs when required to exclude them from [...]

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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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