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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HPE Miami 2021: Subsector Insights | Pharmacy

McDermott partner Karen Gibbs joined Matthew Thompson, general partner at Enhanced Healthcare Partners, and Drew Walk, chief executive officer at Soleo Health, in an insightful discussion of what’s next for investment in the pharmacy space.

Access the PDF here.

  1. New therapies and the accompanying technologies to deliver them make pharmacy an appealing space for investment in 2021. In particular, organizations that can find ways to effectively manage escalating costs will be successful.
  2. The COVID-19 pandemic has highlighted the value and game-changing solutions that pharmacy can bring to the healthcare ecosystem at large. Pharmacy is an end point of care, and its extraordinary innovation is driving better patient outcomes.
  3. Regulatory scrutiny is always evolving in the pharmacy industry and should remain top-of-mind for any company considering an investment in the space.
  4. A transition to true and effective value-based care in the pharmacy sector will require significant collaborating between payers, providers, suppliers and manufacturers.
  5. COVID-19 has created headwinds in this sector because pharmacy is downstream from elective surgeries and other elective care. There is a backlog of care stemming from the pandemic, however, which presents an opportunity for accelerated growth in the pharmacy space moving forward.
  6. Innovations that help establish “arm-in-arm” relationships between physicians and pharmacists will help drive [...]

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Bills Ban Gag Clauses in Pharmacy Contracts

On October 10, 2018 President Trump signed two bills that ban “gag clauses” in pharmacy contracts. Congress passed the two bills—one for Medicare prescription drug plans (“Know the Lowest Price Act”) that will go into effect in January 2020, and another for commercial employer-based and individual policies (“Patient Right to Know Drug Prices Act”) effective immediately—by almost unanimous vote in September 2018.

While many states have already prohibited the use of these clauses, this is the first such action on a federal level.

Gag clauses are sometimes found in contracts between pharmacies and insurance companies, pharmacy benefit managers or group health plans and bar pharmacists from telling customers that they could save money by paying cash for their prescriptions rather than using their health insurance. If pharmacists violate the gag rule, they risk penalties and/or contract termination. Under the new legislation, pharmacists are not required to tell patients about the lower cost option, but they also cannot be contractually prohibited from engaging in the cost conversation.

The legislation is consistent with the position of the Centers for Medicare & Medicaid Services (CMS), which, in May of this year, issued guidance stating that “gag clauses” are unacceptable in the Medicare Part D program.




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