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
Centers for Medicare & Medicaid Services
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Managed Care Spotlight: 2020 Year in Review and 2021 Outlook

The past year saw significant developments in managed care regulation at the federal and state levels and we anticipate the rapid pace of change will continue through 2021. In this webinar, we analyzed the most significant legal developments affecting health plans in 2020 and explored what to expect in 2021. Our thought leaders discussed the impact of managed care regulations on a broad range of industry subsectors, from plans and providers to vendors and pharmacy benefit managers.

PROGRAM INSIGHTS

  • The Biden administration seeks to set a tone of order and predictability in its COVID-19 relief and response efforts. These efforts include a swath of executive orders on topics such as data aggregation, support for the National Guard and strategies for vaccine distribution. The acting secretary of Health and Human Services also recently sent a letter to state governors stating that the agency will likely extend the public health declaration—and its attendant regulatory flexibilities—through 2021.
  • The direct contracting model is the next step in the evolution of the Medicare accountable care organization portfolio. The model allows participating organizations to take on a greater level of financial risk, including the Centers for Medicare & Medicaid Services’ version of global capitation. The direct contracting global or professional options may be particularly attractive to managed care organizations, because these options allow new entrants with low or no fee-for-service beneficiaries.
  • The coming year will likely see a continued trend toward financial risk assumption in value-based contracting. Within this trend, there are two common variations. [...]

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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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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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