Long-Term Care

(Washington, D.C.) — The Pharmaceutical Care Management Association (PCMA) today filed a lawsuit challenging the Trump Administration’s rebate rule.

PCMA’s lawsuit, filed in the district court for the District of Columbia, asks the court to set aside the rebate rule under the Administrative Procedure Act. The PCMA lawsuit also includes a request for a declaration from the court that federal law protects the rebates that Office of Inspector General, U.S. Department of Health and Human Services is seeking to remove from the discount safe harbor regulation.

“The Trump Administration’s last-minute decision to finalize the rebate rule will drastically increase Medicare Part D premiums for seniors, while significantly increasing costs for taxpayers,” said PCMA President and CEO JC Scott. “The haphazard process to finalize a rule that had already been withdrawn circumvented the proper rulemaking process and imposes an effective date that utterly fails to take account of the CMS timeline for issuing implementing guidance, creating chaos for the upcoming plan year. In addition, the agency failed to consider the significant impacts on beneficiaries and government costs that were articulated in thousands of public comments opposing the rule when it was originally proposed. The rebate rule cannot be implemented and should be invalidated.”

To read the court filing, click here.

In addition, Medicare Part D enrollees will be less likely to support elected officials who back proposals resulting in premium increases, according to a new poll from North Star Opinion Research. The poll also indicates that seniors are overwhelmingly satisfied with their drug plans and the drug plan choices offered in the Part D program.

Click here to see widespread stakeholder opposition to the rebate rule including: AARP, AHIP, the Better Medicare Alliance, academics, and high-ranking lawmakers. 

The SUPPORT for Patients and Communities Act, signed into federal law in October 2018, requires, by January 1, 2021, all controlled substance drugs under Medicare Part D and Medicare Advantage Prescription Drug Plans must be electronically prescribed and received by the filling pharmacy. Electronic Prescribing for Controlled Substances (EPCS) mandates are helping to address the opioid epidemic and reduce the abuse of prescription drugs.

EPCS can help reduce fraud and abuse of controlled substances, as it is a Drug Enforcement Agency (DEA)-certified solution, mandated at the state level, requiring proof of identity to ensure that only an authorized prescriber is issuing prescriptions. It has the potential to help reduce medication errors, prescription theft, and forgery, and helps ensure prescriptions are securely transmitted from provider to retail or mail-order pharmacies.

How will Long Term Care Pharmacy be impacted?

The SUPPORT Act included exceptions for certain circumstances, to be specified by the Secretary of HHS. One of the exceptions listed – an individual who is “a resident of a nursing facility (as defined in section 1919(a))” of the Social Security Act.

CMS issued a Request for Information (RFI) on August 4, 2020.  The MHA Legislative Affairs Team has communicated with various stakeholder groups as comments were drafted in response to the RFI. We are in support of submissions calling on this exception to be recognized by the Secretary.  We will update MHA members as further details from CMS are reported.

To review comments submitted by the American Society of Consultant Pharmacists (ASCP) and the Senior Care Pharmacy Coalition (SCPC), please use the following links:

ASCP Comments     SCPC Comments

Issue: Whether the U.S. Court of Appeals for the 8th Circuit erred in holding that Arkansas’ statute regulating pharmacy benefit managers’ drug-reimbursement rates, which is similar to laws enacted by a substantial majority of states, is pre-empted by the Employee Retirement Income Security Act of 1974, in contravention of the Supreme Court’s precedent that ERISA does not pre-empt rate regulation.

For updates and information please visit:  SCOTUS Updates: Rutledge v. Pharmaceutical Care Management Association (Link)

12/10/2020: SCOTUS UNANIMOUS RULING ALLOWING STATES TO REGULATE PBMS

On Thursday, the Supreme Court of the United States delivered a landmark ruling on Arkansas v. PCMA, siding with Arkansas to uphold state law that regulates prescription drug reimbursement rates.  The decision overturns the Eighth Circuit’s ruling that the Employee Retirement Income Security Act of 1974 (ERISA) pre-empts state law.  SCOTUS’s ruling was unanimous (8-0) with Justice Barrett sitting out as she joined the Court after oral arguments. Read the Official Opinion of the Court Here