PHARMACY

NACDS reacts to Texas Federal District Court’s ruling to strike down ACA

BY Sandra Levy

In response to the announcement last Friday by a federal district court in Texas to strike down the Affordable Care Act, the National Association of Chain Drug Stores issued a statement which said, “The law is expected to remain in effect as the court’s decision is appealed to a federal appeals court and perhaps to the U.S. Supreme Court.”

“This latest development magnifies the importance of NACDS and the National Community Pharmacists Association’s successful litigation on Medicaid pharmacy reimbursement more than a decade ago. This latest development also underscores the potential need for ongoing advocacy on these issues—particularly if the federal district court’s ruling on Friday ultimately is upheld.” NACDS said.

NACDS went on to say that the federal district court ruled Friday that the “individual mandate” to purchase insurance is unconstitutional. The Supreme Court originally ruled that the individual mandate was constitutional because it imposed a tax on individuals who failed to purchase insurance. However, the federal district court in Texas ruled that the individual mandate is no longer a constitutional tax because Congress zeroed out the tax in 2017.

“Furthermore, the court in Texas held that all the other provisions of the ACA must also be struck down because they are not “severable” from the individual mandate, which the Court found was “essential” to the ACA. This severability issue, which concerns whether all the other provisions of the ACA can survive, will remain a central issue as the case is appealed. Proponents of the ACA argue Congress concluded that the individual mandate is not essential to the ACA in 2017, when Congress eliminated the individual mandate tax but refused to repeal the ACA,” said NACDS.

NACDS said that one issue for pharmacies is the implications of the court decision for Federal Upper Limits, or FULs on reimbursement for generics in the Medicaid program. “As a reminder, in 2007 CMS issued a rule that threatened to cut pharmacy reimbursement by billions of dollars by improperly including non-pharmacy sales in Average Manufacturer Price, or AMP, which are used to calculate FULs. NACDS and NCPA successfully litigated against the rule, resulting in a court order that halted implementation of the rule, and CMS eventually withdrew the rule rather than defend it in court.”

“The ACA included provisions that prohibited the use of non-pharmacy sales in AMPs. However, the court decision striking down the ACA should not impact the calculation of AMPs, because the court decision in our AMP lawsuit still demonstrates that CMS cannot include non-pharmacy sales in AMPs. However, if the ACA is eliminated then CMS will revert to the pre-ACA method of calculating FULs. Without new legislation, Medicaid FULs for generics would be set at 250% of the lowest reported AMP, whereas today FULs are calculated as no less than 175% of the weighted average AMP. If this were to happen, NACDS would need to work with our members to ascertain the possible impact on pharmacies but our preliminary analysis indicates that a large negative impact on pharmacy reimbursement would be unlikely,” said NACDS.

Finally, NACDS said it is prepared for “additional advocacy in the Congress and with the Trump Administration if needed to maintain fair and adequate Medicaid reimbursement.”

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CRN: Farm Bill offers promise for hemp, lacks VMS SNAP measure

BY Sandra Levy

With the Farm Bill — the Agriculture Improvement Act of 2018 — headed to the president’s desk, one aspect of it is particularly promising to the supplement industry. The Council for Responsible Nutrition responded with praise for the provision of the bill that legalizes hemp and creates a pathway to bring hemp and its byproducts — including cannabidiol — to consumers, with one key hitch.

“CRN applauds the inclusion of the Hemp Farming Act in the Farm Bill that removes hemp from the definition of marijuana in Schedule I of the Controlled Substances Act and provides a framework for the lawful cultivation and marketing of hemp and its constituents, including cannabidiol, or CBD,” said CRN president and CEO Steve Mister. “This provision removes one of the barriers to the lawful marketing of CBD in a range of dietary supplement, food and personal care products, and will allow for greater research and understanding of this substance as a legitimate agricultural commodity.”

Mister also said that the dietary supplement and functional food industry now is able to work with the Food and Drug Administration to address the legal concerns it has raised with respect to CBD as a legitimate ingredient in food and dietary supplements. “However, in anticipation of increased market interest in CBD, CRN reminds industry that the Farm Bill has no effect on FDA’s position that CBD is excluded from use in food and dietary supplements, citing a definitional matter that prohibits ingredients from being marketed in food or supplements if they were previously studied in clinical trials for pharmaceutical purposes. CRN looks forward to engaging with FDA to address those concerns,” Mister said.

Emphasizing that CRN also is disappointed that the SNAP Vitamin and Mineral Improvement Act was dropped from the conference version of the Farm Bill, Mister said, “An important step toward improving the nutrition status of low-income Americans, this provision would have allowed Supplemental Nutrition Assistance Program recipients to purchase a multivitamin-mineral dietary supplement with their program benefits. CRN is encouraged by the strong support this effort received within Congress and among industry stakeholders, despite ultimately being derailed by political concerns. We are saddened that low-income Americans will not be given access to this option to help improve nutrient gaps in their diet. CRN remains committed to expanding consumer access to multivitamins and will continue to support policies that ensure all Americans, regardless of socioeconomic status, have equal opportunity for good nutrition.”

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NACDS grant partners increase adult vaccination awareness

BY Sandra Levy

The National Association of Chain Drug Stores’ grant partners have published articles in the journal Vaccine, outlining the results of projects designed to increase adult vaccination.

The prevalence of vaccine-preventable diseases in adults remains a significant public health issue in the United States. The demonstration projects were supported by the Centers for Disease Control and Prevention and NACDS.

NACDS’ Washington State partner’s article shows that community pharmacists contribute to improving adult immunizations through vaccine “forecasting” and proactive recommendation. The Nebraska and Iowa partners’ article details the implementation of a technology platform aimed at increasing adult vaccination rates in community pharmacies.

In total, these three projects provided more than 300,000 adult immunizations. Over 300 participating pharmacies were connected to their state-based immunization registry, with 150 pharmacies newly connected as a result of the grant.

The accessibility of pharmacies has been an important and documented factor in increasing immunization rates over the past two decades.

NACDS has consistently advocated for pharmacists to provide vaccinations. Pharmacists have the legal authority to administer immunizations in all 50 states.

The demonstration projects were supported by $800,000 funded by the CDC. NACDS contributed an additional $300,000.

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