USHCC welcomes Boehringer Ingelheim as strategic partner
WASHINGTON — The United States Hispanic Chamber of Commerce on Thursday welcomed Boehringer Ingelheim Pharmaceuticals to its family of corporate members as a strategic partner. "Boehringer Ingelheim’s commitment to educating the Hispanic community on the impact of chronic disease is particularly noteworthy," the group noted. "Their dedication to community health was highlighted during last year’s launch of a highly successful initiative, in partnership with Univision, that promoted best practices for preventing and treating diabetes. The company seeks to further advance these efforts through its partnership with the USHCC, working with small business owners to encourage healthy living for the benefit of these small firms and their employees."
"The USHCC is proud to welcome an industry leader like Boehringer Ingelheim into our association. Together, we will implement programs that raise awareness of how chronic diseases like diabetes have a negative effect on the productivity and viability of small businesses, and have a deep impact in the Hispanic community as a whole," stated Javier Palomarez, USHCC president and CEO. "At the USHCC, we understand that to effectively serve the business community, our efforts can’t solely be focused on the bottom line. For a business to thrive, it must have a healthy and productive workforce – BIPI understands this imperative, and that is why our partnership is so valuable," he said. "We are delighted that BIPI is also investing in bringing together American leaders from the political and regulatory sectors with our country’s small business owners at the USHCC Legislative Summit, as well as helping convene the largest gathering of Hispanic business leaders at our National Convention."
"Our association is proud of this new partnership and would like to expand the reach of BIPI’s programs to specifically include the Hispanic business community, so our American entrepreneurs can continue to build businesses that are not only profitable, but most importantly, healthy and sustainable," added USHCC Chairman Emeritus Nina Vaca.
GAO: Federal upper limits 1.4% lower than National Average Drug Acquisition Cost
WASHINGTON — In a report publicly released Thursday by the U.S. Government Accountability Office, the GAO found that the total draft federal upper limits amount based on the new formula under the Patient Protection and Affordable Care Act was about 1.4% lower than the total National Average Drug Acquisition Cost amount in aggregate for 1,035 outpatient drugs subject to the FUL in first quarter 2013. GAO found large differences between the total PPACA-based FUL amount and the total NADAC amount for generic and for branded generic versions — brand-name drugs with other versions that can be substituted for one another — of the drugs subject to the FUL in first quarter 2013.
GAO found that the total PPACA-based FUL amount for the generic versions was 19% higher than the total NADAC amount, but for the branded generic versions was 26% lower. GAO’s work indicates that CMS is close to having a formula under which FULs would better reflect pharmacy acquisition costs, but continues to apply FULs that were calculated more than 4 years ago. Additionally, the relationship between PPACA-based FULs and NADACs may be affected by several factors, including rebates and discounts that are not reflected on pharmacy invoices. To determine whether GAO’s early results of the relationship between the PPACA-based FULs and the NADACs holds over time will require continued monitoring by CMS, GAO reported.
To develop a national benchmark for retail pharmacy acquisition costs of Medicaid covered outpatient prescription drugs — known as the National Average Drug Acquisition Cost — the Centers for Medicare & Medicaid Services within the Department of Health and Human Services surveys each month randomly selected retail community pharmacies for invoice data on their actual drug acquisition costs. CMS then calculates an average acquisition cost for each drug based on invoice data received from about 500 to 600 pharmacies. CMS officials expressed confidence in their current process, but noted that some limitations may exist, GAO noted. For example, CMS officials stated the extent to which NADACs reflect rebates and discounts is limited because most occur off-invoice or are not tied to a specific drug purchase. CMS has developed and published more than 5,000 NADACs, which CMS has estimated apply to more than 90% of the drug claims reimbursed by Medicaid.
GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
WASHINGTON — The Food and Drug Administration’s proposed rule on prescription drug labeling would add $4 billion annually to the nation’s healthcare costs, undercutting the cost savings that generic medicines have brought to America’s patients and healthcare system, according to an analysis released Wednesday by economic consulting firm Matrix Global Advisors.
“Flooding the marketplace with multiple versions of labels for the same medicines would not only seriously jeopardize patient safety, but also would burden consumers, taxpayers, large and small businesses, and state and federal governments with billions of dollars in increased costs for generic medicines,” said Ralph Neas, president and CEO of the Generic Pharmaceutical Association. “The study demonstrates that in proposing this rule, the FDA overlooked its very real financial impact on the affordability and availability of generic medications for patients and all stakeholders in the drug supply chain.”
Of the projected increase in healthcare costs, MGA estimates that Medicare and other government programs will incur $1.5 billion in annual new spending, while private insurers and patients will pay $2.5 billion per year.
The proposed rule would expose generic drug manufacturers to substantial new tort liability costs, which in turn would require them to adjust prices to stay in business, withdraw products or decline to launch new affordable versions of brand medicines, the report cautioned. Increased liability also would accrue to pharmacists, physicians and the other principal participants in the healthcare system, beyond the substantial confusion for all stakeholders, impeding healthcare decisions and delivery.
“New labeling regulations should protect patients, facilitate care and reduce costs,” Neas said. “Unfortunately, the Proposed Rule does none of these things — the unintended consequences of this rule would be nothing short of catastrophic. The FDA and others need to take a hard look at the potential harmful impact on patient access and national healthcare costs of a Proposed Rule that changes 30 years of law requiring generic and brand medicines to have the same labels, and permits for the first time labeling changes for generic drugs without FDA approval."