PHARMACY

E-prescribing of generics may be limited by pending legislation

BY Alaric DeArment

NEW YORK — Bills introduced in the legislatures of nearly a dozen states have pharmacy benefit managers and the generic drug industry fearing that the bills could lead to limits on doctors’ abilities to prescribe generics through e-prescribing.

The Pharmaceutical Care Management Association, the main lobby for PBMs, said the bills would prohibit doctors from seeing lower-cost drug options, including generics and preferred brands; would prevent the e-prescribing software from showing safety information; and would disallow lower-cost pharmacy options.

The bills are pending in Indiana, Kansas, Mississippi, Missouri, Nebraska, New Mexico, New Jersey, North Dakota, Oklahoma, Pennsylvania and South Dakota.

According to a copy of the Indiana bill that Drug Store News obtained from the PCMA, the proposed legislation would prohibit “interference or limitations” that allegedly could get in the way of a drug order being entered into the software and transmitted. These would include the display of multiple messages and the display of advertisements or messages that offer encouragement, endorsement or incentives to use a “specific pharmacy or prescription of a specific drug or device at the point of care.”

Pfizer, the world’s largest drug maker, has lobbied on behalf of the legislation.

“The e-prescribing legislation under consideration in several states would actually increase physicians’ ability to select the right therapy for a patient, be it branded or generic,” Pfizer spokesman Raul Damas told Drug Store News. “Pfizer strongly supports e-prescribing policies that preserve patient autonomy, reduce healthcare costs and ensure quality patient care. Pfizer is actively working with legislators, physicians and patient groups to enact e-prescribing policy that reflects our shared priorities.”

But the generic drug industry doesn’t see those priorities as reflective of its own. The industry’s main lobbying group, the Generic Pharmaceutical Association, supports e-prescribing, as the PCMA does, but it also has expressed concerns about the bills, similar to the PCMA’s.

“The consumer may not know when there’s a generic equivalent available,” GPhA VP state government affairs Shawn Brown told Drug Store News. “I don’t know why you’d want to be less transparent for the patient and the physician, unless you’re just trying to protect your market share.”

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PHARMACY

NACDS to House committee: More focus on patients, less on paperwork

BY Antoinette Alexander

ALEXANDRIA, Va. — In a statement submitted to the House of Representatives Small Business Committee, the National Association of Chain Drug Stores further emphasized its support of legislation to repeal the 1099 business tax form reporting requirements. NACDS indicated that such requirements would force pharmacies to spend inordinate amounts of time and human resources on additional paperwork, leading to less time alloted to helping patients with their healthcare needs.

"While NACDS shares the concerns of the broader business community about the additional administrative burdens and costs associated with the 1099 reporting requirement, chain pharmacies, as healthcare providers, are also deeply concerned the mandate could hinder the delivery of patient care," NACDS said in its statement. "The 1099 mandate is a prime example of an administrative mandate that will interfere with pharmacies’ ability to furnish convenient and cost-effective health care."

The 1099 business tax form reporting requirements were enacted as part of the Patient Protection and Affordable Care Act. In addition to submitting the statement, NACDS applauded the panel for convening a hearing to address the problematic issue for businesses, including pharmacy.

The provision would require businesses to report to the Internal Revenue Service on a 1099 form total payments in excess of $600 in one year to an individual vendor. According to NACDS, this dramatically would increase data collection and reporting requirements, putting a tremendous and costly administrative burden on accounting departments in every organization in America, including neighborhood pharmacies.

"Pharmacies are the face of neighborhood health care and are a highly trusted source of healthcare information, products and services," the letter continued. "The 1099 reporting requirements will force pharmacies, ­ whether large national companies or small local drug store chains, ­ to spend inordinate amounts of time and human resources on additional paperwork. This will take away from the time that pharmacies and pharmacists have to help patients address their medication and other healthcare needs."

Last week, the NACDS endorsed an amendment introduced by Sen. Debbie Stabenow, D-Mich., which would lift burdensome reporting requirements affiliated with the 1099 business tax form, which could have limited pharmacist-patient interaction and patient care. The amendment passed in the Senate.

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Makena receives FDA approval

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for preventing preterm births.

The agency announced Friday the approval of Baxter Pharmaceutical Solutions’ Makena (hydroxyprogesterone caproate) injection, for reducing the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of at least one spontaneous preterm birth.

Makena will be manufactured by Baxter for KV Pharmaceutical/Ther-Rx. Ther-Rx, which will market the drug, said it will be available in March. Makena is a specialty injectable and will be available through a network of specialty pharmacies and distributors that specialize in distributing specialty injectables and will be express mailed directly from the pharmacy/distributor to the healthcare provider or to the patient, depending on the preferred location for administration of weekly injections.

“Preterm birth is a significant public health issue in the United States,” FDA Office of New Drugs deputy director Sandra Kweder said. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”

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