Push for reform to continue at NACDS
ALEXANDRIA, Va. The National Association of Chain Drug Stores promotes community pharmacy as “the face of neighborhood health care.” In 2010, federal and state policy-makers and ordinary Americans will know that face even better, said NACDS president and CEO Steve Anderson.
“Obviously, running a trade organization in an economy like this has been a very unique and historic opportunity,” Anderson told Drug Store News. “And in Washington, in terms of what we do, we’ve probably never had a more challenging, active, but more successful, year at NACDS than we did in 2009.”
As the health-reform debate raged in Washington throughout 2009, NACDS and its retail members were everywhere on Capitol Hill, working to educate lawmakers and policy staff on the critical value community pharmacy can bring to a more cost-effective, outcomes-based health system. Their prime objective: to advance the so-called Principles of Health Care Reform adopted by NACDS and its members in 2008.
In a wide-ranging, exclusive interview Dec. 17, Anderson recapped the dramatic highs and lows of a year dominated by economic crisis and health reform, and expressed determination to keep the lobbying heat on in 2010. Guiding those efforts will be the health-reform principles hammered out two years ago, Anderson said.
“NACDS has probably never been more active in the public policy arena,” Anderson noted. “After those principles were adopted, we had significant victories” in the policy and legislative arenas, he added. Among them: the inclusion of language in various health-reform bills to address the low reimbursement structure for Medicaid generic prescriptions; the end of restrictions in the military’s TRICARE health program that discouraged the use of retail pharmacies by TRICARE beneficiaries; and passage of a law cracking down on rogue Internet pharmacies.
In a coordinated lobbying campaign, NACDS and other pharmacy groups also have convinced many lawmakers to overturn newly hatched restrictions that would make it almost impossible for many pharmacy retailers to sell durable medical equipment and diabetic supplies to patients enrolled in the Medicare Part B program. At press time, a delay of those new rules was set for expiration Jan. 1, but industry leaders were hoping Congress would grant another stay.
Year 2009, Anderson said, “has really been a watershed year in telling the story of pharmacy.” The health-reform debate, in particular, “has given us an opportunity to be on the field when a lot of people are in the stands,” he added. “It’s given us the opportunity to tell the value story of retail pharmacy … on Capitol Hill, as we attempt to lower health costs and improve patient care. There’s no profession that fits that bill better than pharmacy … and if we don’t tell the story, who’s going to?”
One recent example has been the largely successful effort to contain the spread of the H1N1 virus through a massive vaccination program, much of it through the nation’s community pharmacies. “Our members did an amazing job in communicating about H1N1 and immunizing Americans,” Anderson noted. To that end, pharmacy retailers successfully cleared away the last state restrictions on pharmacist-administered immunizations in 2009. “Maine was the last state” to change its laws, Anderson observed. “Now all pharmacies have the ability to vaccinate.”
NACDS and its top executives are closely monitoring the progress of health-reform legislation, as the Senate and House work to iron out differences between the health-reform bills from both sides of the Capitol. Of particular concern: the provision in the Senate bill for Medicaid pharmacy reimbursement at a paltry 130% of the average manufacturer’s cost that pharmacies pay for generic medications. Many other issues — such as the way medication therapy management services by pharmacists would be reimbursed, and plans to allow for direct importation of drugs from Canada and other countries not under the purview of the Food and Drug Administration — also remain clouded as lawmakers in both houses of Congress debate health reform.
“My concern is that there are considerable unintended consequences in this bill that will affect quality and cost,” Anderson said. To that end, he added, “We’re focusing in the coming year on things that aren’t even enacted yet.” Anderson often has cited three key issues of critical interest to pharmacy advocates in the health-reform debate. They include reforming Medicaid pharmacy reimbursement, expanding the availability of medication therapy management and exempting pharmacies that sell durable medical equipment from what he calls “the redundant and access-threatening requirements of accreditation and surety bonds.” All three provisions are in the various versions of health-reform legislation.
Perhaps the single most critical issue of concern to NACDS’ members is the future of Medicaid payments to pharmacies dispensing generic drugs. As of the end of the year, the organization still was locked in a long fight to win a fair reimbursement for pharmacies dispensing generics to patients enrolled in the program amid efforts by the House and Senate to reconcile differing health-reform proposals, including different payment rates for pharmacies serving Medicaid.
Meanwhile, a legislative delay and a federal court injunction, both secured by NACDS in coordination with the National Community Pharmacists Association, have worked to prevent draconian cuts to Medicaid pharmacy payments. Since that court order went into effect, Anderson said, “We’ve probably saved the industry $4 billion through that injunction.”
Walgreens offering free review sessions to Medicare Part D beneficiaries
DEERFIELD, Ill. Walgreens now is offering free review sessions to Medicare Part D beneficiaries at all of its more than 7,100 pharmacies throughout the country.
Following the open enrollment period for Medicare Part D insurance plans, Walgreens is assisting those beneficiaries who’ve made changes to their prescription drug coverage. Review sessions with Walgreens pharmacists are available daily by appointment through Jan. 31, and are designed to help patients maximize their plan benefits.
Review sessions include:
- A review of beneficiary’s current medications, tiers within their selected plan, co-pays and cost-savings opportunities
- Discussion of available health and wellness services including pneumonia and shingles vaccinations and 90-day prescription benefits
- Checks for potential drug interactions
Watson files FDA application for generic LoSeasonique
MORRISTOWN, N.J. Watson Labs, a subsidiary of specialty pharmaceutical company Watson Pharmaceuticals, has filed an abbreviated new drug application to the Food and Drug Administration for an oral contraceptive.
Watson is seeking approval to market its levonorgestrel and ethinyl estradiol (0.10-mg/0.02-mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, a subsidiary of Teva. Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Teva’s LoSeasonique, which is indicated for the prevention of pregnancy.
On Nov. 23, 2009, pursuant to the Hatch-Waxman Act, Watson notified Duramed that its ANDA requesting approval from the FDA for a generic version of LoSeasonique contained a paragraph IV certification asserting that the LoSeasonique patent is invalid, unenforceable and/or not infringed. Teva Women’s Health filed suit against Watson on Jan. 6, 2010 in the U.S. District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,615,545. Based on available information, Watson believes it may be entitled to 180 days of generic market exclusivity or shared exclusivity should its product receive approval.