PHARMACY

With new push, pharmacy groups seek inclusion in health reform’s ACOs

BY Jim Frederick

ALEXANDRIA, Va. — Independent and chain pharmacy groups are making a new push to stake a firm claim to the new healthcare system emerging with the health-reform law enacted earlier this year.

Weighing in on a major aspect of the new law, the independent pharmacy lobby is urging federal health officials to untangle government red tape that could prevent pharmacies from fully participating in newly created health-provider organizations.

In a letter to the Centers for Medicare and Medicaid Services, the National Community Pharmacists Association staked out its position on the shifting healthcare landscape that will take shape over the next few years. The letter was authored by John Coster, NCPA’s SVP government affairs.

Noting that “the Affordable Care Act establishes a new category of healthcare structure: the accountable care organization within the Medicare program,” Coster called on CMS to assure pharmacists a full stake in the new health-delivery model. That means allowing independent pharmacies to collaborate with other health entities without fear of antitrust regulations.

Community pharmacists, he added, provide such services as medication therapy management and medication adherence that can play a “critical role” in ACOs, “as well as in similar entities, such as ‘medical homes,’ ‘transition of care’ teams and ‘medication reconciliation activities.’ These services,” Coster reminded CMS officials in his letter, “have been offered for years by pharmacists in such models as the Asheville Project … as well as other integrated healthcare teams.”

What’s more, noted the group’s government affairs chief, “pharmacists are increasingly gaining recognition for the integral role that they play in encouraging preventative care and promoting wellness, given their subject matter expertise and access to patients in the communities in which they are located. To help fulfill the intent of the new healthcare law to improve medication use, pharmacists should be allowed to collaborate with other providers and negotiate with insurers to deliver patient care services and serve as patient advocates in ACOs.”

That kind of collaborative care model involving pharmacists as part of healthcare teams, Coster told CMS, “will ensure that a greater number of patients will have access to this type of innovative care, resulting in a potential reduction in overall healthcare costs through improved medication use." He called “the inclusion of pharmacists in these collaborative care models” a “natural fit given the profession’s growing utilization of electronic prescribing and electronic health records.”

Coster urged the agency to assure that independent pharmacists — many of which practice in “very rural and/or very urban areas not typically served by chain pharmacies” — are able to compete on a level playing field. Among other things, that means assuring that pharmacists and “allied healthcare providers” are assured a “safe harbor” to shield them from antitrust laws, he pointed out.

“In order for independent community pharmacists to be able to actively participate in the envisioned ACOs and other collaborative care models,” Coster told CMS, “these practitioners need to be able to collaborate with one another in order to form provider networks that can realistically compete on an equal footing with pharmacy networks made up of chain pharmacies.” Both Congress and the Federal Trade Commission may have to get involved, he pointed out, to provide pharmacies with “an antitrust exemption in order to collectively negotiate.”

Also making its voice heard Tuesday was the National Association of Chain Drug Stores. In a letter to CMS administrator Donald Berwick, NACDS VP public policy Julie Khani urged the agency to consider the role pharmacy plays in delivering patient-centered care as it develops rules for ACOs. To that end, she noted, MTM should be a core element in the new health accountability framework.

“A critical factor in the success of an ACO is improving health outcomes and reducing healthcare costs related to chronic conditions through better medication adherence and medication therapy management,” Khani stated. “MTM is one solution that has been proven to improve patient medication adherence by leveraging face-to-face consultation with community pharmacists.”

NACDS also highlighted the importance of provider-pharmacy partnerships in providing patient-centered care. “By partnering with community pharmacies, solo and small practice providers will be able to ensure that their patients receive assistance in medication management from qualified pharmacies, leading to better medication adherence, which will lead to better health outcomes, enhancing the ability of the provider to effectively treat the patient,” Khani told Berwick.

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PHARMACY

Indies, PBMs renew clash over transparency

BY Jim Frederick

ALEXANDRIA, Va., and WASHINGTON — The war of words between independent pharmacies and the pharmacy benefit management industry again is heating up. And again, the two groups are at odds over the question of how transparent — or opaque — the PBM industry’s business dealings with its clients are, and whether those business practices demand reform.

The newest spat over the issue came Tuesday after the National Community Pharmacists Association testified during a federal public hearing on labor practices affecting welfare benefit plans. At that hearing, NCPA’s VP PBM transparency Zachary French urged the U.S. Department of Labor to impose new disclosure standards on PBMs as the government mulls new rules for employee benefit providers for pension and health plans.

French told Labor Department officials that independent pharmacies struggle against an “extremely concentrated PBM marketplace” with “minimal … state and federal regulation” and an opaque business model that fosters “fraudulent and deceptive conduct.”

What’s more, he asserted, “one of the PBM’s primary profit streams is derived from rebates provided by drug manufacturers for driving [branded] drug market share on drugs purchased on behalf of PBM clients. PBMs retain all or a very large percentage of these rebates, even though they are generated by the welfare benefit plans’ pharmacy ‘spend.’”

French argued that the practice is “a clear conflict of interest on the part of the PBM serving in its role as a service provider to a welfare benefit plan.”

The NCPA executive told the agency that the recently enacted healthcare-reform legislation “now mandates a certain degree of PBM transparency in the form of aggregated required disclosures of all of the PBMs that will serve any of the state insurance exchange health plans, as well as in Medicare Part D.”

In equally harsh language, the Pharmaceutical Care Management Association was quick to respond. “The independent drug store lobby continues its ‘disclosure double standard’ campaign of opposing pricing transparency for themselves in Medicaid while demanding more transparency for pharmacy benefit managers,” the group said. “This campaign puts its congressional and retail pharmacy allies in the embarrassing role of attacking and defending the same policy, depending on whether it applies to them or other members of the pharmacy supply chain.”

The PCMA was referring to a new effort by the NCPA to exempt independent pharmacies from antitrust laws so they can fully collaborate in accountable care organizations and other new healthcare provider teams envisioned by the health-reform law.

“While the federal ‘transparency’ provision in the healthcare law already applies to PBMs — but not independent retailers — an interesting irony remains: independent drug stores are themselves the least ‘transparent’ part of today’s pharmacy supply chain,” PCMA asserted. “PBMs support policies that empower payers to make informed healthcare purchasing decisions. However, so-called ‘transparency’ proposals that would give drug stores and drug makers access to competitive information would undermine these efforts and only increase prices.”

What’s more, the group argued, “the [Federal Trade Commission] has explored this issue and concluded that the PBM market is extremely competitive and that this kind of ‘transparency’ would increase, not decrease, costs for consumers.”

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Momenta, Sandoz file patent suit against Teva over generic Lovenox

BY Alaric DeArment

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Momenta said Teva infringed two patents covering analysis processes for the drug enoxaparin sodium. Momenta co-developed and marketed enoxaparin under a partnership with Sandoz, the generic drug division of Novartis. The drug is a generic version of Sanofi-Aventis’ Lovenox.

Teva, whose application for its own generic version of Lovenox is under review by the Food and Drug Administration, denied that it infringed the two patents and said the lawsuit was “without merit.”

The marketing of generic Lovenox by Momenta and Sandoz became a hot topic because of its potential implications for the implementation of the regulatory approval pathway for biosimilars provided by the healthcare-reform law. Though the FDA classifies Lovenox as a pharmaceutical drug, its chemical complexity and manufacturing process mean it has more in common with biologics than with traditional pharmaceuticals, and experts said the FDA’s approval of the generic version could influence its approach to biosimilars in the future.

 

 

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