John Coster, PhD, RPh

The Coalition for Community Pharmacy Action (CCPA) has been working toward ensuring that health care reform legislation favors community pharmacies-included here are some top issues and when the change will take effect. 

     Julie Khani                                  John Coster, PhD, RPh

On March 23, 2010, President Obama signed into law HR 3590, the Patient Protection and Affordable Care Act, which the US House of Representatives passed 2 days earlier. 

The National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS), through the Coalition for Community Pharmacy Action, have been working together for many months to ensure that health care reform legislation includes favorable provisions for community pharmacies. We wanted to provide you with a summary of the top issues affecting pharmacy and a timeline of when the changes will take effect. 

Medicaid Generic Drug Pharmacy Reimbursement (AMP Fix) 

The Deficit Reduction Act of 2005 would have reimbursed pharmacies below their acquisition cost for many Medicaid generic drugs. These cuts have been delayed because of a December 2007 court injunction that was won by NACDS and NCPA. We have advocated a legislative solution to permanently reverse these generic drug cuts, and this bill provides that relief in part. 

The health care reform bill improves the definition of average manufacturer price (AMP) so that it includes only manufacturers’ sales to retail pharmacies. It directs the Centers for Medicare & Medicaid Services (CMS) to set the Medicaid federal upper limit for reimbursement of generics at a rate of “no less than 175% of average weighted AMP.” 

These reforms are important now: the bill also expands Medicaid coverage— starting in 2014&mdash;to individuals up to 133% of the federal poverty level, adding an expected 16 million more individuals to the program. 

The bill requires the secretary of the Department of Health and Human Services (HHS) to implement the new Medicaid generic rates as early as October 2010. This means pharmacies in some states may see a reduction in generic drug reimbursement at that time, but that is uncertain until AMP data becomes available. This new law mitigates the impact of the more draconian generic drug cuts planned before changes were made, saving pharmacies approximately $3 billion in Medicaid generic drug cuts. 

Pharmacists Exempted from Medicare DME Accreditation 

The bill provides an exemption for most pharmacies from the burdensome accreditation requirements to provide durable medical equipment (DME) to Medicare patients, and changes current law so that those pharmacies still needing to obtain accreditation have until January 2011 to do so. Accreditation is still required of all pharmacies that submit competitive bids. Exemption is contingent upon a pharmacy: 

• Having total Medicare DME billings that are 5% or less of total prescription sales 

• Having no adverse fraud/abuse determination for the past 5 years 

• Submitting an attestation that its total Medicare DME, prosthetics, orthotics, and supplies billings are and continue to be less than a rolling 3-year average of 5% of total pharmacy sales 

• Submitting documentation to the secretary of HHS (based on a random sample of pharmacies) that would allow the secretary to verify the information 

For pharmacies that have stepped down from providing DME to Medicare patients in anticipation that Congress would enact an exemption, we expect CMS to allow those pharmacies to step back up soon. Those pharmacies that have already obtained accreditation will be exempt from reaccreditation if they meet the above criteria. 

The health care reform bill envisions an expanded patient care role for pharmacists in new health care system models. These new responsibilities will help ensure more appropriate use of prescription medications, especially for those patients who have chronic illnesses. These include pharmacist roles in accountable care organizations, medical homes, “transitions of care” teams, and medication reconciliation activities. 

The bill also includes a medication therapy management (MTM) grant program that will help test new and innovative methods to provide MTM, which will help to reduce the estimated $290 billion in health care expenditures that result from inappropriate medication use or noncompliance with taking medications. 

Community pharmacies may be eligible for this grant funding, but the government’s process will take many months and will be subject to the annual appropriations process. â–  

Julie Khani is vice president of federal health care programs at NACDS. John Coster, PhD, RPh, is senior vice president of government affairs at NCPA. Ms. Khani and Dr. Coster are copresidents of the Coalition for Community Pharmacy Action.

Articles

Health Care Reform's Impact on Community Pharmacy

Julie Khani, Vice president of federal healthcare programs at NACDS 

John Coster, PhD, RPh Senior vice president of government affairs at NCPA 

The National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS), working together as the Coalition for Community Pharmacy Action (CCPA), have continued their efforts over the last few years to prevent the Centers for Medicare & Medicaid Services (CMS) from impeding patient access to valuable Part B durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) from community pharmacies. 

Recently, CCPA achieved a major success in convincing Congress and the president to delay implementation of the deadline for pharmacies to obtain accreditation as a condition for new or continued participation in the Part B DMEPOS program. Because the president signed HR 3663 into law on October 13, 2009, pharmacies have until January 1, 2010, to become accredited. 

Suppliers providing only Part B drugs and vaccinations do not have to meet the accreditation requirements, but they must meet the surety bond requirement, as must all pharmacies, in order to remain as a supplier in the Medicare Part B program. 

CMS has indicated that, for pharmacies that have already stated they will only provide Part B drugs, but subsequently become accredited to provide DMEPOS, CMS will capture the accreditation information automatically from the accrediting organization. The supplier can then start to bill for all supplies and services for which they have been accredited as of the date of accreditation, without submitting a new 855S form to CMS. 

In addition, CCPA has worked to obtain inclusion of 2 provisions in the House and Senate health care reform bills that would provide permanent, albeit limited, exemptions from the accreditation requirement. 

The Senate Finance Committee bill includes a provision that exempts those pharmacies whose Medicare DMEPOS billings are <5% of pharmacy sales, have been enrolled as suppliers with no adverse final actions against them over the prior 5 years, and are willing to submit verification documentation. The secretary may determine more appropriate accreditation standards for pharmacies, as may be done for the other 17 types of medical professionals that are exempted from the accreditation requirements. 

In the House TriCommittee bill, pharmacies that supply diabetic testing supplies, canes, and crutches are exempt from the accreditation requirements. In addition, those pharmacies that have been enrolled as DMEPOS suppliers for at least 5 years without any final adverse action would be exempt from the surety bond requirement. Accreditation would still be required for competitive bidding. 

CCPA will continue to work with Congress and CMS to address the situation on a more permanent level, especially considering that passage of a health care reform bill may not occur before the extension deadline of January 1. 

Finally, CCPA is continuing to address the position of community pharmacy in the DMEPOS competitive bidding program. CMS has indicated in a recent final rule that it will likely include retail diabetes testing supplies in future rounds of competitive bidding. CCPA is working to oppose this position as well as attempts to drastically reduce fee schedules for the DMEPOS supplies that community pharmacies provide to their patients. 

We are working on all these issues to enable community pharmacies to continue to be able to provide vital Part B DMEPOS, and other supplies and services, to their patients.

The Coalition for Community Pharmacy Action (CCPA) is an alliance between the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA), which together represent more than 55,000 community pharmacies. CCPA leverages the support, effort, and infrastructure of NACDS and NCPA while engaging community pharmacy to participate and advocate on issues affecting the industry. 

CCPA has fought steadily over the last few years to prevent the government from hindering patient access to valuable DMEPOS from community pharmacies. 

NCPA, NACDS Fight to Preserve Patient Access to Needed DMEPOS 

Ms. Khani and Dr. Coster are copresidents of the Coalition for Community Pharmacy Action.

Vice president of federal healthcare programs at NACDS

President Barack Obama's commitment to health care reform was made clear last month when he held a White House Health Care Reform Summit and issued the first budget proposal of his administration. The $3.1-trillion fiscal year federal 2010 budget proposal creates a reserve fund of $634 billion over 10 years dedicated to paying for health care reform, primarily expanding health insurance coverage to uninsured Americans. The budget proposal, as well as the summit, brings a focus to health care reform that has been absent in Washington for many years.

The Coalition for Community Pharmacy Action (CCPA) applauds such a significant down payment on health care reform, and we believe there are great opportunities for pharmacy moving forward. We want to be part of a reformed health care system, and have developed a series of principles that emphasize the importance of expanding pharmacists' clinical services to improve the outcomes of medication use. We also are advocating for greater health care interoperability for the pharmacist, so that we have information that helps us provide better patient care services&#8212;such as laboratory and diagnosis information. We also believe that the Medicare Part D medication therapy management (MTM) program can be made more meaningful and effective for our patients.

Senior vice president of government affairs at NCPA

But a commonly heard phrase in Washington is "the devil is in the details." Some of the money used to pay for potential health care expansions comes from cuts to federal health care programs. Fortunately, the proposed budget outline makes no mention of reductions to pharmacy reimbursement or the use of average manufacturer price (AMP) as a reimbursement benchmark.

Targeting fraud, waste, and abuse (FWA), however, in Medicare was highlighted in the proposal. CCPA supports the goal of eliminating FWA in public programs, but some misguided attempts directed at reducing FWA have resulted in unnecessary and onerous mandates for pharmacy. These include the recent requirements that pharmacies obtain both accreditation and surety bonds to continue to provide durable medical equipment for Medicare Part B beneficiaries. CCPA will monitor this issue as legislation is developed to ensure that FWA efforts are targeted at unscrupulous operators and do not place additional burdens on legitimate providers.

Other spending reductions in President Obama's budget include eliminating $177 billion over 10 years in subsidies paid to health insurers that operate Medicare Advantage plans. The budget also would increase the Medicaid rebates paid by drug manufacturers from 15.1% to 22.1% of the AMP and apply the additional rebate to new drug formulations. In addition, it would allow states to collect rebates on medications provided through Medicaid managed care plans. Proposed tax increases also would contribute to the health care reserve fund.

As the budget moves through the legislative process, CCPA continues to advocate for the role of pharmacists in health care reform. Highly knowledgeable and easily accessible in nearly every community, highlighting and expanding the role of pharmacists in our health care system would result in improved health outcomes and reduced costs.

Uniform standards are currently lacking for MTM in Part D, and this lack of standardization is unfair to Medicare beneficiaries and limits the potential of MTM to improve care and maximize savings to the Medicare program. CCPA will advocate for an improved MTM program&#8212;as well as ensuring wide availability of MTM for Medicare beneficiaries at community pharmacies.

Other items of interest in the budget proposal include plans to establish a regulatory pathway for the approval of generic biopharmaceuticals; new efforts by the FDA to allow Americans to buy safe and effective drugs from other countries; and efforts to build on the economic stimulus bill to increase adoption of health information technology and the use of electronic medical records.

CCPA will work with the president and Congress as legislation is advanced to provide high-quality, cost-effective health care coverage for all Americans.

The Coalition for Community Pharmacy Action (CCPA) is an alliance between the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA), which together represent more than 55,000 community pharmacies. CCPA leverages the support, effort, and infrastructure of NACDS and NCPA while engaging community pharmacy to participate and advocate on issues affecting the industry.