CMS Rule Eases Restrictions on Medicare Part D Assistance

The Inside Source on the Public Health Service 340B Drug Discount Program Volume 5, No. 5 May 2008 CMS Rule Eases Restrictions on Medicare Part D As...
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The Inside Source on the Public Health Service 340B Drug Discount Program Volume 5, No. 5

May 2008

CMS Rule Eases Restrictions on Medicare Part D Assistance

IN THIS ISSUE Pharmacy Services Support Center Taps Scholz as Senior Director

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Drug Rebates Increasingly Fund AIDS Assistance Programs

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Maryland Poised to Begin Closing Medicare Part D “Doughnut Hole”

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CMS Final Regulations Will Make Distribution of Marketing Materials Easier; May Make Hospitals More Attractive to Part D Plans

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CMS Publishes Final Rule to Protect Low Income Enrollees

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National Workgroup Recommends Standardized Billing Code Modifiers for 340B PhysicianAdministered Drugs

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House Passes Legislation to Extend Moratorium on Medicaid Rules

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In a major victory for safety net health care providers, the Centers for Medicare and Medicaid Services (CMS) has ruled that providers owned or funded by the government can waive or reduce Medicare Part D drug beneficiaries' co-pays in ways that allow such aid to be counted toward the beneficiaries’ true out-of-pocket (TrOOP) expenses. The computation of TrOOP is critical to safety net providers because any aid they give to Part D beneficiaries that does not count toward their expenses slows down the beneficiaries’ progression through Part D’s so-called “doughnut hole,” in turn reducing the percentage of an enrollee's drug costs reimbursed by Medicare. Under the standard Part D drug benefit package, the coverage gap for beneficiaries who do not qualify for a “lowincome” subsidy or other federal or state gap assistance begins when their total drug spending, including what Medicare and they themselves pay, reaches $2,510 and ends when their TrOOP expenses reach $4,050. Beneficiaries are responsible for 100 percent of their drug costs while in the gap. After they cross the $4,050 threshold, their drug plans’ catastrophic coverage takes effect and Medicare begins to pay all but a small fraction of their subse-

quent drug costs. The scope of the doughnut hole varies for plans that deviate from the standard package. Many low-and moderate-income beneficiaries who cannot afford their TrOOP expenses while in the doughnut hole have turned to safety net providers for help, leading to increased financial burden for some safety net providers (See December 2006's Monitor). However, the assistance from many safety net providers may be considered a “government-funded health program,” thereby excluding the assistance from TrOOP under Part D regulations. Because some contributions toward Medicare beneficiaries' out-ofpocket costs may not count toward beneficiaries' TrOOP, beneficiaries are perpetually stalled in the doughnut hole. “We help [patients] as much as we can, but the problem is that it’s a hole you never get out of it if the help we are providing doesn't count toward TrOOP,” says Sandra Durley, Associate Director of Ambulatory Care Pharmacy at the University of Illinois at Chicago (UIC). In the new regulations, which are part of a series of “technical corrections” set to go into effect June 9, CMS states that this prohibition against counting contributions toward TrOOP will only apply to a government-funded health program to the continued on pg. 6

COPYRIGHT 2008 BY SAFETY NET HOSPITALS FOR PHARMACEUTICAL ACCESS ALL RIGHTS RESERVED. This newsletter is pro-

tected by U.S. Copyright Law. Reproduction, photocopying, storage, transmission or any other sharing with any unauthorized third party of any portion of this newsletter by any means (including electronic redistribution) is strictly prohibited, except with the prior written permission of Safety Net Hospitals for Pharmaceutical Access and payment of any applicable licensing fee. Violation of copyright may result in legal action, including civil and/or criminal penalties and immediate suspension or revocation of subscription services without refund. Those desiring authorization to copy or use any portion of this newsletter should contact Katie O’Dowd at [email protected] or (202) 552-5856.

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Pharmacy Services Support Center Taps Scholz as Senior Director

May 2008

Lisa Scholz, a Houston health system pharmacy direcand Clinical Pharmacy Services Collaborative, which is tor deeply versed in the 340B drug discount program, has designed to promote best practices at safety net pharmabeen named Senior Director of the Pharmacy Services cies. “The collaborative will work with numerous naSupport Center (PSSC). tional organizations and best practice sites to help safety net organizations team together to integrate pharmacists She replaces Harry Hagel at PSSC, which is the techinto the primary care team to provide clinical pharmacy nical assistance wing of the Office of Pharmacy Affairs services to the safety net patient population,” Scholz ex(OPA) that the American Pharmacists Association (APhA) plains. “This is truly an exciting time.” has run under a contract with the Health Resources and Services Administration (HRSA) As Senior Director, Scholz will also oversince 2002. HRSA recently awarded APhA a see PSSC’s information networking and edufive-year, $16 million contract extension (See cation programs and work closely with OPA November 2007’s Monitor). and the 340B Prime Vendor Program. Hagel, a veteran pharmacist who as“I enjoy helping people,” Scholz says. sumed leadership of PSSC in 2006, was “The opportunity to assist other safety net named APhA’s Senior Vice President for organizations at a national level, while workGovernment and Professional Affairs late ing closely with OPA and APhA, helps me do last year. Prior to Hagel’s tenure, PSSC was what I enjoy.” headed by Diane Goyette, a pharmacist and In her most recent post, Scholz was reattorney. sponsible for pharmacy operations at Ben Scholz was a consultant to PSSC for two Taub General Hospital (a 650-bed Level 1 years while serving as Administrative Trauma Center), LBJ General Hospital (a Senior Director Lisa Scholz Director of Pharmacy Operations for 332-bed hospital Level 3 Trauma Centhe Harris County Hospital District (HCHD) in Houston, ter), Quentin Mease Rehabilitation Hospital, 12 ambulaTexas. HCHD is an integrated public health care system tory health center pharmacies, eight school-based pharmafor the nation's third most populous county. cies, nine homeless program pharmacies, and seven departments of public health and environment pharmacies. “It's always valuable to have people that have been on the front lines implementing and working with the Scholz says her “understanding of the day-to-day op340B program,” Hagel says. “We are very excited to have erations in a safety net organization that is made up of [Scholz] coming on board. We are very fortunate to have multiple facets that HRSA services” will help in her new found the absolute right candidate for PSSC—she has role at PSSC. great rapport, great presence, and great credibility.” “She will help lead PSSC to a higher level,” says OPA Scholz says she is excited to be arriving at PSSC just Director Jim Mitchell. “We are excited for her to come on as it is assuming a lead role in HRSA’s new Patient Safety board.” continued on pg. 10

THE MONITOR MANAGING EDITOR Katie O’Dowd

The Federal Drug Discount and Compliance Monitor is a national monthly newsletter that covers the legal and political issues surrounding the Public Health Service 340B drug discount program and other developments in federal drug pricing law and policy. The Monitor also updates subscribers on breaking news stories through e-mail alerts. The Monitor is published by Safety Net Hospitals for Pharmaceutical Access, a Washington D.C.-based

CONTRIBUTING EDITOR trade association representing over 400 hospitals in the 340B program. Tom Mirga

SUPERVISING EDITORS Ted Slafsky William von Oehsen

Federal Drug Discount and Compliance Monitor 1501 M. Street, NW Washington, DC 20005 Phone: (202) 552-5853 Fax: (202) 552-5868 www.drugdiscountmonitor.com For information on The Monitor, including advertising opportunities, contact Katie O’Dowd at [email protected] or (202) 552-5853.

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May 2008

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Drug Rebates Increasingly Fund AIDS Assistance Programs Tight State Budgets, Growing Caseloads Are Driving Growth, Annual Study Finds State and territorial programs that provide HIV/AIDS drugs to record-high numbers of poor people are depending much more on drug rebates for their funding as their federal and state aid shrinks, a new national survey has found. The trend, revealed in an annual survey of AIDS Drug Assistance Programs (ADAPs) released last month, bears close watching because rebates are a dicier source of revenue than direct government aid. As the survey report notes, rebates “may be variable and unstable, may be subject to a lag, and could require intense labor on the part of the ADAP staff to collect.” They also are unavailable to some states due to their type of drug purchasing system. The annual survey is conducted by the National ADAP Monitoring Project, a joint effort of Henry J. Kaiser Family Foundation (KFF) and the National Alliance of State and Territorial AIDS Directors (NASTAD). All of the nation’s 57 ADAPs participate in the 340B drug discount program. Unlike hospitals, community health centers, and other 340B providers, ADAPs can opt to forgo direct 340B discounts on drugs bought directly from wholesalers in favor of participating in a rebate model. Under that option, a pharmacy network under contract with an ADAP can buy drugs for the program at prices above 340B levels and then apply to manufacturers for a rebate for essentially the difference between those higher prices and 340B levels. As of June 2007, according to the report, 29 ADAPs reported buying drugs directly while 24 reported buying through a pharmacy network and then seeking rebates. Nationwide, ADAPs spent just over a combined $100 million on drugs that month, up 5 percent from June 2006. The national ADAP budget totaled $1.4 billion in Fiscal Year 2007. The largest share, 54 percent, came from the federal ADAP earmark, down 1 percent from FY 2006 and the first such decline in the program’s history. State funding accounted for the second largest share at 21 percent and it too fell, by 4 percent from 2006 to 2007, amid signs of a possible national recession. Rebates were the third largest budget component at 18 percent, mushrooming from just 6 percent a year earlier. They accounted for roughly one-third or more of the ADAP budget in 11 states in 2007. Rebates and ADAP Supplemental Drug Treatment Grants, which now account for 3 percent of ADAP budgets nationally, were the only

two funding sources that grew from 2006 to 2007. “The rise of drug rebates as a source of revenue is an important development that is in part due to the need for states to seek additional funding as client demand continues,” the report explains. Overall ADAP enrollment rose to 146,000 in 2007—the highest level since the program's inception. According to the report, 12 of the 29 ADAPs that purchase drugs directly from wholesalers participate in the 340B Prime Vendor Program (PVP), which negotiates discounts and distribution services for 340B providers. Several states that participate in the 340B program also have state laws regarding negotiation processes that result in lower prices. In addition, NASTAD's ADAP Critical Task Force negotiates directly with manufacturers for prices below the 340B price on behalf of both rebate and direct purchase ADAPs that have resulted in an estimated $425 million in savings since the task force’s inception. Agreements, which are currently in place with 14 manufacturers, are provided to all states. “The task force really came about to try to get reduced prices across the board for all ADAPs,” says Beth Crutsinger-Perry, NASTAD's Program Manager for Care and Treatment Programs. In April 2006, the Government Accountability Office (GAO) issued a hard-hitting report criticizing ADAPs and the Health Resources and Services Administration (HRSA) for not adequately monitoring drug pricing through the 340B program. According to the GAO, ADAPs routinely pay more than 340B prices for pharmaceuticals, whether they purchase directly or through the rebate model. The GAO recommended that HRSA and ADAPs collaborate on improving oversight of the program. The report specifically called for regular comparisons of the prices ADAPs report paying with actual 340B prices to ensure that ADAPs are not overpaying (See May 2006's Monitor). Crutsinger-Perry says NASTAD provides ongoing technical assistance to ADAPs but that the process is very individual because each state system is different. “[NASTAD] is working diligently, as are the states, to make sure they are getting the absolute lowest price possible,” she says. continued on pg. 10

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May 2008

IN FOCUS MEDICARE PART D UPDATE Maryland Poised to Begin Closing Medicare Part D “Doughnut Hole” More Than 7,500 Will Receive Subsidies Under Public-Private Partnership Maryland Gov. Martin O’Malley (D) will soon sign legislation he sought to help close the “doughnut hole” in more than 7,500 Maryland senior citizens’ Medicare Part D prescription drug benefits beginning next year. Observers say that with many states struggling to balance their budgets, Maryland could end up being the only one this year to considerably expand or enact new Part D “wrap around” benefits. According to the National Conference of State Legislatures (NCSL), more than 20 states now have such benefits reaching upward of 1.8 million people. State steps to subsidize their senior citizens’ Part D expenses “have dropped off very significantly,” says Richard Cauchi, NCSL’s Health Program Director, noting that “it’s far easier to expand services during times of budget surpluses” than it is amid deficits. He also attributes the dropoff in activity to “a general feeling” in many statehouses that “we have done enough already.” The Maryland bill, passed unanimously by the state House (HB 1492) and Senate (SB 906) in mid-March, codifies a public-private partnership that O’Malley and state Del. Peter Hammen (D), the chairman of the House Health and Government Operations Committee, forged with CareFirst BlueCross BlueShield, the Mid-Atlantic region’s largest nonprofit health insurer. Under the agreement, announced on February 15, CareFirst will contribute $4 million per year to the state to subsidize drug costs for enrollees in Maryland’s Senior Prescription Drug Assistance Program (SPDAP) who fall into Medicare Part D’s coverage gap, better known as the doughnut hole. The gap begins when plan participants’ total drug spending, including what Medicare and they themselves pay, reaches $2,510 and ends when their true out-of-pocket (TrOOP) expenses reach $4,050. Participants are responsible for 100 percent of their drug costs while in the gap. Once participants cross the $4,050 threshold, their drug plans’ catastrophic coverage takes effect and Medicare begins to pay all but a small fraction of their subsequent drug costs. Congress included the gap in the 2003 bill that created the Part D drug benefit to contain the program’s cost. Critics say it encourages Part D beneficiaries to stop buying and

taking vital medications, making them sicker and driving up health spending. Although the state has no “iron clad evidence that Part D beneficiaries stop taking their medications once they hit the gap, some Part D plans have told us they have seen such evidence,” says Richard Popper, Executive Director of the Maryland Health Insurance Plan (MHIP), SPDAP’s parent agency. An analysis of the bill by the legislature’s Department of Legislative Services (DLS) found that 7,500 SPDAP enrollees entered the coverage gap in 2006. That number is expected to rise when final figures for 2007 are tallied, Popper says. Forty-eight percent of the enrollees who fell into the gap in 2006 had TrOOP expenses under $500. Another 22 percent has expenses between $500 and $1,000, 12 percent between $1,001 and $1,500, and 17 percent between $1,501 and $3,000. According to Popper, the top limit on the doughnut hole subsidy has yet to be determined but is expected be in the range of $1,000. The state, he says, will not provide subsidies to SPDAP members directly but instead would “act like a secondary payer or re-insurer behind the scenes.” Part D drug plans, he explains, will expand SPDAP members’ benefits up to the still-to-be determined maximum subsidy. “Once a member hits the gap, our subsidy will apply and the plan will then bill us for the costs they incur in filling the gap.” The DLS analysis notes that the state has already obtained approval from the Centers for Medicare and Medicaid Services (CMS) for the subsidy. The subsidy, it continues, will be provided through a funding agreement with Part D drug plans that will wrap around the existing drug plan benefits. Four plans have already signed agreements to administer the subsidy, the analysis says, and three others have expressed interest. Popper says his agency will be able to monitor subsidy recipients’ TrOOP expenses and look into whether they are being charged more for medications while in continued on pg. 5

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May 2008

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IN FOCUS MEDICARE PART D UPDATE continued from pg. 4 the doughnut hole than they are when they are out. He also says that CMS screening of participating plans will ensure that they have adequate networks of retail pharmacies to offer subsidy recipients convenient access to medications. CareFirst already contributes $14 million each year to SPDAD, which now offers about 29,000 poor and near-poor seniors who do not qualify for the Part D low-income subsidy up to $25 per month to defray the cost of their premiums for approved Medicare Rx or Medicare Advantage prescription drug plans. CareFirst receives an exemption from a state tax on health insurers in exchange for the contribution. The doughnut hole subsidy program is expected to cost about $7 million annually. SPDAP now spends only between $10 million and $11 million of the $14 million it receives annually from CareFirst for its Medicare Part D premium subsidies. The unspent $3 million to $4 million balance would be added to CareFirst’s new $4 million annual contribution to cover the doughnut hole subsidy’s cost. Popper says the state has no means of determining what shares of SPDAP members obtain their pharmacy services from hospitals, health centers, and other qualified entities participating in the federal 340B drug discount program. Pharmacy benefit officials at two of the state’s disproportionate share hospitals declined to comment on the bill’s potential impact on their operations, saying they had not yet had time to study the measure in depth.

CMS Final Regulations Will Make Distribution of Marketing Materials Easier; May Make Hospitals More Attractive to Part D Plans In addition to the true-out-of pocket (TrOOP) regulation (see pg. 1), the Centers for Medicare and Medicaid’s (CMS) final “technical” regulations offer support in other areas for 340B hospitals and other covered entities that participate or want to participate in the Medicare Part D drug benefit program. One of the technical clarifications in the package of regu-

lations will make it easier for a pharmacy or health care provider to distribute marketing materials for the Part D plans (PDPs) that they contract with. Before the clarifying amendment to the Part D regulation, pharmacies and other providers or provider groups were permitted to distribute information comparing benefits of different plans so long as they accepted and displayed materials from all Part D plans, regardless of whether they actually contracted with those plans. This rule clarifies that pharmacies and other providers are not required to display comparative marketing information for those plans with which they do not contract. Under the existing marketing guidelines, pharmacies and other providers have been permitted to educate and assist potential enrollees in enrolling in PDPs as long as they do not steer a potential enrollee towards a particular plan. Assisting in enrollment is deemed to include helping the potential enrollee complete an application and objectively appraising for the potential enrollee the relative merits of each plan based on the potential enrollee's particular needs. The provider may not receive compensation directly or indirectly from a plan for providing the assistance and may not encourage the enrollee to enroll in a particular plan. The final regulations also make hospitals that provide institutional long-term care (LTC) services or that have a pharmacy that provides home infusion services more attractive to PDPs needing to extend their pharmacy networks to meet patient access standards. The regulations clarifies that a hospital will qualify as an institutional LTC facility under the Part D law if it receives payments for institutional care under Medicaid law. This clarification is important, CMS states in the rule's preamble, because PDPs must ensure they provide “convenient access” to LTC pharmacies, including in-house hospital pharmacies. Access, it says, must be available to enable patients who exhaust their Part A inpatient-days benefits and thereby become eligible for Part D drug coverage to readily access Part D drugs.

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May 2008

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IN FOCUS MEDICARE PART D UPDATE CMS Publishes Final Rule to Protect Low Income Enrollees The Centers for Medicare and Medicaid Services (CMS) published a final regulation on April 3 designed to help nearly 1 million low-income Medicare Part D drug beneficiaries remain in their current prescription drug plans (PDPs) without having to pay a premium. The change is expected to ease considerable paperwork burdens on pharmacies serving patients enrolled in Part D’s “extra help” low-income subsidy (LIS). The subsidy frees eligible low-income beneficiaries from having to pay the full cost of their drugs when they enter Part D’s “doughnut hole.” LIS enrollees whose PDPs drop their zero-premium coverage and who do not pick a new plan are involuntarily switched to a PDP in their region that offers coverage without a premium. According to CMS, the new rule changes the method it uses to set regional LIS benchmarks, which it says will result in about 850,000 fewer LIS beneficiaries having their drug coverage disrupted by having to change PDPs in order to avoid paying a premium. The benchmark reflects the amount of a plan’s premium that the federal government covers through the LIS. Under the new rule, the benchmarks will be weighted based on each plan’s share of enrollees receiving the LIS, rather than on their share of total Part D enrollment as had been proposed in CMS’s proposed rule. According to CMS, this change means that “plans with a greater number of [LIS] enrollees will be a larger factor when CMS calculates the benchmark,” which in turn will “help ensure that the premium subsidy amount better reflects the plans that [LIS] beneficiaries are enrolled in.” As a net result, far fewer LIS enrollees will have their plans switched, boosting “program stability for both beneficiaries and plans,” the agency says.

CMS TrOOP Regulations continued from pg. 1 extent that the entity pays for the cost of the drugs using public or a mix of public and private funds. If a 340B covered entity can demonstrate to a Part D prescription drug plan (PDP) that it is using only non-public funds to pay for the waived cost of the Part D drugs, the cost-sharing waivers

or reductions in cost-sharing count toward the patients’ TrOOP. This raises the issue of what it means to use only non-public funds for cost-sharing assistance. The regulation does not provide guidance on whether the money has to be kept in a separate bank account or if a separate line on the hospital’s ledger is sufficient. In the preamble to the new regulation, with regard to disproportionate share hospital (DSH) hospitals, CMS states that it views DSH payments as adjustments to Medicare and Medicaid reimbursements, and that the receipt of a DSH payment does not render a DSH facility or any Part D network pharmacy it owns or operates a government-funded health program. Nevertheless, DSH hospitals may be deemed to be government-funded health programs because of other government funding they may receive, and if they use those other government funding streams to pay for Part D cost-sharing through waivers or reductions in copays, those payments will not count toward the patient's TrOOP. DSH payments, on the other hand, can be used to help subsidize cost-sharing waivers and will be counted toward TrOOP. In January 2007, CMS issued its final Coordination of Benefits (COB) guidance to PDPs on coordinating the Medicare drug benefit with other pharmacy benefit programs, including how PDPs should track TrOOP. Under the COB guidance, it appeared that most contributions by safety net pharmacies toward Medicare beneficiaries' out-of-pocket costs would not count toward beneficiaries' TrOOP, leaving them stalled in the doughnut hole. Since Part D began two years ago, provider advocacy groups have urged CMS to revise and clarify sections dealing with how TrOOP is counted. In comments on the guidance, they asked CMS to clarify that costsharing waivers offered by a safety net hospital could count toward TrOOP if the waivers are voluntarily furnished and financed exclusively by private funds, even if the hospital uses public funds to pay for other operations. CMS declined to address this issue in the final COB guidance, but seemingly left open the possibility that hospitals and other 340B providers may avoid the doughnut-hole problem by strictly limiting funding for Part D cost-sharing waivers to private sources.

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May 2008

National Workgroup Recommends Standardized Billing Code Modifiers for 340B Physician-Administered Drugs NDC Billing Remains a Challenge for Many 340B Pharmacies A group that helps state Medicaid agencies standardize their accounting and billing codes is advising hospitals to add the modifier “UD” to claims submissions for outpatient, physician-administered, 340B discounted drugs as part of their compliance with the Centers for Medicare and Medicaid Services’ (CMS) controversial National Drug Code (NDC) reporting requirement. The National Medicaid EDI HIPAA Workgroup (NMEH), a project of the National Association of State Medicaid Directors (NASMD), issued the recommendation in January during its monthly teleconference. Robert Pozniak, Director of the Health Insurance Portability and Accountability Act (HIPAA) Practice Group, says adoption of the UD modifier would mainly benefit 340B providers that serve Medicaid-eligibles from multiple states. The modifier would also help states determine which physician-administered drugs were bought through 340B, and therefore, which drugs are subject to rebates and which are not. Pozniak urged NMEH to develop national NDC standards for 340B eligible hospitals and clinics last year. When providers bill payers for drugs, procedures, and equipment provided to patients, they often add modifiers to Healthcare Common Procedure Coding System (HCPCS) codes to further define such services. The modifiers U1 through U9 and UA through UD are reserved for state Medicaid assignment. “The UD modifier would assist in recognizing when it’s a 340B submitted price,” Pozniak says. “UD is just a modifier code that each state can define as it pleases. But we're suggesting that all states agree to define UD as a 340B drug obtained and being billed at the 340B discount price when used with a HCPCS code defined as a drug.” A final regulation issued to implement the Deficit Reduction Act of 2005’s (DRA) Medicaid and pharmacy provisions requires states to collect NDC numbers on physician-administered drugs billed to Medicaid. CMS issued the rule to require states for the first time to collect rebates from manufacturers for those drugs. Hospital advocacy groups say many hospital outpatient pharmacy departments and clinics lack electronic billing systems capable of collecting, tracking, and submitting NDC numbers for drugs billed to Medicaid.

NMEH initially tabled its NDC reporting recommendation for 340B entities in part to obtain formal input from CMS. Specifically, the workgroup was trying to determine the best way to indicate whether a drug billed to Medicaid was or was not purchased through the 340B program. CMS' interpretation is that 340B hospitals are exempt from NDC reporting if they bill the state no more than actual acquisition cost (AAC)—the price actually paid by the 340B pharmacy, which is either the 340B ceiling price or a sub-ceiling price. AAC varies with the size of the drug container purchased and the source of purchase. Coney Island Hospital in Brooklyn, N.Y., has always had to bill at ACC, according to Director of Pharmacy Warren Lakoff. “We normally didn't have to put the NDC down—that's where it's very problematic,” he says. The University Medical Center of Southern Nevada has already been denied reimbursement for its Medicaid patients' drugs due to its inability to comply with the requirement and estimates a loss of $5.1 million in revenue annually (See April's Monitor). CMS has now granted 36 states extensions to comply with the rule. However, those delays are for a maximum period of six months (See January's Monitor). Florida, Georgia, Idaho, Kansas, Nevada, New Jersey, and West Virginia have all moved forward with the January 1 implementation date. States that have not received extensions and that fail to comply risk losing their federal Medicaid matching funds. While Pozniak hoped every state would agree to adopt the UD standard, he says that has not been the case. “It's now a big patchwork quilt out there,” he adds.

ADVERTISE IN THE MONITOR FOR A FRACTION OF THE COST OF OTHER NICHE PUBLICATIONS, AN ADVERTISEMENT IN THE MONITOR ALLOWS YOU TO REACH THOUSANDS OF: HEALTH CARE PROFESSIONALS, PHARMACISTS, DRUG PURCHASERS, GOVERNMENT AGENCIES, & HOSPITAL MANUFACTURERS FOR MORE INFORMATION ON OUR RATES, CONTACT KATIE O’DOWD AT [email protected] OR (202) 552-5853.

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May 2008

House Passes Legislation to Extend Moratorium on Medicaid Rules

JOIN THE AMERICAN PHARMACISTS ASSOCIATION

Court to Hear Hospital Case The House has voted decisively in favor of extending a congressional moratorium on several controversial Medicaid regulations, but it is unclear if the bill will gain sufficient Senate support to override President Bush's threatened veto. A moratorium on two of the regulations directly impacting public hospitals is set to expire May 25. Protecting the Medicaid Safety Net Act of 2008 (H.R. 5613), introduced by Reps. John Dingell (D-MI) and Tim Murphy (R-PA), would prohibit the Centers for Medicare and Medicaid Services (CMS) from implementing seven Medicaid regulations through April 1, 2009. The Bush administration says the rules would shift about $13 billion in Medicaid costs from the federal government to the states over five years, but opponents say the changes could cost the states five times that amount. The House passed the bill 349-62 on April 23, a margin well above the two-thirds majority needed to override a veto, but it is unknown whether backers can muster 67 “aye” votes in the Senate. In a statement, the Bush administration said blocking the rules would undermine “the fiscal integrity of the Medicaid program, would put billions of dollars of federal funds at risk, and would turn back progress that has already been made to stop abusive state practices.” On March 11, the National Association of Public Hospitals and Health Systems (NAPH) and a number of hospital groups filed suit in the U.S. District Court for the District of Columbia to block one of the Medicaid regulations that they say would cut $5 billion in funding to safety net hospitals. NAPH argues that the regulation would significantly narrow intergovernmental transfers between states and public hospitals and would limit Medicaid payments to public providers to cost while continuing to allow private providers to be paid under a different methodology. The court is expected to hold a hearing on the suit on May 7 and to issue a judgment by May 23. “These regulations would dramatically reduce funding to safety net hospitals and health systems and other providers and harm millions of children, elderly and disabled individuals,” NAPH President Larry Gage said.

Health Policy Analyst The American Pharmacists Association (APhA) has an immediate need for a Health Policy Analyst to identify, monitor and analyze federal and state health care issues, including legislation and regulations, affecting the pharmacy profession. Responsibilities: • Identify, monitor and analyze federal and state legislation and regulations affecting pharmacy • Serve as staff support to the Government Affairs Committee • Prepare written communications (testimony, statements, comment letter etc.) for Congressional committees and Federal agencies concerning APhA’s position Requirements: Must have degree in pharmacy, and an advanced degree preferably in political science, public policy or related health care • Minimum of five years experience required, including a previous history that includes legislative activities and a health care or health care policy background • Knowledge and experience related to Medicaid, Medicare is highly desirable, Pharmacy benefit design highly desirable • Must possess excellent writing and editing skills, excellent written and oral communication skills, strong organizational skills, detail-oriented • Ability to establish priorities and handle multiple projects effectively • Must be proficient with Microsoft Word, Excel, and PowerPoint •

Competitive salary and benefits. Email resume, cover letter and salary requirements w/ Health Policy in subject line to [email protected]. EOE.

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May 2008

Page 10

New PSSC Senior Director

SNHPA JOB OPPORTUNITY

continued from pg. 2 Previously, Scholz served as a supervisor, operations manager, and director of ambulatory services at HCHD over an eight-year period. She also worked at Eckerd Drug for 12 years where she filled a variety of positions, ranging from drug clerk, to pharmacy technician, to pharmacist-in-charge. “Lisa brings a whole wealth of knowledge on 340B utilization in a large health system and public hospital arena as well as integration with community health centers,” Hagel says. Scholz earned her doctorate in pharmacy from the University of Houston College of Pharmacy in Houston, Texas, and a master's degree in business administration from Madison University in Gulfport, Miss.

Annual ADAP Survey Findings continued from pg. 3 The 2006 reauthorization of the Ryan White CARE Act, the federal program under which ADAPs were established, has changed the way funding is distributed, including instituting a minimum drug formulary requirement for antiretrovirals. Prior to reauthorization, there was no minimum requirement for ADAP formularies. The new formulary requirement has expanded access to medications in some states but may pose resource challenges for others. On a more positive note, the ADAP annual report found that for the first time since the Monitoring Project’s inception, waiting lists to participate in ADAPs were nearly eliminated in 2007. Many ADAPs reported that the introduction of the Medicare Part D drug benefit helped “to ease constraints and/or provide a new avenue for prescription drugs for people with HIV.” Approximately 12 percent of ADAP clients are also Medicare-eligible. HIV positive patients may qualify for Part D coverage if they meet the requirements to be deemed disabled by the government. Beneficiaries enrolled in both Part D and ADAPs are using ADAPs to “wrap around” the Part D benefit, by relying on the programs to pay for their Part D deductibles, premiums, and co-pays, and for drugs while they are in the coverage gap commonly referred to as the “doughnut hole.” However, money spent by ADAPs on their Medicare-enrolled clients may not count toward those clients' true out-of-pocket (TrOOP) spending. Fifty-three of the 57 ADAPS responded to the survey.

Director of Pharmacy and Educational Services Safety Net Hospitals for Pharmaceutical Access (SNHPA) is an organization of over 400 public and private non-profit hospitals and health systems that participate in the Public Health Service 340B drug discount program. SNHPA was formed to increase the affordability and accessibility of pharmaceutical care for the nation's low-income and underserved populations. SNHPA monitors, educates, and serves as an advocate on federal legislative and regulatory issues related to drug pricing and other pharmacy matters affecting safety net providers. SNHPA is dedicated to protecting the 340B program and creating new opportunities for member hospitals to save on pharmaceuticals.

About the Position: SNHPA is hiring a pharmacist or other professional with experience in pharmacy operations to work full time for our Washington, D.C.-based non-profit hospital advocacy organization. Candidate must have experience in analyzing drug pricing data and with participating in the 340B drug discount program, pharmaceutical manufacturer patient assistance programs and, preferably, the Medicare Part D program. Experience at a disproportionate share hospital that participates in the 340B program is a significant plus. Public speaking experience and strong writing skills are also a plus.

Responsibilities: • • • • •



• • • • •

Provide pharmacy expertise to staff, members and outside organizations Take lead role in conducting and supervising various pricing analysis projects for organization Recruit new member hospitals and corporate partners to SNHPA Recruit exhibitors/sponsors for conferences Assume role in coordinating conferences, workshops, teleconferences, web casts, including developing agenda and recruiting speakers Liason to other pharmacy organizations (ASHP, APhA, etc.), industry groups and the 340B Prime Vendor Program, Pharmacy Services Support Center and other 340B-related organizations Serve as lead contact with members and industry on patient assistance programs Provide support to SNHPA’s regulatory and legislative team on pharmacy-related matters Draft letters, conference descriptions, policy pieces and other documents as needed Assume other duties that require pharmacy expertise Pharmacy degree preferable but not required

Pay is based on experience. Please send cover letter and resume to [email protected] or fax to SNHPA Administrator at 202552-5868. Please state the starting date of your availability, salary requirements and how you became aware of this job.

COPYRIGHT 2008 BY SAFETY NET HOSPITALS FOR PHARMACEUTICAL ACCESS ALL RIGHTS RESERVED. Unauthorized photocopying is prohibited by law. See page one.

12th Annual 340B Coalition Conference Improving Access to Pharmaceutical Care and Ensuring Compliance with Federal and State Laws Co-hosted by:

THE 340B COALITION

Omni Shoreham Hotel Washington, DC July 14-16, 2008 Topics that will be addressed include: •

How the 340B program will be impacted by a new Presidential administration

Hemophilia Alliance, Inc.



National Alliance of State and Territorial AIDS Directors

Legislation to expand the 340B program to new entities



Future funding options for the Office of Pharmacy Affairs

National Association of Children’s Hospital



Changes to the definition of patient and plans to expand contract pharmacy options under 340B

National Association of Community Health Centers



Impact of Deficit Reduction Act on the 340B discount and Medicaid drug rebate programs

National Association of Counties



Status report on efforts to recover 340B overcharges



Efforts to prevent drug diversion



Medicaid billing procedures used by 340B providers and the pharmaceutical industry for both self-administered and physician-administered drugs

National Health Care For the Homeless Council



State and local government partnerships with providers

National Hemophilia Foundation



New studies on pharmaceutical manufacturer patient assistance programs

340B Coalition Members

National Association of Public Hospitals & Health Systems National Family Planning & Reproductive Health Association

National Rural Health Association Planned Parenthood Federation of America, Inc. Safety Net Hospitals for Pharmaceutical Access

To register, go to www.340Bcoalition.org. To reserve a room at the Omni, call 1-800-843-6664. Be sure to mention the “340B Coalition Conference” to get our discounted rate of $188 per night. Please contact Mike Hess at 202-552-5869 or [email protected] with any questions.

For more information, go to www.340bcoalition.org

Subscribe online at www.drugdiscountmonitor.com or Mail or fax subscription form to:

The Federal Drug Discount and Compliance Monitor 1501 M Street, NW, 7th Floor Washington, DC 20005 Fax: (202) 552-5868

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