Ronnie J. DePue, Jr, PharmD

: Medicare Part D has changed since its inception in 2006, with some changes defined by statute and others resulting from guidance issued by the Centers for Medicare & Medicaid Services (CMS). This article describes and catalogs the changes for 2010.

: To review changes to the benefit for 2010 and interpret these changes and provide implications for plan sponsors, pharmacists, beneficiaries, and pharmaceutical companies.

: We reviewed policy statements and other communications from the CMS released between January 1, 2009, and November 30, 2009, as well as any related Medicare Part D publications.

: Changes to Part D in 2010 include an update of the standard benefit design, negotiated price definition change, addition of utilization management limitations, introduction of a nonmatched National Drug Code list, and new guidance for medication therapy management programs.

: The year 2010 represents a year of favorable changes to Medicare Part D for beneficiaries. Although some patients will still face the coverage gap in the coming year, the trend toward a more robust benefit with enhanced patient protections continues.

	2010 will be another year of refinement for the Medicare Part D program with several enhancements benefiting enrollees.

		The Centers for Medicare & Medicaid Services has taken actions to reduce the number of drug plan reassignments for beneficiaries who qualify for the low-income subsidy.

		The definition of negotiated prices has changed, creating greater transparency in pharmacy reimbursement.

		Plan sponsors will be further restricted in their utilization management criteria; overly burdensome prior authorization protocols, as well as required trials on non—US Food and Drug Administration–approved medications, will be prohibited.

	The Medicare Prescription Drug Benefit, known as Medicare Part D, is a voluntary insurance program that provides coverage for prescription medications for people who are eligible for Medicare Part A or Part B. Medicare Part D has changed since its inception in 2006, with some changes defined by statute and others resulting from guidance issued by the Centers for Medicare & Medicaid Services (CMS). The year 2010 brings another round of changes, some of them significant, to Medicare Part D. The purpose of this article is to describe relevant changes to Medicare Part D in 2010 and the implications for plan sponsors, pharmacists, beneficiaries, and pharmaceutical companies. Previous articles addressed changes in years 2007 through 2009.

How Did the Coverage Thresholds for the Standard Part D Benefit Change in 2010?

	The standard drug benefit is the foundation for Part D coverage. In 2010, most of the benefit parameters of the standard drug benefit increased (

 Plan sponsors must offer the standard drug benefit or one that is actuarially equivalent. In addition to the standard drug benefit, plans may offer 1 or more enhanced coverage options for a higher premium. If sponsors have multiple offerings, the choices all must be substantially different.

 Based on the bids submitted to CMS by the plan sponsors, the average premium that beneficiaries will pay in 2010 for the standard drug benefit will increase 7% from $28 in 2009 to $30 in 2010.

 More realistic is the weighted monthly prescription drug plan premium, which is based on the number of enrollees in each type of plan. This amount is expected to increase 11% from $35.09 to $38.91.8 Another premium benchmark is the base beneficiary premium, which is used each year to calculate the late enrollment penalty for beneficiaries who did not enroll in Part D when they were initially eligible. For 2010, the base beneficiary premium is $31.94.

. In 2010, the higher costs of the standard drug benefit and premiums will place a greater financial burden on beneficiaries. Plan sponsors will need to be attentive to the higher cost of administering Part D and the increases in pharmaceutical prices. Beneficiaries will continue to observe efforts by the plans to manage costs by encouraging generic dispensing of medications, and implementing utilization controls such as prior authorization and step therapy. Pharmaceutical companies may oppose plans’ efforts to restrict access or increase cost sharing because any of these strategies may lead to reduced adherence or unfilled prescriptions. It will be important for the success of the benefit to maintain the balance between beneficiaries’ cost sharing and their access to medications so that all stakeholders’ needs are being met.

How Has the Definition of “Negotiated Price” Changed for 2010?

	For 2010, CMS has revised Medicare’s definition of negotiated prices. Prior to this rule taking effect, plan sponsors were permitted to report either the amount paid to their pharmacy benefit manager (PBM) for each prescription drug event (PDE) or the amount paid to the pharmacy for each PDE as their negotiated price. Under the new rule, plans must report to CMS the price actually paid to the pharmacy as the negotiated price. If a difference exists between the price paid by the plan to the PBM and the price paid by the PBM to the pharmacy, the difference will be considered an administrative cost and must be reported as such.

. This move toward greater transparency in negotiated pricing has been anticipated by plan sponsors for several years. Plan sponsors will now be required to count the “spread” captured by their PBM. The spread is the difference paid to the PBM by the plan sponsor and what the PBM actually pays the pharmacy, and is reported as administrative costs rather than drug costs. Although plan sponsors will now know exactly how much their PBMs are marking up their reimbursements for prescription claims, this new method may impact the plan sponsor’s risk corridor payments from CMS and delay the time it takes beneficiaries to reach the doughnut hole, putting plan sponsors at greater financial risk. Beneficiaries, however, will benefit from lower prices at the pharmacy counter and the potential delay in the time it takes for them to reach the coverage gap.

What Are the Changes to Utilization Management Criteria in 2010?

	The most significant changes to utilization management criteria in 2010 will be around off-label use requirements and overly burdensome criteria. CMS has specified that plans will no longer be able to require the trial and failure of medications for a condition for which they do not have US Food and Drug Administration (FDA) approval before allowing a patient to receive a medication that does have FDA approval for the condition. There is a caveat to this new rule stipulating that plans may require patients to try a medication for an off-label indication first only if it is supported by widely used treatment guidelines or clinical literature that CMS considers to represent best practices.

	Furthermore, CMS will prohibit plans from maintaining overly burdensome criteria for medication access. As a general rule, CMS will not allow plan sponsors to require patients to try more than 2 formulary agents prior to receiving the originally prescribed medication. The only exception will be when the originally prescribed medication is considered in the clinical literature to be fourth-line therapy.

. These rule changes will limit the amount of control plan sponsors have on trying to shift patients to lower-cost generics. Because plan sponsors are at financial risk, it is advantageous for them to have their members on medications that cost as little as possible. Some (although not all) plan sponsors often take a cost-minimization approach rather than a cost-effectiveness approach. As a result, some sponsors have required trial and failure of medications that do not always have the long-term durability and safety information demonstrated by an FDA approval, even though these medications may have been used in clinical practice to treat certain conditions. CMS has made these utilization management criteria revisions for 2010 to help ensure that Part D beneficiaries receive appropriate evidence-based medicine and decrease the number of steps they must go through prior to receiving treatment.

What Is the Nonmatched National Drug Code List?

	For a drug to be reimbursed by CMS, it must have a properly listed National Drug Code (NDC) with the FDA. A nonmatched NDC list was constructed by comparing the list of NDCs included in the CMS database with those included in the FDA NDC directory. Beginning January 1, 2010, CMS will use this list to reject PDEs that are submitted with a nonmatched NDC. If the prescription claim was processed for an NDC on the nonmatched list, then that claim will encounter the new PDE edit and be rejected by CMS, and the plan sponsor will not be reimbursed for that claim.

. It was the intent of CMS to have manufacturers properly list their impacted NDCs with the FDA prior to January 1, 2010, to limit any potential impact. Should these NDCs not be properly listed, rejections will occur at point of sale and lead to patient disruption. Proper communication with and education of pharmacies by plan sponsors and PBMs will help to alleviate confusion and help to identify properly listed NDCs to be processed for Medicare beneficiaries. Generic manufacturers, repackagers, and labelers with NDCs on the nonmatched list will need to determine whether a proper listing at the FDA for their product(s) is necessary. Wholesalers and pharmacies will need to justify stocking nonmatched NDCs as these drugs may not be covered by participating Part D plan sponsors. Pressure will be put on plan sponsors and PBMs to call for these actions to prevent confusion in their beneficiary population.

How Has the Design of Medication Therapy Management Programs Changed for 2010?

	In the 2010 Call Letter, CMS mandated several changes to medication therapy management (MTM) programs.

 In 2010, those plan sponsors with an opt-in enrollment MTM program will be required to switch to an opt-out enrollment program for qualifying beneficiaries. Beneficiaries who meet the qualifying criteria, unless they explicitly state otherwise, will be automatically enrolled into MTM programs. Plan sponsors will be required to target members at least quarterly during the benefit year rather than once yearly. Additionally, plan sponsors must target at least 4 of the 7 chronic condition categories identified by CMS. These categories are hypertension, heart failure, diabetes, dyslipidemia, respiratory failure, bone disease, and mental health. Plan sponsors may not require qualifying beneficiaries to have more than 3 of the 4 targeted chronic conditions and may not require qualifying beneficiaries to be receiving more than 8 Part D drugs. Furthermore, the threshold for the annual cost of Part D drugs the beneficiary is likely to incur to be eligible for MTM services has been reduced from $4000 to $3000. CMS also announced minimum requirements for MTM services, and these services must target both beneficiary and provider. At a minimum, the MTM program must perform a comprehensive medical review, which is a comprehensive review of the beneficiary’s medications (both prescription and nonprescription drugs) done by a qualified provider or pharmacist, at least quarterly and the program must offer prescriber-targeted communications.

. Reduced thresholds and opt-out enrollment methods will lead to a larger number of beneficiaries participating in MTM programs. The increased frequency of quarterly comprehensive medical reviews will increase the number of opportunities to impact outcomes and improve patient care. Program requirements and an increased mandate on beneficiary/prescriber interaction with the plan sponsor will lead to heightened demands on sponsors implementing these MTM programs. For 2010, plan sponsors will need to decide how to implement such programs, or if services will need to be contracted to an external MTM vendor. This provision will affect the bid process and premiums for 2010 as plan sponsors determine the financial impact of these MTM provisions on their Medicare business.

	It is generally accepted that Medicare Part D is successful in providing access to prescription drug coverage for beneficiaries who otherwise lack coverage; however, gaps still remain. One of the most challenging aspects of Part D is the coverage gap, which impacts 25% of beneficiaries each year. In addition, some believe that offering a public option in Part D, in which the government negotiates drug prices directly with pharmaceutical companies, can help to reduce pharmaceutical spending.

	The Patient Protection and Affordable Care Act of 2010, signed into law by President Obama on March 23, 2010, made many changes to Medicare Part D.12 One of the most important changes is the closure of the coverage gap, starting with a $250 rebate provided to Medicare beneficiaries who enter the coverage gap in 2010. The coinsurance rate in the coverage gap will be phased down starting in 2011 until it reaches 25% by 2020. Starting in 2011, all brand name drugs for beneficiaries in the coverage gap will be offered at a 50% discount. Other changes that will take effect in 2011 include discretionary rights for CMS to designate protected classes of drugs in Part D, changes to low-income benchmarks for plans eligible for low-income subsidy (LIS) enrollment, allowing plans to waive de minimis premiums to maintain LIS enrollment, providing formulary information to reassigned LIS beneficiaries, and free generic first drug fill option for Part D plans.

	The year 2010 represents a year of favorable changes to Medicare Part D for beneficiaries. Although the standard drug benefit parameters and cost-sharing amounts underwent their annual increase, there was a move toward greater transparency in negotiated prices that may result in lower out-of-pocket costs to beneficiaries and a potential delay in entering the coverage gap. CMS mandated several changes to MTM programs to increase the number of beneficiaries enrolled and improve the services and quality of the programs. Although the fundamental structure of Medicare Part D remained the same in 2010, the beneficiary provisions continued to improve. It is anticipated with the advent of healthcare reform, Medicare Part D will continue to reach toward the goals of access to necessary medications and improved therapeutic outcomes for all Medicare beneficiaries.

From Forest Research Institute (RJD), Richmond, VA; Department of Pharmacy Practice (JS), University of Illinois at Chicago, Chicago, IL; and Coventry Health Care (DCB), Kansas City, MO.

The authors (RJD, JS, DCB) report no source of funding for the work represented in this article.

The authors (RJD, JS, DCB) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Concept and design (RJD, JS, DCB); acquisition of data (RJD, JS, DCB); analysis and interpretation of data (RJD, JS, DCB); drafting of the manuscript (RJD, JS, DCB); critical revision of the manuscript for important intellectual content (RJD, JS, DCB); statistical analysis (JS); provision of study materials or patients (RJD); and administrative, technical, or logistic support (RJD).

JoAnn Stubbings, RPh, MHCA, Department of Pharmacy Practice, University of Illinois at Chicago, 833 S Wood St, Chicago, IL 60612. E-mail: 

Medicare Part D: selected issues for pharmacists and beneficiaries in 2007. 

Articles

Although the fundamental structure of Medicare Part D remained the same in 2010, the beneficiary provisions continued to improve.

Medicare Part D Policy Update and Implications for 2010

The Medicare Drug Benefit was designed to provide coverage for outpatient prescriptions to Medicare beneficiaries. Since its inception in January 2006, there have been numerous refinements; however, the overall purpose and structure of the benefit remain the same.

To (1) review changes to the benefit for 2009 and (2) describe the Part D provisions of the Medicare Improvements for Patients and Providers Act of 2008. 

We reviewed policy statements and other communications from the Centers for Medicare & Medicaid Services released between January 1, 2008, and September 30, 2008, and the Medicare Improvements for Patients and Providers Act of 2008.

Changes to Part D in 2009 include availability of Part D data, changes in the coverage amounts in the standard drug benefit, outreach to vulnerable populations, the United States Pharmacopeia 3-year cycle, revisions to the best-available-evidence policy, new standards for e-prescribing, and new guidance for medication therapy management programs.

Various refinements and clarifications to the benefit have been made to date; however, opportunities for improvement remain. The availability of Part D data will allow researchers to determine the impact of drugs on overall health outcomes and costs for Medicare beneficiaries.

Various refinements and clarifications to the Part D benefit were made for 2009; however, the overall purpose and structure of the benefit remain the same.

In 2009, the Part D standard benefit is more costly to beneficiaries, with increases in the deductible and premium, and a larger coverage gap. 

Part D data now are available for research and other purposes on request through the Centers for Medicare & Medicaid Services. 

Starting in 2009, prescribers will receive incentive payments when they adopt qualified e-prescribing systems.

Medicare is now the largest public payer of prescription drugs, accounting for 18% of total drug expenditures in the United States in 2006, versus 2% in 2005.

 Since the inception of Part D, there have been numerous refinements to the benefit; however, its overall purpose and structure remain the same. Most changes have been administrative in nature. Others involved changes in coverage; examples include elimination of coverage for drugs for erectile dysfunction and inclusion of coverage for newer vaccines such as herpes zoster.

 The purpose of this article is to review changes to the benefit for 2009 and to describe the Part D provisions of the Medicare Improvements for Patients and Providers Act of 2008. A question-and-answer format is used, followed by discussion of the implications for providers, patients, and sponsors.

When will Part D data be available for research purposes? 

Effective June 22, 2008, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that allowed the agency to release Part D claims data to other federal government agencies, states, external researchers, and beneficiaries for their personal health records.

 Data initially will be available for plan year 2006. The final rule balances access to the data with safeguards for beneficiary privacy and commercially sensitive Part D plan information. Updated information on Part D claims data can be found at the CMS Web site.

 Information also can be obtained from the Research Data Assistance Center at www.resdac.umn.edu.

. The availability of Part D claims data in 2009 allows researchers and others to attempt to determine, on a national level, the impact of drugs on overall health outcomes and costs for Medicare beneficiaries in ways not possible before. Part D claims data may be linked with claims data from Part A (hospitalizations) and Part B (physician services) and will offer a rich and robust source of information.

How did the standard Part D benefit change in 2009?

Most parameters of the standard Part D benefit (defined by CMS as the minimum required plan design) increased in 2009.6 These changes are outlined in the Table. According to CMS, the overall average increase in the standard drug benefit parameters from 2008 to 2009 was 7.54% versus an average increase of 5.97% from 2007 to 2008. Annual updates to the standard benefit design are statutory requirements of the Social Security Act and will continue throughout the life of the program. Plan sponsors can offer the standard benefit design or may vary their design as long as it is actuarially equivalent to the basic coverage.

. Medicare Part D is more costly to beneficiaries in 2009. The coverage gap, which is the period of no coverage, continues to be a challenge to beneficiaries and pharmacists. Beneficiaries who may be affected by the coverage gap should consider one of the enhanced Part D plans during their open enrollment period. This option allows some coverage of prescriptions in the coverage gap, albeit at a higher monthly premium, while limiting financial risk to the sponsor. In 2009, 25% of Part D plans offer coverage of some or all generics in the coverage gap.

 Beneficiaries also might consider the availability of lower-cost generics while in the coverage gap, the low-income subsidy (LIS), or patient assistance programs if they qualify. They should seek the advice of their pharmacist or physician.

What efforts are being made to assist vulnerable beneficiaries?

The LIS provides extra help for individuals who have limited income and resources to help pay Part D costs such as monthly premiums, copayments, and the annual deductible (

). The Centers for Medicare and Medicaid Services has determined that there are approximately 3 million people in the United States who potentially meet the criteria for LIS but have not yet applied. In 2008, CMS permanently removed the late enrollment penalty for anyone who applies for the LIS and qualifies, thus freeing up those who qualify to enroll in Medicare Part D without fear of paying a penalty.

. If beneficiaries are having difficulty paying for their medications, the first question a pharmacist or physician should ask is whether the beneficiary has applied for LIS. Providers should be aware that individuals can apply for LIS at any time during the year. Applications are available through the Social Security Administration (www.ssa.gov) or by calling 800-772-1213.

At the inception of Part D in 2006, CMS requested that the United States Pharmacopeia (USP) develop a model for Medimulary containing drug classes, categories, and drug types.

 All plan sponsors must include coverage for at least 2 drugs from each therapeutic category and class, unless only 1 drug exists. It is not a requirement that all plans use the USP formulary design for their formularies, but it is considered the gold standard to which all plans will be compared. On May 20, 2008, USP announced that they reached an agreement with CMS to move from an annual time line for revision of the model formulary to a 3-year cycle.10 Revisions will occur, although less frequently, to reflect changes in therapeutic uses of existing medication and additions of new medications to the market. The Centers for Medicare and Medicaid Services will use the current version 4.0 without changes through 2011. Implications. The change in review cycle may benefit Part D plans slightly. Once plans satisfy the minimum category and class requirement the first year of a new USP model formulary release, they will not have to worry about this requirement for 2 more years, unless they modify their formularies significantly.

What is the new best-available-evidence policy?

Best available evidence (BAE) is a phrase used to describe the specific information plans use to update their eligibility records when an eligibility dispute occurs and a member is assessed an incorrect copayment. A class action lawsuit was filed against CMS by full-benefit, dually eligible Medicare beneficiaries who were unable to receive the full benefits of Medicare Part D prescription drug coverage.

 On June 19, 2008, a settlement was reached, and on August 4, 2008, CMS released a clarified BAE memorandum.

 The relevant revisions to the new BAE policy are outlined in 

. The new BAE policy will help prevent beneficiaries from being turned away from pharmacies when they are entitled to a subsidized copayment. This policy also will benefit pharmacies, especially those that provided patients with necessary medication and held the difference in copayment as an account receivable in hopes that the eligibility issues would get resolved and the claims could be reprocessed. Although this policy is good for beneficiaries and pharmacies, it may have a negative short-term impact on plan sponsors. The new requirements place an administrative burden on sponsors that was not previously required, and they may need to increase staffing or reallocate existing staff to fulfill these guidelines.

What is the final rule for e-prescribing?

CMS released 4 new e-prescribing standards that became effective on April 1, 2009.

These standards are listed in the Box. They supplement the basic e-prescribing program that was introduced at the inception of Part D. The standards apply to all Part D sponsors, prescribers, and dispensers that electronically transmit prescriptions and prescription-related information for Part D—eligible individuals. Although plans and pharmacies are required to adhere to the CMS standards, prescribers are not yet required to prescribe electronically. In an effort to encourage prescribers to adopt eprescribing, the Medicare Improvements for Patients and Providers Act of 2008 provides Medicare Part B incentive payments for providers to use qualified e-prescribing systems.

 The payments are 2% in 2009 and 2010; 1% in 2011 and 2012; and 0.5% in 2013. Providers will be required to e-prescribe starting in 2011. Payments to providers who fail to e-prescribe will be reduced by 1% in 2012; 1.5% in 2013; and 2% thereafter.

Implications. The hope for e-prescribing is that it will reduce the number of adverse drug events. The Centers for Medicare and Medicaid Services estimates that more than 500,000 adverse drug events per year occur for Medicare beneficiaries. In addition, e-prescribing is expected to reduce prescription errors, provide information to prescribers on formulary coverage so they can make better prescribing decisions, and decrease the time it takes for a patient to receive necessary medications.

What changes have been made to medication therapy management programs? In August 2008, CMS released a memorandum reaffirming that sponsors have the flexibility to develop and implement medication therapy management programs (MTMPs) that best meet the needs of their specific patient populations.

 Although CMS did not change any of the criteria for members to qualify for an MTMP, they did outline the permissible changes to a sponsor’s program. This policy is outlined in 

. The Centers for Medicare and Medicaid Services also announced that they entered into a contract with Optimal Solutions Group to monitor MTMPs and to ensure that sponsors are evaluating their programs in compliance with the outcome measures stated in their CMS-approved MTMP application.

. The types of allowable changes for MTMP are consistent with CMS-allowable changes in other areas such as plan formularies. For example, changes made in the beneficiary’s favor always are allowed, whereas more restrictive changes are not. In addition, most Part D sponsors would agree that a deeper analysis of MTMP plan data by CMS has been anticipated. This is a step towards more rigorous program standards that are tied directly to patient outcomes.

Future changes are planned for Medicare Part D. The Medimulary care  improvements for Patients and Providers Act of 2008 was enacted on July 15, 2008, after Congress overturned a veto by then President Bush.

 The legislation contains provisions that pertain to Medicare Part D. The provisions that are effective in 2009 have been outlined in this article. Other provisions will be effective in 2010 and beyond, and they are described below.

Protected Classes of Drugs. Starting in 2010, the current Part D policy on coverage of protected classes of drugs will be codified, or enacted into legislation. Through rule-making, the Secretary of Health and Human Services will identify protected categories and classes of drugs. These drugs will be protected either (1) because restricting their use would have a major or life-threatening clinical effect or (2) because individuals need access to multiple drugs in a category or class (eg, cancer drugs) because of unique chemical actions and pharmacologic effects. Part D sponsors will be required to cover all drugs in the category or class that the secretary identifies as a protected class unless there are exceptions based on scientific evidence and medical standards of practice. Prompt Pay Requirements. Starting in 2010, Part D sponsors will be required to pay claims from all pharmacies (other than mail-order and long-term care pharmacies) within 14 days after transmission if submitted electronically or 30 days if submitted otherwise. If claims are not paid according to this schedule, sponsors will be required to pay interest to the pharmacy. Coverage of Barbiturates and Benzodiazepines. Starting in 2013, Part D sponsors must cover barbiturates if used to treat epilepsy, cancer, or a chronic mental health disorder, and benzodiazepines.

The year 2009 represents a year of continued refinement to Medicare Part D in terms of the availability of Part D data, the structure of the standard drug benefit, outreach to vulnerable populations, the USP 3-year cycle, the BAE policy, new standards for e-prescribing, and new guidance for MTMPs. The Medicare Improvements for Patients and Providers Act of 2008 legislated additional changes to Medicare Part D for 2009 and beyond. Policy changes may be considered that lead to further improvement of Medicare Part D as more research becomes available on the economic and clinical impact of the benefit, prices paid by sponsors for medications for dual eligibles, and the coverage gap.

: From the College of Pharmacy (JS), University of Illinois, Chicago, IL; and Coventry Health Care (RJD), Glen Allen, VA. Dr DePue is now with Forest Research Institute, Jersey City, NJ.

: The authors (JS, RJD) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (JS, RJD); acquisition of data (JS, RJD); analysis and interpretation of data (JS); drafting of the manuscript (JS, RJD); critical revision of the manuscript for important intellectual content (JS, RJD); provision of study materials or patients (JS, RJD); administrative, technical, or logistic support (JS); and supervision (JS).

: JoAnn Stubbings, RPh, MHCA, Department of Pharmacy Practice, University of Illinois, 833 S Wood St, MC 886, Chicago, IL 60612. E-mail: jstubbin@uic.edu.

 September 2008. http://www.kff.org/rxdrugs/upload/3057_07.pdf. Accessed September 23, 2008.

 Medicare Part D: selected issues for pharmacists and beneficiaries in 2007. 

 Medicare Part D: selected issues for plan sponsors, pharmacists, and beneficiaries in 2008. 

4. Centers for Medicare & Medicaid Services

. Medicare Program; Medicare Part D Claims Data. 42 CFR Part 423 [CMS-4119-F]. May 22, 2008. http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/Downloads/PartDDataReg.pdf. Accessed September 27, 2008.

5. Centers for Medicare & Medicaid Services. 

Part D Claims Data. www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp#TopOfPage. Accessed August 18, 2009.

6. Office of the Actuary, Centers for Medicare & Medicaid Services.

Announcement of Calendar Year (CY) 2009 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies

. April 7, 2008. http://www.cms.hhs.gov/MedicareAdvtgSpecRateStats/Downloads/Announcement2009.pdf. Accessed September 28, 2008.

7. Centers for Medicare & Medicaid Services. 

2009 Resource and cost-sharing limits for low-income subsidy

. Memo to all Part D plan sponsors. October 22, 2008.

8. Hoadley J, Thompson J, Hargrave E, Cubanski J, Neuman T; for the Kaiser Family Foundation.

Medicare Part D Data Spotlight: The Coverage Gap

. November 2008. http://www.kff.org/medicare/upload/7834.pdf. Accessed November 8, 2008.

9. Centers for Medicare & Medicaid Services.

Federal Register 42 Parts CFR Medicare Program; Standards for EPrescribing Under Medicare Part D and Identification of Backward Compatible Version of Adopted Standard for EPrescribing and the Medicare Prescription Drug Program (Version 8.1).

 April 7, 2008. http://edocket.access.gpo.gov/2008/pdf/08-1094.pdf Accessed October 30, 2008.

. Medicare Part D model guidelines move to three year revision cycle [press release]. May 20, 2008.

11. US District Court for the Northern District of California.

Order Granting in Part and Denying in Part Defendant’s Motion to Dismiss.

 Situ et al. v. Leavitt. http://www.websupp.com/data/NDCA/3:06-cv-02841-56-NDCA.pdf. Accessed October 30, 2008.

12. Centers for Medicare & Medicaid Services. 

. http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/MemoClarifiedBAEGuidance_08.04.08.PDF. Accessed October 30, 2008.

13. Medicare Improvements for Patients and Providers Act of 2008 (MIPPA

). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h6331eh=.txt.pdf. Accessed October 25, 2008.

14. Centers for Medicare & Medicaid Services, Center for Drug and Health Plan Choice

Changes to Part D Sponsors’ Medication Therapy Management Program (MTMP)—REVISED

. August 5, 2008. http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/MemoMTMChanges_08.05.08.pdf. Accessed October 30, 2008.

15. Centers for Medicare & Medicaid Services, Center for Drug and Health Plan Choice.

. October 16, 2008. http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/Memo_MTMMonitoring_Introduction_10.16.08.pdf. Accessed October 30, 2008.

Various changes to the Part D benefit were made in 2009, including availability of the data for research and increased cost of the standard benefit.

Ronnie J. DePue, Jr, PharmD

Articles

Medicare Part D Policy Update and Implications for 2010

Medicare Part D: Selected Issues for Plan Sponsors, Pharmacists, and Beneficiaries in 2009