As featured in The American Journal for Nurse Practitioners.
The author focuses on the realities of Medicare Part D prescription drug coverage by reviewing the history, politics, and cost of the program. Epidemiologic data related to Medicare recipients are presented, and the disparities created by the Part D plan are identified. Medicare Part D pitfalls that result in medication non-adherence are discussed, along with ways for advanced practice nurses to avoid these consequences. The role of the APN as patient advocate and educator is also described. The author discusses the financial, ethical, and legal impact of the Medicare Prescription Drug Improvement and Modernization Act, along with bills on the floor of Congress designed to amend and expand this act. Various stakeholders’ competing and conflicting priorities are examined from both economic and healthcare perspectives. Ways for APNs to optimize Medicare Part D are presented, and barriers and facilitators of this plan are identified, along with possible negotiation points for APNs to lobby to achieve a more affordable and appropriate Rx drug benefit for seniors in the United States.
Since 1965, seniors (adults aged ≥65 years) and medically disabled persons in the United States have had universal health insurance through the Medicare program. Part A of this program provides hospital coverage. For an added fee, deducted from Social Security benefits, enrollees can receive Part B coverage for outpatient care. Medicare traditionally pays 80% of the allowable charges to participating hospitals and providers. Seniors are responsible for the remaining 20% unless they have a Medigap or Medicare supplemental policy, paid through additional monthly premiums to a private insurance company. In 1997, Medicare plus Choice (Part C) became available to enrollees in Parts A and B (Table 1).1 Part C allowed private health insurance companies to create preferred provider organizations (PPOs) and health maintenance organizations (HMOs) for Medicare. Although these programs covered 80%-95% of all inpatient and outpatient medical costs, seniors without secondary insurance needed to pay 100% of their Rx drug costs.2
As prices of Rx drugs escalated and seniors lived longer with multiple chronic diseases, the cost of medications became out of reach for many. In December 2003, Congress responded by enacting the Medicare Prescription Drug Improvement and Modernization Act (MMA).1 On January 1, 2006, Medicare Part D was offered to assist seniors with ever-growing Rx drug costs. Medicare Part D was designed by the Center for Medicare and Medicaid Services. This plan, like Part B, has monthly premiums that are paid directly to private insurance companies.3
In 2010, the Medicare Part D plan includes a deductible of $0-$310, a cost-sharing feature of $0 to up to 25% of the drug cost (co-pay), and a drug coverage threshold (coverage gap) when enrollees reach a set amount ($2830). Persons who reach the coverage gap (also known as the donut hole) are required to pay 100% of their drug costs out of pocket (OOP) until they meet the next threshold of about $4450 (catastrophic coverage).4 When the plan was initiated in 2006, typical OOP costs of medications ranged from $989 to $17,000.5 The coverage gap was $3400 in 2009 and $1620 in 2010.4
The Medicare Advantage plan, which replaced Medicare Part C, is an HMO, a PPO, or a fee-for-service plan offered by private insurance companies that can be used instead of Medicare Parts A, B, and D. Under this plan, enrollees pay the Part B premium and a monthly fee for the Advantage program. Enrollees are restricted to the use of certain physicians, hospitals, and healthcare centers, and frequently incur a co-pay charge of $0-$40 per office visit (Table 1).4 A total of 10.1 million beneficiaries are enrolled in a Medicare Advantage plan, up from 5.3 million in 2003.
Helping Seniors Choose a Medicare Part D Plan
Each fall, Medicare patients receive information from multiple insurance companies with varying benefits, costs, and formularies contracted to provide Part D prescription drug coverage.6 One 85-year-old man received 34 pieces of unsolicited mail related to Medicare during the last 3 months of 2009.7 From this massive array of information, seniors are asked to choose a plan by December of each year.1 Program regulations prohibit changing formularies or coverage until the following December, even if an enrollee is diagnosed with a new condition or is prescribed a new medication that year. Patients rely on their practitioners to decipher this information and guide them in making informed choices. APNs are in an ideal position to assist seniors in sifting through the wide assortment of information they receive and in choosing the best plan for them. Also, APNs who understand their patients’ Rx drug benefit plans can better help them adhere to their treatment regimen and decrease their OOP costs.
People purchase insurance policies to cover most of the costs associated with unforeseen catastrophic events. Nevertheless, Medicare Part D coverage is designed around patients’ current health status and prescription needs, and affords little protection for unexpected needs that arise. The Medicare website—www.Medicare.gov—offers the most objective cost analysis of the various Rx drug plans that are available. But, again, APNs must realize that these plans take into account only a patient’s current prescription needs,4 so some educated guesswork may be involved in helping someone choose an optimal plan. But even the “best” plan will not work if a patient does not use it in an optimal fashion.
Impact of Medicare Part D Coverage on Medication Adherence
Madden et al8 analyzed the effect of Medicare Part D prescription drug coverage on cost-related medication non-adherence, and found a small yet significant decrease in such non-adherence after Part D implementation. However, the sickest enrollees showed no net decrease in missed doses of medications even after acquiring Part D coverage. Cronk et al5 reported that 26% of Medicare Part D enrollees who fell into the coverage gap reported not filling a prescription, stopping their medication, or using less medication than prescribed. An additional 10% of respondents bought their medication outside the United States, took someone else’s medication, or obtained free samples.
According to Hsu et al,9 limiting reimbursement for Rx drugs for seniors will increase the risk for institutionalization in nursing homes. These authors found that a cap on drug benefits was associated with lower drug consumption and unfavorable clinical outcomes. Increased visits to an emergency department and hospitalizations offset the cost savings of the coverage gap. Wilson et al10 found that, as the number of chronic diseases increased, so did non-adherence to Rx drug regimens. Forty percent of seniors with financial problems stopped taking all or some of their medication without ever discussing the cost factor with their practitioner.
Disparities exist in the prices Medicare beneficiaries pay for medications. Brill3 reported that the price of 10 commonly prescribed drugs for Medicare patients enrolled in one of the 10 drug plans with the highest enrollment was higher than Canadian prices, federally negotiated prices, and Internet prices for the same drugs.3 Medicare patients are disqualified from many pharmaceutical assistance programs and are prohibited from using many of the rebate or discount cards provided by drug companies. When the cost of non-covered Rx medications is examined in relationship to available income and the rising costs of other necessities, the financial burden of medications gets even larger for seniors and disabled citizens.
APNs can help patients avoid the coverage gap by prescribing generic medications whenever possible. As an example, if a senior male with diabetes requires an antihypertensive medication, APNs should start him on a generic angiotensin-converting enzyme inhibitor (ACEI) instead of an angiotensin receptor blocker (ARB), even if the ARB is on the patient’s Rx drug plan’s formulary. Many generic ACEIs are on the $4 plan at discount pharmacies. If this senior pays cash (and asks the pharmacist to not submit the prescription to the insurance company) for the ACEI, he is less likely to reach the coverage gap during the year.
Financial and Ethical Impact of Medicare Part D
The financial impact of Medicare Part D continues to adversely affect seniors on fixed incomes. Under 2010 rules, once the Part D plan pays out $2830 in benefits (at that point, they have entered the donut hole), enrollees must pay 100% of their Rx drug costs until the catastrophic limit is reached.4 Catastrophic benefits begin at $4550 this year instead of $6100. The 2010 gap still leaves patients with an OOP expense of about $2000, not including the premiums paid each month for the insurance or the co-pays for each Rx drug, which range from $2.40 to 25% of the list price of the medication.4
Overall, according to a recent national study, 39% of Rx drugs available as generics were filled with the brand-name formulation.11 Because brand-name drugs usually retain a substantial price premium even after generic equivalents are introduced, persistent use of brand-name products has resulted in billions of dollars of excess spending. As an example, a 68-year-old woman with hypertension, osteoporosis, and gastroesophageal reflux is using Norvasc 5 mg/day, Benicar 20 mg/day, Boniva 150 mg/month, and Nexium 40 mg/day. The annual cost of these brand-name products—based on information from the Medicare.gov website—ranges from $3275 to $6246, including the monthly Part D premiums of $23-$70. If this woman used generic amlodipine instead of Norvasc, generic benazepril (an ACEI) instead of the ARB Benicar, generic alendronate once-a-week instead of Boniva, and generic ranitidine instead of Nexium, the cost of the medications would drop to $474-$1717 per year, including the monthly premium.4 The cash price of these same generic medications using a discount pharmacy would be $270 per year without enrolling in Medicare Part D!
The commonly used method of reference-based pricing prohibits even the Medicare.gov website from projecting the cost of some medications. Reference-based pricing, a technique used by many Part D insurance companies, greatly inflates the price of a brand-name medication if a generic alternative is available. In Europe, reference-based pricing has been shown to keep the cost of medication down; when the price for brand-name products is so high, the consumer will opt for the generic alternative. However, this system works only if the consumer understands the process or pharmacy personnel take the time to explain to the senior that choosing the generic version will save them X amount of dollars. An example is the medication Lamisil, an Rx agent used to treat onychomycosis (nail fungus). This product is on the $4 plan at a national discount pharmacy chain for anyone electing to pay cash for the medication. However, a Medicare patient can legally be charged the $98 co-pay plus the full price of the drug ($401) minus a generic price ($134), for a total of $365 a month.12
The Medicare Part D program has failed to meet its primary goal—to “care” for the medication needs of the elderly and disabled. Physicians and APNs have not been properly educated about the intricacies of the Part D program, and often prescribe medications without careful cost analysis, forcing patients to reach the coverage gap sooner into the fiscal year than would otherwise be necessary with thoughtful prescribing practices.13 APNs can educate their patients that, even if a brand-name drug is on the Medicare formulary, a generic drug will be prescribed whenever possible to preclude a patient from entering the donut hole later in the year. Furthermore, if the generic equivalent is on a local pharmacy’s shelves, the enrollee should ask the pharmacy to not run the prescription though the insurance company system; instead, the enrollee should pay the cash price.
Pharmaceutical sales representatives detail prescribers about their branded drug products, carefully avoiding factors such as cost, and highlighting plan coverage and discount plans from which Medicare patients are excluded. Prescribers are more likely to prescribe Rx drug products after a visit from a company representative, and even more so if the relationship between the practitioner and the company representative is considered close and personal.13 APNs who are conscious of this influence will continue to prescribe an inexpensive generic medication first, even if there are no samples or sales representatives for the product, saving patients money and increasing adherence.14
Both the government and prescribers have an ethical responsibility to provide affordable health care to Medicare enrollees. Given the present system, this goal will be accomplished only by overhauling the Part D prescription drug plan.
MMA: Political Implications and Future Trends
In December 2003, a group of Congressional members narrowly passed the MMA. Going into the 2004 election, incumbents could boast that they took part in legislation designed to help reduce seniors’ rising Rx drug costs. As Election Day neared, pollsters and journalists intoned that senior voters were a key factor in the election.15 Seniors are known to vote in a proportion greater than that of other demographic groups.16
t the time of the election, pressure was applied by political forces such as AARP (formerly known as the American Association of Retired Persons) to help seniors with the cost of their Rx medications. The strategy paid off politically, as most incumbents were re-elected, retaining the Presidency and control of both houses of Congress. In 2004, Republicans kept their majority in the House of Representatives, with a net gain of 2 seats, and in the Senate, with a net gain of 4 seats.15
Medicare Part D was not officially rolled out until January 1, 2006, the start of another Congressional election year. According to the Alliance for Retired Americans, few incumbents running for office in November 2006 highlighted their support for Medicare Part D because the expense and weakness of the program had begun to leak out to the media.16 The 2006 election changed the balance of power in the Senate, with a net loss of 6 Republican seats, and the House, by an overwhelming loss of 27 Republican seats.17 Since then, more than 100 bills have been introduced to modify and improve the MMA, but none have passed into law. In fact, most bills are referred to a few committees to die an inevitable death.18
Political awareness of this problem on the national level is fairly high, given the number of bills that have been introduced (but not passed) over the past few years. Drug companies, insurance companies, and pharmacy management companies are large contributors to political action committees that provide funding for US legislators’ campaigns.19 Questions arise regarding whether most of the political interest is merely a pretense to gain votes from senior citizens and whether insurance and pharmaceutical companies’ contributions to campaigns helps delay the passing of a bill to help rectify the problem.20
Public awareness of the problem has been increasing over the past year, but many misconceptions persist in both the healthcare and Medicare beneficiary communities. Nurse practitioner organizations have not published a position statement concerning the MMA or bills currently on the floor to improve this act. In September 2009, an NP roundtable drafted a letter to Congress to address wording in the current reform bill and proposed some changes but did not officially go on record as supporters of the current legislation. The American Medical Association did go on record to support the House version of the reform bill.21 APNs who stay informed can help lobby for improvements in the current system.
The Medicare Prescription Drug Savings and Choice Act of 2009 (S 330), introduced in the Senate on January 27, 2009, initially looked promising.18 This bill proposes a national Rx drug program that uses the same negotiated formulary for everyone. The bill, because of the huge bargaining power of the multitude of Medicare enrollees, would force drug pricing to be highly competitive. The formulary would resemble most private formularies, with step therapy, use of generics as preferred medications, and prior authorization of non-preferred drugs. S 330 lacks bipartisan support and, with the recent passing of House bill HR 3962 (the Affordable Health Care for America Act) and the Senate version (HR 3590; the Patient Protection and Affordable Care Act), the earlier bills will most likely stay in limbo. Most political analysts believed that a hybrid of these two current healthcare reform bills would be passed in the first part of 2010. The recent election of Scott Brown, a Republican, to the vacated Kennedy seat in Massachusetts, limits the supermajority power recently held by Democrats and has changed the balance of power. This election has given the Republicans filibuster power and may delay healthcare reform unless bipartisan support is found for the bill. The healthcare summit held on February 25, 2010, failed to move health reform past the current stalemate between Republicans and Democrats. The Democratic caucus could try to pass a comprehensive plan without GOP support, by using controversial Senate budget reconciliation rules that would disallow filibusters, but the political stakes are high if they choose this option.
The Medicate Advantage Program has been a costly option for the government; both the Senate and House versions of the health reform bill propose reductions to this program.22 In 2009, Medicare Advantage HMO plans were paid 13% above traditional Medicare, or $1188 more per member, increasing expenditures for the Medicare program by $157 billion over the next decade, according to estimates by the Congressional Budget Office.23 Both the Senate and House health reform bills recommend restructuring Medicare Advantage Plans; the difference lies only in how rapidly the restructuring is accomplished. The Senate bill phases it down by 2013 and the House version allows a 4-year phase-down. Although this move will save taxpayers money, seniors may find comparable coverage difficult to obtain for the same price in the open Medicare Part D and supplemental (Medigap) policies. The most important legislation in the current health reform bills for Medicare Part D lies in the Senate version (HR 3590), which, like S 330, provides for an immediate (upon passage) negotiated formulary for all Medicare Part D enrollees, and in the House version (HR 3962), which phases out the donut hole completely by 2019.23 The Senate version proposes only a one-time reduction in the donut hole by $500, whereas the House version provides for a phase-in over the next 4 years of a universally negotiated formulary for Medicare Part D enrollees (Table 2).22
Competing and Conflicting Priorities of the Stakeholders
Heaney21 evaluated the 49 special interest groups that participated in the process of creating the MMA and Medicare Part D. He determined which of these groups had the greatest influence on policymakers. Among the groups cited most often were the AARP, the Archer MSA (medical savings account), the National Federation of Independent Business, the American Medical Association, and the Christian Coalition of America. Given the narrow margin by which the bill passed, Heaney argued that a strong case could be made that the efforts of both the Archer MSA coalition and the AARP were pivotal in enacting the legislation.21 No APN organization appears to have voiced an opinion on the MMA.21
Stakeholders in Medicare Part D include beneficiaries (elderly or disabled persons), insurance companies, the pharmaceutical industry, pharmacies, prescribers, taxpayers, and politicians. Organizations that represent enrollees (eg, AARP) or other special interest groups have been active in the “fight” as well. The enrollees’ priority is to have affordable, effective Rx medications available to treat their health conditions. Taxpayers do not expect to shoulder the burden for other people’s health care, yet they want assurance that the same benefits will be available to them when they become eligible for Medicare. Insurance companies and pharmaceutical companies are for-profit businesses that are traded on stock exchanges; as such, their goal is to make as large a profit as possible for their stockholders. Politicians must sit quietly on the fence, taking care not to anger the senior voting caucus or the insurance companies, prescribers and pharmaceutical companies. Because all these stakeholders have conflicting goals, Rx drug reform has had a difficult time moving though the political process.
In 2006, the insurance company Humana had a plan that would provide for medications throughout the gap (ie, the donut hole) for a higher monthly premium, but the company quickly abandoned this plan in 2007 when it was found to not be profitable.10 Tucker Sutherland, in a January 5, 2006, editorial published in Senior Journal, accused AARP and Patricia Barry (author of an AARP analysis) of softening on the legalization of imported drugs from Canada (AARP benefits as one of the leading providers of Medicare Part D benefits).23 Reference-based pricing techniques used by some insurance plans have resulted in excessive prices for medications that bear little relationship to their real cost,14 resulting in huge profits for insurance companies that will protest if legislation is passed to prohibit this practice. The year 2009 brought great change to the political arena, and the multimillion dollar salaries of CEOs of major companies are derided as most Americans struggle to pay for basic needs. While stakeholders’ priorities are at odds, the general voting public has begun to demand change and bring equity to healthcare costs. Because of the recession and the world’s focus on the economy, stakeholders may realize that the time has come to unite to develop a fair plan that benefits as many individuals as possible.
Proposal for Improving Medicare Part D
If APNs join forces with seniors, change in the current Medicare Part D program is more likely to evolve. The portion of HR 3590 that immediately provides for a universal formulary is a place to start. In addition to establishing a universal formulary, the donut hole closure described in HR 3962 would position Medicare Part D to be a more effective prescription plan for seniors, leading to less cost-related non-adherence.
Imposing higher premiums on enrollees who smoke, use illicit drugs, or abuse alcohol after participating in at least one outpatient or inpatient program designed to promote cessation of dangerous habits;
Capping health insurance company profits;
Delivering extra proceeds to enrollees in the form of premium reductions or rebates using the model of member-owned cooperatives;
Subsidizing the cost of essential medications (eg, newer insulins, biologicals) that are not available in generic formulations;
Directing National Institutes of Health-sponsored research toward new drug development marketed to private pharmaceutical companies at a controlled price similar to that of generic medications;
Prohibiting reference-based pricing from all health insurance companies;
Instituting tort reform on limits of litigation—similar to those backed by the government for vaccines—to reduce class action suits against pharmaceutical companies;
Eliminating direct-to-consumer marketing on television and in lay magazines;
Reducing marketing to practitioners by drug company sales representatives; and
Reducing sampling of medications.
If these methods are implemented, the overall cost of even brand-name medications would decline, greatly limiting the financial strain on the Medicare system.
Further savings can be realized by government-negotiated formularies and by a decrease in Rx drug non-adherence, leading to less utilization of Medicare Parts A and B and allowing for a Medicare Part D program that has no gap in coverage and does not cost more than enrollees can afford to pay. Promotion of more healthful behaviors by charging higher premiums for persons who engage in less healthful behaviors may also help the nation reach the goals of Healthy People 2010.
Conclusion
Medicare Part D is not meeting the needs of millions of enrollees. Revisions to the plan appear in both the Senate and House versions of the health reform bills. The bargaining power of the combined number of beneficiaries could be used to negotiate medication prices to a much lower level. The current gap in benefits leads to medication non-adherence, which, in turn, increases morbidity and mortality and ultimately drives up costs.
Opposition to these changes is expected from insurance companies, pharmaceutical companies, and benefit management companies that profit from the present system. The voting public of existing and future Medicare enrollees is formidable; this group can unite in its lobbying efforts to effectuate meaningful change in current law. APNs can unite with beneficiaries to yield a stronger political force.
For more than 40 years, the United States has provided universal health coverage for seniors and the disabled. Originally designed to cover hospital and provider office visits, these benefits have been expanded to include Rx drugs. A more encompassing prescription benefit plan for Medicare recipients would enhance quality of life for beneficiaries. Medicare was developed for this reason. Fundamental changes must occur in Part D to allow beneficiaries to truly “benefit” from this healthcare coverage. As healthcare advocates and prescribers, APNs are the ideal healthcare providers to lead the way to more affordable Rx medications for the Medicare population.
Susan Riley is a DNP student at Georgia Southern University and a family nurse practitioner at Family Health Care Center, P.C., both in Statesboro, Georgia. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.References