Medicare Part D

Medicare Part D is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States. It was enacted as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and went into effect on January 1, 2006.^[1]

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Program specifics

The drug benefit is not part of the 'Original' Medicare program, which includes Part A for hospital care Part B for physician, outpatient care and durable medical equipment. The benefit is administered by private insurance plans that are reimbursed by the Centers for Medicare and Medicaid Services (CMS).^[2]

Beneficiaries can obtain the Medicare Drug benefit through two types of private plans: beneficiaries can join a Prescription Drug Plan (PDP) for drug coverage only or they can join a Medicare Advantage plan (MA) that covers both medical services and prescription drugs (MA-PD).^[3] There are 34 PDP regions and 26 MA regions in the U.S. The drug plans control drug costs through a system of tiered formularies in which lower cost drugs are assigned to lower tiers and thus are easier to prescribe.

Medicare beneficiaries have to affirmatively choose and enroll in the plan, unless they are dual eligible, having both Medicare and Medicaid. Dual eligibles are automatically enrolled into a random Prescription Drug Plan (PDP) in their area. If the dual eligible person is already enrolled in an MA-only plan, then they are automatically removed from the MA plan upon enrollment in the PDP.

Enrollment

Enrollment for most beneficiaries is voluntary. The initial enrollment period took place from November 15, 2005 through May 15, 2006. Potential beneficiaries who did not enroll by the May 15 deadline (or within a given time frame after their initial eligibility date) incurred a late enrollment penalty of 1% per month based on the average cost of the premium until their enrollment.

Annual enrollment periods for Medicare Part D begin on November 15th of the prior plan year. The initial enrollment period for the second year of Medicare Part D started November 15, 2006.^[4] In its first year, beneficiaries eligible for both Medicaid and Medicare (dual eligibles) were transferred from Medicaid prescription drug coverage to a Medicare Part D plan on January 1, 2006.

Hundreds of Medicare prescription drug plans are available, allowing participants to choose a plan that best meets their individual needs. Plans can choose to cover different drugs, or classes of drugs, at various co-pays, or choose not to cover some drugs at all. Medicare has made available an interactive online tool called the Prescription Drug Plan Finder that allows for comparison of drug availability and costs for all plans in a geographic area. The Prescription Drug Plan Finder can be used to perform a personalized or general search for plans; in either case, the tool allows one to enter a list of medications along with pharmacy preferences. The Plan Finder output includes the beneficiary's total annual costs for each plan, along with a detailed breakdown of the plans' monthly premiums, deductibles, and prices for each drug during each phase of the benefit design (initial coverage period, coverage gap, and catastrophic coverage period). Plans are required to update this site with current prices and formulary information every other week throughout the year. Some enrollees criticize the Prescription Drug Plan Finder as complex to use, especially for many Medicare beneficiaries who have limited computer skills and Internet access^{[citation needed]}. Nonetheless, use of this tool is essential in order for people to make an informed choice considering the actual costs for each plan.

Costs to beneficiaries

The MMA establishes a standard drug benefit that Part D plans may offer.^[5] The standard benefit is defined in terms of the benefit structure and not in terms of the drugs that must be covered. In 2007, this standard benefit requires payment of a $265 deductible. The beneficiary then pays 25% of the cost of a covered Part D prescription drug up to an initial coverage limit of $2400. The defined standard benefit is not the most common benefit offered by Part D plans. Only 10 percent of plans for 2008 offer the defined standard benefit. Most eliminate the deductible and use tiered drug co-payments rather than coinsurance.^[6]

Once the initial coverage limit is reached, the beneficiary is subject to another deductible, known officially as the Coverage Gap but referred to more commonly as the "Donut Hole," in which they must pay the full cost of medicine. When total out-of-pocket expenses on formulary drugs for the year, including the deductible and initial coinsurance, reach $3850, the beneficiary then reaches catastrophic coverage, in which he or she pays $2.15 for a generic or preferred drug and $5.35 for other drugs, or 5% coinsurance, whichever is greater. The $3850 amount is calculated on a yearly basis, and a beneficiary who amasses $3850 in out-of-pocket costs by December 31 of one year will start their deductible anew on January 1. Most low-income subsidy patients are exempt from all or part of the donut hole and the deductible. Twenty-nine percent of plans will offer some form of gap coverage in 2008 - this is an increase from 15 percent in 2007. Relatively few beneficiaries choose Part D plans with gap coverage.^[7]

The only out-of-pocket costs that count toward getting out of the coverage gap or into catastrophic coverage are True Out-Of-Pocket (TrOOP) expenditures. TrOOP expenditures accrue only when drugs on the enrolled-in plan's formulary are purchased in accordance with the restrictions on those drugs. Any other purchases do not count toward either the coverage gap or catastrophic coverage. Monthly premium payments do not count towards TrOOP.

It should be noted that the thresholds above related only to the "standard" defined benefit structure. Individual health insurance providers often offer their own variations of the standard benefit (sometimes known as "enhanced" benefit plans) that may eliminate the deductible phase completely and/or extend the Initial Coverage limit to shrink the size of the donut Hole. Typically, the premiums for these enhanced plans are higher to offset the increased benefit.

Beneficiary premiums for Part D plans vary widely, and increased from 2006 to 2007. Premiums are projected to increase for 2008 as well. Premiums are significantly higher for plans with gap coverage. Major Part D plan sponsors are dropping their more expensive options, and developing lower cost ones.^[8]

Most plans use specialty drug tiers, and some have a separate benefit tier for injectable drugs. Beneficiary cost sharing can be higher for drugs in these tiers.^[9]

Low Income Subsidies

One option for those struggling with drug costs is to have a Low Income Subsidy applied to their existing prescription account. Depending on a variety of factors (not the least of which is actual income) a member of an existing plan may have their premium paid for, all or in part, and may have a reduced copay for their medication. To request a review for subsidy contact the Social Security Administration at 800-772-1213.

The subsidy award is given a level with the following effects.^{[citation needed]};

Note: A common source of confusion; When the award letters where sent out for 06' and 07' subsidies the wording referred to a plan’s premium being paid for 100%. In actuality the amount paid is usually matched to the amount charged for the basic plan offered by the carrier. If this is the plan the customer has then, as expected, the premium is paid for. If the member has selected other than the most basic level of coverage then the premium will likely be higher the amount paid for by the subsidy. This may lead the member to be charged a monthly amount while thinking they have no monthly bill.

Excluded drugs

While CMS does not have an established formulary, Part D drug coverage excludes drugs not approved by the Food and Drug Administration, those not for use in their medically accepted indication, drugs not available by prescription for purchase in the United States, and drugs for which payments would be available under Parts A or B of Medicare.^[10]

Part D coverage excludes drugs or classes of drugs which may be excluded from Medicaid coverage. These may include:

• Drugs used for anorexia, weight loss, or weight gain
• Drugs used to promote fertility
• Drugs used for erectile dysfunction
• Drugs used for cosmetic purposes (hair growth, ect.)
• Drugs used for the symptomatic relief of cough and colds
• Barbiturates
• Benzodiazepines
• Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations
• Drugs where the manufacturer requires as a condition of sale any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee

While these drugs are excluded from basic Part D coverage, drug plans can include them as a supplemental benefit, provided they otherwise meet the definition of a Part D drug. However plans that cover excluded drugs are not allowed to pass on those costs to Medicare, and plans are required to repay CMS if they are found to have billed Medicare in these cases.^[11]

Plan formularies

Part D plans are not required to pay for all covered Part D drugs.^[12] They establish their own formularies, or list of covered drugs for which they will make payment, as long as the formulary and benefit structure are not found by CMS to discourage enrollment by certain Medicare beneficiaries. Part D plans that follow the formulary classes and categories established by the United States Pharmacopoeia will pass the first discrimination test. Plans can change the drugs on their formulary during the course of the year with 60 days notice to affected parties.

Typically, each Plan's formulary is organized into tiers, and each tier is associated with a set copay amount. Most formularies have between 3 and 5 tiers. The lower the tier, the lower the copay amount. For example, Tier 1 might include all of the Plan's preferred generic drugs, and each drug within this tier might have a copay of $5 - 10 per prescription. Tier 2 might include the Plan's preferred brand drugs with a copay of $20 - $30, while Tier 3 may be reserved for non-preferred brand drugs which are covered by the plan at a higher copay level - perhaps $40 - $50. Tiers 4 and higher typically contain specialty drugs, which have the highest copays because they are generally quite expensive.

The Plan's tiered copay amounts for each drug only apply during the initial period before the coverage gap. Once in the coverage gap, also known as the Donut Hole, the person must pay for 100% of the prescription costs, based on prices established by the Plan.

Number of participants

At the start of the program in January 2006, it was expected that eleven million Americans would be covered by Medicare Part D. Of those, six million people would be dual eligible. About two million people who are currently covered by employers would likely lose their employee benefits.

Medicare as a whole covers more than 39 million individuals for prescription coverage, with the others spread across the Retiree Drug Subsidy (RDS), Federal retiree programs such as TRICARE and Federal Employees Health Benefits Plans (FEHBP) or alternative sources, such as the Department of Veterans Affairs. As of January 30, 2007, nearly 24 million individuals were receiving prescription drug coverage through Medicare Part D, according to CMS.^[13]

As of April 2006, the primary private insurance plans providing Medicare Part D coverage were UnitedHealth with 3.8 million subscribers, or 27 percent of the total, Humana with 2.4 million, or 18 percent, and WellPoint with 1 million, or 7 percent. Companies with the next largest shares were MemberHealth, with 924,100 subscribers (7 percent); WellCare Health Plans, with 849,700 (6 percent); and Coventry Health Care, with 596,100 (4 percent).^[14] CMS offers updated enrollment numbers on their website.^[15]

Program costs

As of January 2006, the expected per capita drug spending was $2,250, making the total cost of the program $42.75 Billion.^[16] This budget compares with revenues of $54 Billion for Pfizer and $48.6 Billion for Johnson & Johnson, the two largest pharmaceutical companies. Other estimates put the 2006 costs at $37.4 billion.^[17] Total costs through 2015 are estimated to be $724 billion. Some of these revenues will be provided by "clawback" of revenues currently provided to the states for Medicaid. The "clawback" is a mechanism by which federal expenditures that benefit states (specifically regarding dual eligibles) are reimbursed back to the federal government. This reimbursement starts at 90%, but then falls to 75% in 2015. Figures also depend on per capita estimates of dual eligible expenditures and the number of dual eligibles that receive benefits.

Implementation issues

• Plan and Health Care Provider goals are not aligned: PDP's and MA's are rewarded for focusing on low cost drugs to all beneficiaries, while Providers are rewarded for quality of care – sometimes involving expensive technologies.
• Conflicting goals: Plans are required to have a tiered exemptions process for beneficiaries to get a higher-tier drug at a lower cost, but plans must grant exception when medically necessary. However, the rule denies beneficiaries the right to request a tiering exception for certain high-cost drugs.^{[citation needed]}
• Lack of standardization: Drugs appearing on Tier 2 in one plan may be on Tier 3 in another. Tier 2 drugs may have a different co-pay with different plans. There are plans with no deductibles and the coinsurance for the most expensive drugs varies widely. Some plans may insist on step therapy, which means that the patient must use generics first before the company will pay for higher priced drugs. There is an appeal process, but the burden is on the beneficiary, as the insurer will not pay for the desired drug during the appeal process.
• Standards for electronic prescribing for Medicare Part D conflict with regulations in many US states. ^[18]

Criticisms

By the design of the program, the federal government is not permitted to negotiate prices of drugs with the drug companies, as federal agencies do in other programs. The Veterans Administration, which is allowed to negotiate drug prices and establish a formulary, pays 58% less for drugs, on average, than Medicare Part D.^[19] For example, Medicare pays $785 for a year's supply of Lipitor (avorstatin), while the VA pays $520. Medicare pays $1,485 for Zocor, while the VA pays $127. Former Congressman Billy Tauzin, R-La., who steered the bill through the House, retired soon after and took a $2 million a year job as president of Pharmaceutical Research and Manufacturers of America (PhRMA), the main industry lobbying group. Medicare boss Thomas Scully, who threatened to fire Medicare Chief Actuary Richard Foster if he reported how much the bill would actually cost, was negotiating for a new job as a pharmaceutical lobbyist as the bill was working through Congress.^[20][21]

In response, the Manhattan Institute, a free-market think tank which is funded in part by pharmaceutical companies, issued a report by Frank Lichtenberg, a business professor at Columbia University. Lichtenberg said that the VA National Formulary excludes many new drugs. Only 38% of drugs approved in the 1990s and 19% of the drugs approved since 2000 are on the formulary. He also argues that the life expectancy of veterans "may have declined" as a result.^[22] However, Lichtenberg has not published these results in the peer-reviewed medical literature.[au]

Paul Krugman came to the opposite conclusion, by comparing patients in the Medicare Advantage plans, which are administered by private contractors with a subsidy of 11% over traditional Medicare, to the VA system. Mortality rates in Medicare Advantage plans are 40% higher than mortality of elderly veterans treated by the V.A., said Krugman, citing the Medicare Payment Advisory Commission^[23]

The plan requires Medicare beneficiaries whose total drug costs reach $2400 to pay 100% of prescription costs until $3850 is spent out of pocket. (The actual threshold amounts will change year-to-year and plan-by-plan.) This coverage gap is known as the "Donut Hole." While this coverage gap will not affect the majority of program participants, a large minority will find themselves without prescription drug coverage for much of the plan year. However, the Washington Post reports that upwards of 80% of enrollees are satisfied with their coverage, despite the fact that nearly half had chosen plans that do not cover the "donut hole"^[24].This means that almost 20% are dissatisfied -- including the patients who can't afford the drugs they need. Medical researchers say that patient satisfaction surveys are a poor way to evaluate medical care. Most respondents aren't sick, so they don't need medical care, so they're usually satisfied. The only respondents who can evaluate care are respondents who are sick, who are usually a minority^[25].

Critics, such as Ron Pollack, executive director of Families USA, said that even the satisfied enrollees won't be so satisfied next year when the prices go up.^[26]

Medicare Part D initially had a six month enrollment window of November 2005 to May 2006. Beneficiaries who enroll after this window are penalized by a 1% increase in the current average premium price per month they wait - and, indeed, cannot enroll until the next Annual Enrollment Period (or AEP). This time constraint pressured beneficiaries to select one of a large number of plans from a complicated system of tiers, and once a beneficiary committed to a plan, it could, in some cases, not be changed until the next AEP. Some critics have argued that the late enrollment penalty is an improperly coercive practice.^{[citation needed]} This penalty is levied on all future premiums, so the effect is permanent. However, if a potential beneficiary can show that they are enrolled in a "creditable" prescription plan that is at least as good as the Medicare Part D drug benefit, the penalty is waived. Part D Providers do not have the right to autonomously waive the penalty as this shows preferential treatment of members, which is forbidden by CMS.

According to a January 2006 article by Trudy Lieberman of Consumers Union, consumers can have up to 50 choices, in hundreds of combinations of deductibles, co-insurance (the percentage consumers pay for each drug); drug utilization techniques (trying cheaper drugs first); and drug tiers, each with their own co-payments (the flat amount consumers pay for each drug). Co-payments differ on whether people buy generic drugs, preferred brands, non-preferred brands or specialty drugs, and whether they buy from an in-network or out-of-network pharmacy. There is no standard nomenclature, so sellers can call the plan anything they want. They can also cover whatever drugs they want.^[27]

Trivia

• Former Miami Dolphins head coach and Pro Football Hall of Famer Don Shula is believed to be the first American to enroll in Part D benefits.^[28]
• Then White House Press Secretary Scott McClellan's brother Dr. Mark McClellan was the Administrator for the Centers for Medicare and Medicaid Services in the United States Department of Health and Human Services from 2004 to 2006 responsible for overseeing Medicare Part D at its inception. ^[29]

See also

• Health
• Health economics
• National pharmaceuticals policy
• Pharmaceutical company
• Pharmacology
• Prescription drug prices in the United States

References

Articles

• "The Big Drug Scam", by Rich Lowry, National Review Online, January 16, 2007.
• "A Recipe for Cynicism", by Jonah Goldberg, National Review Online, November 29, 2006.
• "Success of Drug Plan Challenges Democrats", by Lori Montgomery and Christopher Lee, Washington Post, November 26, 2006.
• "Medicare Part D Gets a Bipartisan F", by Jerry Mazza, Online Journal, February 3, 2006.
• "Part D From Outer Space", by Trudy Lieberman, The Nation, January 30, 2006.
• "The Great Society Meets the 21st Century", by Michael Johns, Orthopedic Technology Review, January 2004.
• Press Gaggle with Scott McClellan and Dr. Mark McClellan Aboard Air Force One En Route Glendale, Arizona, August 29, 2005; Scott on Katrina readiness and Mark on upcoming Medicare prescription drug benefit.
• The States Step In As Medicare Falters; Seniors Being Turned Away, Overcharged Under New Prescription Drug Program, by Ceci Connolly, Washington Post, Saturday, January 14, 2006.
• Troubles with Medicare Prescription Drug Program, PBS NewsHour with Jim Lehrer, January 16, 2006.

Other resources

• "Medicare Part D Formulary Information", provides links to websites and formularies for Part D providers.
• http://cvs.planprescriber.com - A free online tool that provides objective and unbiased assistance regarding your prescription drug plan options.
• "Patient's Digest - Your Guide To Medicare Part D", Help is available in the premiere issue of Patient's Digest, a publication devoted to providing clear, concise and practical information for patients.
• "Medicare Part D Briefing Room", from the American Society of Consultant Pharmacists.
• "Medicare Prescription Drug Benefit Weekly Q&A Column", from the Kaiser Family Foundation.
• "My Medicare Matters", from the National Council on Aging.
• "Medicare Part D Health Issues", from the National Senior Citizens Law Center.
• "Bob Dole On Medicare", from Enrollment/Education campaign of former Senator Bob Dole
• "Medicare Prescription Drug Plan Guide", from America's Health Insurance Plans.