Congress will soon consider adding a
provision for prescription drug coverage for seniors enrolled in
the financially troubled Medicare program.
Many
Members of Congress have promised seniors high-quality prescription
drug coverage through traditional Medicare and argue that it would
be superior to alternatives that rely on the private sector to
price and deliver drugs. They also tell seniors that Medicare has a
superior record of cost control and that seniors would get a much
better price for prescription drugs through Medicare than from a
new public-private partnership modeled on the Federal Employees
Health Benefits Program (FEHBP), which serves federal employees and
retirees.
However, seniors may not realize that the
traditional government health programs that cover prescription
drugs most often control prescription drug costs by limiting
reimbursement and supply of available drugs. These supply
limitations are often complex and take various forms, but they can
degrade the quality of care, particularly for senior citizens.
Senior citizens need look no further than
Medicaid, the huge government program that covers the poor and the
indigent, for examples of supply limitations to reduce costs.
Medicaid is run by the Centers for Medicare and Medicaid Services
(CMS), the same federal bureaucracy that runs the Medicare
program.
THE BASIC POLICY OPTIONS
Beyond cost considerations, Congress must
decide how to administer a prescription drug benefit for the
Medicare population. One option is to deliver prescription drug
coverage through a pluralistic system of competitive private
providers,
similar to the way in which drugs are routinely delivered to most
Americans enrolled in private health insurance plans.
Another leading option is simply to add a
drug benefit to the existing Medicare program, prescribing drug
coverage, the conditions of drug access, and pricing through a
system of direct government control and regulation--similar to how
other benefits are tightly controlled by law and government
regulation in the current Medicare program.
One
possible compromise is to combine the best features of the private
sector (patient choice and market competition) with the best
features of the public sector (security and predictability) in a
public-private partnership. A good model for a public-private
partnership already exists in the Federal Employees Health Benefits
Program (FEHBP).
In
the FEHBP, drug coverage is universal and fully integrated into
private health insurance plans. Moreover, all of the competing
health plans in the FEHBP are subject to the administrative
authority of the U.S. Office of Personnel Management (OPM), the
federal agency that administers civil service law. Thus,
federal employees and retirees have a choice of coverage and can
seek better plans and benefits if they are dissatisfied with their
drug coverage or any other benefit coverage. The President and
leading Members of Congress from both political parties have
embraced this well-tested model.
RISING COSTS AND GOVERNMENT
RESTRICTIONS
Medicare faces formidable financial
pressures. The Congressional Budget Office (CBO) projects that
Medicare spending between 2004 and 2013 will amount to $3.9
trillion, including $271 billion for 2004. By 2013, when the first wave
of the 77 million baby boomers has retired, the Hospitalization
Insurance (HI) trust fund will be running a cash deficit, based on
assumptions under current law, and these deficits will deepen for
each following year during the entire period of the baby-boomers'
retirement.
Future
Crisis
Medicare's projected deficits and the looming insolvency
of the HI trust fund will place increasing demand on general
revenues from the taxpayers to keep the program afloat. According
to Thomas Saving, a professor at Texas A&M University and
Medicare trustee, this means that by 2026, when the HI fund is
exhausted, 20 percent of all federal income taxes will be required
to finance Medicare alone.
Adding a prescription drug program to
Medicare dramatically increases the financial pressures on
taxpayers. According to the CBO, "For the period 2004 through 2013,
CBO estimates that spending for prescription drugs by and on behalf
of the Medicare population will total $1.8 trillion, or nearly 50
percent of the projected $3.9 trillion in Medicare outlays over
that same period."
As
noted, many Members of Congress strongly oppose private-sector
delivery of prescription drug coverage and would legislate a
universal government-run drug benefit, effectively displacing the
existing private market that delivers prescription drugs to the
senior population. The costs of any future Medicare drug benefit
would, of course, depend on its design and the incentives created
by that design.
According to Professor Saving, adding a
new Medicare drug benefit that pays just 25 percent of prescription
drug costs would require 24 percent of all federal income tax
revenue to pay for the entire Medicare program in 2026. A far more
generous drug benefit paying 75 percent of drug costs would
increase total Medicare costs to an estimated 35 percent of federal
income tax revenue in 2026.
Given the huge financial pressures on
traditional Medicare, both Congress and the Medicare bureaucracy
would be under relentless political and economic pressure to cut
costs in such a Medicare prescription drug program.
Medicaid's
Current Crisis
While Medicare faces long-term financial problems,
Medicaid's financial difficulties are more immediate. States, which
pay a large portion of Medicaid funding, are facing major financial
problems because of the economic downturn and record spending
increases in recent years. Medicaid enrollment is increasing,
partially because of the downturn in the economy, and Medicaid
spending is consuming ever-larger chunks of state budgets. Medicaid
spending as a percent of state expenditures increased from just
over 10 percent in 1987 to 20.4 percent in 2002.
Unlike Medicare, Medicaid already covers
outpatient prescription drugs. Medicaid is funded jointly by the
federal government and the state governments, with the federal
government providing the majority of the funding. State government
officials determine, within federal limits, eligibility
requirements and the precise configuration of benefits.
Like
other Medicaid benefits, prescription drug benefits are subject to
various pricing and regulatory restrictions. Faced with sharply
rising costs, Medicaid is a showcase of how government officials
can and do control prescription drug costs by limiting the
available supply of drugs to patients.
LIMITING ACCESS TO PRESCRIPTION DRUGS
Attempting to control Medicaid costs, a
number of states have started cutting back on prescription drug
coverage for the poor. According to a major report of the Kaiser
Commission on Medicaid and the Uninsured, 45 states impose various
controls on prescription drugs. State officials have devised
a variety of ways to implement restrictive prescription drug
policies, including formularies, prior authorization requirements,
and complicated reimbursement arrangements.
Price
Regulation
As states battle to control the cost of Medicaid, state
officials see reducing the price of prescription drugs as a way to
slow spending growth. In many states, in order to have a drug
covered by Medicaid, pharmaceutical companies must agree to sell
their products to the state at a discounted price--either "the
greater of 15.1 percent of the average manufacturer's price (AMP)
or the difference between the AMP and the manufacturer's best price
and...an additional rebate for any price increase for a product
that exceeds the increase in the Consumer Price Index (CPI-U)" for
innovator drugs and 11 percent AMP for generic drugs.
Some
states, such as Florida and Michigan, are requiring additional
rebates for listing drug companies' products in their drug
formulary. If drug companies refuse to offer a rebate on a
particular drug, patients in the affected state will have
difficulty accessing that drug--assuming they can do so at all.
These Medicaid experiences are directly
relevant to the upcoming debate on adding a prescription drug
provision to Medicare. Price controls, while invariably appealing
to politicians as a quick fix to rising costs, have enormously
negative health and economic consequences. Members of Congress and
senior citizens to whom they have promised artificially cheap drug
coverage through traditional Medicare should be fully aware of
these trade-offs. A poorly designed Medicare drug benefit would
undoubtedly be accompanied by formidable pressures that drive up
costs and result in political pressure to impose some form of price
control system at least as strict as the pricing measures currently
employed in Medicaid.
While Medicaid beneficiaries are faced
with reduced prescription drug coverage, solid evidence from
several industrialized countries indicates that pricing regulations
and negotiations over government pricing compromise the
availability of new drugs. A study by the Boston
Consulting Group in 1999 found significant delays in accessing new
drugs in countries with price controls compared to those with
relatively few. Belgium and Greece had an average delay of 12
months; France and Switzerland had an average delay of 10 months
for new drugs to reach the market compared to the minimal delays in
the United States, the United Kingdom, and Germany, which have
significantly fewer market interventions.
If
Members of Congress promise current and future Medicare
beneficiaries a cheap or low-cost prescription drug benefit through
traditional Medicare, they will be tempted to control costs through
price regulation of one form or another. If they resort to price
regulation, Medicare patients can be expected to have difficulty
accessing the latest, most effective drugs. In some cases, the
effects of government price fixing will eat up precious time that
sick Medicare patients do not have.
Drug
Formularies
Formularies are preferred drug lists, the official lists
of drugs made available to patients. Formularies exist in
conventional employment-based health insurance in the private
sector, but state officials also use them in the Medicaid program.
Of the 43 states surveyed, 40 exclude some drugs from their
formularies.
Generic
Substitution
The Kaiser Commission has reported that Medicaid officials
in 16 states require the use of generic drugs over brand-name drugs
because they are generally cheaper than brand-name drugs.
Prior
Authorization
In some states, officials require doctors to obtain prior
authorization when prescribing newer or more expensive drugs before
Medicaid will pay for them. Under the prior authorization process,
state government officials require physicians to fill out
burdensome paperwork, justify their decisions to a state board,
and/or try less expensive generic drugs first (until they fail)
before Medicaid will pay for certain (often brand-name) drugs.
According to the Kaiser Commission, "Authorizations usually have
several possible levels of review, with clerks or interns often
making initial, simple decisions." Prior authorization is
required for some drugs in 36 states.
Prescribing and
Dispensing Limitations
In some cases, officials even restrict the size of drug
dosages, the number of prescriptions allowed in a month, and even
the number of pills covered in a certain period of time. In
addition, Medicaid takes an average of 20 months after a new drug
is approved by the Food and Drug Administration (FDA) to add it to
the Medicaid list of approved drugs. The picture is even bleaker
for Medicaid patients: Amounts of medication per prescription,
number of prescriptions per month, and number of refills are
limited in 41 states.
While the various forms of drug limitation
may save the government money in the short term, the accumulated
costs to patients and taxpayers over time can be high. Serious
costs result from potentially ineffective treatment, treatment
delay, the inevitable worsening of mistreated medical conditions,
and repeated visits to doctors or medical specialists. Hence, many
professional medical organizations and disease groups have gone on
record against this method of cost control.
Medicaid has imposed prescription drug
restrictions that affect millions of poor and indigent persons
enrolled in Medicaid. Under Medicare, patients' access to medical
technology is already limited, and Medicare itself is
administered by one of the most poorly performing federal
agencies. If Congress does not reform
Medicare and instead retains the central planning and price
regulation that govern both Medicaid and Medicare, similar cost
controls are likely to be imposed on any new Medicare prescription
drug plan. Under these circumstances, America's senior citizens in
a government-managed drug benefit will pay a very high price in
service quality.
CHOICE IS THE KEY TO A SUPERIOR MEDICARE
DRUG PROGRAM
Patients without a choice of health plans
are often dissatisfied with the quality of their coverage.
Federal employees and retirees have a very
different situation under the Federal Employees Health Benefits
Program, which covers them and their families--approximately 8.3
million Americans. All health plans in the FEHBP have drug
coverage, and in recent years most of these plans have paid 80
percent or more of prescription drug costs. Most important, if
federal workers or retirees do not like their health plan's drug
coverage or its restrictions on coverage, they can choose another
plan.
The
ability of federal workers or retirees to "vote with their feet"
and leave overly restrictive health plans is a key feature of the
FEHBP. Not surprisingly, this power of personal choice also affects
the character of pharmacy benefit managers (PBMs) who are common to
these health plans and who often contract with health plans and
administer drug benefits for health plans, including the
negotiation of drug prices with pharmacies and drug manufacturers.
They also process drug claims and employ formularies or preferred
drug lists. According to the U.S. General Accounting Office (GAO),
FEHBP health plans generally use PBMs, like those in private
employer-based health insurance. The GAO also reports that
PBMs in the FEHBP have "generally nonrestrictive drug formularies
across a broad range of drugs and therapeutic categories."
In
controlling costs, the GAO found that PBMs in the competitive
environment of the FEHBP were successful in passing on significant
savings.
In retail pharmacies, federal employees and retirees were able to
secure an average discounted price for 14 selected "widely used
brand name drugs" at about 18 percent below the average for "cash
paying customers" without drug coverage. For four selected generic
drugs, the GAO found that the PBM negotiated retail pharmacy prices
that were 47 percent below the prices paid by cash-paying
customers.
In
the FEHBP, health plans that employ PBMs also use them to provide
options for mail-order prescription drugs to federal employees and
retirees. On average, the GAO found that prices of the 14
brand-name drugs were 27 percent lower for mail-order prescription
drugs than prices at retail pharmacies, and the four generic drugs
were 53 percent lower.
A
Medicare reform proposal based on the FEHBP would give current and
future senior citizens a superior program for prescription drug
coverage without the kind of restrictions that are found in
Medicaid today and will surely be imposed in Medicare tomorrow.
CONCLUSION
Medicaid, which provides medical benefits
for the poor and the indigent, is imposing significant restrictions
on patient access to prescription drugs. This is not surprising. In
Medicare and Medicaid, there is no interaction between the demand
for medical services and the supply of those goods and services.
Free-market functions that control costs in every other sector of
the economy are absent. Rather, cost control in Medicare and
Medicaid is largely a function of political decision-making and
budgetary allocations.
Government officials cannot control the
demand for medical goods and services in these government programs;
they can only control the supply. They routinely control cost by
limiting supply, usually through some form of price regulation. In
Medicaid, boards made up of government officials, pharmacists, and
uninvolved doctors also limit the supply of drugs available to
Medicaid patients, sometimes with clerks or interns making initial
decisions when prior authorization is required.
For
senior citizens, the Medicaid experience is a lesson. If Congress
adopts a drug benefit through traditional Medicare without
reforming that program to respond to consumer demand and patient
choice, senior citizens can expect Medicare officials to impose
similar restrictions on prescription drugs.
Medicaid limits and delays a doctor's
choice of prescriptions for the patient, the number of
prescriptions allowed per month, and the number of pills allowed
per prescription. Access to the newest, most effective drugs is
also limited.
Medicaid has these restrictions because of
financial pressures and budget constraints. The financial pressures
facing Medicare have hardly begun, but they will become even more
formidable. Seniors should realize that efforts to control costs in
Medicare will likely tie the hands of physicians by limiting
treatment options, as they have in Medicaid.
There is a better way. Instead of a system
based on government central planning and price fixing, Congress
should encourage market competition and give full sway to patient
choice. The best available model for a new Medicare program is the
Federal Employees Health Benefits Program, the consumer-driven
health program that covers federal workers and their families.
Unlike many private employer-based plans, the FEHBP allows a broad
choice of health plans, allowing individuals and families to choose
the coverage they want, including prescription drug coverage. At
the very least, the next generation of retirees should be able to
choose the kind of prescription drug coverage that best suits their
needs in a new and strengthened Medicare program.
Derek Hunter is a Research Assistant
in the Center for Health Policy Studies at The Heritage
Foundation.
APPENDIX
EXAMPLES OF STATES LIMITING DRUGS THROUGH
PRIOR AUTHORIZATION AND OTHER RESTRICTIONS
The
following are examples of the ways by which state Medicaid
officials use prior authorization and other bureaucratic methods to
limit drug coverage.
FLORIDA
Drugs That Require Prior
Authorization:
- Leukine
Helps the body produce more white blood cells during chemotherapy to help fight infection.
- Targretin
Used to treat skin problems caused by cutaneous T-cell
lymphoma.
- Cytogam
Used to fight cytomegalovirus (CMV), the most common cause
of infection after an organ transplant. CMV is associated with
kidney, lung, liver, pancreas, and heart transplants.
- Procrit
Helps the body make red blood cells during
chemotherapy.
- Neupogen
Helps to maintain high white blood cell count during
chemotherapy.
- Myobloc
Treats abnormal head position and neck pain associated
with cervical dystonia, a painful disorder affecting the cervical
area of the spine, causing involuntary contraction of shoulder and
neck muscles.
Other
Restrictions
In Florida's Medicaid program, officials restrict Paxil
(for anxiety disorder and depression). Paxil in 10 mg form is not
permitted; it must be prescribed in 20 mg tablet form, and the
patient is to use one-half of a tablet. Likewise, patient claims
for OxyContin (for chronic pain and terminal cancer) is limited to
four doses per day except for the OxyContin 160 mg strength, which
is limited to two doses.
Florida also limits the number of
brand-name drugs that can be prescribed per patient during any
given month to four. Any additional prescriptions require prior
authorization.
If a
drug is not on the Florida Medicaid program's Preferred Drug List
(PDL) and the provider cannot quickly obtain authorization, a
72-hour supply may be dispensed by the pharmacist until the request
can be reviewed.
VERMONT
Examples of Drugs That Require
Prior Authorization:
- Infergen
Used to treat hepatitis C.
- Amerge
Short-term treatment for migraines; prior authorization
required for more than nine tabs.
- Adderall
Used to treat attention deficit hyperactivity disorder
(ADHD).
- Nexium
For the treatment of chronic heartburn.
- Lipitor
For lowering cholesterol.
- Xalatan
Used in the treatment of glaucoma.
LOUISIANA
Examples of Drugs That Require Prior
Authorization:
- Vioxx
Used to treat osteoarthritis and rheumatoid arthritis and
relieve menstrual cramps.
- Allegra
Used to treat seasonal allergies.
- Atacand
Used to treat high blood pressure.
- Amerge
Used to treat migraines.
- Zagam
An antibiotic.
- Relenza
An anti-viral drug used to treat influenza.
- Pletal
Used to treat intermittent leg pain that occurs while
walking, enabling patients to walk longer distances.
- Detrol
Used to treat bladder conditions that cause the inability
to control urination.
- Evista
Used to prevent osteoporosis in postmenopausal women.
- Sonata
Used to treat insomnia in adults and the elderly.
- Lumigan
Used to treat hypertension.
- Rescula
Used to treat open-angle glaucoma or ocular
hypertension.
NORTH CAROLINA
Examples of Drugs That Require Prior
Authorization:
- Procrit
Used to increase red blood cell count.
- Neupogen
Helps to maintain high white blood cell count during
chemotherapy.
- OxyContin
Used to treat chronic pain and terminal cancer
patients.
- Rebetron
Used to treat hepatitis.
- Vioxx
Used to treat osteoarthritis and rheumatoid arthritis and
relieve menstrual cramps.
- Celebrex
Used to treat osteoarthritis and rheumatoid
arthritis.
Other
Restrictions
North Carolina Medicaid officials are very specific in
their drug regulations. They require prior authorization for
Procrit for:
(1) anemia associated with renal failure
if patient is not on dialysis (six-month authorization); (2) anemia
associated with HIV Infection (six-month authorization)
specifically Anemia related to zidovudine therapy in HIV-infected
patients; or (3) the anemia is associated with chemotherapy
(six-month authorization).
North Carolina Medicaid officials require
prior authorization of Neupogen therapy, which helps maintain high
white blood cell counts during chemotherapy to help fight
infection. Neupogen therapy is authorized only for those cases that
meet one of two criteria: (1) "To decrease the incidence of
infection due to severe neutropenia (low white blood cell count)
caused by myelosuppressive anti-cancer therapy; (2) To decrease the
incidence of infection due to severe neutropenia in AIDS patients
on zidovudine therapy."
North Carolina Medicaid officials require
prior authorization for OxyContin when the patient has failed
therapy with generic products (oxycodone or a similar narcotic
analgesics) and has had a diagnosis of chronic pain syndrome of
four-week duration. North Carolina also limits
the number of pills that can be prescribed per day to four.
MAINE
Examples of Drugs That Require Prior
Authorization:
- OxyContin
Used to treat chronic pain and terminal cancer
patients.
- Lotrisone
An anti-fungal cream.
Other
Restrictions
Maine's plan to provide discounted prescription drugs to
citizens that do not qualify for Medicaid and do not have
prescription drug coverage could further limit access to drugs for
the state's Medicaid population. The plan "requires drug makers to
give it the same rebates that companies already give for Medicaid
drugs--about 20% off retail prices." If a company "refuses to
play ball" and agree to the discounts, it "will find its products
shut out of the significant state-bought portion of the Maine drug
market."
In
May 2003, the Supreme Court of the United States lifted a temporary
injunction blocking implementation of Maine's plan, under which,
according to The New York Times, "manufacturers that did not
cooperate faced having their products subject to a 'prior
authorization' procedure." The Times added, "Doctors
and patients tend to seek alternatives to drugs for which
pre-authorization is required."
MISSOURI
Examples of Drugs That Require Prior
Authorization:
- Provigil
Used in the treatment of narcolepsy.
- Xenical
Used to help obese people lose weight and maintain weight
loss.
- Clozaril
Used to treat schizophrenia.
Other
Restrictions
In order to prescribe a brand-name drug, the prescriber
must both provide documentation that a generic drug was tried and
document the length of the trial. If there was no trial, the
prescriber must provide a "medical justification" for using a
brand-name drug. For example, "documentation is required showing
that all four lipid-lowering classes have been tried before Xenical
is required."
MICHIGAN
Examples of Drugs That Require Prior
Authorization:
- Celebrex
Used to treat osteoarthritis and rheumatoid
arthritis.
- Vioxx
Used to treat osteoarthritis and rheumatoid arthritis and
relieve menstrual cramps.
- Ritalin
Used to treat ADHD.
- Prescription
Tylenol
Used to treat pain.
Other
Restrictions
Michigan has one of the nation's most restrictive
formularies. Drug manufacturers have agreed to offer supplemental
rebates to the state in order to have drugs placed on the state's
formulary.
Data
gathered through a prescription access hot line found that 66 percent of
callers reported medication delay, denial, or switching with
negative consequences. The types of negative consequences reported
included:
subsequent hospitalization; required new
medication not working as effectively as previous drug; forced
switching to a product causing allergic or other negative reaction;
reduced ability to perform Activities of Daily Living; going
several days, or even weeks, without any medication at all; forced
switching to a product form (such as tablet, chewable or liquid)
which the consumer could not tolerate; and loss of continuity upon
discharge from a hospital (i.e., hospital physicians/patients are
not under prior authorization, but have to deal with it immediately
upon discharge).
In
the same report, a health care provider from Washtenaw County,
Michigan, said, "It's just the biggest mess you can imagine. It's
really horrible customer service. The patients are waiting longer
and longer for their medications." Another Washtenaw County health
care provider said, "I am running into trouble with the randomness
of this [program]. It's too capricious. I'm getting acceptance one
day and the next a denial for the same medicine. It is taking up
too much time, and requiring patients to be switched too often."