| Idee | Pilotprojekt | Strategiepapier | Gesetzgebung | Umsetzung | Evaluation | Veränderung/Richtungswechsel | ||
|---|---|---|---|---|---|---|---|---|
| Implemented in this survey? |
California governor Arnold Schwarzenegger has proposed a program called Cal Rx that would leverage voluntary discounts from drug manufacturers and pharmacies to make low-cost prescription drugs available to low-income uninsured Californians. Portions of Cal Rx have been enacted, and the legislature is debating the remainder. Critics question Cal Rx?s ability to produce significant discounts, while supporters assert that the voluntary discounts approach will be easier to implement successfully.
California Governor Arnold Schwarzenegger has introduced plans for a program called Cal Rx. Cal Rx aims to lower the cost of prescription drugs for the state's uninsured low-income residents by negotiating voluntary discounts from drug manufacturers and pharmacies and leveraging discount programs already offered by the pharmaceutical industry for low income individuals. The plan has three parts:
For the state of California, the incentive for implementing the Cal Rx plan over other, more coercive policy options is that Cal Rx is more likely to avoid prolong legal challenges from the
pharmaceutical industry and/or the federal government, and thus can be implemented more quickly. As an added incentive for the state, the Pharmaceutical Researchers and Manufacturers
Association (PhRMA) has committed $10 million in private funds to establish and promote a web-based "clearing house" to help Cal Rx members access free and reduced price drugs. This is nearly three
times the $3.94 million that the state has proposed to establish and administer the Cal Rx program.
For the pharmaceutical industry, the incentive to participate in the Cal Rx plan is that its implementation will likely head off other, more coercive or punitive prescription drug acts and/or the
legalization of reimportation. Additionally, the potential size of the untapped beneficiary pool represents new clients who would likely be unable to afford their drugs otherwise. What is more,
the successful implementation of the Cal Rx plan would provide a much-needed image boost for the beleaguered pharmaceutical industry.
Cal Rx will be available to uninsured Californians who make less than 300% of the federal poverty level (that is, less than $27,936 for an individual and less than $56,569 for a family of four). This
amounts to around 5 million people who would be eligible. The administration estimates that approximately 1 million of these would actually enroll. The state Legislative Analyst's Office
indicates that this estimate may be high; in other, similar discount drug card programs in other states, enrolment was sometimes as low as 5% of eligible participants.
Lower the cost of prescription drugs for California's uninsured low-income residents by leveraging new and existing voluntary discounts from pharmaceutical companies and pharmacies.
Qualifying low-income uninsured Californians (around 5 million people ), Pharmaceutical companies, Pharmacies
The Cal Rx plan comes in response to growing concern over the rapidly rising cost of prescription drugs in California and across the US.
Schwarzenegger's approach to the prescription drugs problems is shaped by his pro-business leanings and his good, some argue overly close, relationship with the pharmaceutical industry. The
pharmaceutical industry contributed more than $300,000 to Schwarzenegger's gubernatorial campaign and also financed the governor's trip to New York City where he delivered the keynote address at the
Republican national convention.
The Republican-controlled federal government strongly oposes coersive methods of reducing drug prices such as prescription drug reimportation or government price controls.
Schwarzenegger, a Republican, has also generally tried to cultivate a close working relationship with the federal government. Thus, he is much less willing than the Democrat-controlled
legislature to enact state policies that contradict or challenge federal government, making alternative, more less coercive drug price reduction policies more attractive.
| Idee | Pilotprojekt | Strategiepapier | Gesetzgebung | Umsetzung | Evaluation | Veränderung/Richtungswechsel | ||
|---|---|---|---|---|---|---|---|---|
| Implemented in this survey? |
Cal Rx attempts to lower the price of prescription drugs for the state's low-income uninsured residents by leveraging existing and negotiating new voluntary discounts from pharmaceutical
companies. Governor Schwarzenegger and his advisors developed the Cal Rx proposal. They worked closely with the pharmaceutical industry, which plays a key role in the plan.
Last year, Governor Schwarzenegger vetoed bills passed by the Democrat-controlled legislature that would have allowed state residents to purchase prescription drugs at a discount from Canadian
pharmacies [See survey from April 2004 entitled "Prescription Drug Reimportation Legislation" and the October 2004 supplement]. Because he cut off this avenue of discount prescription drugs, the
governor announced he would be introducing his own alternative drug discount program in the coming year. Increasing the pressure on the governor to follow through on this promise, democrats in
the state legislature have reintroduced reimportation bills this session.
The pharmaceutical industry has been a major driver of prescription drug policy in the state in the past year, actively lobbying the governor to veto drug-reimportation legislation, and pushing
heavily for the Cal Rx plan. Along with pledging $10 million to support part of the Cal Rx plan, the pharmaceutical industry has raised $7.7 million for a political action committee to promote
the plan. This is in addition to the nearly $250,000 that the industry contributed (through legal channels) in the fall of 2004 to candidates supported by Schwarzenegger in the two weeks after
the Governor vetoed the reimportation legislation.
Existing California programs to reduce the cost of prescription drugs for low-income individuals are mostly aimed at senior citizens and persons with disabilities, and have failed to solve the
problem of high prescription drug costs for the low-income uninsured. A 1999 law requires pharmacies to sell prescription drugs to Medicare recipients at prices just above those paid by the Medicaid
program. A second drug discount program called the Golden Bear Pharmacy Assistance program was adopted in 2001. This plan aimed to help the same group of citizens affected by the 1999 law by
passing on rebates that drug companies paid to the state to these individuals. The Golden Bear program has never been implemented, partially due to administrative challenges.
Other states have implemented programs similar to Cal Rx with mixed results. A voluntary drug discount program in Iowa failed to produce significant discounts for beneficiaries. Ohio launched a
voluntary drug discount program in January 2005 with the active support of the AFL-CIO and a coalition of union and non-profit groups as well as the pharmaceutical industry. In Maine, the Main
Rx program imposed a more coercive method by linking a drug company's listing on the state's Medicaid prescription drug formulary to their willingness to provide discounts for the Main Rx
participants. This program is just now being rolled out after years of legal battles with The Pharmaceutical Research and Manufacturers of America (PhRMA), the trade association representing the
large pharmaceutical companies. Schwarzenegger has indicated he wishes to avoid these kinds of protracted struggles.
Stakeholders In Favor
The pharmaceutical industry is decidedly in favor of the governor's plan. BIOCOM, the trade association for southern California's life science industry, Californians United for Research,
Economic Development, and Saving Lives (CURES) and The Pharmaceutical Research and Manufacturers of America (PhRMA) are sponsors, and PhRMA has raised millions of dollars to help implement portions
of the plan and to promote it to the voters in the case of a special election. The California Pharmacists Association, representing the state's pharmacists, has signed on to the plan as have several
Physician's organizations, including the powerful California Medical Association.
The American Association of Retired Persons (AARP), representing many senior citizens, are traditionally heavy users of prescription drugs, have endorsed the plan. Also endorsing the plan are
some patient groups.
Stakeholders Opposed
Some more liberal consumer and health advocacy groups have come out strongly against the plan, including CALPIRG, a consumer group, and Health Access, a health advocacy organization. Several of
these have introduced alternative plans, in the form of ballot initiatives for the special election that the governor may call in November 2005. The plans call for the use of more state
"muscle", such as by leveraging the purchasing power of the state's Medi-Cal program, to obtain drug discounts for the uninsured.
Many Democrats in the California legislature believe the governor's plan reflects the needs of the pharmaceutical industry rather than the needs of the low-income individuals it is supposed to
help. They have reintroduced drug reimportation legislation that was vetoed by the Governor last year [see survey from April 2004 entitled "Prescription Drug Reimportation Legislation"]. As
they debate Cal Rx, Democrats in the legislature will likely try to get some guarantees of the drug discount levels for the Cal Rx plan if it is implemented.
Non-Partisan Observers:
The non-partisan Legislative Analyst's Office, which offers advise to the legislature on pending bills, has suggested changes to the governor's plan. Specifically, the legislative analyst calls
for the governor's voluntary plan to be implemented, but coupled with a "trigger" mechanism. Under this trigger mechanism, if pharmaceutical companies did not make good on their promises of big
discounts, the state would automatically begin making participation in Cal Rx a requirement of being included in the state's Medi-Cal prescription drug formulary.
Elements of the Cal Rx program were originally proposed as amendments to various pieces of legislation last year, but were not adopted.
Governor Schwarzenegger announced revised and expanded plans and proposed funding for California Rx in the state budget that he announced in early January 2005. Senators Deborah Ortiz, a
Democrat, and Chuck Poochigian, a Republican, wrote the legislative bill describing the program and introduced it on January 6, 2005. The legislature will debate the budget and the bill in the coming
months. The fact that Governor Schwarzenegger was able to convince Senator Ortiz, the Democratic chair of the senate Health Committee, to author the Cal Rx legislation is significant, and may
help him garner support in the Democrat-controlled senate.
Only the portion of the drug discount plan that requires the state to negotiate with drug companies requires legislation. The web-based clearinghouse of existing manufacturers discounts will be
funded by the pharmaceutical industry and will go into effect in the spring of 2005.
Potential changes to the plan could come during the legislative process, and may be influenced by the budget negotiations and by the success of other prescription drug bills that have been introduced
by Democrats in the legislature.
If the Governor decides to call a special election in November of 2005, at least 5 different prescription drug plans, including Cal Rx, could go before voters. If this occurs, the Governor's
political clout and the pharmaceutical industry's financial backing would give Cal Rx a large boost with the voters.
If passed as proposed, the web-based clearinghouse for manufacturers discounts would go online in the spring of 2005, and the Cal Rx discount program would begin enrolling participants in January
2006.
Before implementation can being, the state Department of Health Services (DHS) must obtain State Pharmacy Assistance Programs (SPAP) status for Cal Rx from the federal Centers for Medicare and
Medicaid Services (CMS). SPAP approval will allow the state to maximize manufacturer discounts, because discounts negotiated for SPAP programs are exempted from the federal lowest-cost
requirements (federal law requires that drug manufacturers sell their products to certain federal health programs below their lowest negotiated prices for other purchasers, however, if the "other
purchaser" is an SPAP, then the SPAP negotiated price can be lower than that offered to federal programs). SPAP status requires the state to contribute general fund dollars to the effort, which the
governor's budget does, to the tune of 3.94 million. The Schwarzenegger administration reports that preliminary discussions with CMS have been positive, and that SPAP approval seems
likely.
DHS will be responsible for administering the program, and must negotiate discounts with drug manufacturers and pharmacies. The DHS says all major drug manufacturers have agreed to participate in the
program, however, it has not negotiated the discount levels that will be available.
The enrolment process will be kept deliberately simple. A one-page form that requires participants to self-certify their financial information will be available to fill out at pharmacies,
physicians offices and on the internet. This information will be reviewed, and if they qualify the applicant will be enrolled in Cal Rx. Enrolment will cost participants $15 each.
Although the language of the bill asks that some sort of evaluation take place, it does not specify how, nor does it appropriate money for it. The non-partisan Legislative Analyst's Office has expressed grave concerns over the lack of a monitoring and evaluation mechanism.
Cal Rx is a program with a limited focus: reducing the cost of prescription drugs for low income Californians who do not have prescription drug coverage. Any discounts that the program is able to
generate will help those individuals enrolled in the program. However, Cal Rx will not reduce the cost of prescription drugs for state health coverage programs like Medi-Cal, health insurers,
and other large purchasers, whose budgets are being severely crunched by rising drug costs.
Cal Rx's reliance on voluntary discounts may fail to produce discounts as deep as other, more coercive programs might. However, it has the advantage of being relatively simple to implement and
it is unlikely to be subjected to protracted and expensive legal and regulatory challenges from pharmaceutical companies and/or the federal government.
By publicizing existing Patient-Assistance Programs (PAPs), Cal Rx has the potential to expand access for a select group of low-income individuals who qualify for the programs. However, simply
publicizing the PAPs may not be enough to encourage uptake. A survey released in March of 2005 cited complex, time-consuming and inconsistent eligibility requirements rather than lack of
awareness of their existence as a primary barrier to PAPs use. If Cal Rx is to significantly increase access to industry programs, it may need to work with the pharmaceutical industry to simplify
eligibility requirements as well as publicize the pharmaceutical programs.
California's debate over how to deal with the rising cost of prescription drugs plays into the larger national-level debate. If California's approach of voluntary cooperation with pharmaceutical
companies works, it will provide ammunition for those who oppose more coercive cost-cutting strategies such as price controls and drug reimportation. The pharmaceutical industry has indicated that it
is willing to spend a great deal of money to increase access to drugs for the poor and thereby discourage the implementation of price control policies. This willingness was evidenced most recently by
the launch of a nationwide website to publicize and facilitate enrollment in existing industry PAPs. Policymakers interested in prescription drug pricing will be watching California's Cal Rx
program carefully.
Saenz, KD, Raube K, Lipton HL. (2005) "Patient-assistance programs: Assessment of and use by safety-net clinics" American journal of health-system pharmacy. 62:726-731
Stickler, Miriam. "Other states' experiences raise questions, offer examples for California proposals to address medication costs". California Healthline, Health Currents. February 28,
2005. Available online at: http://www.californiahealthline.org/index.cfm?Action=dspItem&itemID=109356&ClassCD=CL116
"Evaluating the administration's California Rx Proposal" The Legislative Analyst's Office. Febraury 2005. Available online at http://www.lao.ca.gov/2005/california_rx/california_rx_021005.htm
Sarah Weston, Institute for Global Health; Carol Medlin, PhD, Institute for Global Health