Before January 1, 2006, thousands of people with cancer, multiple sclerosis, or other serious diseases received free medications through pharmaceutical companies’ Patient Assistance Programs (PAPs). These programs have enabled people to receive the treatment they need as many of the drugs cost tens of thousands of dollars annually. Yet with the beginning of Medicare Part D, everything changed. Panicked phone calls from people being unable to continue their drug therapy due to outrageous costs flooded the Health Insurance Counseling & Advocacy Program (HICAP) offices in the months of January, February, and March. What has happened to these people; how are they or are they not coping now? And what has happened to the much needed PAPs? This article provides both an overview of the plight of some of the most seriously affected beneficiaries with Medicare Part D and a discussion of continuing changes in the PAPs due to a recent Office of the Inspector General (OIG) advisory opinion (no. 06-03) and growing public outcry.
The horror stories…
Besides the beneficiaries with both Medicare and Medicaid, people who had relied on PAPs to receive their needed drugs are among the most seriously affected by Medicare Part D. For the most part, these are people with incomes over the Medicaid (Medi-Cal in California) and Low-Income Subsidy (LIS) limits, yet in many cases, below the annual cost of the drugs they need. Many oral cancer and MS drugs cost between $20,000 – $40,000 per year, and some are even significantly more expensive. For example, ImClone Systems and Bristol-Myers Squibb’s colorectal cancer medication Erbitux is about $10,000 per month ($120,000/yr.), and one of Schering-Plough’s cancer drugs, Temodar, costs about $12,000 per month ($144,000/yr.). Many people did not realize the significant price of these drugs until their free supply ended with the beginning of Part D.
In January, these people received letters from their PAPs saying that they would no longer provide free medication. Instead, Medicare Part D would cover the drugs for them. Most people assumed Medicare’s coverage would be similar to the PAPs, and, not understanding the implications of this change, signed up for a Part D drug plan. Yet as mentioned above, the first visit to the pharmacies revealed quite a different and extreme situation. People three weeks into oral chemotherapy were calling HICAP saying they were going to have to stop treatment. MS patients and/or their families were calling desperate for a way to continue the medications imperative to prevent further degeneration. Paying for the drugs was not an option. The rare disease organizations, that in the past referred Medicare beneficiaries to the PAPs to get their needed drugs, are now for the first time paying the actual costs of these expensive drug payments/copays. Many of these organizations are hurting and cannot continue to cover these costs for all the people needing these medications. So what is happening to these people? The frantic phone calls have died down but the underlying problem has not. Some people may have given up, while others, joined together with some advocacy organizations have been building the flames of a public outcry.
While media coverage on this issue over the past few months as been rather mute, the April OIG advisory opinion and subsequent discussions major pharmaceutical companies are having with the Senate Financing Committee, Federal Trade Commission, and the Centers for Medicare and Medicaid Services (CMS) point to the building political and public pressure felt by the drug industry. An article by the Kaiser Family Foundation noted that some pharmaceutical companies are concerned that the high prices of their medications will “spark the kind of patient outrage that high AIDS-drug prices unleashed more than a decade ago.” In an effort to prevent such an outrage, several companies are re-evaluating their PAPs and deciding whether or not, with approval from the OIG, to continue offering some form of drug assistance for Medicare beneficiaries.
Where do the PAPs stand now?
As discussed in a May Center for Medicare Advocacy ‘Alert,’ the recent OIG Advisory Opinion (06-03) has lessened many fears around offering PAPs to beneficiaries that arose after the OIG issued a special advisory bulletin on November 22, 2005 discussing ways PAPs might violate the anti-kickback statute. While the recent OIG Advisory Opinion refers only to Schering-Plough, it sets a precedent for the other pharmaceutical companies to follow in continuing to offer PAPs to some beneficiaries. Although the situation is in a state of flux, below tentatively outlines where several major pharmaceutical companies currently stand in regards to their PAPs. Regardless of this information, however, beneficiaries and advocates are encouraged to continue contacting the PAPs about reapplying as companies may continue to change their ‘rules’ with building political and public pressure. Beneficiaries can also ask to be put on a company’s ‘notification list’ where they will be contacted about any changes in PAP availably.
In addition, as some advocates have found, what high-ranking pharmaceutical representatives and press releases say about the availability of these programs do not always correlate with the realities beneficiaries face when talking to PAP customer service staff. Although the CEOs may say the PAP is available, the customer service reps may say otherwise and they are the door keepers to these important programs. People who encounter such difficulties can report them to their local HICAP office. California Health Advocates also encourages people to keep a record of such accounts and to work closely with the media to increase awareness and pressure for action and change on this issue.
Note: Income guidelines are not sited below as they do not apply in all situations. Some companies will make exceptions to their standard income guidelines as long as a beneficiary, his/her advocate, and/or doctor can claim special circumstances of financial or medical hardship.
In a reversal of an earlier announcement, GlaxoSmithKline has decided that its Patient Assistance Programs will be available through the remainder of the year to beneficiaries who have enrolled in Part D, have limited income, and are not eligible for the Part D Low-Income Subsidy (LIS). Patients who may be eligible for the LIS will be required to apply for this benefit. GSK will continue to supply these patients with their medicine until a decision has been made as to whether they will receive the subsidy. Patients who do not qualify for the Low Income Subsidy and have not enrolled in Medicare Part D can also continue to get medicine through GSK’s patient assistance programs. To speak to a GSK customer service representative (CSR) about their PAPs, call (866) 728-4368.
Johnson & Johnson
J&J and its pharmaceutical operating companies will continue offering their patient assistance programs (PAPs) to seniors and disabled patients who qualify for, but have not enrolled in, the Medicare Part D prescription drug benefit. For low-income beneficiaries who are enrolled in Part D, J&J and at least four other pharmaceutical companies are seeking approval from the Office of Inspector General to jointly offer a patient assistance program that would help these people pay for medications in the “donut hole” coverage gap of the drug benefit. Under the program, called Companion Rx, the companies would pay 65% of drug costs in the donut hole, with beneficiaries paying the remaining 35%. It is not yet known whether the value of the prescriptions would continue to count toward the $5,100 in total annual drug costs before the Medicare coverage resumes. J&J and the other participating companies are seeking to add other pharmaceutical companies to the coalition as well.
J&J may also cover beneficiaries who drop Part D. For information on J&J’s existing PAPs, call the Partnership for Prescription Assistance at (888) 4PPARX-NOW (1-888-477-2669), or visit the PPA website at www.pparx.org.
Eli Lilly will continue operating its existing LillyAnswers PAP through the end of the year for Medicare beneficiaries who were enrolled in the program as of December 31, 2005 and have not yet signed up for the Medicare drug benefit. No new enrollees will be accepted. Pending OIG approval, next year Lilly may launch a new LillyMedicareAnswers PAP for certain low-income Medicare beneficiaries who have enrolled in the drug benefit and have applied for and been denied the Part D low-income subsidy. If launched, this program would help beneficiaries obtain the osteoporosis treatment Forteo and the antipsychotic Zyprexa. The drugs covered under LillyMedicareAnswers would not count toward the $5,100 catastrophic coverage trigger.
For beneficiaries who were enrolled in LillyAnswers as of December 2005, have since enrolled in Part D, and are prescribed either Forteo or Zyprexa, Lilly is considering continuing to provide these medications to them. If they do, qualifying beneficiaries will be required to provide a signed certificate stating that he/she will not count any cost incurred or associated with the medicines toward the $5,100 catastrophic coverage trigger. For questions or more information about Eli Lilly’s PAPs, call (877) 795-4559.
Merck will continue offering their PAP to low-income beneficiaries who are not enrolled in Part D. They may cover beneficiaries who drop Part D. For questions or additional information, call (800) 727-5400 or visit their website.
AstraZeneca will continue offering their PAP to low-income beneficiaries who are not enrolled in Part D. Although a May press release announced that they would also continue offering their PAP to low-income beneficiaries enrolled in Part D as long as they have applied for and been denied the low-income subsidy, this is currently not the case. AstraZeneca has not yet reached a decision. Beneficiaries who would like to be notified when a decision is made can call AstraZeneca’s PAP Help Line at (800) 424-3727. Their name, address and phone number will be added to a notification list.
Novartis, the maker of several important cancer drugs including Gleevec, will continue offering their PAP to low-income beneficiaries who are not enrolled in Part D. It seems that beneficiaries who are enrolled in a Part D plan and are taking Novartis transplant or oncology medications may also be able to continue using the Novartis PAP as long as they meet certain eligibility criteria, do not qualify for and have been denied the LIS, and show financial hardship in affording their medications despite the Part D benefit coverage. When calling Novartis, these beneficiaries must explicitly state that they are inquiring about the PAP for transplant and oncology medications. The PAP for non-oncology medications has a different policy and does not accept anyone with Medicare Part D.
Novartis may also first refer beneficiaries to an outside organization to help with Part D copays, and if that does not work, beneficiaries may file an ‘appeal’ with Novartis to use their PAP. Novartis states that other beneficiary cases will be evaluated individually, based on the particular Novartis product, specific circumstances and financial hardship experienced. For more information on the Novartis PAP program, visit their website or call (800) 277-2254.
Although Schering-Plow has OIG approval to continue two patient assistance programs for qualified Medicare beneficiaries regardless of whether they have Part D, it is still unclear whether the programs are actually available to those with Part D. The information received depends on the number called and the person spoken to. With that said, the two PAPs available are Commitment to Care and SP Cares. The first, Commitment to Care, offers free outpatient prescription drugs for cancer and hepatitis. Qualified beneficiaries must demonstrate that their prescription drug expenses exceed three percent of their annual household income. The second program, SP-Cares, offers allergy, asthma, dermatology and cardiovascular prescription drugs, and also requires that a person’s drug expenses exceed three percent of their annual income. Beneficiaries who have not enrolled in Part D are required to apply to, and be rejected by, the low-income subsidy. They must also attest that they cannot find an affordable Part D plan in order to be eligible to participate in the PAP. Beneficiaries who are enrolled in Part D and want to apply must submit proof of spending at least three percent of their annual income on drugs through their Part D plan. For information or questions on Commitment to Care, call (800) 521-7157. For information on SP-Cares, call (800) 656-9485.
Pfizer will continue offering their PAP to low-income beneficiaries who are not enrolled in Part D. They may cover beneficiaries who drop Part D. For questions or additional information, call (800) 869-9979.
Bristol-Myers Squibb, Teva Pharmaceuticals (a company that manufactures treatments for multiple sclerosis) and several other pharmaceutical companies have ended their PAPs for Medicare beneficiaries this year and have not yet reinstated them. Beneficiaries and advocates, however, should continue to call them in the next several months to see if they change their policies.
The good news is that a few PAPs are back and more may come. The challenge lies in ensuring access to these programs as promised in the press releases and by company officials. It also lies in getting consistent, reliable information from the customer service representatives serving the PAP hotlines. As noted above, this information often changes depending on the number called and person spoken to. In addition, while some of the pharmaceutical companies are offering limited assistance to those enrolled in Part D, most PAPs still require that a person not be enrolled. This requirement contradicts the letters that these companies sent to participating beneficiaries late last year and early this year. The letters told beneficiaries that they could no longer get their drugs through the PAP and that they needed to sign up for Part D for continued coverage. Many past participants have done just that and are now enrolled in Part D unable to pay the costs of the drugs they need. This situation raises questions, such as can these people drop Part D and then re-enroll in a PAP? While several programs have stated that they may accept people who drop Part D (i.e. an enrolled beneficiary doesn’t pay her monthly Part D plan premiums and the plan disenrolls her), this option puts beneficiaries at considerable risk. Unless they get prior confirmation from a PAP that they can indeed re-enroll if they drop Part D, they risk loosing their Part D coverage and having no prescription coverage for the remainder of the year.
Also, for those people enrolled in Part D participating in a PAP, it is still unclear if PAPs offer drugs completely outside of Part D, or if beneficiaries must first reach the Part D donut hole before the PAP begins providing drugs. Much remains to be seen as to how the actual workings of the PAPs unfold. As advocates and beneficiaries, please keep records of the situation and work closely with your HICAP office and local, state, and national media contacts.