Statement of the American Medical Directors Association, Columbia, Maryland

The American Medical Directors Association (AMDA) represents more than 7,000 medical directors, attending physicians, and others who practice in nursing facilities. On average, AMDA physicians see 100 nursing facility patients per month (which constituted approximately 8.5 million visits in 2000, or 42 percent of the total number of nursing facility visits that year). AMDA physicians also care for patients in other venues in the long term care continuum, which includes home health care, assisted living settings, hospice and other sites of care for the frail elderly.  The majority of members (59 percent) also maintain a private practice outside of their long term care responsibilities.  Our comments reflect that experience, as well as the commitment to provide the best quality of care to our patients.

Since Part D implementation on January 1, AMDA has been relaying member problems and concerns regarding the new Part D drug benefit to the Centers for Medicare and Medicaid Services (CMS) in weekly conference calls and frequent e-mails.  Despite CMS efforts, we are still seeing significant problems for physicians in obtaining medically necessary drugs for their patients. 

Time is a critical issue for our physicians.  Over 38 percent of AMDA members who responded to a recent survey report spending 4-7 uncompensated hours per week trying to get appropriate medications for their patients under Part D.[i]  Nearly 13 percent reported spending 8 or more hours per week.  That is time spent largely taking care of paper, rather than taking care of patients.  Requirements for prior authorizations are of particular concern, with 70 percent of respondents reporting frequent or very frequent problems.  Exceptions requests also present problems, with 55 percent reporting frequent or very frequent difficulties.

Many physicians are having problems accessing particular drugs or types of drugs, with 23 percent citing problems obtaining drugs to treat Alzheimer’s disease.  Some drug plans require prior authorizations for all drugs to treat dementia, a disease which

affects 40 percent of all nursing facility residents.  A member from Maine told us, “The hurdles created are resulting in a lower level of care being provided for nursing home patients.  They are now less likely to be prescribed uncovered medication even if the alternative is inappropriate because it takes too much time and effort for everyone involved.”

The problems are exacerbated by the myriad drug plans and drug plan options with which physicians must deal.  Each drug plan maintains its own formulary, policies and procedures, with no uniformity among them.  Our members have seen light use of the standard form that CMS has requested drug plans to use.  Only 16 percent of respondents indicate that the majority of drug plans with which they work are using the standard form.

Recurrent problems our members report include:

Lack of Critical Information about the Drug Plan

• The drug plans have often not made available correct information regarding contacts and policies, despite CMS requests since January to do so.
• Drug plans have not provided clear information regarding procedures for exceptions and appeals, as well as prior authorizations.  Likewise, there is a lack of access to drug plan forms that physicians must complete for exceptions and appeals, as well as for prior authorizations.
• Each plan develops its own procedures and forms.  Although CMS is promoting use of a standard coverage determination process, its use is not mandated.
• Apparently most drug plans do not provide information on formulary alternatives when they deny coverage of a drug.  The physician is often hard-pressed to discover what alternatives may be substituted.
• Our members continue to report lengthy delays in telephone access; frequent problems getting through to plans at all (e.g., busy signals, referred to other numbers; long waits).  We receive frequent reports of delays of 30 to 45 minutes, after which the call is simply terminated by the drug plan.

Lack of Access for Emergency Medications

• In at least some instances, drug plans have not been available on a 24-hour basis for coverage determinations on emergency medications.  In such cases, CMS is advising physicians and pharmacists to rely on the 1-800-Medicare number for emergency access, but problems have been reported with that system as well.
• We received reports of lack of access to influenza medications that may be required on an emergency basis to prevent influenza outbreak in long term care facilities.  The Centers for Disease Control have approved antivirals oseltamivir (TamiFlu) and zanamivir (Relenza) to treat influenza this year.  Some physicians report having difficulty obtaining oseltamivir because it is not on some plan formularies, while drugs that are on formularies to treat influenza are contraindicated for patients with seizures or Alzheimer’s disease.
• We also received reports of drug plans that require prior authorization for all drugs to treat influenza. This is a special problem in long term care, where prompt treatment and prophylaxis is crucial to prevent an influenza outbreak.
• In other instances, drug plans authorized appropriate drugs but with quantity limits that were sub-therapeutic.

Onerous Administrative Requirements

Members are reporting a wide array of requirements imposed on physicians by Part D plans in order to have prescriptions honored.  Many requirements entail personal contact by the physician with the drug plan, or access to the enrollee’s health record, which is often not accessible to the physician, as it remains at the long term care facility.  Drug plan communications with the physician sometimes leave the nursing facility completely out of the loop.  Some requirements seem designed simply to deter physicians from requesting prior approvals or exceptions. For example, one physician last week reported that her nursing facility worked with the drug plan for more than four hours and still could not obtain the drug the patient needed.

As noted above, prior authorizations present serious challenges for long term care physicians.  Prior authorizations are extra hurdles that physicians must jump in order to access drugs that are on a drug plan’s formulary. 

One member noted, “I am spending a lot of time on prior authorizations, sometimes 14 a day, and some alternative drugs are the cheap ones which cause harm.  I have had patients on some of these drugs for years and have already tried the viable alternatives.”  Anther told us, “Many patients are being forced to change their medications, even after years of success.”  And another physician reports that “Almost anything non-generic has become a problem.”

Specific problems our members have encountered include but are not limited to:

• Requiring personal telephone calls from physicians by some plans, rather than accepting faxes or e-mails for prior authorizations or exceptions requests. This is a major problem that consumes significant amounts of the long term care physicians’ time and delays access to medications.  The problem is exacerbated by the fact that patients’ medical records remain in the nursing facility and may not be available to the physician when he or she finally gets through to the drug plan.
• Requiring prior authorization for all drugs in a class (e.g., drugs to treat Alzheimer’s disease and influenza).
• Requiring additional documentation as part of prior authorization (e.g., requiring a mini-mental status score for drugs for Alzheimer’s, even of patients who are too ill to take such an exam).
• Requiring prior authorizations for inexpensive drugs.
• Requiring physicians to complete a form in order to obtain the correct form to complete for prior authorizations or exceptions.

Additional problems:

Some additional problems include:

• Lack of recommendations by the drug plan for alternative drugs when a prescribed drug is not on the formulary.  Physicians often do not have access to patient records or drug plan formularies when they are called regarding adverse coverage determinations, and the suggestion of appropriate alternative drugs that are on formularies could expedite the prescribing process.
• Omission of all forms and doses of formulary drugs from drug plan formularies.  Long term care patients may require alternative strength doses or alternative delivery system (liquid, sustained release, intravenous, etc.) for medical reasons, such as no longer being able to chew or swallow, but physicians are sometimes required to pursue exceptions for such different forms and dosages of drugs that are on the plan formulary.

There seems to be little understanding on the part of drug plans of the requirements regarding unnecessary drugs contained in the CMS Conditions of Participation for nursing facilities (42 CFR 483.25(1)(1), 483.25(1)(2)(i)), or of the extensive related guidance to surveyors regarding unnecessary drugs and drugs whose use may be contraindicated in elderly patients.  That federal guidance, contained in CMS’ State Operations Manual, recognizes that some drugs are simply inappropriate for use in frail elderly patients. We have heard of numerous incidents in which drug plans formulary drugs are medications that are considered potentially harmful in the elderly.

Finally, we are extremely concerned with the incredible burdens the new drug benefit is imposing on physicians.  Physicians are reporting spending up to an hour trying to obtain just one drug for just one of their patients.  Sometimes it seems that if physicians pursue problems high enough up the drug plan chain of command, problems are resolved, but our current system for providing and paying for care does not support that level of physician involvement.

 In at least one instance when a physician could not obtain emergency authorization for drugs to treat an outbreak of influenza in a nursing facility and prevent the transmission to other patients, the physician had to argue for one day and discuss his willingness to speak to the press about the need to obtain the medications to prevent patient deaths in order to obtain the necessary drugs.   Physicians simply should not have to go to such lengths to obtain medically necessary medications for their patients.  Nor do Medicare physician payments encompass such an increased amount of work. 

Right now, our members are taking on the drug plans to fight for the medicines they believe their patients need.  But the current level of effort of 4 or more extra hours per week is not likely to be sustainable.  The result may be that physicians have to defer to the drug plan formulary choice, regardless of whether it is the best drug for their patient. 

In one such case, a physician was unable to convince the drug plan to approve his choice of antibiotic for some of his patients, arguing that the formulary alternatives would not adequately treat the patients’ infection.  The patients grew sicker on the drug plan’s choice of antibiotics and required hospitalization for pneumonia.  One nursing facility reported that some patients went without their medications for days.  It seems that the pharmacy did not refill the prescriptions because prior authorizations were needed, but no one had told either the attending physician or the nursing facility

We are extremely concerned that the impediments to medically appropriate medication that many of our members are now experiencing will result in increased adverse drug interactions in our frail, elderly patients, as well as increase reactions between drugs and patients’ other medical problems.  We ask for your assistance in preventing more of these situations.

AMDA Recommendations

Congress should consider how to reshape the Medicare drug benefit to simplify the program for Medicare beneficiaries and for administration.  Simplification could make the program more attractive to beneficiaries, ease the administrative burden on physicians and health care providers, and reduce the cost of the program.

In the meanwhile, several steps could be taken that would immediately improve implementation of the drug benefit, including:

• Legislation should require CMS to mandate drug plan use of one uniform procedure and form for exceptions, prior authorizations and appeals. This step is urgently needed to reduce inordinate amount of time physicians are spending trying to deal with myriad drug plan procedures and forms.  As one member told us, “It is incumbent on the Medicare program to develop universal minimum standards and hold the providers to them”.  The current system of voluntary compliance simply is not working.
• Legislation should specify that CMS will provide clinical direction and clarifications as needed to drug plans to ensure prompt access to medically necessary medications.  Clinical directions should include, among others:
  • Requiring drug plans to include on their formularies, without prior authorization or quantity limits, drugs that CDC recommends to treat influenza each year;
  • Requiring drug plans to provide formulary alternatives, without prior authorization requirements, for formulary drugs that are considered inappropriate for use in the elderly, particularly those listed as inappropriate in CMS guidance to long term care surveyors.
  • Prohibiting prior authorization requirements for all drugs in a class;
  • Requiring drug plans to offer medications alternatives when they refuse to cover a drug;
  • Requiring prior authorizations to be provided for one year, with timely renewal notices to physicians and nursing facilities;
  • Prohibiting inappropriate and onerous requirements for drug utilization programs (such as prior authorization for inexpensive, safe, common medications, requiring prior authorizations for all drugs to treat Alzheimer’s’ disease, and requiring completion of one form in order to receive a second form which must be completed for drug plans to decide whether to cover medications).
• Congress should require greater CMS oversight of drug plans with quarterly public reports, and prompt application of sanctions against non-compliant drug plans.
• Congress should amend the Medicare drug benefit to eliminate co-payments for all dual-eligible beneficiaries who receive long term care services.  Currently, nursing facility residents are not required to make Part D co-payments, because they pay all but a small portion of their incomes to the institution that is caring for them.  But dual-eligibles residing in assisted living facilities, or who are enrolled in the APCE program or receiving home can community-based long term care services, are required to make co-payments, although they also must also pay most of their income to their care provider

The Medicare Part D drug program was based on a managed care model which may work well for younger, healthier, ambulatory individuals.  However Part D requires more flexibility in dealing with the needs of clinically fragile long term care patients with multiple drug therapies and multiple co-morbidities.  A member told us, “Watching the process unfold for the past 5 months it is becoming clear to me that nursing home patients are simply being treated like community dwelling Medicare recipients.  As a result, we are now seeing signs of a system failure and patients not getting their medications on time or not at all.”

Long term care physicians need your help in making the Medicare drug benefit work for their patients, and preserving the quality of medication therapy that they were previously receiving.

Thank you for the opportunity to share our experiences with you. 

[i] Preliminary results of May, 2006, survey.