Keeping the Promise We Made to Patients

Just over a dozen years ago, as a member of the Senate Finance Committee, I helped lead a bipartisan band of lawmakers to establish the Medicare Part D program, a landmark commitment to America’s seniors that acknowledged the essential role of pharmaceuticals to their health.

In the decade since, Part D has proven to be an unqualified success, providing access to lifesaving innovations and coming in considerably under budget. Unfortunately, however, some in government just can’t let a good thing be, and despite the great strengths of the program and its unquestioned benefit to seniors, the Medicare Payment Advisory Commission (MedPAC) is threatening to undermine the program by stripping away vital patient protections provided by Part D’s “Six Protected Classes” policy, with potentially devastating consequences for Medicare beneficiaries.

MedPAC, a legislative advisory board, that delivers advice on Medicare policy to Congress, has submitted a draft recommendation to revise the prescription drug benefit program by removing antidepressant and immunosuppressant medicines from the six drug classes that are currently required to be on all Part D health plan formularies by federal law.

Medicare beneficiaries have relied on the full range of these medicines – used to treat diseases from schizophrenia to epilepsy to cancer to HIV/AIDS – since the program’s founding, and removing protected-class status for any of these drug classes would undermine both the program’s success for patients with these conditions, as well as its popular support.

The program has and is working well for beneficiaries: over the past 10 years, Part D beneficiaries have saved $11.5 billion, translating to an average of $1,407 for each enrollee. But while the cost savings manifest a significant benefit, guaranteed access to drugs in all of the program’s six protected classes – namely anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants – represents an equally important component of the program for Part D enrollees.

Indeed, a recent survey found that nearly 9 out of every 10 seniors are satisfied with Medicare Part D, and unsurprisingly, three-quarters of those respondents felt that their plans cover all of the medicines that their doctor prescribes.

In addition to its popularity, the assurances that the protected classes policy provides to beneficiaries is central to the Part D program’s overall success in promoting health outcomes. This policy provides an immutable guarantee that the most critically important drugs and treatments will always be available to the patients who need them, regardless of health plan. It ensures that doctors are given the necessary discretion to design a drug regimen based only on a patient’s condition and symptoms, rather than on the restrictions of a drug formulary.

And it recognizes that the unique and varied characteristics of these medications – and the diseases they are designed to treat – require a policy approach that maximizes access, capitalizes on medical innovation, and allows for the complexities inherent to pharmacology.

MedPAC’s proposal to eliminate antidepressants and immunosuppressants would have a particularly stark effect on the treatment of patients who suffer from both physical and mental illnesses. The co-morbidities of certain diseases – such as depression and cancer – demand a well-tailored, stable treatment plan that takes into account the complicated interactions of disease and medicine. Changing the equation by forcing patients onto a new drug regimen could have a disastrous effect on a patient’s likelihood to adhere to their treatment and possibly on their overall health.

The entire basis of MedPAC’s recommendation is to reduce prescription drug costs, but a gutting of the protected classes policy ignores the costs that such a move will likely have on the rest of the Medicare program. Savings generated by limiting the range of antidepressants and immunosuppressants covered by Part D will likely be outweighed by the additional costs incurred by hospitals, providers, and patients when distorted and inferior drug options lead to higher hospitalization rates and more costly medical procedures. In short, producing savings through the elimination of these protected classes is a misguided approach that simply transfers costs into other parts of the program rather than providing any relief to patients or payers.

When Congress designed the Part D program in 2003, my colleagues and I tried to balance these concerns by crafting a program that would do two things: improve health outcomes and lower cost. Removing antidepressants and immunosuppressants from the protected classes fulfills neither of these goals, and as I made clear on the Senate floor in 2007, the protected classes policy – for all six drug classes – has always been an essential part of the Medicare Part D program.

That point was reiterated recently in 2014, when the Senate Finance Committee unanimously opposed a Centers for Medicare and Medicaid Services (CMS) proposed rule that would have similarly restricted the breadth of the protected classes. As an agency inherently tied to the legislative branch, MedPAC’s recommendations should reflect the clear and unambiguous intentions of the Congress – and the body has unmistakably voiced its support for the protected classes policy to remain unchanged.

Health policy and patient advocacy stakeholders have similarly voiced their concerns over the effects that limiting access to antidepressants and immunosuppressants could have on Medicare beneficiaries. A diverse set of patient and physician groups have been outspoken in their opposition, demonstrating a true consensus on challenging any unnecessary alterations to the protected classes policy. These groups, representing the populations that will be most affected by this draft recommendation, should be the first voices that policymakers listen to when considering any changes to Part D.

The success of the prescription drug benefit is a source of great personal pride and more importantly, a source of critical support for our nation’s seniors. By drastically changing the protected classes policy, MedPAC’s recommendation would force Medicare beneficiaries to face new, unwarranted obstacles to accessing the life-saving drug therapies they need.

It would weaken physicians’ ability to consider only patient care when prescribing medications and designing complicated treatment plans. And while MedPAC is doing this in the name of cost savings, any real reductions in Part D spending are simply going to lead to greater costs in Parts A and B of the Medicare program as well as the Medicaid program.

I remember battling over these issues in Congress when Part D was first created. While MedPAC may want to reopen old scars, the efficacy and undisputed popularity of the protected classes policy should prove that some old ideas are better off left alone.

Gordon Smith is a former U.S. Senator from Oregon and was one of the key architects of the Medicare Part D program. Medicare Part D was signed into law by President George W. Bush as a part of the Medicare Modernization Act in December 2003.