Medicare must protect access to innovative treatments for seniors

Medicare must protect access to innovative treatments for seniors
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The Trump administration has made patient access to innovative treatments a critical priority and enjoyed great success with the "right to try" act and regulatory changes at the agency level.  

Yet impediments to access remain as a result of bureaucratic drag, leaving some critical treatment options available for patients with private insurance at arm’s length for Medicare patients. 

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Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma recently lamented that bureaucratic barriers can limit patient access to groundbreaking new treatments noting, “Innovation has remained adversely affected by government roadblocks.” By classifying certain medical innovations as a part of a treatment package with equal financial weight as rubber gloves, CMS itself has missed opportunities to give patients breakthrough treatments by blocking adequate reimbursements to physicians wanting to use these protocols.

Examples abound, including Omidria, the first and only FDA-approved ophthalmic drug approved for cataract surgery to help expand the pupil and reduce post-surgical eye pain.

It has clinically demonstrated success in reducing pain, improving surgical outcomes and preventing complications —all system savings. With an estimated 2 million Americans addicted to opioid-based painkillers (many after receiving them for surgery) Omidria effectively reduces pain and the need for opioids.

Recognizing its many benefits, in 2018 the Department of Veterans Affairs mandated the drug be available in all VA facilities performing ophthalmic surgery. Despite this move by the VA, its CMS counterparts have not indicated they will remove Omidria from its small list of drugs packaged in the facility fee in outpatient and ambulatory surgical centers, rendering this clinically significant medication equal to standard surgical supply status. 

The refusal to exclude this non-opioid medication from the packaging framework disincentivizes doctors from using it since they will not be adequately reimbursed. This leaves Medicare patients with less effective, less safe approaches that have led to some appalling health outcomes for cataract patients, in some cases even blindness.

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Other ill-conceived reimbursement policies include the lag in approving radiopharmaceutical diagnostic imaging even though it is incredibly effective in diagnosing diseases that hit the Medicare population hard, such as prostate cancer, Parkinson’s and Alzheimer’s. These important, innovative products are also treated by CMS as common medical supplies.

CMS has also decided to no longer cover another innovative product, Auryxia, an FDA-approved medication that treats iron deficiency anemia in patients with chronic kidney disease. The only other alternative for many anemic patients is an IV drip, costing taxpayers significantly more than an effective oral alternative and creating hardship for patients.

In some cases, the financial and transportation burden to access IV treatment is so cumbersome that patients remain untreated and often end up in a hospital receiving blood transfusions that put them at additional risk and less likely to receive a kidney transplant. As with Omidria, most patients with commercial and government insurance other than Medicare have access to this innovative kidney disease treatment.  

Many flawed reimbursement policies are a result of CMS’ earnest effort to strike a balance between controlling costs and safeguarding access to innovative treatments. While this effort is commendable, these examples demonstrate how purported cost-controlling objectives often restrain physicians’ treatment determinations and ignore medical needs of beneficiaries. Ironically, by not covering these breakthroughs, CMS will likely end up incurring higher costs as patients develop avoidable complications — and taxpayers get the bill.

Payment policies should put patient safety and access as its first priority, especially for low-risk treatments with no FDA approved alternative. Socialized medicine schemes in Canada and the UK are criticized for manipulating access to patient care to control costs — a practice the U.S. should never emulate.

CMS can make small but important changes to ensure beneficiary access to valuable therapies. It should revise its surgical packaging policy on Omirdia to exclude ophthalmic drugs approved by the FDA for post-operative indications and pay for them separately.

For radiopharmaceutical diagnostic imaging, CMS can expand access by no longer classifying it as a common medical supply. In the case of Auryxia, CMS should restore coverage for this cost-effective pill. These solutions help ensure Medicare patients are not uniquely disadvantaged.

When it comes to access to some innovative treatments for America’s elderly that alleviate suffering, lower system costs and prevent pricey and painful complications, CMS is out of sync with Trump Administration goals.

If America is to continue as an incubator for some of the world’s most consequential medical breakthroughs, all agencies must align rhetoric with reality by making innovative and life-saving treatments accessible to patients who benefit most. 

Similar fixes are available for other innovative therapies, providing the administration with a golden opportunity to be a champion for patients by supporting the clinical judgements of physicians treating them. Doctors should not have to choose between a personal financial loss and providing the best standard of care.

Seniors on Medicare are not just our most vulnerable medical population —they are a national treasure. Every arm of the government healthcare bureaucracy should harness its internal pollical will and treat them as such.

Kerri Toloczko is a senior policy fellow at Institute for Liberty, a public policy organization dedicated to limited government, free enterprise and individual pursuit of the American dream.