Is the Medicare Part B Proposed Rule ‘Bad Medicine’?

May 10, 2016 - Two months ago, the Centers for Medicare & Medicaid Services (CMS) announced a new proposed rule that would create new payment models meant to reimburse providers for assigning prescription drugs. This would change the payment structure of Medicare Part B. The proposed regulations are meant to help providers find the right medication for their patients under a renovated Medicare Part B payment system. However, not all stakeholders are onboard with this change.

The Community Oncology Alliance (COA) submitted comments to CMS two days ago stating that this proposed rule should be completely blocked, according to a COA press release.

The organization directs CMS to data that shows this new proposed rule for Medicare Part B payment policy is “bad medicine, flawed economics, and destructive.” In fact, COA is concerned enough about this particular change that it is willing to pursue legal action to put an end to the proposed rule, the press release mentions.

The problem at hand is that this new proposed rule for Medicare Part B reimbursement could potentially endanger patients by changing the way oncologists assign medication. In particular, the proposed rule seeks to reform clinical decision-making without having a clear understanding of the way drugs are prescribed in the oncological setting.

Additionally, the release states that CMS does not have a system for allowing patients to “opt-out” of this new drug prescribing structure nor does the proposed rule allow for “informed consent.” The comments from COA argue that in order to have positive patient health outcomes, oncologists should not be pushed to utilizing lower-priced drugs.

The organization further contends that CMS attempts at cutting costs on cancer care and prescription medication only further led patients into being admitted to hospitals, which ultimately leads to more expensive medical care.

“It’s alarming to think that some government bureaucrats, who have never practiced medicine, are telling me, a Board-certified oncologist with 18-years of experience, that I’m not treating my patients appropriately,” Jeffrey Vacirca, MD, Vice President of COA and CEO of NSHOA Cancer Center in East Setauket, N.Y., said in a public statement. “My patients come first – always come first – and I spend a lot of time personalizing their care and treatment. What the government wants to do is come between me and my patients, forcing cookie-cutter medicine that they think is right.”

The letter from COA sent to Andy Slavitt, Acting Administrator at CMS, regarding the Medicare Part B proposed rule outlines that there may be legal issues tied to revamping drug prescribing practices for cancer care among seniors.

Bruce Gould, MD, President of the Community Oncology Alliance, writes in the letter that CMS is suggesting oncologists around the country are not using the best standards of care when it comes to treating their patients. This type of questioning, according to Gould, is not productive at improving payment models within the oncology field.

By incentivizing physicians to choose low cost drugs, it could negatively impact the quality of care and health outcomes of Medicare beneficiaries and essentially “treat them as second-class citizens” instead of ensuring the best standards of medical care.

The letter goes on to explain why the proposed rule for Medicare Part B is “bad medicine.” There are not many examples where substituting a cancer drug for a less expensive option is actually safe or effective in treating patients. Less expensive treatments are often older and not as advanced, which could negatively affect health outcomes when compared to more innovative, newer therapies.

Additionally, there have been flaws in the economics of cutting Medicare Part B costs. Prior experiments to reduce expenditure have led cancer care to shift to the hospital setting among Medicare beneficiaries instead of less expensive outpatient clinical appointments. Along with these complaints, Gould wrote that the Medicare Part B proposal is “destructive policy.”

“CMS is using Section 1115A of the Patient Protection and Affordable Care Act to effectively overturn legislation that was passed by Congress and signed into law (the Medicare Modernization Act of 2003, which fixed Medicare Part B drug reimbursement). If the Part B Proposal is implemented, the Executive branch could effectively overturn any Medicare law passed by Congress simply by creating a CMMI mandatory, national ‘model,’” Gould wrote in the letter.

Instead of pushing additional payment reforms on physicians and hospitals, it may benefit CMS to work with pharmaceutical companies to create more negotiating power when it comes to the costs of drugs. However, at the same time, CMS “should not be setting prices,” said Dr. David Friend, Managing Director of BDO’s Center for Healthcare Excellence & Innovation.

“In theory, the Congress of the United States should not be setting prices. There’s no other part of the economy that’s had this happen,” Friend said. “We haven’t had wage price control since Nixon in the 1960s and it really failed. As a matter of policy, the US tried wage price control under the Republicans in the ‘60s and it didn’t end well.”

“I think what’s really happening is that we’re moving to bundling, moving to indication-based pricing, or pricing based on rebates if it doesn’t work or providers get a free trial. Pricing is really a market mechanism that describes how much innovation you have, how much competition you have, and what kind of regulation you have. When you take those three things that’s how you end up with a price on anything you buy in our capitalist economy.”

“Really, the areas that Congress should focus on is good regulation – like the patent system – competition – especially on generics, and we also know we want better innovation on cancer drugs, stem cell drugs, and better immunology. We need to foster an environment that people can get returns on investment to stimulate innovation.”

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