UPFRONT

Grab a Glass of Wine

Peter K. Kaiser, MD

It seems that, in every column, we explore yet another change to our healthcare system brought on by the Affordable Care Act (a.k.a. Obamacare). This month, it is the Center for Medicare and Medicaid Services’ Medicare Program Part B Drug Payment Model.

In phase I, half the country will have payments reduced to the Average Sales Price (ASP) plus 2.5% and a flat $16.80 fee. With sequestration, the new reimbursement would be ASP plus 0.86% plus $16.80. The rest of the country will remain at ASP plus 6% (4.3% after sequestration in 2013), which has been used since 2003.

In phase II, CMS will add value-based purchasing arrangements in half the country, in which CMS will set payment rates for drugs that are therapeutically similar and will vary payments based on the government’s determined clinical effectiveness. We will be split into four groups nationwide: (1) ASP+0.86%+$16.80; (2) value-based purchasing arrangements; (3) both changes; and (4) a control group with no changes.

The ASRS was asked to perform a study of eight high-volume practices and found that the cost to acquire, store, administer, and bill for of these drugs was a mean of 98.9% (ranging from 96.5% to 103.2%) of the total drug payment. Thus, for most practices in the United States, unless they are very efficient, they will lose money with the new payment system. This loss is especially onerous for smaller practices. CMS seems to think the ASP plus 6% signifies profits for physicians. It most decidedly does not.

By essentially forcing physicians in the demonstration to use Avastin to treat retinal diseases, CMS has eliminated choice for our patients. The demonstration reimbursement rate makes it almost impossible to use FDA-approved drugs in retinal diseases. This situation is especially worrisome in, for example, a diabetic patient with 20/100 vision and retinal thickness of 450 μm, when we have clinical trial data that show a significant difference in vision between drugs.

CMS has essentially made changes to the statutory set reimbursement rate, imposing untested purchasing arrangements without guidance from our legislative bodies, physicians, and patients. Moreover, it is performing clinical research on patients and doctors without informed consent, patient opt-out, or IRB approval.

Recently, the House of Representatives Energy & Commerce Committee’s Subcommittee on Health explored the issue in committee. Retina specialists did not have a seat at the table, but our voices were heard through a letter from the ASRS distributed to the committee members.

Thankfully, we are not fighting this demo alone. Almost 300 representatives have written to CMS opposing the trial. Moreover, Rep. Larry Bucshon, MD (R-IN), has introduced legislation (H.R. 5122) to prevent the Secretary of Health and Human Services from taking any action to “finalize, implement, or enforce the proposed demo program.”

Hopefully, CMS will reconsider its plan to implement the demonstration, or at least to ask for comment from the people affected by it. In this issue, we explore other advancing issues from Obamacare and what they will mean to you, your practice, and your patients. Pour a glass of wine before reading it. You will need it.