December 20, 2018

Deadline for Comment on “Protected Classes” Approaching – Please Speak Up Now!

As described in the 11/29 issue of this column, the Centers for Medicare and Medicaid Services (CMS) has issued a proposed regulation that would potentially endanger protection for some of the drugs currently covered in Medicare’s “six protected classes” of essential drugs. One of the protected classes, established in 2006 is HIV/antiretrovirals (along with anticonvulsants, antidepressants, antineoplastics, antipsychotics and immunosuppressants). Approximately 25% of all Americans living with HIV now rely on Medicare Part D for their outpatient medication. This CMS revision would limit their access to the individualized combination of antiretrovirals that is essential to achieving and maintaining viral suppression and high quality of life.

In addition, CMS is proposing to subject drugs in the protected classes to prior authorization and other forms of utilization management, including step therapy – in which patients are required to try lower cost drug combinations and to “step up” to more expensive therapies only if the first drugs fail. The Academy strongly supports reference to ARV treatment guidelines when payers, public and private, are building formularies and preferred regimens.

The Academy vigorously opposes implementation of the limitations that CMS proposes because they will result in predictable negative impacts on medical providers’ ability to provide optimal care.

We have joined forces with the HIV Medicine Association in urging all our members to speak out individually against this CMS proposal before January 25, 2019 at 5 PM ET.

Submitting an individual comment is easy and quick. Click here to read a joint statement from AAHIVM and HIVMA and also learn how to submit your comment — including a template and sample language that may help you frame the points you want to make. As a healthcare provider, your objections can make a real difference in influencing this proposed regulation.

Please feel free to contact Anna Forbes at the Academy if you have questions. We would also welcome a copy of your public comment for our files. If you are willing to share it, please forward a copy to

ACA Enrollment Barely Dips, Despite Obstacles

Against expectations, over 8.5 million people got insurance during the ACA enrollment period this year.  That preliminary figure, announced by CMS after last Saturday’s deadline, does not include enrollments in a dozen states including California and New York.  While this was a slight drop (about 4%) from last year’s 8.82 million, it is substantially higher than expected given the drastic cuts imposed by the Administration on funding to raise public awareness, hire ACA navigators and otherwise support efforts to encourage and promote enrollment at ACA marketplaces.

Reversal of the legal requirement to have health insurance and the CMS’ active promotion of short-term, inexpensive (“junk”) insurance policies were among the other factors that had less impact than expected on the rate of ACA insurance uptake this year.

View the latest Policy Update here.