Lower Limb LCD Policy Updates: What Has Happened after the Comment Period Closed and the August 26 Events


AOPA updated you on all the events on the LCD Policy Proposal – the comments we submitted and helped members and patients submit, the rally at HHS, the meetings we had with CMS, the open DME MAC meeting, the PR campaign, etc.

But what has happened since the closing of the comments on August 31st?

AOPA Meets with Office of Management & Budget

On September 16, AOPA Executive Director Tom Fise, along with our health care council, met with 7 representatives from the Office of Management & Budget (OMB) relating to the CMS Final Rule on Prior Authorization (you’ll recall the comment period closed about a year ago) which must be approved by OMB before it can be published.  During the meetings with CMS on August 26 relating to the LCD, AOPA secured a promise from CMS’ Chief Medical Officer to look closely at the Prior Authorization rule, as we contended that the combined effects of moving on both the LCD and Prior Authorization would have an exponential adverse impact on amputee patient care.

Getting OMB to intervene is a high bar to surmount, but AOPA had a positive exchange with them.  Overall our central message addressed three key points: (1) the Prior Authorization regulation was a CMS attempt to solve a problem which does not exist–no such extraordinary steps are needed to control Medicare expenditures for prosthetics because data shows that contrary to the OIG report, those expenditures have gone down in each of the past three years, and 2013 expenditures were less that expenditures in 2007; (2) the rule would prompt a decline in quality of care; and (3) it would delay patient receipt of care.  The discussion included AOPA’s assertion that the rule should NOT be enacted, but adding that if it was to be enacted, five criteria outlined in AOPA’s comments (including that it needs to be a guarantee of payment, that it needs to establish that there would be no medical necessity audits once Prior Authorization was secured, and that the prosthetist notes prohibition must be fixed).  We cited materials from the LCD press and amputee demonstration, including Senator Kerrey’s characterization that the LCD (and by analogy the Prior Authorization) was an instance of the government ‘creating a problem, not solving one.’

We will be providing some follow-up materials in areas of questions.  We will get no response (as they are not allowed to hint at the Final Policy), other than what we can observe in whether the rule moves forward into publication, and what provisions it contains.

United Health Care (UHC) Denies Medical Necessity of Vacuum Pumps: AOPA’s Strategy Moving Forward

In this new policy, which seems to be a result of the LCD Proposal, United Health Care deems vacuum pumps for residual limb volume management “…unproven and not medically necessary” as of October 1, 2015. Read the policy here.

AOPA is pursuing a two part strategy: (a) AOPA partnered with a congressional representative in UHC’s state, who contacted UHC requesting that they set up a high level meeting with AOPA reps; and (b) AOPA is joining in a letter of objection to the policy from the O&P Alliance, together with the Amputee Coalition, due for release this week, challenging the assertion that there is no scientific evidence to support this treatment, and seeking a meeting with UHC’s Medical Director.  We believe the results can be additive and symbiotic, not divisive, in bringing attention to the problem from multiple directions.

We promise to continue to keep you posted on the UHC issues, but we have also received an early indication about another mischievous outgrowth of the commercial sector jumping on the draft LCD as an opportunity for cutbacks–this time from one of the state BCBS plans.  We are waiting to see documentation, but if this proves correct, we will again communicate with the insurer AND communicate to CMS (as we did when the UHC policy first arose) underscoring yet again the need for a quick decision to rescind the draft LCD.

Wall Street Journal Article Published

After the initial media buzz of more than 400 press articles on the HHS rally and LCD Proposal, the media is still picking up on the issue in a big way: On September 20, The Wall Street Journal published an article on the issue.

Senators Dan Coats and Amy Klobuchar

Senators Coats (R-IN) and Klobuchar (D-MN), co-chairs of the Senate Medical Technology Caucus communicated with CMS Acting Administrator Andy Slavitt, urging CMS to immediately reconsider the policy proposal. Other legislators have weighed in with letters to HHS Secretary Sylvia Burwell and to  CMS Administrator Slavitt; read those letters here.