OGR Release Letter Criticizing LCD; and Wrap up of Last Week’s Events

Last week was a remarkable week for O&P! We had FOUR exciting things happen:
1.) AOPA hosted a press event to call attention to the Lower Limb LCD’s effects in the private sector; 2.) A bill was introduced that would place a moratorium on implementing an LCD Proposal; 3.) AOPA hosted the Policy Forum and the new O&P Legislation Writing Congress; and 4.) The Oversight and Government Reform Committee released a letter criticizing the LCD.

Prior to the Policy Forum, AOPA sponsored a press event about the proposed Lower Limb LCD influencing private sector insurers like United and CIGNA, who began denying payment for vacuum pumps reflecting a provision in the flawed and withdrawn LCD Proposal. On Monday, April 25, Rep. Renee Ellmers (R-NC) and Rep. Jan Schakowsky (D-IL) introduced H.R. 5045, a bill that would establish a moratorium on any action on the LCD through Spring 2017 and remove the withdrawn LCD from the CMS and DME MAC websites and establishing that, contrary to some legal interpretations at HHS, CMS indeed can, and is obliged to manage and instruct its contractors, including the DME MACs, what to do across topics including LCD issues.

On Tuesday morning, April 26, former Senator Bob Kerrey led a one of a kind O&P Legislation-Writing Congress, where AOPA Policy Forum attendees authored a simple bill that would fix most of the problems that are undercutting the quality of care for Medicare beneficiaries who have O&P needs.  Tuesday afternoon, while Policy Forum attendees were learning the ins and outs of a range of government policies and actions, Senator Kerrey had personal meetings with eight Senators to explain the new bill, and how some simple steps could rectify the problems and injustices unnecessarily burdening Medicare beneficiaries and the O&P professionals committed to providing care for those patients.On Wednesday, April 27, 135 O&P providers and patients spent the day on Capitol Hill in more than 400 meetings with their legislators, seeking their support for the new bill and related proposed legislation-the central, indispensable exercise of citizens’ rights that is the core of every AOPA Policy Forum.

The next day, the first fruits of a months-long effort spearheaded by AOPA appeared as the House Oversight and Government Reform Committee released a letter it has initiated to HHS Secretary Sylvia Mathews Burwell, criticizing the prosthetic LCD efforts of CMS and its contractors, and launching an oversight inquiry with a request for a substantial collection of documents.
It was a truly remarkable week for O&P, though there is much work that remains to be done to deliver on these needed remedies.

Legislative Needs
The O&P community needs a simple bill that would mirror the actions outlined in S. 829, introduced by Sens. Chuck Grassley (R-Iowa) and Mark Warner (D-Virginia). Specifically, it is extremely important to address by legislation three acutely needed actions:
1. Assure that CMS shall treat prosthetics and orthotics (P&O) separately from durable medical equipment (DME) and shall amend its regulations to define orthotics and prosthetics as a covered service, separate and distinct from the provision of DME.
2. Assure that CMS shall enforce Section 427 of the Benefit Improvement and Protection Act (BIPA) through issuance of federal regulations and only reimburse custom P&O care upon receipt of proof that an appropriately credentialed prosthetist/orthotist-licensed and/or certified-has clinical notes and documentation sufficient to determine that the P&O care being provided to a patient is a medically necessary plan of care that is corroborated solely by a signed physician prescription. All such documentation is considered part of the patient’s medical record for purposes of determining the medical necessity of P&O care. A rule to implement Section 427 is 16 years overdue. We know that CMS will say that the first proposal ever to implement this provision is poised for release, but even if true, what counts is a fair rule in the form of a final rule on the books; even if this proposal were released today, it would be a tall order to get that done before this administration concludes on Jan. 20, 2017.
3. CMS needs to recognize that plans of care that include custom-fabricated prostheses and custom-fabricated and -fitted orthoses continue to be completely inappropriate for inclusion in competitive bidding, and that the standards established in the Medicare Modernization Act need to be diligently and narrowly construed and followed.

Administrative and Legal Action Required
CMS should rescind the LCD. Last month, the House Oversight and Government Reform Committee, in bipartisan action, initiated oversight activities on this topic via a substantial request to the HHS Secretary for documents on this issue. It seems broadly recognized that the proposal issued jointly by the four DME MACs in July 2015 suffered from at least three serious shortcomings:
  • The draft LCD was developed via a process that was not transparent.
  • The process of preparing the draft LCD did not assure or include any stakeholder input.
  • There was little, if any, bona fide scientific evidence to support the proposed actions.
In the six months since the contemporaneous announcements on Nov. 2, 2015, by the White House and CMS that they did not intend to pursue this proposed LCD, CMS has indicated that it has appointed an Interagency Committee comprised solely of federal employees to work on this issue, though CMS has refused to identify the names of any of those appointees.

A process that was deemed deficient because it was nontransparent and without stakeholder inputhas been replaced by another process that is not transparent, and which offers no assurance or method for stakeholder input. CMS needs to rescind the July 2015 LCD; have it removed from all websites from entities supported by government funds; and assert that CMS does have the authority to manage all aspects of LCDs and other activities by all of its contractors, including the DME MACs.

If CMS cannot accomplish these steps, H.R. 5045, a moratorium on this LCD, needs to be enacted into law to fix this horrendous problem hampering some of our most vulnerable citizens-patients who suffer from either limb loss or chronic limb impairment.

Finally, there continue to be indications that a proposed rule to implement BIPA 427 may be released soon for comments by CMS. The week of the 2016 Policy Forum was a special week, though we can’t rest for a minute on these interim accomplishments. We need to drive hard to the finish line.