Consensus Emerging on “Qualified Practitioners” and “Qualified Suppliers”

After lengthy discussions among NAAOP’s Board of Directors, O&P Alliance organizations, and other stakeholder groups, consensus on the proposed rule that interprets BIPA Section 427 is beginning to emerge.  The Benefits Improvement and Protection Act of 2000 (BIPA) Section 427 stated that “no payment will be made” by the Medicare program for prosthetics and custom-fabricated orthotics unless they are provided by “qualified practitioners” and “qualified suppliers.”  On January 12, 2017, CMS finally issued proposed regulations on this provision in order to implement this long-overdue requirement.

CMS surprised many by interpreting the statute broadly, applying new training, education, and certification requirements on all “professionals” who submit Medicare claims for custom fabricating O&P, including physicians, physical therapists, and occupational therapists.  The proposed rule also requires accreditation of all qualified suppliers by ABC, BOC or an “equal” accrediting organization designated as such by CMS.  Off-the-shelf orthotics are not impacted by the proposed rule.

NAAOP’s board and its membership have been grappling with its comments to the proposed rule because of the broad scope of the rule.  On the one hand, the proposed rule could be viewed as a major victory for the O&P profession in that CMS has recognized the importance of specific training, education, and credentialing in order for health care professionals and suppliers to provide complex and customized O&P care.  This interpretation bolsters our arguments that O&P is fundamentally different from DME, that prosthetists and orthotists are important members of the rehabilitation team, and that O&P practitioners’ clinical notes should be considered part of the patient’s medical record for purposes of determining medical necessity.

On the other hand, NAAOP is concerned that such an expansive interpretation of BIPA Section 427 will engender significant opposition from various stakeholders, increasing the likelihood of further delays, or perhaps leading to no final rule being published at all.  We must not allow the proposed rule to become a pyrrhic victory.  NAAOP believes that the purpose of BIPA Section 427 was, and is, to protect patients from unqualified practitioners and suppliers of custom O&P care, and to protect the integrity of the Medicare program from fraud, waste and abuse.  It was never intended to restrict patient access to care from health professionals who routinely provide specific types of orthoses with no established record of patient harm (e.g., hand orthoses provided by certified hand therapists).

The proposed rule was published by the former Administration.  The final rule faces a stiff headwind in the new regime which is focused on lessening, not increasing, regulation on business and, in the health care area, health care providers.  NAAOP seeks to strike the right balance to ultimately secure timely publication of a final rule that works well for O&P patients, the providers who serve them, and the Medicare program.

  • Written by NAAOP

President Trump Issues Regulatory Relief

In its first two weeks in office, the Trump Administration made good on its promise to reduce fiscal burdens on businesses and others trying to comply with federal regulations. This came in the form of three major announcements, including the following:

  1. An Executive Order issued on January 20th directing federal agencies administering the Affordable Care Act (ACA) to exercise all authority and discretion, to the maximum extent permitted by law, to waive, defer, grant exemptions, from, or delay ACA requirements that impose a fiscal burden on providers, patients, health plans and others.
  1. A letter from the President’s Chief of Staff, Reince Priebus, to all federal agency directors instructing them to impose a moratorium of 60-days on all regulations scheduled to go into effect, pending review from the new Administration. In that letter, all regulations scheduled to be printed in the Federal Register we instructed to be withdrawn pending further review.
  1. An Executive Order issued on January 30th directing all federal agencies to identify two or more existing regulations to be repealed when it publishes a new proposed or final rule. The net cost of these regulations, taken together, must be budget neutral or save the government money.

There are significant upsides and downsides to these three initiatives but one thing is clear; the regulatory process will be much more complex in the future. There are significant questions as to the impact of these directives and how much latitude the federal agencies will be able to exercise without violating the Administrative Procedures Act (APA), the law that regulates the process to be used by the federal government when issuing regulations. Regardless of the fiscal burden of some regulations, the agencies will not be able to simply waive notice and comment rulemaking without violating the law. And statutory law cannot be waived through the regulatory process. Because of these ambiguities, the Office of Management and Budget (OMB) is expected to issue additional guidance in the near future on these issues.

These developments will clearly impact the O&P community. For instance, if CMS were to repeal the final rule implementing the definition of “off-the-shelf” orthotics, which greatly expanded OTS orthotics, the definition of that term would revert back to the statutory definition, which states that OTS orthotics include orthoses that are subject to “minimal self-adjustment.” This would significantly reduce the range of orthoses that could be subject to competitive bidding in the future, assuming CMS proceeds with its authority in this area, a very positive development.

Conversely, securing a final rule on Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA), will likely be more challenging under these new rules. BIPA Section 427 links Medicare payment to qualified practitioner and qualified suppliers and is pending as a proposed rule, comments for which are due on March 13th. These regulatory developments complicate the process to get these regulations issued in final form. NAAOP will be working with its Alliance partners to advance this regulation and will inform our membership as developments occur.

  • Written by NAAOP

Recent Developments in Affordable Care Act Reform

To: NAAOP Members and Friends

From: Peter W. Thomas

Date: January 25, 2017

Subject: Recent Developments in ACA Reform


Since the beginning of the New Year, there has been significant activity in the area of health care from a legislative and executive perspective, particularly focused on repeal and replace of the Affordable Care Act. The following is a summary of key developments:

  • Budget Reconciliation Bill: The House and Senate have already passed a “budget reconciliation” bill that enables Congress to consider in the future repealing and replacing the Affordable Care Act through expedited procedures. A reconciliation bill allows the Senate to pass legislative provisions with only 51 votes, rather than the 60 required for other legislation. With only 52 Republicans in the Senate, Senate Republicans would not be able to pass an ACA repeal without using this budgetary procedure.
  • “Repeal and Replace” Takes Hold: Republican leaders were pressing for a quick repeal bill coupled with a two- or three-year implementation period, when Congress could fashion an ACA replacement. But in recent weeks, the message of ACA supporters to not repeal without replacing the ACA at the same time has taken hold. The professed goal at this point is to pass both a repeal and a replacement of ACA by the end of April.
  • House and Senate Begin Drafting Repeal and Replace Bill: The House Ways & Means and Energy & Commerce Committees and the Senate Finance and Health Education Labor and Pensions (HELP) Committees are currently examining specific proposals to repeal and replace the Affordable Care Act through this reconciliation legislative vehicle. Individual groups of Senators are also beginning to introduce different versions of replacement legislation. The earliest the Congressional committees could report ACA repeal and replacement proposals is January 27, but indications are that these committees will bring forward public proposals in February or March.
  • Reconciliation Bill Contents: A reconciliation bill is limited in terms of its contents. The only provisions that can be included are those provisions that impact the federal budget in a positive or negative direction. This means that any budget neutral provision in the Affordable Care Act cannot be addressed through this mechanism. This means that while Congress can include in the reconciliation bill a repeal of federal subsidies to help purchase insurance, for instance, they may not be able to include a repeal of many of the consumer protections, which may be determined not to have a direct impact on the federal budget. While it will only take 51 votes to repeal key portions of the Affordable Care Act through the budget reconciliation bill, it will take at least 60 votes to pass any type of replacement legislation.
  • Setting Expectations: Wildly different statements have emerged over the past three weeks in terms of the scope of the ACA replacement plan. President Trump, Vice President Pence, Secretary of Health and Human Services (HHS) Nominee, Tom Price, and various legislators have all sent signals that the “rug will not be pulled out” from under current ACA enrollees; preexisting condition exclusion protections will continue in some form; the 20 million that currently have ACA coverage will continue to have coverage; “We’re going to have insurance for everyone”; and other statements that do not seem to be reconcilable with the repeal of the individual mandate and other key provisions including federal subsidies to help purchase insurance for low income individuals. Nonetheless, the congressional committees continue to do their work.
  • HHS Secretary Nominee Tom Price: Congressman Price has now been through two different hearings and will soon be scheduled for a vote to confirm his nomination. Timing for this vote is likely to be in early to mid-February. Democrats have raised a number of ethical concerns and have been frustrated by the lack of specificity of his responses to committee members’ questions. Congressman Price has suggested that the repeal and replace legislation is the prerogative of Congress and that he will administer whatever Congress passes. In the hearings, he did not reaffirm support for his own legislation to repeal the Affordable Care Act (which he introduced in the 114th Congress) and avoided specific endorsement of block grants for Medicaid and moving Medicare toward a defined contribution, rather than a defined benefit, program. Because his confirmation only requires 51 votes, he is expected to have a favorable vote.
  • Executive Order on ACA: President Trump’s first Executive Order issued on January 20th consisted of a directive to all federal agencies which states, in relevant part:

“To the maximum extent permitted by law, the Secretary of Health and Human Services (Secretary) and the heads of all other executive departments and agencies (agencies) with authorities and responsibilities under the Act shall exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act that would impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.” [Emphasis added.]

 

The question now is how this executive directive will be interpreted by the federal agencies. Many of the provisions of the ACA were regulated and can only be materially altered through public notice and comment rulemaking. There is also speculation that those actions the HHS Secretary could take unilaterally may be deferred until Congress acts in a more comprehensive fashion.

  • Memorandum from White House Chief of Staff on Federal Regulations: Also on January 20th, Reince Priebus, Assistant to the President and Chief of Staff issued a Memorandum to the heads of the Departments and Agencies placing a moratorium on federal regulations for sixty days, with certain exceptions, pending agency review. This will clearly impact health care regulations, including Medicare and Medicaid, but will not impact public comment periods for currently pending regulations. Early indications are that the freeze in regulations is being interpreted broadly government-wide. Numerous regulations have been placed on hold or withdrawn pending further review. Some will emerge in altered form while others are likely never to be published.
  • Impact of Executive Order: The key question for incoming Secretary Price is whether he will use these executive authorities to limit or eliminate federal subsidies under the Affordable Care Act or otherwise eliminate the individual and employer mandates. Congressman Price was asked this specific question at the Finance Committee hearing yesterday and essentially did not answer the question.
    • Factors weighing against implementation of this Executive Order to invalidate the ACA through the regulatory process include the fear that if certain portions of the ACA are no longer in effect, the whole system may implode. There is significant discussion in the insurance community about the insurance “death spiral” that may occur if the individual mandate is lifted and the federal subsidies are halted, but certain requirements and consumer protections are maintained. In this event, the cost of insurance is expected to immediately increase dramatically and many are expected to lose coverage. Republicans profess that this is not their intent but once the ball is set in motion it is not completely within their hands. The insurance markets and consumers will respond and react according to their own self-interest.
  • Additional Executive Orders: Most recent statements from the Administration indicate that President Trump will order additional Executive Orders to roll-back the ACA. There is a possibility that Republicans will have to replace the ACA without votes from Democrats, meaning they will likely maximize their regulatory authority to roll back ACA regulations while issuing directives to stabilize insurance markets. There appears to be an emerging consensus to extend the ACA for two years with no coverage changes under the ACA repeal and replace legislation in order to promote market stability.
  • Recent ACA Findings: Recent findings by various organizations are raising the level of pressure to find an ACA replacement plan that can attract eight Democratic votes in the Senate, including:
  • With respect to a repeal bill that would eliminate the individual and employer mandate but keep the insurance market reforms in place, the Congressional Budget Office issued a report on January 17 which states:

“The number of people who are uninsured would increase by 18 million in the first new plan year following enactment of the bill. Later, after the elimination of the ACA’s expansion of Medicaid eligibility and of subsidies for insurance purchased through the ACA marketplaces, that number would increase to 27 million, and then to 32 million in 2026. https://www.cbo.gov/sites/default/files/115th-congress-2017-2018/reports/52371-coverageandpremiums.pdf

    • “Repealing the Affordable Care Act will kill more than 43,000 people annually.”       Washington Post, January 23, 2017.
    • “Five percent of people with chronic illness [i.e., heart disease, diabetes, cancer] gained coverage in 2014 when the law’s individual mandate and coverage expansion took effect.” Annals of Internal Medicine, The Affordable Care Act and Americans with Chronic Disease; www.annals.org.

It will be an extraordinarily busy year from a legislative and regulatory perspective. Assuming HHS Secretarial Nominee Tom Price is approved by the Senate, Seema Verma, the Nominee to become Administrator of the Centers for Medicare and Medicaid Services (CMS) will undergo the Senate’s advice and consent process. Not only is Congress aiming to approve a reconciliation bill containing ACA repeal and replace by April, but they will also have to figure out how to fund the federal government by the end of April through the remainder of fiscal year 2017. After these major pieces of legislation, Congress is expected to address comprehensive tax reform which may be “budget neutral.” This means that Congress will seek to save money in entitlement programs (e.g., Medicare and Medicaid) and in other ways in order to provide tax relief without creating additional deficit spending.

NAAOP will continue to keep its members informed as key developments occur.

  • Written by NAAOP

Special Alert: BIPA Section 427 Proposed Rule Finally Published!

After years of waiting and advocating for its publication, the Centers for Medicare and Medicaid Services (CMS) this week finally released a proposed rule on Section 427 of the Benefits Improvement and Protection Act (BIPA) of 2000, comments for which are due on March 13, 2017.

BIPA Section 427 states that “no payment” shall be made by the Medicare program to any practitioner or supplier of custom orthotics or prosthetics who is not qualified to provide this level of care. The proposed rule broadly interprets this statute, establishing a requirement that ANY practitioner or supplier that provides custom orthotics or prosthetics, including physicians, physical therapists, occupational therapists, prosthetists and orthotists, and others, must be licensed to provide orthotics and prosthetics if the state has O&P licensure. If not, the practitioner or supplier must be specifically trained and educated to provide and manage the provision of custom O&P care and be certified by either ABC, BOC or an accreditation organization approved by the HHS Secretary.

This is a major milestone for the O&P profession! It treats O&P practitioners in a similar manner to physicians and therapists for the purpose of providing custom O&P patient care. The proposed rule also bolsters the profession’s contention that the prosthetist’s and orthotist’s clinical records should be considered part of the patient’s medical record, and it further separates O&P from DME.

While publication of this favorable proposed rule is great news, there is a downside to the breadth with which CMS interpreted these provisions of the Medicare law. As a result, we could see opposition to this rule from certain organizations. In addition, since the nominee for Secretary of HHS is an orthopedic surgeon who may be sympathetic to any potential physician resistance to this draft rule, NAAOP and its sister O&P organizations will have to think strategically about their comments to CMS on this issue and, above all, ensure that the rule is published as soon as possible in final form. We cannot allow publication of this proposed rule to be a pyrrhic victory.

There are at least two other policy issues on which NAAOP and other O&P organizations are likely to comment. The first involves the definition of a “fabrication facility,” which appears to conflate central fabrication and patient care facilities. The second involves a proposal to revoke the supplier number for any provider or supplier who submits a Medicare claim for payment without complying with this new regulation. A more appropriate sanction may be for CMS to simply deny payment of the claim, but further analysis of these issues is still required.

We welcome any feedback from our members to the proposed rule, which can be accessed here.

  • Written by NAAOP

O&P Policy Challenges in the Year Ahead

2016 brought important policy victories that bear repeating. But as we enter the new year, a whole new set of challenges and opportunities will confront O&P patients and providers.

O&P Research: NAAOP participated in a major effort to pass S. 800/H.R. 1631, legislation that will elevate the stature and better coordinate rehabilitation and disability research at the National Institutes of Health (NIH), including orthotic and prosthetic research and development. O&P research policy and funding was the issue on which NAAOP was founded 30 years ago and we continued to have an impact on this critical issue in 2016.

ALJ Appeals Backlog: In a major victory for Medicare providers in which NAAOP counsel participated, the D.C. District Court recently compelled the Secretary of HHS to eliminate the extensive backlog of ALJ Medicare cases by 2020. HHS must now figure out how to dispose of the cases within the court’s timeframe. The government may appeal the decision by the deadline in early February, but pressure will continue to build on HHS to settle thousands of ALJ appeals in order to reduce the 750,000 case Medicare backlog. NAAOP will be pushing to have O&P claims considered for potential settlements, assuming providers have the option to accept the settlements.

Incoming Trump Administration and the 115th Congress: The incoming Trump Administration and a Republican-led House and Senate will mean that many proposals to fundamentally restructure and reform major government health care programs will be hotly debated, and significant changes to long-standing programs may occur, including:

  • Affordable Care Act: Repeal and replace the existing private health insurance law
  • Medicare: Restructure the program into a “defined contribution” approach
  • Medicaid: Repeal Medicaid expansion and “block grant” the traditional program

Despite serious challenges on many fronts, incoming HHS Secretary, Tom Price, a former Georgia Congressman and orthopedic surgeon, understands the world of DMEPOS and may offer some key opportunities to advance O&P policy.

NAAOP will continue to assess all proposals based on their impact on the O&P patient and the providers who serve them, and is expecting an extraordinarily busy year.

Thank you for your past membership and continuing support of NAAOP and we look forward to confronting the challenges and opportunities in 2017 together.

  • Written by NAAOP

114th Congress Goes Out with a Bang!

A flurry of activity after Election Day culminated in an incredibly busy December thus far. As the 114th Congress makes its way out of town and the Trump Transition Team prepares to take over, there were at least four major developments important to the O&P community:

 

  1. Court Compels the Department of Health and Human Services (HHS) to Extinguish the Administrative Law Judge (ALJ) Backlog:

The D.C. District Court this week compelled HHS to eliminate the extensive backlog of ALJ cases pending decision by 2020. Despite a 90-day statutory deadline for such decisions, ALJs are taking as long as 832 days due to the fact that over 750,000 Medicare denied claims await ALJ review. HHS must now figure out how to dispose of the cases within the court’s timeframe. This is a major victory for Medicare providers that NAAOP counsel, the Powers Law Firm, participated in. The decision will place great pressure on HHS to pursue settlement discussions.

 

  1. The Agency for Healthcare Research and Quality (AHRQ) Seeks Guidance on Evidence Base for Lower Limb Prostheses:

AHRQ released a questionnaire and seeks public comment on the evidence base for lower limb prostheses. The questions are complex and require the attention of researchers, clinicians, and those in academia. NAAOP is working with the O&P Alliance, the Amputee Coalition, NCOPE, and allied health organizations to provide a comprehensive response to this questionnaire by the deadline on December 20, 2016.

 

  1. O&P Medicare Legislation Makes Gains and Poised for Action in 2017:

Despite extensive efforts lead by AOPA and supported by NAAOP and the Alliance organizations, O&P legislative provisions advanced in Congress but were not included in the final legislation to pass in the 114th Congress. No viable legislative vehicle emerged on which to append Medicare provisions. However, the O&P community is well positioned to advance these provisions in the new Congress. These provisions include recognition of the prosthetist’s clinical notes, separation of DME from O&P, and other provisions.

 

  1. Congress Passes Bill Promoting Rehabilitation Research at the NIH:

As part of the 21st Century Cures Act, Congress passed legislation that NAAOP has considered a priority for the past several years. These provisions would elevate the stature and better coordinate rehabilitation and disability research at NIH. This bill will enhance NIH’s capacity and focus on O&P research. O&P research was the reason NAAOP was founded in 1987, an effort which culminated in legislation creating the National Center for Medical Rehabilitation Research (NCMRR). The mission of NCMRR is to conduct and support medical rehabilitation research “including orthotic and prosthetic research and development.”

 

HAPPY HOLIDAYS AND THANK YOU FOR YOUR NAAOP MEMBERSHIP!

  • Written by NAAOP

SPECIAL ALERT: Election Analysis and Impact on Health Care Policy

Executive Summary

The Republican Party won the Presidency and maintained control of the United States Congress, with businessman Donald J. Trump (R) winning the Presidential election to become the 45th President of the United States. Donald J. Trump (R) defeated Hillary Clinton (D) in the Electoral College but not the popular vote. Overall, President-elect Trump won 279 electoral votes to Secretary Clinton’s 228.  The popular vote totaled 59,623,049 votes for Secretary Clinton, while Mr. Trump received 59,418,103 votes (a difference of 204,946 votes). Secretary Clinton raised $1.3 billion and President-elect Trump raised $795 million, respectively, for their presidential campaigns— equating to a whopping $2.1 billion Presidential race.

In the Congressional races, Senate Republicans maintained their control of the chamber with 51 members, with one race still undetermined (Louisiana). While House Democrats made some gains, adding a net of six seats in the United States House of Representatives as of this writing, Republicans retained control of the chamber with at least 238 seats to their party. Republicans now control the Executive branch and the Legislative branch for the first time since 2005-2006 in the 109th Congress during the presidency of George W. Bush.

Net Changes in the 115th Congress & Governors

  Senate House Governors
Republicans 51 (-1) 238 (-6) 34 (+3)
Democrats 46 (+2) 193 (+6) 15 (-3)
Independents 2* (same) 0 1
*Sens. Angus King (I-ME) and Bernie Sanders (I-VT) currently caucus with the Democrats.
Senate: Louisiana results still being determined, and are not included.
House: Results for California Districts 7, 25, and 49, and Louisiana Districts 3 and 4 are still being determined and are not included.
Governors: The result in North Carolina is still being determined and is not reflected by this table.
Republicans are in red text, Democrats are in blue text, Independents are in purple text.

 

Republicans lost Senator Mark Kirk’s seat in Illinois.  Congresswoman Tammy Duckworth won this seat, making her the only bilateral amputee in the Senate and a strong supporter of the O&P policy agenda.  At the time of this writing, Republicans have held on to at least 51 seats in the chamber.  Of the 34 Senate races, the following twelve races were, at most times during 2016, the most competitive:

Most Competitive Senate Races

State Elected Defeated
Arizona John McCain (R)* Ann Kirkpatrick (D)
Colorado Michael Bennet (D)* Darryl Glenn (R)
Florida Marco Rubio (R)* Patrick Murphy (D)
Illinois Tammy Duckworth (D) Mark Kirk (R)*
Indiana Todd Young (R) Evan Bayh (D)
Louisiana TBD TBD
Missouri Roy Blunt (R)* Jason Kander (D)
New Hampshire Maggie Hassan (D) Kelly Ayotte (R)*
North Carolina Richard Burr (R)* Deborah Ross (D)
Nevada Catherine Cortez Masto (D) Joe Heck (R)
Ohio Rob Portman (R)* Ted Strickland (D)
Pennsylvania Patrick Toomey (R)* Katie McGinty (D)
Wisconsin Ron Johnson (R)* Russ Feingold (D)
Results from Louisiana are to be determined (TBD); Louisiana is scheduled to hold a runoff vote on December 10, 2016.
Republicans are in red text, Democrats are in blue text.
* Incumbent.

Potential Impact of Elections on the Lame Duck Session

The House and Senate reconvene the week of November 14 for a week of business, followed by a week off and then a two-week session leading up to the December 9 expiration of federal funding. Current Senate Majority Leader Mitch McConnell (R-KY) and current Speaker of the House Paul Ryan (R-WI) have stated that they would like to address the annual appropriations bills, and seek to pass the 21st Century Cures/Innovation for Healthier Americans legislative packages surrounding medical innovation. This may provide some opportunity to try to amend some of the O&P legislation we have been promoting to legislation that is otherwise moving through Congress.  However, the legislative climate surrounding the health care innovation package and all legislation remains uncertain, as the smoke clears from the election.

Throughout the presidential campaign, candidate Donald J. Trump repeatedly stated that he will seek to dismantle the Affordable Care Act (ACA). Whether a Republican-led House and Senate will repeal the ACA, engage in negotiations for significant reform, or completely replace the ACA with their vision for health care reform remains in question.  President-elect Trump’s vision for action on the ACA borrows heavily from the Republican Party’s Platform and House Speaker Ryan’s healthcare blueprint published this past summer entitled, “A Better Way.”

Who will lead the Department of Health and Human Services under the Trump Administration is another question on which speculation is already rampant.  Who is chosen to lead HHS promises to more fully inform the direction a Trump Administration would take on health care issues.  Candidates most often mentioned include Former House Speaker Newt Gingrich; former Republican Presidential candidate Ben Carson, a neurosurgeon; and Florida Governor, Rick Scott.  But, there is also speculation that a health care business leader could also be a logical choice for Trump to make given his statements on running our country more like a business.

Conclusion

Few predicted the wave that swept Donald Trump to the Presidency and limited the losses in both the House and Senate for Republicans.  There are many details that will emerge in the coming months that will signal how President-elect Trump plans to proceed on health care issues, and NAAOP will inform its members and friends as developments occur.

  • Written by NAAOP

Reflections on 30 Years of O&P Advocacy

2017 marks NAAOP’s 30th Anniversary of advocacy on behalf of the O&P patient and the professionals who serve them.  We wanted to take some time to reflect on this milestone.

But first, Medicare developments continue to occur.  CMS recently announced the selection of the Recovery Audit Contractors (RACs) for the next several years.  The current hiatus in RAC auditing will soon end as a result, unless one of the companies not awarded a contract files a protest, which would further delay implementation of the RAC program.  When the RACs begin their work, there will be one national RAC for all claims involving DMEPOS, durable medical equipment, prosthetics, orthotics and supplies.  NAAOP will continue to keep you informed.

November is a month for giving thanks, and we at NAAOP wish to express our profound gratitude to the leaders and members who have made our work possible for these many years.  For those who may not know, NAAOP was launched in 1987 as the American State of the Art Prosthetic Association.  It was the brainchild of the late George DePontis, a real innovator who recognized the appeal of amputees performing challenging athletics.  He published National’s Magazine, the official magazine of the National Handicapped Ski Championships at the time.  DePontis asked his good friend George Breece to help set up and run the organization for one year and George has been helping lead NAAOP ever since.  We owe George a huge debt of gratitude for his dedication and personal commitment over the past three decades. NAAOP has also been extremely fortunate over these many years to have Peter Thomas play such a significant role in formulating NAAOP’s public policy and becoming a leading voice for O&P issues on Capitol Hill. Peter was, in fact, the very first Consumer Vice President of our Association thirty years ago and continues today as the NAAOP General Counsel.

NAAOP would not have formed without pioneers such as John Sabolich, Glenn Hutnick, Alan Finnieston, Brad Rosenquist, Harold Sears, and Tom Guth.  In fact, Tom Guth is the organization’s longest serving board member and continues to help lead the organization today.

Some of NAAOP’s finest leaders and past presidents were critical to NAAOP’s success including John Billock, Mike Allen, Dennis Cole, Lou Haberman, Mark DeHarde, Jan Stokosa, Paul Prusakowski, and our current President, Dave McGill.  We simply could not have thrived without these individuals’ commitment of time, treasure, energy, and intellect.

Many of our long-standing members went above and beyond when we confronted major challenges, often contributing more than their membership dues required.  Even non-members rose to the occasion by offering significant funding when we needed it most.  The Board of Certification, International, was one such organization.  For instance, when the draft LCD debacle of 2015 occurred, BOC stepped up to contribute for the good of the profession, adding to its previous contributions.  The American Board for Certification (ABC) also contributed mightily when we needed the support the most.  We are forever in their debt.

Clinical, manufacturer and supplier members have borne incredible burdens over the years in supporting NAAOP, and Hanger is at the top of that list. Ossur, Ottobock, Endolite, Freedom Innovations, ALPS, Knit-Rite and Scheck & Siress stand out with Hanger for going the extra mile and helping NAAOP defend and advocate for the O&P profession.  We offer our sincere appreciation for  their generosity.

Finally, we could never comprehensively list the hundreds of individual prosthetists, orthotists, solo practices, and small businesses that have made NAAOP what it is today.  We are so very grateful for their contributions through the years, especially long time members like the Muilenburg family of Houston, Texas, Mike Reith in St. Petersburg, Florida, Richard Williams in Tallahassee, Florida and the Leimkuehler families of Cleveland, Ohio and Pittsburg, Pennsylvania to name but a few of our dedicated and generous membership.  We cannot thank you enough and hope to continue to earn your trust as we represent the O&P profession in Washington in the future.

  • Written by NAAOP

Court Poised to Compel HHS to Decide Medicare Cases within 90 Days

On October 3, 2016, the U.S. District Court for the District of Columbia held a status conference in the ALJ delay suit filed by the American Hospital Association (AHA) against the Secretary of Health and Human Services (HHS), Sylvia Burwell.  Judge James E. Boasberg stated that he will likely issue a writ of mandamus ordering the Secretary to comply with the 90-day deadline for deciding Administrative Law Judge (ALJ) appeals.  This clarified his earlier decision on September 19, 2016, where he declined to “stay” (i.e., delay) proceedings in AHA’s ALJ delay suit.  At the status conference, Judge Boasberg came as close as he could to confirming his intention to order mandamus, compelling the government to decide ALJ cases within 90 days.

Judge Boasberg scheduled expedited briefing on potential “remedies” to address the ALJ backlog, recognizing that he could not simply wave a magic wand to make over 750,000 pending ALJ appeals go away.  The judge is looking to issue in this case before the end of the year, but HHS implied that it would appeal to the D.C. Circuit Court, thereby delaying by several months a full resolution of this case.  Nonetheless, the District Court continues to exert tremendous pressure on HHS to make significant progress in reducing the ALJ backlog and the extentive amount of time it takes to resolve Medicare denials.

The status conference began with Judge Boasberg stating his view that it is not practical to order HHS to comply with the ALJ deadline within the next six months.  Instead, he asked the parties to suggest potential remedies for clearing the backlog.  Counsel for AHA suggested that HHS could settle more appeals than it is currently.  AHA also proposed that HHS waive recoupment and the assessment of interests against providers appealing cases.  Although this would not clear the backlog, it would lessen the harm from the delay.  AHA also stated that HHS should place greater limits on Recovery Audit Contractors and sanction them for incorrectly denying claims.

HHS responded that it is making progress toward clearing the ALJ backlog.  HHS reported that it has restarted the settlement program for inpatient status appeals (i.e., short inpatient stays)—the program that led to over 200,000 settled cases in 2014.  HHS stated that statutory constraints prevented it from adopting some of AHA’s suggested remedies.  HHS also requested briefing not only on potential remedies, but also on whether the court should issue the writ of mandamus at all.  HHS stated that it wanted to “preserve the record” on the mandamus issue, which implies that HHS intends to appeal any mandamus order to the D.C. Circuit.  The judge ordered briefing on both issues on an accelerated timeframe.  The first brief by AHA is due October 14th, the government responds on November 4th, and then AHA submits its reply brief by November 14th.  Again, a decision in the case is very possible by year’s end.

If the Court does decide to issue the mandamus order, the government is expected to appeal that decision to the Court of Appeals, again.  This will delay this case well into 2017, but given what the Appeals Court held the last time it reviewed this case, the demand to decide ALJ cases within 90 days is not likely to go away.

  • Written by NAAOP

Major Victory on Medicare ALJ Hearing Backlog

On September 19, 2016, the U.S. District Court for the District of Columbia declined to delay proceedings in the ALJ backlog suit filed by the American Hospital Association (AHA) against the Secretary of Health and Human Services (HHS), Silvia Burwell. The court gave strong signals that it will likely order the Department of HHS to comply with the 90-day statutory deadline to decide Administrative Law Judge (ALJ) appeals, but stopped short of doing so in its opinion. Instead, it called for a status conference with the litigants to discuss the matter further on October 3rd.

AHA filed suit in 2014 against the Secretary of HHS, seeking a “writ of mandamus,” which is an order directing a government official to comply with a duty. Here, the duty is to decide ALJ appeals within 90 days as required by the Medicare statute. In December 2014, the court dismissed AHA’s suit. The court believed at that time that the extensive delays in ALJ decisions should be addressed by HHS and Congress, not the courts. AHA appealed to the D.C. Circuit Court of Appeals.

The D.C. Circuit reversed the district court. The D.C. Circuit held that AHA satisfied the core requirements for mandamus jurisdiction because hospitals have a clear right to ALJ decisions in 90 days; the Secretary has a clear duty to decide ALJ appeals in 90 days; and hospitals [as well as all other providers] have no adequate alternative remedy other than mandamus. The D.C. Circuit noted that the ALJ backlog is having a real impact on human health and welfare because some providers are admitting fewer cases that are likely to be targeted by Recovery Audit Contractors (RACs). The D.C. Circuit remanded to the district court, however, to determine whether Congress and the Secretary are making “significant progress” toward solving the ALJ backlog.

The Secretary’s first action on remand was to request that the district court stay—delay—proceedings for seventeen months, until September 30, 2017, arguing that the agency’s initiatives and legislation pending in Congress would clear the backlog without judicial intervention. AHA opposed the stay under the theory that the Secretary’s initiatives would actually result in an increase in the ALJ backlog unless Congress provides substantial additional funding, which is unlikely. Although this case was brought by the American Hospital Association, the ultimate decision of the court in this case will apply equally to all providers and suppliers who serve Medicare patients, including orthotists and prosthetists.

On September 19, 2016, the district court denied the Secretary’s motion to stay. Although the court did not formally decide whether to order the Secretary to comply with the deadline, the judge did weigh factors for and against the issuance of a mandamus order when analyzing whether to grant the stay. In other words, the judge was clear that the outcome of the motion would indicate whether or not he would grant the writ of mandamus. In the Secretary’s favor, he noted the intrusiveness of a writ of mandamus and the Secretary’s assurances that solving the backlog is a high priority. The court also cited Congress’s awareness of the ALJ delay.

Ultimately, the District Court determined that the factors in favor of a writ of mandamus outweigh the factors against. The court agreed with AHA that the Secretary’s current initiatives would not solve the ALJ backlog and would actually result in it growing over time. The court emphasized that “significant progress toward a solution cannot simply mean that things get worse more slowly than they would otherwise.” The court also faulted the Secretary for not exercising greater control over the RAC program.

The court concurred that Congress is unlikely to solve the backlog. The court pointed out that the House and Senate Budget Committees have refused to hold hearings on the President’s 2017 budget, which would provide significant additional funding for ALJs. The court also stated that lack of action on the AFIRM Act to date shows that this bill is unlikely to relieve the backlog in the near term.

Analysis

For all these reasons, the court denied the motion to stay, and at the same time, the court strongly implied that it will order HHS to comply with the ALJ deadline. The court stated, however, that it cannot simply waive a “magic wand” to eliminate the backlog. The court scheduled a status conference for October 3, 2016 “to discuss how to proceed.” NAAOP will attend that status conference and provide our members with an update following that conference.
While this decision will not solve the ALJ backlog overnight, it is a very important decision that will place tremendous pressure on CMS to meaningfully address the over 750,000 cases it has pending at the Office of Medicare Hearings and Appeals. This means that O&P practitioners and facilities that have Medicare claims pending at OMHA will likely begin to see some relief from the lengthy delays in getting their ALJ appeals heard and decided. However, the question of when this will occur still remains uncertain. We will be closely monitoring this situation as developments occur.

  • Written by NAAOP