Legislative Update: Forecasting Healthcare Policy Through the Wound Care Lens

In July, Congress suspended its regular legislative session for a period of vigorous campaigning kicked off by the Republican and Democratic National Conventions in Cleveland and Philadelphia, respectively. As the election cycle dominates the political airwaves over the next several months, it can be easy to lose sight of the real work that Congress has done. Some campaign rhetoric may even suggest very little has been accomplished. However, for those working in the healthcare industry, the 114th Congress (2015-16) has hosted a revival of policy debate and legislative activity that will have lasting impacts. This article will give an overview of those initiatives that should be of particular interest to the wound care community as well as provide a list of opportunities for advocacy under each piece of legislation discussed.

The Word on MACRA 

The enactment of the Medicare Access and CHIP Reauthorization Act (MACRA) in April 2015 heralds a new chapter of Medicare physician reimbursement policy. The landmark legislation to tie physician payment incentives and penalties to value, quality, performance, and outcomes is a major bipartisan accomplishment of this Congress. MACRA implementation is likely on the minds of wound clinic administrators and practitioners in a major way due to the challenges brought on by a range of significant issues such as: 1) determining which payment pathway to participate in – alternative payment models (APMs; eg, accountable care organizations [ACOs], patient-centered medical homes, bundled-payment models) or the Merit-Based Incentive Payment System (combines parts of the Physician Quality Reporting System, the value-based payment modifier, and the Medicare electronic health record [EHR] incentive program into one program that eligible professionals will be measured on); 2) the new requirements of the Meaningful Use of EHRs; and 3) the lack of quality measures relevant to wound care to measure performance against. Rest assured Congress is also concerned with MACRA implementation. As healthcare providers are working through these issues, Congress will be playing an active oversight role. The Alliance of Wound Care Stakeholders (Alliance), a trade association that aims to unify the voice of wound care professionals, is an example of an organization that has raised many concerns it sees on the proposed rule regarding MACRA implementation to the Centers for Medicare & Medicaid Services (CMS) during a recent comment period. MACRA also has a profound effect within the halls of Congress. Since 2003, Congress has passed laws each year (sometimes multiple times during a given year) to prevent Medicare physician reimbursement cuts dictated by the sustainable growth rate system. This annual exercise, more commonly known as the “doc fix,” sapped the bandwidth of the congressional committees and was often paid for with cuts to other health programs. In this regard, MACRA relieved a strain that was impeding Congress’ ability to turn its attention toward the future of health policy.

Beyond MACRA: 

5 Pieces of Legislation for 

The Wound Care Community

With a cornerstone piece of legislation on its resume, the 114th Congress has already made its mark on healthcare. However, health policy leaders and engaged stakeholders are charging forward with other major initiatives that deserve the attention of healthcare stakeholders. What follows are a few of the significant legislative efforts that wound care providers and manufacturers, as well as the trade associations representing them, should be paying attention to as they evolve:

1. Senate Chronic Care Work Group

The human toll — and the growing cost of care — for chronic disease presents a serious health policy concern, which Sen. Mark Warner (D-VA) summarizes in a recent press release from the U.S. Senate Committee on Finance: “As our population ages and individuals are surviving acute illnesses to an extent previously unimaginable, one of the next big challenges for our nation’s healthcare system is how to effectively deliver care for Medicare beneficiaries [living] with chronic conditions.” In May 2015, the Senate Finance Committee set out to explore policy solutions to improve outcomes for vulnerable Medicare beneficiaries living with multiple chronic health conditions. A bipartisan Senate working group was formed for the purpose of analyzing current law, discussing alternative policy options, and developing bipartisan legislative solutions that would be presented to the full committee for consideration. The Senate process has included a series of public hearings with testimony from patients, providers, payers, and government agencies. An invitation for stakeholder comments generated 530 submissions. The Chronic Care Working Group (CCWG) reviewed the comments in detail, accounted for input from public meetings, and published a policy options document in December. The paper included two-dozen proposals that serve as a framework for further discussion. More recently, there have been indications that the CCWG’s efforts to pass a legislative package will be a 2017 exercise. While a new law may have to wait for the 115th Congress, addressing chronic care challenges in the Medicare community will remain a priority for the remainder of the 114th, and wound care should be part of the conversation. 

Opportunity for wound care community: Patients living with chronic wounds frequently have comorbidities such as diabetes or obesity. Chronic wounds such as venous stasis ulcers, pressure ulcers, or diabetic foot ulcers, for example, are conditions that should be relevant to the CCWG’s deliberations. 

There is opportunity for the wound care community to meet with CCWG members, committee staff, and health policy leaders to educate them on how and why wound care should be addressed in policy recommendations/legislation they are developing. This is something to watch and certainly something to voice an opinion on in terms of opportunities to insert relevant wound care issues into the chronic care conversation. 

2. Biotech Innovation: 21st Century Cures/Innovation for Healthier Americans Act

America is a world leader in technological and healthcare innovation. However, as we forge ahead with new medical discoveries that affect countless lives, our regulatory framework can find itself outpaced and outdated. The 114th Congress has been working to close that gap to speed biotech development and ultimately patient access to new therapies and technologies. The House of Representatives and Senate are both pursuing far-reaching biotech innovation bills that seek to streamline regulatory pathways for delivering new medical technologies to patients and provide additional federal resources for research and development. The House overwhelmingly passed the 21st Century Cures Act (H.R. 6) in July 2015. The Senate is working on assembling a similar package — Innovation for Healthier Americans Act. The 21st Century Cures Act has the stated goal to “bring our healthcare innovation infrastructure into the 21st century.” The act increases funding for the National Institutes of Health (NIH) and the U.S. Food and Drug Administration, includes steps to streamline clinical trials, advances personalized medicine by encouraging greater use of drug development tools (such as biomarkers), and creates incentives for developing drugs for uncommon (but deadly) diseases. While this is overall biotech innovation legislation, there are some components of interest to wound care in terms of the potential impact on the development of innovating technologies and therapies and the pathways in which manufacturers bring new technologies to market. Also of interest to health systems and wound clinics is the act’s attention to patient data: The legislation promotes extensive use of patient data through support for development of a nationwide health information technology (IT) infrastructure for the exchange of electronic health information and addresses the development process for health IT interoperability standards. These specific provisions have had the support of many patient groups, but have sparked concerns by groups including the American Hospital Association. It’s important to weigh both perspectives. When the Senate’s Innovation for Healthier Americans Act package is unveiled, it’s anticipated there will be significant thematic overlap with the 21st Century Cures Act despite substantive differences in the content. The main challenges ahead for “Cures/Innovations” is to bridge the differences between the two and settle on funding levels (and offsets) for some of the desired policies such as additional NIH resources. Legislation of this magnitude is always difficult to shepherd through Congress, but the dedication of Congressional champions in the House and Senate, as well as invested stakeholders, may see this biotech innovation omnibus enacted before this Congress adjourns.

Opportunity for the wound care community: “Cures/Innovations” is moving. As Sen. Lamar Alexander (R-TN), chairman of the Senate Health, Education, Labor & Pensions Committee, remarked, “Rarely do we have such an opportunity: It includes support for the president’s precision medicine initiative and the vice president’s Cancer Moonshot. Speaker [Paul] Ryan has said ‘21st Century Cures’ is a major part of his healthcare agenda. Majority Leader [Mitch] McConnell says he wants to pass the bill this year.” The Senate intends to wrap up its work on the bill in September, queuing up the real potential to see a second major healthcare omnibus bill passed out of this Congress (the first being MACRA). The window for affecting the content of the Senate version is closing, and the House has laid down its marker; however, there will be differences between the two bills that will need to be reconciled by the two chambers. During this process, it will be important for Congress to hear from clinical stakeholders, biotech innovators, and patients about what they think is important to keep or change in that reconciliation process. There will also be offsets needed to pay for the bill, and offsets for healthcare legislation are typically sourced from within the health sector — always something to look out for. “Cures/Innovations” is likely to retain a broad base of stakeholder support; however, nothing is guaranteed in the legislative process. Opponents of a bill are likely to express their concerns, but voices of support can be more hesitant. If “Cures/Innovations” looks like positive change to modernize our regulatory framework, the wound care community should let its support be known.

3. House Hospital Reform Bill: A Step Towards (and Relief From) Site-Neutral Payments

The House passed the Helping Hospitals Improve Patient Care Act (HIP-C) of 2016 (H.R. 5273) June 7. HIP-C includes a five-year extension of the Rural Community Hospital Demonstration Program (which aims to test the feasibility and advisability of cost-based reimbursement for small, rural hospitals too large to be considered critical access hospitals) and an introduction of socioeconomic risk adjustment to Medicare’s Hospital Readmissions Reduction Program. However, of primary interest to the wound care community are the two sections of the legislation that deal with an area of increasing policy interest: site-neutral payments. Site-neutral payment reform seeks to equalize payment for services delivered in multiple settings under different fee schedules to patients with similar clinical profiles. This is not a new concept; the Medicare Payment Advisory Commission has called for site-neutral policy changes for years, and the Obama Administration has expressed support for some site-neutral reforms. The concept is a major shift in reimbursement policy that affects providers in different ways depending on setting and whether or not they are participating primarily in fee-for-service (FFS) Medicare or an alternative payment model (such as an ACO). HIP-C touches on site-neutral payments in two ways: 1) providing an incremental step toward testing site-neutral payments in the inpatient versus outpatient setting; and 2) providing relief for a recent site-neutral change to off-campus hospital outpatient departments (HOPDs).

HIP-C lays the groundwork for coding across inpatient and outpatient settings by requiring the secretary of the U.S. Department of Health & Human Services to establish Healthcare Common Procedure Coding System versions of Medicare severity/diagnosis related groups for at least 10 surgical services. Although no reimbursement changes are prescribed under this provision, the coding “crosswalk” is a necessary step to potentially test the consolidation of inpatient and outpatient payment schedules. This is a measured, meaningful step into much broader consideration of site-neutral payments and it is worthy of close monitoring — even if the services selected do not immediately impact wound care. HIP-C also provides relief from previously enacted site-neutral payment reforms affecting HOPDs. 

In November 2015, Congress passed the Bipartisan Budget Act (BBA), which prescribes that any new HOPD located more than 250 yards from the main hospital campus would not be eligible for reimbursement under the Hospital Outpatient Prospective Payment System (OPPS). Instead, new facilities (eg, new wound clinics) would be reimbursed under the ambulatory surgical center prospective payment system (56% of OPPS) or under the Physician Fee Schedule. Existing off-campus HOPDs are exempt from this change and are permitted to continue operating under OPPS. Among the criticisms of this change is that off-campus HOPDs in various stages of planning or construction are not afforded a similar exemption as existing HOPDs. In many cases, millions of dollars had been invested in these HOPD projects under a business model predicated on existing law governing Medicare reimbursement. Recognizing these circumstances, HIP-C provides relief for “mid-build” off-campus HOPDs by “grandfathering” projects that had executed a contract for construction of the facility by Nov. 2, 2015. 

Opportunity for wound care community: Congressional consideration of site-neutral payment policy is far from over. It is critically important that the wound care community is heard in this debate so that any policy proposals affecting wound care services or settings fully contemplate the clinical perspective. The HIP-C “crosswalk” may provide important insight into how such policies will be implemented from a coding perspective, but the overarching policy discussion may significantly impact the future shape of FFS reimbursement. The site-neutral reimbursement reductions included in the BBA apply to all future, planned, and mid-build wound clinics. Stakeholder support is needed to legislatively advance any relief for planned and mid-build projects. Stakeholders should also consider, and engage lawmakers on, impacts to existing off-campus HOPDs. For example, if a grandfathered HOPD is sold separately from its hospital, it will no longer be eligible to bill under OPPS. Additionally, only services offered by a grandfathered HOPD as of November 2015 are eligible to be billed under OPPS; so establishing new wound care services, regardless of the status of the off-campus HOPD, would bill under a different fee schedule. Legislative action is necessary to fix any of these issues, and Congress will only act if it knows this is a high priority. For wound clinic providers, this is an opportunity to make one’s advocacy voice heard.

4. Stark Law Reform: Removing Barriers for Care Coordination

Stark Law governs and limits physician self-referral for Medicare and Medicaid patients. Along with the Anti-Kickback Statute and the False Claims Act, Stark Law provides CMS with powerful enforcement tools to combat potential fraud and abuse. However, these laws were enacted to address potential conflicts of interest and anticompetitive activities that could drive inappropriate utilization in an FFS world. 

As new reimbursement models are shifting to value-based care that incentivize quality and outcomes, these laws are now posing obstacles to some of the care coordination and financial arrangements that are needed under the new paradigm. As MACRA implementation pushes physicians even further toward value-based care and APMs, there is a growing consensus in Congress that it’s time to undertake a deliberate modernization of Stark Law. To that end, the Senate Finance Committee and House’s Committee on Ways and Means have gathered stakeholder feedback on Stark Law reform. On June 30, Orrin Hatch (R-UT), Finance Committee chairman, released the white paper Why Stark, Why Now?  Suggestions to Improve the Stark Law to Encourage Innovative Payment Models, which contemplates different policy options such as removing the compensation arrangement prohibition, expanding waivers, limiting penalties for technical violations, and even full repeal. While the specific pathway to Stark reform has not yet been plotted, the paper provides a map of the different directions the Senate Committee could take. In a July hearing by the Finance Committee, Hatch said his committee would try to do something on Stark by the end of the year. That does not necessarily mean a bill will be signed into law by the end of this Congress, but it does signal that Stark reform will begin to take shape over the coming months and start opening the doors to the care coordination needed under MACRA. 

Opportunity for wound care community: As wound care patients tend to live with many comorbid conditions and receive care from a range of medical specialists, wound care clinics are no doubt interested in issues impacting care coordination. While Stark Law reforms are still being contemplated on Capitol Hill, this is definitely something for clinicians, wound clinics, and health systems to watch and voice opinions on. 

5. Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act

It may seem that massive omnibus legislation amounts to the only bills that make it to the president’s desk. But there can’t be an omnibus without the individual bills that make up its various divisions, titles, and sections. These bills are not plucked out of the ether; they are usually hard-fought, standalone pieces of legislation that have been introduced by a member of Congress, referred to a committee with jurisdiction over healthcare, and hard-fought by the stakeholders seeking their enactment. 

The HELLP Act is one such bill, and it’s directly relevant to wound care as it ensures Medicaid patients have access to podiatric care. Currently, access to care provided by a podiatrist is considered an optional benefit not covered by all state plans, thus limiting Medicaid patient access to specialized foot and ankle med/surg care. The bill would remedy this limitation to care and recognize podiatrists as physicians in order to ensure Medicaid patients have timely, equal, and full access to providers of foot and ankle care. The legislation would bring the Medicaid program in line with the Medicare program, which has recognized doctors of podiatric medicine as physicians since 1967. The bill also clarifies and streamlines care coordination in Medicare’s Therapeutic Shoe Program for patients living with diabetes. 

Opportunity for wound care community: By rectifying the exclusion of podiatrists from Medicaid, the HELLPP Act and its reforms ensure access to podiatric physicians, who represent a core part of wound care clinics and wound management teams. Wound care patients will benefit from the HELLPP Act, and wound care providers have an opportunity to submit letters of support to keep this act moving forward into the next Congress. For an example of a letter of support, visit https://bit.ly/HELLPPletter.

Conclusion

Although political perspectives may differ on policy, it cannot be denied that the 114th Congress has made a lasting impact on healthcare policy. While there are few legislative days left before this Congress adjourns, the remaining legislative sessions have the potential to be very meaningful to the wound care community. 

The upcoming September session is expected to see progress in the Senate on the “Cures/Innovations” biotech innovation initiative, and the groundwork that Congress has laid on various healthcare policy efforts may be leading towards a highly productive “lame duck” post-election session. We only need look back to the 113th Congress (2013-14), when that Congress passed over one-third of its laws in its final month, to see the kind of activity that is possible. Even if Congress is not able to enact some of its priorities this year, the healthcare policy debates of the 114th Congress will undoubtedly be picked up by the 115th and be joined by the priorities of a new administration. Important policy initiatives that warrant attention from the wound care community will continue to move forward. There is opportunity to have a voice by submitting letters of support (or disagreement), scheduling meetings with legislative staff, attending public hearings, and more. Clinician voices carry weight on healthcare policy issues and trade associations such as the Alliance of Wound Care Stakeholders provide opportunity to have a collective voice on key issues. It’s an important time to be an engaged participant in a reinvigorated and innovative Congress. 

Dave McNitt is a partner at Oldaker Law Group LLP, Washington, DC. Marcia Nusgart is executive director of the Alliance of Wound Care Stakeholders.