Author: Katie O. Orrico
Progress Report on the Washington Committee 2017-18 Legislative and Regulatory Agenda
The Washington Committee is making steady forward progress on our 2017-18 legislative and regulatory agenda. Positive outcomes to date include:
- Legislation expanding funding for the Children's Health Insurance Program (CHIP) for ten years was signed into law (P.L. 115-120). CHIP provides coverage to nine million children in families who earn too much to qualify for Medicaid but cannot afford private insurance. Neurosurgery has long supported reauthorization of this program to ensure that our nation's children have health insurance coverage.
- Support continues to grow for bills that provide additional Medicare graduate medical education (GME) funding. If enacted, these bills - H.R. 2267/S. 1301, the Resident Physician Shortage Reduction Act - will fund an additional 15,000 slots over a five year period. To ensure an adequate supply of physicians, organized neurosurgery has been on the frontlines advocating to improve the current GME system. The Washington Committee has also helped prevent legislation (H.R. 2373) that would effectively eliminate the single accreditation system for allopathic and osteopathic residency training from gaining traction.
- Congress repealed the Independent Payment Advisory Board (IPAB) with the passage of the Bipartisan Budget Act of 2018 (P.L. 115-123). Repealing this unelected, unaccountable board has been a top legislative priority since the passage of the Affordable Care Act (ACA). Leading the repeal effort, the Washington Committee also aligned with the Physician IPAB Repeal Coalition, the Alliance of Specialty Medicine, and more than 800 health care stakeholder organizations who supported IPAB repeal.
- The House passed comprehensive medical liability reform legislation, and multiple other medical liability reform bills have been introduced. The House passed H.R. 1215, the Protecting Access to Care Act, and most recently, the House Energy and Commerce Committee passed H.R. 1876, the Good Samaritan Health Professionals Act, out of committee where it now awaits floor action. Bills that have been introduced in the House and Senate include:
- Legislation suspending the medical device tax for an additional two years through 2019 was signed into law (P.L. 115-120). This excise tax - a 2.3 percent tax on medical device companies' gross revenue - was initially adopted to help fund the ACA. Repealing the device tax is one of organized neurosurgery's top legislative priorities as it would hinder medical device innovation and reduce incentives for medical device research.
- Improvements to Medicare's Quality Payment Program (QPP) to reduce the reporting burden and minimize penalties have been made, including:
- 2018 program rules provide greater flexibility, reduce complexity and reduce the potential for penalties;
- Bipartisan Budget Act of 2018 (P.L. 115-123) included additional flexibility for 2012-23 to make it easier for physicians to meet program requirements and eliminate the mandate that electronic health record (EHR) standards become more stringent over time, while also maintaining EHR hardship exemptions.
- Massive changes to global surgery codes will not likely be forthcoming in 2019. Last year, the Centers for Medicare & Medicaid Services (CMS) contracted with RAND to conduct a national survey on global surgery services. Last fall, in the Surgical Coalition letter, the Washington Committee raised significant concerns about the survey, not the least of which is that it is too long and any data collected will be flawed and from too small a sample. RAND made some changes and is currently piloting the survey. Following a meeting earlier this year with CMS, it appears that the agency has received quite a bit of data from the claims-based data collection effort, but the data have not yet been analyzed. The lack of progress on the data collection front means that it seems highly unlikely that CMS will make wholesale changes to the global surgery codes for 2019. The Washington Committee estimates that if implemented, changes to global surgery code values could result in cuts in neurosurgical reimbursement of more than 25 percent.
CMS Unveils "Patients over Paperwork Initiative"
The Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma launched the "Patients over Paperwork Initiative," a crosscutting, collaborative process that evaluates and streamlines regulations with a goal to reduce unnecessary burden, increase efficiencies, and improve the beneficiary experience. The Washington Committee is focusing on a handful of topics for regulatory relief including:
- Medicare's Quality Payment Program;
- Appropriate use criteria (AUC) for advanced diagnostic imaging;
- Electronic health records;
- Global surgery code data collection;
- Prior authorization; and
- FDA-related topics, such as off-label use, approval of devices and streamlining paperwork requirements for FDA volunteer experts.
Ann R. Stroink, MD, chair of the Washington Committee, and Katie O. Orrico, Esq., director of the Washington Office, have had multiple meetings with high-level U.S. Department of Health and Human Services (HHS) officials. Most recently, as part of this effort, the House Ways and Means Committee convened a "Red Tape Relief Roundtable," to discuss ways in which Congress and CMS can provide regulatory relief for physicians. Ms. Orrico represented the Alliance for Specialty Medicine at the meeting, which highlighted a wide- variety topics, such as prior authorization reform, E&M documentation guidelines and minimizing the reporting burdens of Medicare's quality payment programs.
CMS Releases 2018 MIPS Eligibility Tool
Neurosurgeons can now use the updated CMS MIPS Participation Lookup Tool to check on your 2018 eligibility for the Merit-based Incentive Payment System (MIPS). Just enter your National Provider Identifier, or NPI, to find out whether you need to participate during the 2018 performance year. To reduce the burden on small practices, CMS changed the eligibility threshold for 2018. Clinicians and groups are now excluded from MIPS if they:
- Billed $90,000 or less in Medicare Part B allowed charges for covered professional services under the Physician Fee Schedule (PFS); or
- Furnished covered professional services under the PFS to 200 or fewer Medicare Part B-enrolled beneficiaries.
This means that to be included in MIPS for the 2018 performance period you need to have billed more than $90,000 in Medicare Part B allowed charges for covered professional services under the PFS and furnished covered professional services under the PFS to more than 200 Medicare Part B enrolled beneficiaries.
Washington Committee Leads Multi-society Response to Cigna Cervical Fusion Coverage Policy
On May 24, the AANS and CNS sent a letter to Cigna in response to its updated cervical fusion coverage policy. The policy is scheduled to take effect on June 15. The recommendations for coverage do not comply with standard spine practices or with the literature and will limit patient access to appropriate spine surgery options for Cigna enrollees. Among other things, the policy fails to allow the incorporation of a posterior cervical fusion at the time of initial laminectomy in patients with cervical stenosis but no evidence of kyphosis, cervical degenerative subluxation of over 3.5 mm, or other evidence of preexistent cervical instability.
Neurosurgery Leads Response to Washington State HTA Review of Single Level Laminectomy
Earlier this spring, neurosurgery took the lead in sending a letter from the AANS, CNS, the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves, Washington State Association of Neurological Surgeons (WSANS), International Society for the Advancement of Spine Surgery, North American Spine Society (NASS) and the American Academy of Orthopaedic Surgeons (AAOS) to the Washington State HTA program regarding a draft evidence report on surgery for symptomatic lumbar radiculopathy prepared by RTI International - Evidence-based Practice Center. The letter builds on a previous letter and statement from the same groups and emphasizes that current literature supports the fact that surgery in patients with symptomatic lumbar radiculopathy secondary to disc herniation or stenosis represents a cost-effective treatment and compares very favorably with other accepted medical and surgical interventions. The HCA HTA Health Technology Clinical Committee met on May 18, to vote on whether and under what circumstances to continue coverage for the procedure. The committee voted to cover (8-1) open decompression with conditions (6 weeks of non-surgical management), and minimally invasive techniques that include laminectomy, laminotomy, foraminotomy, and discectomy, with conditions (6 weeks of non-surgical management). The Committee voted for non-coverage of any technique described by a CPT Cat. III or t-code (lasers, thermal, energy ablation, etc.) and chose not to make a determination on reoperations, leaving coverage determinations on reoperations on a case-by-case basis. More information is available here.
FDA Issues Multiple Safety Warnings
Recently, the Food and Drug Administration (FDA) issued three safety notices of interest to neurosurgeons.
- Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices. On April 28, the FDA issued a safety notice with preliminary information concerning magnetic resonance (MR) thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices. MRgLITT devices are commonly used in neurosurgical procedures for minimally invasive ablation of brain tumors, epileptic foci or radiation necrosis. During these procedures, the tip of a laser probe is stereotaxically placed within the tissue to be ablated, and controlled thermal energy is delivered to the target tissue. The FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment and may have resulted in harm to patients.
- Monteris Medical NeuroBlate probe. On March 22, the FDA issued a Class I recall notice due to the potential for unintended heating and patient injury with use of the Monteris Medical NeuroBlate probe, which is part of the NeuroBlate System. A Class I recall is issued when the agency believes the use of the device may cause serious injuries or death. Monteris issued three product advisories between Oct. and Dec. 2017, which were part of the Class I recall.
- Magnetic Resonance Angiography (MRA). On March 12, the FDA issued a safety notice due to the potential for increased image artifact associated with Magnetic Resonance Angiography (MRA) imaging for patient follow-up of certain post neurovascular embolization coil procedures. The agency has received reports indicating that when MRA is performed on patients implanted with neurovascular embolization coils containing 304V stainless steel (either as part of the coil implant itself, or left behind as part of the detachment process), the images may contain larger than expected MR artifact, or image voids when compared to other metals. In these cases, the reduced quality of the MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions.
Neurosurgery Blog Hosts Spine-Focus Awareness Campaign
Throughout March, April and May, Neurosurgery Blog hosted a spine-focus awareness campaign. To maximize attention on spine related issues, we planned our efforts around the 2018 Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves. Our goal was to shed important light on spine facts, innovation and the role of spine interventions. Misinformation regarding spine care in the U.S. is a significant hindrance to understanding the critical issues surrounding the care of patients with spinal conditions. To this end, we highlighted these issues through patient stories, epidemiology, economics, value, innovation, and advocacy. We invite all neurosurgeons to continue the conversation using the SpineMonth hashtag so we can grow awareness through social media. Additionally, we encourage you to visit the blog and subscribe to it, as well as connect with us on our various social media platforms. This will allow you to keep up with the many health-policy activities happening in the nation's capital and beyond the Beltway.