• Volume 59, March/April 2019 CNS DC E-Newsletter

    • Apr 01, 2019

    Legislative Affairs

    Washington Committee Sets 2019 Legislative and Regulatory Agenda

    Based on a survey of the CNS and AANS members, the CNS/AANS Washington Committee has developed the following legislative and regulatory agenda for 2019:

    • Protect patients’ timely access to care by reforming utilization review practices, such as prior authorization, step-therapy and Medicare’s appropriate use criteria program for advanced diagnostic imaging.
    • Fix the broken medical liability system by adopting proven reforms that are in place in California and Texas.
    • Improve the health care delivery system, including maintaining existing insurance market reforms and advancing solutions that will lower costs and expand choice, including out-of-network options, with appropriate patient protections for unanticipated medical bills.
    • Support quality resident training and education by increasing the number of Medicare-funded residency positions and preserving the ability of surgeons to maximize education and training opportunities within the profession’s current regulatory structures.
    • Alleviate the burdens of electronic health records, including promoting interoperability, reducing unnecessary data entry and improving the functionality of EHR systems to enhance, not hinder, the delivery of medical care.
    • Continue progress with medical innovation by repealing the medical device tax and implementing the 21st Century Cures Act.
    • End the opioid epidemic by implementing the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment or Patients and Communities Act (SUPPORT Act).
    • Champion fair reimbursement by maintaining a viable fee-for-service option in Medicare and by empowering patients and physicians to privately contract fee arrangements. Additionally, Medicare must maintain the 10- and 90-day global surgery payment package and minimize the burdens associated with the global surgery code data collection initiative.

    Additional details will be posted on the CNS and the AANS websites in the near future.

    CNS and AANS Urge Congress to Adopt Principles in Surprise Medical Bills Legislation

    On Feb. 7, the CNS and AANS joined more than 100 state and national medical societies in sending Congress a letter outlining organized medicine’s core principles on so-called “surprise medical bills.” Given growing concern over the practice of unanticipated medical bills — largely driven by narrow insurance networks, which leaves some patients on the hook with the bill if they receive care from an out-of-network provider — Congress and the Trump Administration are considering legislation and/or regulations to address this problem. The principles include:

    • Insurer accountability to ensure network adequacy;
    • Limits on patient responsibility to in-network cost-sharing for unanticipated care;
    • Transparency about out-of-network providers and costs for scheduled care;
    • Setting benchmark payments, if any, based on charge data from an independent claims database (e.g., FAIR Health);
    • Alternative dispute resolution, such as baseball-style arbitration; and
    • Keep patients out of the middle.

    Last October, the CNS and AANS submitted comprehensive comments in response to a draft bill circulated by Sen. Bill Cassidy, MD (R-La.), and we continue to participate in an American Medical Association-led workgroup on this issue.

    Congress Introduces Bills to Fund Additional Residency Training Slots

    Legislation expanding Medicare funding for additional residency training slots has been introduced in Congress. Sponsored by Sens. Robert Menendez (D-N.J.), John Boozman (R-Ark.) and Charles Schumer (D-N.Y.) in the Senate, as well as Reps. Terri Sewell (D-Ala.) and John Katko (R-N.Y.) in the House, the “Resident Physician Shortage Reduction Act” (S. 348 / H.R. 1763) would:

    • Increase the number of Medicare-supported GME residency slots by 15,000 over the next five years;
    • Direct one-half of the newly available positions to training in shortage specialties;
    • Specify priorities for distributing the new slots (e.g., states with new medical schools); and
    • Study strategies to increase the diversity of the health professional workforce.

    The CNS and AANS endorsed the bills, sending letters to both House and Senate sponsors.

    Neurosurgery Urges Congress to Reauthorize the Pediatric Subspecialty Loan Repayment Program

    On Feb. 1, organized neurosurgery joined the American Academy of Pediatrics (AAP) and 70 other professional medical and public health advocacy groups in sending a letter calling on Congress to reauthorize the Pediatric Subspecialty Loan Repayment Program. The program provides loan repayment in exchange for service in areas of medical need. Specifically, in return for participants agreeing to work full-time for at least two years in a pediatric medical specialty — including pediatric surgical specialties — in a medically underserved area, the program pays up to $35,000 in loan repayment for each year of service for a maximum of three years. The letter stressed the need to reauthorize the Pediatric Subspecialty Loan Repayment Program, as it will help to ameliorate workforce shortages.

    Neurosurgery Sends Letters of Support for H.R. 594/S. 864, Ellie’s Law

    On Jan. 16, Rep. Yvette Clarke (D-N.Y.) introduced H.R. 594, Ellie’s Law. On March 25, Sen. Richard Blumenthal (D-Conn.) also introduced a senate companion bill, S. 864. Both bills would provide $25 million over five years for the National Institute of Neurological Disorders and Stroke (NINDS) to support brain aneurysm research. Following the introduction of both bills, the CNS and AANS sent letters of support for both the House and Senate legislation.

    CNS and AANS Join Urge Congress to Increase Funding for NIH

    Joining more than 300 organizations, the CNS and AANS have endorsed the Ad Hoc Group for Medical Research’s FY 2020 funding recommendations for the National Institutes of Health. The coalition is recommending at least $41.6 billion for the NIH, a $2.5 billion/6.4 percent increase over the FY 2019 funding levels. The groups are also for an increase to the discretionary budget caps for FYs 2020 and 2021. Without relief from the discretionary spending caps, nondefense discretionary programs face a steep, $55 billion funding cliff that would reverse many of the funding gains made in the last few years and hamper efforts to continue investments in medical research, among other priorities.

    Neurosurgery Sends Letter to Congress Urging Funding for CDC Gun Violence Prevention Research

    On Feb. 21 the CNS and AANS joined 164 national, state and local medical, public health and research organizations in sending letters to House and Senate appropriation leaders urging them to provide $50 million in funding for the Centers for Disease Control and Prevention (CDC) to conduct public health research into firearm morbidity and mortality prevention.

    Coding and Reimbursement

    CNS and AANS Urge CMS to Issue Guidance to MA Plans on Prior Authorization

    Each year, the Centers for Medicare & Medicaid Services (CMS) issues its annual “Advance Notice of Methodological Changes for Calendar Year (CY) 2020 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2020,” otherwise known as the “Call Letter.” Unfortunately, despite neurosurgery’s ongoing advocacy to improve MA plan prior authorization practices, this year’s Call Letter fell woefully short. To this end, working with the American Medical Association, the CNS and AANS joined nearly 100 state and national medical associations in submitting a comment letter to CMS, asking the agency to direct MA plans only to target prior authorization requirements where they are needed most. Specifically, the letter states, “CMS should require MA plans to selectively apply PA requirements and provide examples of criteria to be used for such programs, including, for example, ordering/prescribing patterns that align with evidence-based guidelines and historically high PA approval rates.”

    Neurosurgery Joins Regulatory Relief Coalition to Send CMS Letter on Step Therapy

    In late January, the CNS and AANS joined the physician Regulatory Relief Coalition, of which we are leaders, in sending a letter to CMS regarding proposed step therapy rules. In the letter, the coalition urged the agency to refrain from finalizing provisions that would authorize MA plans to institute step therapy restrictions — the so-called “Fail First Coverage Restrictions” — on access to Part B drugs and biologicals and to expand the use of Fail First Coverage Restrictions for Part D “protected class” drugs and biologicals. The coalition has been pressing for step therapy reform, and the initial focus of these efforts has been directed at reforming utilization review tools used in the Medicare Advantage program. 

    CMS Approves Coverage for VNS for Depression for Patients in Clinical Trials

    On Feb. 15, CMS posted its Final Decision Memo announcing that the agency will cover FDA-approved vagus nerve stimulation (VNS) devices for treatment-resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year. The CED includes the possibility of extending the study to a prospective longitudinal study when the CMS-approved trial has completed enrollment, and there are positive interim findings. VNS is not covered for the treatment of TRD when furnished outside of a CMS-approved CED study. The CNS and AANS provided several comment letters to CMS during the coverage decision process, the most recent of which is available here.

    Neurosurgery Objects to Washington State Plan not to Cover SI Joint Fusion

    On Jan. 18, the Washington State HTA Health Technology Clinical Committee (HTCC) voted not to cover SI Joint Fusion procedures. David W. Polly, Jr., MD, made a presentation at the meeting on behalf of the American Academy of Orthopaedic Surgeons (AAOS), AANS, CNS, International Society for the Advancement of Spine Surgery (ISASS) and the Washington State Association of Neurological Surgeons (WSANS), supporting coverage for SI Joint Fusion for appropriately selected patients. On Nov. 9, the AANS, CNS, AANS/CNS Section on Disorders of the Spine and Peripheral Nerves (DSPN), AAOS, North American Spine Society (NASS) and the WSANS had sent a letter to the Washington State Health Care Authority (HCA) Health Technology Assessment (HTA) program regarding a draft evidence report for Sacroiliac (SI) Joint Fusion. ISASS sent their own more detailed letter, but was generally in agreement with the multispecialty letter. The negative coverage decision is a disappointment, as the evidence report prepared for the meeting was considered reasonable. On Feb. 20, organized neurosurgery sent a letter to object and request a reconsideration. More information on the Washington State HCA HTA program consideration of SI Joint Fusion is available here.

    CMS Releases Tool to Compare Medicare Surgical Procedure Costs

    CMS has made a new online tool available that displays cost differences for certain outpatient surgical procedures. The Procedure Price Lookup website allows patients to compare national average prices for procedures performed in both ambulatory surgical centers and hospital outpatient departments. The tool comes as a result of a requirement for greater price transparency included in 21st Century Cures Act (P.L.114-255). A press release with more details is available here.

    Anthem Reverses Course on Minimally Invasive Ablative Procedures for Epilepsy

    Based on comments provided by the CNS and AANS, Anthem reversed course, finding that the treatment of medically refractory epilepsy using stereotactic laser techniques (MRI-guided laser interstitial thermal ablation [MRIgLITT]), including stereotactic laser amygdalohippocampotomy (SLAH) is considered medically necessary when the following criteria are met:

    • Documented disabling seizures, despite the use of two or more tolerated antiepileptic drug regimens; and
    • Documented presence of two or fewer well-delineated epileptogenic foci accessible by laser.

    The use of stereotactic radiofrequency thermocoagulation (RF-TC) in the treatment of hypothalamic hamartomas is considered medically necessary.

    Quality Improvement

    HHS Takes Steps to Address EHR-Related Burden

    As required by the 21st Century Cures Act (Public Law 114-255, Section 4001), the Office of the National Coordinator for Health Information Technology (ONC) released its draft “Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs.” In response to this document, the CNS and AANS sent a letter to ONC. In our comments, we addressed issues and recommendations for clinical documentation, health information technology usability and user experience, electronic health record reporting, interoperability and accessing and exchanging data from medical devices. In addition, neurosurgery joined forces to submit additional letters with the Alliance of Specialty Medicine, as well as the Physician Clinical Registry Coalition (PCRC). ONC stated that the final version would be published in late 2019.

    New QPP Payment Adjustment Resource Now Available on QPP Resource Library

    CMS has posted a new Merit-based Incentive Payment System (MIPS) resource to the Quality Payment Program (QPP) Resource Library to answer questions and provide additional resources on 2019 payment adjustments. In July 2018, each MIPS-eligible clinician received a 2017 MIPS final score and associated payment adjustment factor(s) as part of their 2017 MIPS performance feedback, available on the QPP website. The new resource addresses frequently asked questions about the application of payment adjustments, which began Jan. 1, 2019. Topics covered include:

    • Services subject to the 2019 MIPS payment adjustment;
    • Changes made to remittance advice documents to reflect 2019 MIPS payment adjustments;
    • Impact that claim assignments have on 2019 MIPS payment adjustments; and
    • Correction of the inclusion of Medicare Part B Drugs and certain items and services in the 2019 MIPS Payment Adjustment.

    The document also provides links to additional resources related to MIPS payment adjustments:

    For questions, contact the Quality Payment Program at QPP@cms.hhs.gov or 1.866.288.8292 (TTY: 1.877.715.6222).

    MIPS Facility-based Preview, New MIPS Resources

    For the 2019 performance year, MIPS includes the option to use facility-based measurement for the Quality and Cost performance categories for MIPS eligible clinicians, groups and virtual groups who are determined to be facility-based. These clinicians will be assessed based on their performance in hospital settings. To determine if your practice is facility-based, CMS will look at your Medicare Part B claims billed between Oct. 1, 2017, and Sept. 30, 2018. You are considered facility-based if you are a MIPS-eligible clinician type and you:

    • Billed at least 75 percent of your covered professional services in a hospital setting;
    • Billed at least one service in an inpatient hospital or emergency room; and
    • Can be attributed to a facility with a Hospital Value-based Purchasing (VBP) score.

    This information is available on the QPP Participation Status lookup tool.

    CMS is providing a facility-based preview that allows you to see what your Quality and Cost performance category scores could look like for the 2019 MIPS performance period, if you are identified as facility-based and attributed to a facility with a Fiscal Year 2020 Hospital Value-Based Purchasing (VBP) score. Please note, these are not your 2019 MIPS performance period Quality and Cost performance category scores under the facility-based scoring option. This preview is based on earlier data from the Hospital VBP and should give you an idea of what your facility-based scores for these performance categories may resemble. To access the facility-based preview:

    • Sign into the QPP website. Don’t have an account? Review the QPP Access User Guide.
    • From the home page, click Preview Facility Score (or click the Facility-Based Preview link in the left-hand navigation).

    To learn more about facility-based measurement for MIPS in 2019, view the 2019 Facility-based Measurement Fact Sheet and the Facility-based Preview FAQs.

    Drugs and Devices

    CMS Open Payments Data “Refresh” Released

    Earlier this year, the Centers for Medicare and Medicaid Services (CMS) posted the Open Payments updated dataset, reflecting changes to the data that took place since the last publication in June 2018. CMS updates the data at least once annually to include changes from disputes and other corrections made since the initial publication. The refreshed Open Payments Data Set includes:

    • Record Updates. Changes to non-disputed records made on or before Nov. 15, 2018.
    • Disputed Records. Dispute resolutions completed on or before Dec. 31, 2018, are displayed with the updated information. Records with active disputes that remained unresolved as of Dec. 31, 2018, are noted to be disputed.
    • Record Deletions. Records deleted before Dec. 31, 2018, were removed from the Open Payments database. Records deleted after that time remained in the database, but will be removed during the next data publication in June 2019.

    Beginning in April 2019, physicians will have a 45-day window to review and dispute 2018 data in advance of the June 30, 2019, annual publication. CMS posted a 2019 Quick Reference Guide outlining the Open Payments program year. More information on the Open Payments program is available here. The CMS Open Payments Search Tool is located here.

    Neurosurgery Joins Other Groups in Letter to CMS on Open Payments and CME

    The CNS and AANS joined the AMA and other state and national medical groups in sending a letter providing feedback to CMS regarding the impact of the Open Payments program requirement for reporting educational materials, such as peer-reviewed journals, journal reprints and medical textbooks as well as continuing medical education (CME) programs. In the letter, the group states, “We have long believed that the Agency’s decision to include educational materials and CME programs as reportable transfers of value is contrary to both the statute and congressional intent and has harmed patient care by impeding ongoing efforts to improve the quality of care through timely medical education.”

    CNS and AANS Respond to FDA De Novo Device Approval Regulation

    On March 7, the CNS and AANS sent a letter to the FDA regarding a proposed regulation to formalize its De Novo Device classification process. The De Novo classification provides a pathway for certain novel medical devices with low to moderate Class I or II designations to obtain clearance without a predicate device required for the 510(k) pathway and without having to submit a premarket approval application (PMA) reserved for higher risk Class III devices. The FDA has issued voluntary guidance for the De Novo process in the past, but this is the first time the agency has proposed an official regulation, which would be binding. In our letter, the CNS and AANS commend the agency for providing clarity but express concern that some of the provision proposed provide unnecessary additional burden for low to moderate risk devices. More information on this topic is available here

    Of Note

    Report Shows Majority of Health Insurance Markets Are Highly Concentrated

    According to a study released by the AMA, 73 percent of US health insurance markets are highly concentrated, based on guidelines used by the Department of Justice and Federal Trade Commission to assess market competition. In 91 percent of the 380 metropolitan statistical areas studied, at least one insurer had a commercial market share of 30 percent or more, and in 46 percent of MSAs, a single insurer’s share was at least 50 percent. “Our findings should prompt federal and state antitrust authorities to vigorously examine the competitive effects of proposed mergers between health insurers,” the report concludes. The findings are based on 2017 data captured from commercial enrollment in fully and self-insured health maintenance organizations, preferred provider organizations and point-of-service plans, consumer-driven health plans and public health exchanges.

    Communications

    CNS and AANS Join 43 Organizations to Issue Press Release on the Medical Summit on Firearm Injury Prevention

    Issued by the American College of Surgeons (ACS) on Feb. 21, the CNS and AANS, along with 43 medical and injury prevention organizations and the American Bar Association, supported a press release about the first-ever Medical Summit on Firearm Injury Prevention. Hosted by the ACS Committee on Trauma (COT), the Summit brought together national health care and legal leaders who have a compelling interest in reducing deaths, injuries and disabilities from firearms. Shelly D. Timmons, MD, PhD, FAANS, participated on behalf of neurosurgery.

    KevinMD.com Highlights Neurosurgery Blog’s Prior Authorization Post

    On Jan. 6, KevinMD.com, the popular health website, published a Neurosurgery Blog post.  Authored by Debraj Mukherjee, MD, and Chaim B. Colen, MD, the piece discusses the negative impacts of prior authorization. Click here to go to the post titled “An approach to prior authorization insurance denials.” Click here for the original post. KevinMD.com receives more than three million monthly page views and exceeds 250,000 followers on Facebook and Twitter. Efforts such as this help expand the reach of neurosurgery’s voice on policy matters affecting the profession.

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    The mission of Neurosurgery Blog is to investigate and report on how health care policy affects patients, physicians and medical practice and to illustrate how the art and science of neurosurgery encompass much more than brain surgery. Neurosurgery Blog has ramped up its reporting efforts to include multiple guest blog posts from key thought leaders and members of the neurosurgical community. We invite 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.

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