Special FDA Safety Announcement for Frameless Stereotaxic Navigation Systems
On June 15, 2017, the Food and Drug Administration (FDA) issued a Safety Communication to make health care providers aware of possible navigational accuracy errors that may occur when using frameless stereotaxic navigation systems. The FDA emphasized that the overall benefits of using frameless stereotaxic navigation systems continue to outweigh the risks, and they have not determined that any particular system carries greater risk than others. The notice also contains recommendations for surgeons to consider to help mitigate associated risks to patients, including repeatedly assessing the navigational accuracy throughout a procedure when using a frameless surgical navigation system.
Neurosurgeons may report device problems to the FDA through the agency’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at www.fda.gov/MedWatch/report; or
- Click here to download a reporting form; or
- Call 1-800-332-1088 to request a reporting form to complete and return by mail or by facsimile to 1-800-FDA-0178.
The American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) are sending this for your information.
House Passes Comprehensive Medical Liability Reform Legislation
On June 28, by a vote of 218 to 210, the U.S. House of Representatives passed H.R. 1215, the Protecting Access to Care Act, as amended. Organized neurosurgery endorsed the legislation. Additionally, the AANS and CNS joined the Alliance of Specialty Medicine and the Health Coalition on Liability and Access (HCLA) in supporting this bill.
Key provisions of the bill include:
- Encouraging speedy resolution of claims. The statute of limitations is three years after the injury or one year after the claimant discovers the injury, whichever occurs first.
- Compensating patient injury. Noneconomic damages are limited to $250,000. Parties are liable for the amount of damages directly proportional to their responsibility.
- Maximizing patient recovery. Courts must supervise the payment of damages and may restrict attorney contingency fees. The bill sets limits — on a sliding scale — on contingency fees.
- Future damages. The bill provides for periodic payment of future damage awards.
- Product liability. A health care provider who prescribes, or dispenses pursuant to a prescription, a medical product approved by the FDA may not be named as a party to a product liability lawsuit or a class action lawsuit regarding the medical product.
- State Flexibility. Protects the rights of states that have already enacted comprehensive medical liability reforms or do so in the future.
Several amendments passed, including one offered by Rep. Richard Hudson (R-N.C.) — by a vote of 222 to 197. The Hudson amendment (1) sets forth expert witness criteria; (2) requires an affidavit of merit prior to bringing a lawsuit; (3) allows a physician to apologize to a patient for an unintended outcome without having the apology count against them in the court of law; and (4) requires a 90-day cooling off period before lawsuits can be filed to facilitate voluntary settlements.
House Passes Health Reform Legislation; Senate Struggles to Find Consensus
On May 4, by a narrow margin of 217 to 213, the U.S. House of Representatives passed H.R. 1628, the American Health Care Act (AHCA). In a letter to House committee leaders, the AANS and CNS registered our views on the bill, as well as other topics not addressed by the AHCA. We also shared with Congress the results of a health care reform survey of neurosurgical leaders.
Following passage, the AANS and CNS sent a letter to Senate leaders expressing our significant concerns about aspects of the AHCA, as well as our opinion on those provisions with which we agree. As with the letter to committee leaders in the House, the AANS and CNS also expressed our views about other health reform issues that need to be adopted as well. Furthermore, on May 23, neurosurgery joined forces with the Alliance of Specialty Medicine to send a letter to Senate lawmakers highlighting several health reform principles that the legislation should incorporate. On June 22, Senate Majority Leader Mitch McConnell (R-Ky.) unveiled Senate leadership’s discussion draft bill, the Better Care Reconciliation Act. In general, the legislation aims to:
- Helps stabilize collapsing insurance markets;
- Repeals the individual and employer mandates;
- Improves the affordability of health insurance;
- Preserves access to care; and
- Provides States with more flexibility under Medicaid.
Despite these goals, the Congressional Budget Office (CBO) estimates that 22 million will lose health insurance coverage under the draft. Finding consensus in the Senate remains elusive; thus stalling forward progress on reform legislation for the moment.
AANS and CNS Send Letter Supporting the CONNECT for Health Act
On June 1, AANS and CNS sent Senate leaders a letter supporting S. 1016, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act. Introduced by Sen. Brian Schatz (D-Hawaii), this bipartisan bill will expand telehealth services in Medicare by removing outdated restrictions and make it easier for patients to connect with their health care providers. Neurosurgery has supported efforts to improve the availability this well-established and expanding service delivery method for Medicare beneficiaries.
Neurosurgery Supports the Affordable Health Insurance for the Middle Class Act
On May 25, the AANS and CNS sent a letter endorsing, S. 1307, the Affordable Health Insurance for the Middle Class Act. Introduced by Sen. Dianne Feinstein (D-Calif.), this bill would expand access to affordable health insurance coverage for those Americans in financial need. The bill is consistent with neurosurgery’s policy that the federal government should provide need-based financial assistance to help individuals obtain health insurance under the individual mandate.
AANS and CNS Endorse the Patient Access to Higher Quality Health Care Act
On May 16, the AANS and CNS along with 50 other organizations sent a letter to Congress supporting H.R. 1156, the Patient Access to Higher Quality Health Care Act. Introduced by Rep. Sam Johnson (R-Texas), this legislation would repeal the moratorium on the expansion and new construction of physician-owned hospitals (POH). The AANS and CNS have a longstanding policy in favor of specialty hospitals and ambulatory surgery centers (ASCs). We did not support the ban, which was included in the Affordable Care Act (ACA), and we have endorsed legislation to repeal or scale back the limitations on physician-owned hospitals since the ACA passed in 2010.
Neurosurgery Joins Call for Increased Funding for NIH
On May 8, the AANS and CNS joined forces with nearly 800 other groups in sending a letter urging Congress to increase funding for the National Institutes of Health (NIH) and other important programs under the auspices of the U.S. Department of Health and Human Services (HHS). In the letter, the group raised concerns that without such an increase, it will be impossible to expand medical research at the NIH.
MISSION Zero Companion Legislation Introduced in the Senate
On May 3, Sens. Johnny Isakson (R-Ga.), Tammy Duckworth (D-Ill.) and John Cornyn (R-Texas) introduced S. 1022, the Military Injury Surgical Systems Integrated Operationally Nationwide (MISSION) to Achieve Zero Preventable Deaths Act. The MISSON ZERO Act would assist U.S. military health care providers in maintaining a state of readiness by embedding military trauma teams in civilian trauma centers. The House introduced companion legislation, H.R. 880, in February. Organized neurosurgery supports this legislation, which would provide $40 million in grant funding to facilitate partnerships between military trauma care teams and high-volume civilian level I, II and III trauma facilities. These partnerships would allow military trauma care providers to gain exposure to treating critically injured patients and increase readiness for when these units are deployed.
AANS and CNS Representatives Meet With HHS and CMS Leaders
On June 20, Washington Committee chair, Ann R. Stroink, MD, FAANS, and Katie O. Orrico, director of the AANS/CNS Washington Office, met with HHS secretary, Tom Price, MD, and CMS administrator, Seema Verma. The meeting was one of three roundtables that Dr. Price convened in connection with his Physician Regulatory Relief project. A wide-range of topics were discussed, including:
- Mandatory appropriate use criteria for advanced diagnostic imaging;
- Delaying the global surgery data collection project;
- Minimizing the reporting burden under Medicare’s Quality Payment Program (QPP);
- Halting mandatory bundled payments;
- Streamlining and reforming prior authorization requirements; and
- Achieving EHR interoperability.
The AANS and CNS will continue to interface with HHS and CMS on this project, which we hope will lead to positive changes for neurosurgeons and their patients.
New Video Shows Physicians How to Avoid Medicare Payment Penalties
As a reminder to neurosurgeons, the Quality Payment Program (QPP) is the new Medicare physician payment system created by the Medicare Access and CHIP Reauthorization Act (MACRA) and administered by CMS. Because the QPP is new this year, the AANS and CNS, and our partners at the American Medical Association (AMA), want to make sure neurosurgeons know what they have to do to participate and the QPP’s “pick your pace” options for reporting. This is especially important for those physicians who have not participated in past Medicare reporting programs and may be less knowledgeable about the steps they can take to avoid being penalized under the QPP.
The AANS, CNS, AMA and others in organized medicine stressed to CMS the importance of establishing a transition period to QPP and, as a result, physicians only need to report on at least one quality measure for one patient during 2017 in order to avoid a payment penalty in 2019 under the Merit-based Incentive Payment System (MIPS).
A new short video developed by the AMA, “One patient, one measure, no penalty: How to avoid a Medicare payment penalty with basic reporting,” offers step-by-step instructions on how to report so physicians can avoid a negative 4 percent payment adjustment in 2019. On this website, ama-assn.org/qpp-reporting, there are also links to CMS’ quality measure tools and an example of what a completed 1500 billing form looks like.
CMS Releases Proposed Rules for the 2018 Quality Payment Program
On June 21, the Centers for Medicare & Medicaid Services (CMS) released the proposed rule for Medicare’s 2018 QPP. Per the document, CMS is proposing to increase the flexibility and reduce the burden of participating in the QPP — particularly for physicians in small practices. CMS will continue the gradual transition, which will minimize financial penalties and give neurosurgeons more time to implement this complex payment program. Click here for a fact sheet on the proposed rule and here for a comprehensive summary of the document. The AANS and CNS will submit a comment letter to CMS in August.
CMS Unveils Lookup Tool for Neurosurgeons to Determine Participation in MIPS
In May, to the CMS unveiled a new interactive tool on the QPP website to determine if neurosurgeons should participate in 2017. To determine your status, enter your national provider identifier (NPI) into the entry field on the tool located on the QPP homepage. You will then receive information on whether or not you should participate in the MIPS this year. To avoid financial penalties and qualify for an opportunity to earn bonus payments in 2019, neurosurgeons should participate in MIPS in 2017 if they:
- Bill Medicare Part B more than $30,000 a year; or
- See more than 100 Medicare patients a year.
Neurosurgeons new to Medicare in 2017 do not need to participate in the QPP. To learn more, review the MIPS Participation Fact Sheet. CMS also recently sent letters in the mail notifying clinicians of their MIPS participation status. For more information, the QPP Service Center may be reached at 1-866-288-8292 Monday through Friday from 8 a.m. to 8 p.m. EDT, or via email at QPP@cms.hhs.gov.
Coding and Reimbursement
Neurosurgery Responds to 2018 Medicare Hospital IPPS Proposed Rule
On June 13, the AANS and CNS sent a letter to CMS addressing several issues in the 2018 Medicare Hospital Inpatient Prospective Payment System (IPPS) proposed rule. In our comment letter, the AANS and CNS reinforced our support for physician-owned hospitals and urged the agency to allow for them to expand. We also stressed that inpatient status should be determined by the admitting surgeon.
Neurosurgery Comments on ICER Non-pharmacologic Spine Care Assessment
On April 28, the AANS, CNS and AANS/CNS Joint Section on the Disorders of the Spine and Peripheral Nerves sent a letter to the Institute for Clinical and Economic Review (ICER) regarding a document related to a future consideration of non-pharmacologic interventions for chronic low back and neck pain. The primary focus of the ICER report is to examine acupuncture, cognitive behavioral therapy, mindfulness, yoga and Tai Chi, as compared to the “usual spine care.” Our letter emphasized that while there may be a role for cognitive and mind-body therapy for a number of patients with chronic neck and low back pain, organized neurosurgery would like to emphasize the importance of exhaustive diagnostic imaging and comprehensive neurological assessment to identify those individuals who would benefit most from timely surgical intervention as opposed to non-operative measures, regardless of modality.
Drugs and Devices
CMS Releases 2016 Open Payments Data
In June, CMS released the 2016 Open Payments data. Open Payments is a program required by the ACA, which collects information about the payments drug and device companies make to physicians and teaching hospitals for things like travel, research, gifts, speaking fees and meals. This data is then provided to the public each year on this website. For 2016, device and drug companies paid $8.18 billion to 631,000 physicians and more than 1,100 teaching hospitals. More than half of the $8.18 billion in payments — $4.36 billion — was for research. To look up individual physician data click here.
Scott Gottlieb, MD, Becomes New FDA Commissioner
On May 9, by a vote of 57 to 42, the U.S. Senate confirmed Scott Gottlieb, MD, as Commissioner of the FDA. Dr. Gottlieb, a former deputy commissioner for medical and scientific affairs at the FDA from 2005 to 2007, most recently served as a venture partner at New Enterprise Associates and resident fellow at the American Enterprise Institute. Among his many areas of responsibility, Dr. Gottlieb will oversee the implementation of the 21st Century Cures Act (P.L 114-225), which provides significant investments to accelerate the discovery, development and delivery of new cures and treatments for all Americans. The AANS and CNS supported Dr. Gottlieb’s confirmation and joined with the Alliance of Specialty Medicine in sending a letter to Commissioner Gottlieb congratulating him on his confirmation.
AANS/CNS Drugs and Devices Committee Hosts Seminar with FDA Officials
On April 26, the AANS/CNS Drugs and Devices Committee hosted a breakfast seminar with FDA staff during the 2017 AANS Annual Scientific Meeting in Los Angeles. The program was coordinated by Committee Chair Robert F. Heary, MD, FAANS, and Carlos Pena, PhD, director of the FDA’s Center for Devices and Radiological Health (CDRH), Division of Neurological and Physical Medicine Devices. FDA Medical Officers, neurosurgeons Christopher M. Loftus, MD, FAANS, and Mohamad Bydon, MD, as well as other FDA staff and neurosurgeons, served as faculty. Slides highlighting the FDA presentations are available here. The committee and FDA staff are planning another educational event during the 2018 AANS Annual Scientific Meeting in New Orleans.
Graduate Medical Education
Neurosurgeon Elected to AMA’s Council on Medical Education
On June 13, CNS alternate delegate to the AMA, Krystal L. Tomei, MD, PhD, was elected to a position on the AMA’s Council on Medical Education (CME). The CME formulates policy on medical education — including graduate medical education financing, medical student debt and physician workforce. The CMS is also responsible for recommending the appointments of representatives to medical education organizations, accrediting bodies and certification boards — including the Residency Review Committee for Neurological Surgery.
Organized Neurosurgery Issues Position Statements on Telemedicine and Motorcycle Helmet Laws
On May 20, the AANS, CNS, AANS/CNS Section on Neurotrauma and Critical Care and the AANS/CNS Joint Cerebrovascular Section issued a position statement on telemedicine. In the statement, the group cited that the timely, effectual and high-quality delivery of neurosurgical care remains the paramount mission of neurosurgeons and their neuroscience colleagues. Organized neurosurgery endorses the appropriate use of telemedicine and telehealth technologies to maintain high-quality standards of care in neurosurgery, as well as the use of streamlined state medical license processes, development of comprehensive malpractice insurance programs, appropriate reimbursement and other necessary tools that would support the efficient adoption of telemedicine and telehealth technologies in neurosurgery.
Additionally, on May 7, the AANS, CNS, AANS/CNS Section on Neurotrauma and Critical Care and the ThinkFirst National Injury Prevention Foundation released a position statement on motorcycle helmet laws. In the statement, the group noted that their core mission is to prevent and mitigate traumatic brain and spine injury. To this end, organized neurosurgery endorsed universal motorcycle helmet laws for all motorcyclists in all states and pledged to oppose efforts of any state to repeal any universal motorcycle helmet law currently in effect. Further, the group urged states that have either repealed their universal helmet laws or have modified their laws to cover only a subgroup of riders with a partial motorcycle helmet requirement, to reinstate universal motorcycle helmet laws.
Neurosurgery Sends Letter to Modern Healthcare Regarding Medical Liability Article
On May 24, Modern Healthcare published an article, “Providers want Trump to stay out of tort reform.” The article incorrectly made assertions that did not represent the views of most physicians and providers, nor did they convey how our broken medical liability system drives up health care costs and threatens patient access to care. Thus, the Health Coalition on Liability and Access (HCLA), led by the AANS and CNS, submitted a letter to the editor, stating:
Contrary to the hypothesis that healthcare providers prefer state-based solutions, the Health Coalition on Liability and Access represents a broad range of providers who support federal medical liability reform. The coalition counts among its members the American Association of Neurological Surgeons, the American Association of Orthopaedic Surgeons, the American Medical Association, and the American College of Surgeons – among many other associations representing physicians and other healthcare professionals and institutions – showing clear support among providers for a comprehensive, uniform solution.
The letter, which was not published in the paper, went on to point out that:
In states across the country, access to care is threatened, and defensive medicine has become the new norm in order to avoid meritless lawsuits. While these lawsuits are dropped, withdrawn, or dismissed 68% of the time, they require a tremendous amount of time, energy, and money to defend against.
Federal medical liability reform will reduce medical lawsuit abuse, maintaining the integrity of the liability system for deserving patients and preserving patient access to care for all Americans.
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