Author: Katie O. Orrico
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 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
- Call 1-800-332-1088 to request a reporting form to complete and return by mail or by facsimile to 1-800-FDA-0178.
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 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 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 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, we 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.
Despite goals to improve coverage, the Congressional Budget Office (CBO) estimates 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.
Neurosurgery Sends Letter Supporting the CONNECT for Health Act
On June 1, the 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 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.
CNS Representatives Meet With HHS and CMS Leaders
On June 20, Washington Committee chair, Ann R. Stroink, MD, 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 authori- zation requirements; and
- Achieving EHR interoperability The 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 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 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 Unveils Lookup Tool for Neurosurgeons to Determine Participation in MIPS
In May, the CMS unveiled a new interactive tool on the QPP website (qpp.cms.gov) 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.
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 :00 am to 8:00 pm EDT, or via email at QPP@cms.hhs.gov.
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 appointment 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 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 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 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.