FDA Safety Announcement
FDA Issues Safety Communication Regarding Cranial Perforator Devices
On Sept. 28, 2015, the Food and Drug Administration (FDA) issued a safety communication to remind neurosurgeons about the techniques for the safe use of cranial perforators with an automatic clutch mechanism. The purpose of the notice is to reduce the risk that these devices will fail to disengage or stop drilling.
Click here for a copy of the notice.
Neurosurgery Joins Alliance in Support of "American Health Care Reform Act of 2015"
On July 20, 2015, the American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) joined forces with the Alliance of Specialty Medicine in sending a letter to Rep. Phil Roe, MD (R-Tenn.), thanking him for addressing several key issues in H.R. 2653, the "American Health Care Reform Act of 2015." In our letter, we commended him for including medical liability reform and repeal of the Independent Payment Advisory Board and Value-based Payment Modifier. The bill currently has 96 co-sponsors.
Neurosurgery Joins Surgical Coalition in Support of “Flex IT 2 Act”
On Sept. 8, 2015, organized neurosurgery teamed up with other surgical organizations in sending a letter to Rep. Renee Ellmers (R-N.C.) expressing appreciation to her for addressing the burdens of Medicare’s electronic health record (EHR) meaningful use (MU) program in H.R. 3309, the "Further Flexibility in HIT Reporting and Advancing Interoperability Act" or "Flex IT 2 Act." In our letter, we applauded her for providing much needed flexibility in the MU program including delaying Stage 3 rulemaking until certain conditions are met; considering the MU quality requirements to be satisfied if Physician Quality Reporting System (PQRS) Qualified Clinical Data Registry (QCDR) requirements are met; and by eliminating the all or nothing approach of the MU program. The bill currently has nine co-sponsors.
In related action, Reps. Ellmers, Tom Price, MD (R-Ga.) and David Scott (D-Ga.) led a Congressional letter effort urging regulatory relief for healthcare providers. The letter, signed by 116 members of Congress, urged Shaun Donovan, director of the Office of Management and Budget (OMB), and Sylvia Burwell, secretary of the Department of Health and Human Services (HHS), to refrain from finalizing Meaningful Use Stage 3. The AANS and CNS worked with our allies on Capitol Hill to gather signatures for this bipartisan letter.
AANS and CNS Urge Senate for CDC Injury Center Funding
On Sept.16, 2015, the AANS and CNS sent a letter to the U.S. Senate Appropriations Committee requesting increased funding for injury prevention at the Centers for Disease Control and Prevention’s National Center for Injury Prevention and Control. This money would be used to fund Injury Control Research Centers (ICRCs) to conduct research in all three core phases of injury control—prevention, acute care and rehabilitation—as well as support training and information centers for the public.
Congressional Neuroscience Caucus Hosts BRAIN Initiative Briefing
On Sept.10, 2015, the Congressional Neuroscience Caucus and the American Brain Coalition hosted a briefing on Capitol Hill. Co-chairs Reps. Cathy McMorris Rodgers (R-Wash.) and Earl Blumenauer (D-Ore.) heard from GE, Inscopix and the Brain and Behavior Research Foundation—organizations that have committed to support the Brain Research through Advancing Innovation Neurotechnologies (BRAIN) Initiative. Launched by the White House in April 2013, the BRAIN Initiative is a private-public partnership that seeks to tackle the essential question of how the brain works. The AANS and CNS are members of the American Brain Coalition and work closely with them on a regular basis.
If you have questions about these or other legislative issues, please contact Katie Orrico, director of the Washington Office, at email@example.com.
Coding and Reimbursement
ICD-10 Implemented on Oct. 1, 2015
As expected, on Oct. 1, 2015, the Centers for Medicare & Medicaid Services (CMS) implemented the ICD-10 diagnosis code set to replace the ICD-9 codes. Providers may no longer bill with ICD-9 codes after this date. However, as a result of advocacy by the AANS, CNS and others, Medicare claims in the first year will not be denied solely based on the specificity of the ICD-10 diagnosis codes provided, as long as the physician submits an ICD-10 code from an appropriate family of codes. For more information on ICD-10, click here.
Neurosurgery Responds to the Proposed 2016 Medicare Physician Fee Schedule
On Sept. 8, 2015, the AANS and CNS sent a letter to the Centers for Medicare & Medicaid Services (CMS) regarding a number of items in the 2016 Medicare Physician Fee Schedule proposed rule, which was released in July 2015. Overall, the proposed changes resulted in a net 1 percent decrease in payments to neurosurgeons, due primarily to a change in the methodology for calculating malpractice relative value units. Among other items in the letter, the AANS and CNS urged CMS to:
- Clarify and assure the accuracy of the data it used to determine neurosurgery professional liability premiums and to publish the data in a format that is readily understandable;
- Maintain the current 10- and 90-day global payment policy; and
- Reject revaluing “add-on” CPT codes 22614, 22840, 22842 and 22845.
In addition to our efforts, organized neurosurgery joined forces with the Alliance of Specialty Medicine to send a separate group letter to CMS regarding the proposed rule. CMS is expected to publish the final fee schedule rule on or about Nov. 1, 2015.
Neurosurgery Comments on Washington State Lumbar Fusion Policy
On Sept. 17, 2015, the AANS, CNS, Joint Section on Disorders of the Spine and Peripheral Nerves and the Washington State Association of Neurological Surgeons (WSANS) sent a letter to the Washington State Health Care Authority Health Technology Assessment (HTA) Program. The letter responded to a draft technical assessment document prepared by the Institute for Clinical and Economic Review (ICER) as part of the HTA Program’s re-review of its current coverage policy for lumbar spinal fusion, which was developed in 2008. An updated coverage policy for lumbar fusion will be considered and voted upon by the Health Technology Clinical Committee on Nov. 20, 2015. The AANS and CNS are working closely with WSANS as the review process goes forward.
CMS Declines to Rescind Inappropriate Edit Prohibiting Reporting of Arthrodesis with Laminectomy
Despite organized neurosurgery’s ongoing efforts, on Sept. 1, 2015, the Centers for Medicare & Medicaid Services (CMS) sent the AANS and CNS a letter stating that the agency will not rescind the National Correct Coding Initiative (NCCI) edit prohibiting the reporting of CPT codes 63042 (laminotomy...; lumbar) or 63047 (laminectomy...; lumbar) with CPT codes 22630 or 22633 (arthrodesis; lumbar) when performed at the same interspace. The AANS and CNS have strongly opposed the edit, urging CMS to repeal this coding change.
AANS and CNS Comment on Proposed Medicare Hospital Outpatient Regulation
On Aug. 31, 2015, the AANS and CNS sent a letter to the Centers for Medicare & Medicaid Services (CMS) regarding a number of provisions in the 2016 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Proposed Rule . In our letter, the AANS and CNS supported the CMS proposal to remove four spine codes from the inpatient-only list — CPT codes 20936, 20937, 20938 and 22552 — requesting that these also be included on the ASC list. The letter stressed, however, that the site of service should be determined by the operating surgeon in consultation with the patient. In addition, organized neurosurgery supported the use of a modifier for reporting a single session of stereotactic radiosurgery (SRS) to allow CMS to collect accurate cost data. We also urged CMS to eliminate the so-called “two-midnight” rule. CMS is expected to publish the final rule on or about Nov. 1, 2015.
Neurosurgery and the Multispecialty Pain Workgroup Send Letter to Washington State Regarding Spinal Injection Policy
On Sept. 15, 2015, the AANS and CNS joined 12 specialty society members of the Multispecialty Pain Workgroup (MPW) and the Washington State Association of Neurological Surgeons (WSANS) in sending a letter to the Washington State Health Care Authority Health Technology Assessment Program regarding draft questions for an updated evidence assessment published on Sept. 1, 2015. The Health Technology Clinical Committee (HTCC) will review and update its current policy, which was developed in 2011, on March 18, 2015. Click here for more information.
If you have any questions regarding these or other reimbursement issues, please contact Cathy Hill, senior manager for regulatory affairs, at firstname.lastname@example.org.
CMS and ONC Release Final Rules for EHR Incentive Programs
On Oct. 6, 2015, the U.S. Department of Health and Human Services released two major rules pertaining to the electronic health record (EHR) meaningful use program. The “Medicare and Medicaid Programs Electronic Health Record Incentive Program–Stage 3 and Modifications to Meaningful Use in 2015 through 2017” final rule includes changes in current reporting requirements, as well as setting forth requirements for meaningful use (MU) Stage 3, which is planned for implementation in 2018. The “2015 Edition Health Information Technology Certification Criteria, 2015 Edition Base Electronic Health Record Definition, and ONC Health IT Certification Program Modifications” rule finalizes new certification criteria for EHR systems that will qualify for achieving MU in Stage 3.
With regard to the modifications rule, CMS, among other things, shortened the 2015 reporting period from a full calendar year to any 90 consecutive days in 2015 and reduced the overall number of measures required to achieve meaningful use (MU). In addition, the rule establishes the requirements for Stage 3 of the program as optional in 2017 but required for all participants beginning in 2018. CMS also continues to encourage the electronic submission of clinical quality measure (CQM) data, establishes requirements to transition the program to a single stage and aligns reporting for providers in EHR incentive programs. CMS officials acknowledged the new rules are almost guaranteed to be revised in the coming months in order to accommodate federal legislation passed earlier this year. In a press statement accompanying the release of the rules, CMS announced “a 60-day public comment period to gather additional feedback about the EHR incentive programs going forward, in particular with the Medicare Access and CHIP Reauthorization Act (MACRA)."
While not clearly explained in the rule, providers who are unable to meet the requirements of MU for the 2015 reporting period for reasons related to the timing of the publication of the final rule may apply for a hardship exception under the "extreme and uncontrollable" circumstances category. Each hardship exception application will be reviewed on a case-by-case basis. Click here for more information on how to apply for a hardship exception.
Prior to the release of the final rules, the AANS and CNS joined the American Medical Association and nearly 50 national medical specialty societies in sending a letter to the Department of Health and Human Services and a letter to the Office of Management and Budget (OMB) urging Secretary Burwell and OMB Director Shaun Donovan to (a) pause MU Stage 3 and reevaluate the program; (b) finalize the Stage 2 modifications rule (allowing for 90-day only reporting); and (c) establish an additional hardship exemption category for physicians who could not anticipate and comply with new program mandates so late into the year. This issue unites the entire physician community, and we remain hopeful that we can make progress so as to bring neurosurgeons relief from this burdensome regulatory scheme.
PQRS Payment Adjustment Review Period Underway
Eligible professionals (EPs) and group practices participating in the Physician Quality Reporting System (PQRS) who believe they were incorrectly assessed a negative payment adjustment for 2016 may ask the Centers for Medicare & Medicaid Services (CMS) to review their adjustment determination through Nov. 9, 2015, by submitting an informal review request at the quality reporting portal. Review decisions are final and should be received within 90 days. Individual EPs, Comprehensive Primary Care practice sites and group practices participating in PQRS must satisfactorily report quality data for covered professional services in 2014 to avoid a 2 percent payment reduction in 2016. For more information, see the CMS fact sheet or watch the CMS video entitled, "PQRS/Value-Based Provider Modifier: What Medicare Professionals Need to Know in 2015.”
AANS and CNS Comment on Proposed 2016 Medicare Physician Fee Schedule Quality Provisions
On Sept.8, 2015, the AANS and CNS submitted comments to the Centers for Medicare & Medicaid Services (CMS) on its 2016 Medicare Physician Fee Schedule (MPFS) proposed rule. In our comments, the AANS and CNS cautioned against moving too quickly to make physician quality and cost performance data available to the public, especially in formats that could result in misuse or misinterpretations of the data. Additionally, with regard to the Physician Quality Reporting System (PQRS) program, we expressed support for allowing group practices to participate via Qualified Clinical Data Registries (QCDRs) and requested that CMS publish specifications for newly proposed quality measures prior to rule making. The AANS and CNS also reiterated our opposition to the measures and methodologies used to make "value" determinations under the Value-Based Payment Modifier (VM) program and encouraged the agency to continue to improve the format and accuracy of Quality and Resource Use Feedback Reports (QRURs). Finally, we offered broad initial recommendations related to the new Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) program, authorized under the Medicare Access and CHIP Reauthorization Act (MACRA), to replace existing federal quality reporting mandates.
Comprehensive Care for Joint Replacement Model
On Sept. 8, 2015, the AANS and CNS submitted comments to the Centers for Medicare & Medicaid Services (CMS) on its newly proposed Comprehensive Care for Joint Replacement (CCJR) model , which is a bundled payment model for hip and knee replacement surgery that would target hospitals in specific locations across the U.S., starting on Jan. 1, 2016, that do not currently participate in CMS' Bundled Payments for Care Improvement (BPCI) initiative. Unlike the BPCI, targeted hospitals would be mandated to accept financial accountability for the quality and cost of treating Medicare fee-for-service beneficiaries during a hip/knee replacement "episode." Although this model would not impact neurosurgeons directly, the AANS and CNS felt the need to take advantage of this opportunity to point out weaknesses should CMS decide to apply this model to other procedures in the future. Organized neurosurgery's concerns include: the unprecedented mandatory nature of the model; CMS' aggressive timeline; the need to ensure that physicians play a leading role; the inadequacy of the proposed risk adjustment methodology; inappropriate spending targets that could put patient access at risk and stifle innovation; a lack of incentives for patients to be more actively involved in their care; and the need to first establish a more robust foundation of data before applying such models.
The AANS and CNS reminded CMS that bundled payment models have a chance of succeeding only where care is being done in a relatively similar and predictable manner. It will be much more challenging and possibly inappropriate for other procedures that are non-elective, have lower patient volumes and are more heterogeneous in regards to approach, costs, outcomes and patient populations. Organized neurosurgery urged CMS to work closely with professional societies and their clinical experts to determine which procedures are most appropriate for this model and which will require more innovative approaches.
AANS/CNS Nominee Appointed to HHS Advisory Committee
Nominated by the AANS and CNS, Harold D. Miller, president and CEO of the Center for Healthcare Quality and Payment Reform, was recently appointed to the new Physician-Focused Payment Model Technical Advisory Committee. Established by the Medicare Access and CHIP Reauthorization Act (MACRA), this committee will provide comments and recommendations to the Secretary of the U.S. Department of Health and Human Services on physician payment models.
Evaluating and Understanding New Payment Model Commercial Payer Contracts
Commercial payers are increasingly pursuing contracts with physicians based on new payment models, such as pay-for-performance and bundled or episode-based payment. These alternative payment models can rely on both cost and quality metrics to determine payment rates for physicians. Navigating the assortment of new payer contracts can be made easier by gaining an understanding of payer agreements, and the portions of those agreements that should be prioritized and can be negotiated. To this end, the American Medical Association (AMA) recently developed two new resources that explain key issues physicians should consider when evaluating such agreements.
If you have any questions regarding these or other quality-related issues, please contact Rachel Groman, vice president for clinical affairs and quality improvement at Hart Health Strategies, via email at email@example.com.
John L.D. Atkinson, MD Receives AWS’ 2015 Past President Honorary Member Award
On Oct. 5, 2015, during the American College of Surgeons’ 2015 Clinical Congress, at its Foundation Awards Dinner, the Association of Women Surgeons (AWS) presented John L.D. Atkinson, MD, with the 2015 AWS Past Presidents’ Honorary Member Award. This prestigious award is given to individuals supportive of the goals of the AWS. Dr. Atkinson is a professor of Neurosurgery at the Mayo Clinic College of Medicine and currently serves on the American College of Surgeons’ Board of Regents.
Maya Babu, MD Selected to Participate in ABMS’ Visiting Scholars Program
On Oct. 5, 2015, Maya Babu, MD was selected to participate in the American Board of Medical Specialties Research and Education Foundation's Visiting Scholars Program for 2015-16. Dr. Babu’s project, “The Practicing Neurosurgeon: Perceptions of Maintenance of Certification (MOC) and Recognized Focused Practice,” will determine clinically active neurosurgeons’ perceptions about the value of MOC and Recognized Focused Practice. It will also explore the construction of a meaningful MOC process that achieves the goals of providing education and confirming clinical competency for the specialty.
Alex B. Valadka, MD Pens Guest Column for Morning Consult
AANS treasurer, Alex B. Valadka, MD, recently authored a guest column for Morning Consult regarding patient access to specialty care. In the piece, Dr. Valadka wrote, “As a physician, I’m very concerned about the current state of our healthcare system. There are many critical issues that have the potential to jeopardize patient access to specialty care. As a nation, we cannot ignore these problems if we are serious about improving the well-being of our patients. It is time for Congress to step up to the plate and address the continued shortcomings of our healthcare system.” Dr. Valadka pointed out the problems associated with the implementation of the Independent Payment Advisory Board (IPAB), a lack of funding for graduate medical education (GME) and the myriad problems associated with electronic medical record (EMR) systems.
AANS and CNS Sponsor Ad Supporting Fast Act
In August 2015, the AANS and CNS joined the American Heart Association/American Stroke Association in sponsoring an advertisement in Politico, urging members of Congress to co-sponsor H.R. 2799, the “Furthering Access to Stroke Telemedicine Act.” This legislation would expand access to certain stroke telehealth services.
Neurosurgery Blog Takes Part in Neurosurgery Awareness Month
In August 2015, organized neurosurgery took part in a variety of activities for Neurosurgery Awareness Month. In recognition of this month, Neurosurgery Blog developed an animation entitled, “Neurosurgeons are NOT Just Brain Surgeons,” which provides a brief overview about the breadth of neurosurgery and neurosurgeons. Within just the first three days, nearly 2,500 people viewed the video. To date, it has over to 5,000 views, making it our most successful video. In addition, Neurosurgery Blog posted multiple blogs with content relating to the month, including:
Additionally, 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.
If you are interested in these communications activities, please contact Alison Dye, senior manager of communications, at firstname.lastname@example.org.