Skip to main content
Category

Medical Innovation

Celebrating 75 Years of NINDS: The Legacy and Impact of the Surgical Neurology Branch

By Medical Innovation, Medical ResearchNo Comments

This year marks the 75th anniversary of the National Institute of Neurological Disorders and Stroke (NINDS), a monumental milestone that offers an opportunity to reflect on its remarkable contributions to neurology and human neuroscience. Among the many significant components of NINDS, the Surgical Neurology Branch (SNB) stands out for its pioneering advancements and transformative impact on the treatment of neurological disorders. Established with the vision of integrating surgical techniques with neurological research, the SNB has played an instrumental role in shaping modern neurosurgery and advancing human neuroscience.

The SNB was established to address the growing need for specialized surgical interventions in the treatment of neurological disorders. Over the years, the SNB has become synonymous with innovation, spearheading groundbreaking research and developing novel surgical techniques that have revolutionized patient care. This translational approach, integral to the SNB, has led to significant advancements in the understanding and treatment of a wide range of neurological conditions. Many dedicated SNB clinician-investigators and basic scientists, including Maitland Baldwin, Igor Klatzo, John M. Van Buren, Ayub K. Ommaya, Richard J. Youle, Edward H. Oldfield, and Russell R. Lonser, have made significant advancements in understanding and treating various neuropathological conditions, including brain tumors, epilepsy, spinal cord injuries, and movement disorders. Their work has provided fundamental insights for delineating differences between cytotoxic and vasogenic edema, advancing treatments for Cushing disease, studying the effects of vascular endothelial growth factor, developing new methods for central nervous system drug delivery, and understanding the underlying pathophysiology and biology of familial tumor syndromes and malignant gliomas.

By fostering an innovative environment that bridges the gap between laboratory research and clinical practice, the SNB has been at the forefront of medical breakthroughs that have improved the lives of countless patients. This commitment to patient-centered care is central to the SNB’s mission. It is reflected in its focus on conducting cutting-edge research and clinical trials aimed at developing new treatments for neurological disorders, as well as translating basic scientific discoveries to the bedside. The branch is dedicated to providing compassionate, individualized treatment plans that address the unique needs of each patient evaluated and treated at the NIH Clinical Center, the world’s largest hospital dedicated solely to clinical research. This approach involves close collaboration between neurosurgeons, neurologists, radiologists, and other healthcare professionals to ensure that patients receive comprehensive, multidisciplinary care. The SNB also places a strong emphasis on patient education and empowerment. By providing patients and their families with detailed information about their condition and treatment options, the SNB helps them make informed decisions about their care. This patient-centered approach not only improves clinical outcomes but also enhances the overall patient experience.

An equally critical component of the SNB’s mission is to train and mentor the next generation of neurosurgeons. Over its history, dozens of former fellows and staff have gone on to become leaders of academic neurosurgery and chairs of neurosurgical departments. In 2010, the SNB further solidified its commitment to education by developing a residency-training program in neurological surgery. This program is designed to provide comprehensive training that encompasses clinical excellence, research acumen, and innovative thinking. By integrating rigorous clinical training with robust research opportunities, the SNB residency program aims to produce neurosurgeons who are well-equipped to tackle the complexities of neurological disorders and contribute to the advancement of neurosurgery. The SNB’s commitment to education also extends beyond its training program, with faculty members regularly participating in national and international conferences, workshops, and symposia. These efforts ensure that the latest advancements in neurosurgery are disseminated widely, fostering a global community of practitioners who are equipped with the knowledge and skills to provide the highest standard of care.

As NINDS celebrates its 75th anniversary, the SNB remains committed to advancing the fields of neurosurgery and human neuroscience through innovative research, education, and patient care. The future holds exciting possibilities, with ongoing research into new surgical techniques, neurotechnologies, and therapeutic approaches that have the potential to further transform the treatment of neurological disorders. The SNB’s legacy of excellence and innovation serves as a testament to the vision and dedication of its founders as well as the many talented individuals who have contributed to its success over the years. As we look ahead to the next 75 years, the SNB will continue to play a central role in shaping modern neurosurgery and advancing human neuroscience, paving the way for discoveries and treatments that will improve the lives of patients around the world.

Kareem A. Zaghloul, MD, PhD
National Institute of Neurological Disorders and Stroke, National Institutes of Health
Bethesda, Md.

2020 — A Year in Review

By Advocacy Agenda, Congress, Health Reform, Medical Innovation, Medical Liability, Prior AuthorizationNo Comments

While 2020 is a year that most people want to forget, the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) made significant strides in accomplishing its legislative and regulatory agenda, thus ensuring that neurosurgical patients continue to have timely access to quality care. Following are some highlights of these advocacy efforts.

Congress Prevents Steep Medicare Cuts

On Jan. 1, the Centers for Medicare & Medicaid (CMS) implemented the new CPT guidelines to report office and outpatient visits based on either medical decision making or physician time. These evaluation and management (E/M) services are valued in line with the AMA/Specialty Society RVS Update Committee (RUC) recommendations. Unfortunately, to comply with Medicare’s budget neutrality requirement, any increases must be offset by corresponding decreases, and CMS estimated that the 2021 policies would increase Medicare spending by approximately $10.6 billion. This necessitated significant cuts for many specialties, including an overall 6-7% payment cut for neurosurgery.

Faced with these steep Medicare payment cuts (and potential future cuts to the 10- and 90-day global surgical codes), in June 2020, the AANS and the CNS — with significant funding support from the Council of State Neurosurgical Societies and the Section on Disorders of the Spine and Peripheral Nerves — along with 10 other national surgical associations, founded the Surgical Care Coalition (SCC). The SCC launched a targeted, multi-faceted advocacy and public relations campaign to prevent these cuts. Specifically, the SCC advocated that Congress adopt legislation that would:

  • Increase the global surgery code values;
  • Halt implementation of the G2211 add-on code for complex E/M visits; and
  • Prevent any additional cuts resulting from the new E/M payment policies.

Working with the SCC and other physician and allied health professional organizations, the AANS and the CNS successfully advocated for legislation to prevent these cuts. On Dec. 27, 2020, President Donald J. Trump signed the Consolidated Appropriations Act, 2021 (H.R. 133) into law (P.L. 116-260) — a massive omnibus spending bill that includes nearly $900 billion for coronavirus relief and an additional $1.4 trillion spending package to fund the federal government through the end of the Fiscal Year 2021. Specifically, the legislation:

  • Prevents steep Medicare cuts by earmarking $3 billion to help offset the budget- neutrality adjustment and by delaying for three years the new G2211 add-on code for certain complex office visits;
  • Extends the moratorium on the 2% Medicare payment sequester for an additional three months through March 2021, allocating $3 billion for this purpose;
  • Increases payments for the work component of the MPFS in areas where labor cost is determined to be lower than the national average through Dec. 31, 2023; and
  • Temporarily freezes alternative payment model (APM) payment incentive thresholds for two years, allowing more physicians to qualify for the 5% APM bonus payments.

As a result of this combined relief, overall, neurosurgeons should not experience any Medicare payment cuts (although the specific impact will depend on the mix of services provided) in 2021.

However, our work is not complete. The surgical community will continue to advocate for CMS to adjust the 10- and 90-day global codes to reflect the increased values of the E/M portion of these codes. In that regard, on Dec. 1, Sen. Rand Paul, MD, (R-Ky.) introduced S. 4932, the “Medicare Reimbursement Equity Act.” If enacted, this legislation would require CMS to value the E/M portion of the global codes equal to the stand-alone E/M codes.

Progress Made in Reforming Prior Authorization

For the past two years, the AANS and the CNS have been tireless in their efforts to reform prior authorization in the Medicare Advantage (MA) program. Significant progress has been made, setting the stage for reforms in the coming year. Neurosurgery-backed legislation — the “Improving Seniors’ Timely Access to Care Act” (S. 5044 / H.R. 3107) — garnered overwhelming bipartisan support from nearly 300 members of Congress. If enacted, this bill would reform the use of prior authorization in Medicare Advantage (MA) through a streamlined and standardized process that focuses on increased transparency and accountability. The bill reflects a neurosurgery-supported consensus statement on prior authorization, developed by leading national organizations representing physicians, hospitals and health plans.

Specifically, the legislation directs the Secretary of the U.S. Department of Health and Human Services to:

  • Establish a real-time, electronic prior authorization process;
  • Minimize the use of prior authorization for routinely approved services;
  • Ensure prior authorization requests are reviewed by qualified medical personnel; and
  • Require MA plans to report on their use of prior authorization, including delay and denial rates.

This legislation will be reintroduced in the 117th Congress. More information is available from the Regulatory Relief Coalition, of which the AANS and the CNS are founding members.

Protecting Patients from Surprise Medical Bills

The AANS and the CNS have been advocating for federal legislation to protect patients from unanticipated medical bills (otherwise known as “surprise” medical bills) while at the same time providing for a fair process for resolving payment disputes. Organized neurosurgery adopted a set of principles for a balanced solution to the problem. After more than two years of sustained advocacy, Congress incorporated into the Consolidated Appropriations Act, 2021 (P.L. 116-260) the “No Surprises Act,” which applies to federally-regulated plans, including ERISA plans, and does not preempt state laws governing state-regulated health plans. The provisions of the new law, which will be implemented on Jan. 1, 2022, meet many of organized neurosurgery’s principles and include the following elements:

  • Patients are protected from surprise medical bills and only responsible for the in-network cost-sharing amount for out-of-network (OON) emergency services and other services provided in in-network facilities.
  • Insurers are required to make initial payments directly to OON providers for OON services within 30 days. The law does not define the payment rate.
  • If a provider objects to the payment, they may proceed to an independent dispute resolution (IDR) process.
  • The IDR process is baseball-style arbitration. There is no negotiation. Both parties submit a payment rate, and the arbiter selects one.
  • The arbiter may consider several factors, including median in-network rates and any other information the provider or health plan submits, other than billed charges, Medicare, Medicaid, CHIP and Tricare rates.

The AANS and the CNS will work with the incoming Biden Administration on the implementing regulations.

Supporting Quality Resident Training and Education

An appropriate supply of well-educated and trained physicians — both in specialty and primary care — is essential to ensure access to quality health care services for all Americans. Looming physician shortages — by 2033, the nation faces a physician shortfall of between 54,100 to 139,000 — threaten this access to care. To help ease this shortage and support quality resident training and education, the AANS and the CNS successfully advocated for legislation to increase the number of Medicare-sponsored residency training positions. The “Resident Physician Shortage Reduction Act” (S. 348 / H.R. 1763), with a total of 242 bipartisan cosponsors, would increase the number of available medical residency positions by 15,000 over five years.

While falling short of what is necessary to adequately address the looming physician workforce shortage, the Consolidated Appropriations Act, 2021 (P.L. 116-260) did provide funding for 1,000 additional Medicare-funded graduate medical education (GME) residency positions. The AANS and the CNS will build on this down payment by advocating for additional funding in the 117th Congress.

COVID-19 and the Global Pandemic

On March 13, 2020, President Trump issued an executive order declaring the COVID-19 pandemic a national emergency. Shortly after that, neurosurgical practices began temporarily suspending non-emergency neurosurgical cases and experiencing significant cash-flow challenges. Working with multiple coalitions of physician organizations in Washington, D.C., the AANS and the CNS stepped into high gear to advocate for financial and other relief for neurosurgeons.

Congress passed several COVID-19-related bills, which included vital assistance for physicians and hospitals. The Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748) and the Paycheck Protection Program and Health Care Enhancement Act (H.R. 266) established and funded the Paycheck Protection Program (PPP), allowing neurosurgical practices to receive grants to help keep their employees paid and their practices afloat. The Consolidated Appropriations Act, 2021 (P.L. 116-260) expanded current PPP legislation, adding $284 billion in funding for the PPP and extending it through March 31, 2021. Legislation also allocated more than $175 billion to the Public Health and Social Services Emergency Fund, helping with bridge funding for neurosurgeons and the hospitals in which they practice.

The expansion of telemedicine, and increased payments for telemedicine services, helped neurosurgeons continue to take care of their patients remotely and will likely be an integral part of neurosurgical practices in the future. Finally, the AANS and the CNS led efforts to secure COVID-19-related medical liability protections. The CARES Act included liability protections for physicians rendering volunteer medical services during the COVID-19 public health emergency. In addition, Reps. Phil Roe, MD, (R-Tenn.) and Lou Correa (D-Calif.) introduced H.R. 7059, the Coronavirus Provider Protection Act, and Sens. John Cornyn (R-Texas) and Mitch McConnell (R-Ky.) introduced S. 4317, the “SAFE TO WORK Act.” Both bills would provide physicians protections from certain COVID-19-related lawsuits. The AANS and the CNS will continue to advocate for the adoption of COVID-19 related liability protections in the 117th Congress.

Turning the Corner to 2021

The inauguration of Joseph R. Biden, Jr. as the 46th president of the United States will bring with it a new administration, along with changes in the 117th Congress, mean new health care policy priorities will be front and center on the national legislative and regulatory agenda. While these changes present organized neurosurgery with new opportunities to continue advocating for sound health policy that improves patient care, 2020 will go down as a year in which the AANS and the CNS made significant positive strides for neurosurgeons and patients alike.

Katie O. Orrico, Esq.
AANS/CNS Washington Office
Washington, DC

A Year in review: Making Progress on Neurosurgery’s Legislative and Regulatory Agenda

By Advocacy Agenda, Congress, Health Reform, Medical Innovation, Medical Liability, Prior Authorization, UncategorizedNo Comments

As we come to the end of a decade and head into 2020, it is fitting to reflect on the progress that the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) have made in advancing organized neurosurgery’s legislative and regulatory agenda to ensure that neurosurgical patients have timely access to quality care. At the beginning of 2019, we set forth an ambitious agenda, and throughout the year, the AANS and CNS continued to make progress on achieving our health policy goals.

Some highlights:

  • Protect Patients’ Timely Access to Care. Prior authorization is a cumbersome process that requires physicians to obtain pre-approval for medical treatments or tests before rendering care to their patients. To protect patients’ timely access to care, as leaders of the Regulatory Relief Coalition, the AANS and the CNS collaborated with key champions in Congress — Reps. Suzan DelBene (D-WA); Mike Kelly (R-PA); Roger Marshall, MD, (R-KS); and Ami Bera, MD, (D-CA) — to introduce H.R. 3107, the Improving Seniors’ Timely Access to Care Act. With 156 sponsors at year’s end, this bill would help protect patients from unnecessary delays in care by streamlining and standardizing prior authorization under the Medicare Advantage program.
  • Improve the Health Care Delivery System. Narrow insurance networks restrict patient access to the physician of their choice and leave patients vulnerable to unanticipated medical bills. Working to improve the health care delivery system, the AANS and the CNS successfully advocated for the introduction of legislation to protect patients from unanticipated medical bills. The Protecting People from Surprise Medical Bills Act (H.R. 3502), and the Stopping The Outrageous Practice (STOP) of Surprise Medical Bills Act (S. 1531), would hold patients harmless and ensure that they would only be responsible for in-network cost-sharing amounts when out-of-network providers take care of them. Patients would also be kept out of the middle of payment disputes between health plans and providers, and a process for fairly reimbursing providers for their services would be established.
  • Support Quality Resident Training & Education. An appropriate supply of well-educated and trained physicians — both in specialty and primary care — is essential to ensure access to quality health care services for all Americans. Looming physicians shortages — by 2032, the nation faces a physician shortfall of between 46,900 to 121,900 — threaten this access to care. To help ease this shortage and to support quality resident training and education, the AANS and the CNS successfully advocated for legislation to increase the number of Medicare-sponsored residency training positions. The Resident Physician Shortage Reduction Act ( 348 / H.R. 1763), with a total of 185 cosponsors, would increase the number of available medical residency positions by 15,000 over five years.
  • Continue Progress with Medical Innovations. America has a long tradition of excellence and innovation in patient care, and neurosurgeons have been on the cutting edge of these advancements. However, due to the medical device excise tax, American medical innovation and patient care have been at risk. Working with our partners in the medical technology industry for the past decade, the AANS and the CNS have been advocating for Congress to repeal this tax. This year, with the passage of H.R.1865, the Further Consolidated Appropriations Act, 2020, Congress demonstrated its commitment to continuing progress with medical innovation by repealing this tax. President Trump signed the legislation into law (P.L. 116-94). This bill also included increased funding for biomedical research in the neurosciences. Finally, Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) released their initial vision for their Cures 2.0 initiative, which aims to modernize insurance coverage policies and improve access to life-saving cures. Cures 2.0 would build on the original 21st Century Cures Act (P.L. 114-255), which aspires to advance medical research and foster a new era of medical innovations.
  • Fix the Broken Medical Liability System. Medical lawsuit abuse is driving up health care costs, and driving good doctors out of the practice of medicine, leaving patients without the care they need when they need it. Many doctors — particularly in high-risk specialties like neurosurgery — are cutting back on high-risk and life-saving services, relocating to states with more patient-friendly liability laws, retiring early or leaving the practice of medicine altogether. To help fix the broken medical liability system, as a leader of the Health Coalition on Liability and Access, the AANS and the CNS worked with leaders in Congress to introduce H.R. 3656, the Accessible Care by Curbing Excessive LawSuitS (ACCESS) Act, which is modeled after proven reforms that are in place in California and Texas. In addition, legislation to help ensure that physicians are available to take care of patients with medical emergencies is pending before the House and Senate — the Good Samaritan Health Professionals Act (S. 1350) and the Health Care Safety Net Enhancement Act (H.R.3984).

We still have our work cut out for us to continue advocating for sound health policy that improves patient care, but 2019 will go down as a year in which the AANS and the CNS made significant positive strides.

          

 

 

The FDA and Regulation – Neurosurgery Partners with FDA for Patient Safety, Innovation and Regulatory Reform

By Access to Care, Drugs and Devices, Guest Post, Health, Medical Innovation, Patient Safety, Regulatory ReliefNo Comments

Clemens M. Schirmer, MD, PhD, FAANS, FAHA (left) Vice-Chair, AANS/CNS Communications and Public Relations Committee Geisinger Wilkes Barre, PA Catherine Jeakle Hill (right) Senior Manager for Regulatory Affairs, Washington Office…

Read More