Window of Opportunity in Washington

The 2000 elections are now several months behind us, and President George W. Bush and the 107th Congress are moving forward to establish a new bipartisan approach to implementing a number of healthcare initiatives that will impact neurosurgeons and their patients. While it remains to be seen whether this cooperative spirit will continue once the legislative process is under way in earnest, having a Republican-controlled government in place should help organized neurosurgery achieve some legislative and regulatory successes over the next two years.

It clearly will not be easy, however, given the fact that the Senate is evenly split between Republicans and Democrats, Republicans hold the slimmest margin of control in the House of Representatives, and the president was elected to office without achieving the majority of the popular vote. Add to this the belief by Democrats that they are within striking distance of regaining control of both houses of Congress in 2002 (and possibly sooner in the Senate) and graciousness may give way to gridlock, thus creating a political dynamic that prevents neurosurgery from advancing its health policy agenda. The AANS and CNS, along with other medical organizations, are moving quickly to take advantage of the “honeymoon” period that currently exists to try to get fast action on a number of key issues.

New Faces in Key Positions
Every election brings change, and this one was certainly no exception. Obviously, with the new Bush Administration there will be a whole host of new players in key positions of power within the Executive Branch. At press time only a handful of appointments had been made, but the confirmation of Wisconsin Governor Tommy Thompson as Secretary of the Department of Health and Human Services is viewed as being positive for organized medicine.

Other key appointments will include the new Administrator of the Health Care Financing Administration (HCFA) and HCFA’s new Director of the Center for Health Plans and Providers. Both individuals will have a great deal of influence over the regulations and policies that impact neurosurgeons, and neurosurgery remains hopeful that they will be individuals who are supportive of physicians.

The 107th Congress likewise brings with it change, including numerous new committee chairmen and members giving organized neurosurgery new opportunities for advancing its agenda. Two important events that have changed the congressional committee structure are noteworthy, as they will impact the process by which legislation moves through the Congress. First, in the House, all members who have held committee chairmanships since 1994 have had to relinquish their positions due to a term limit rule implemented when the Republicans took control. As a result, virtually all of the House committees with jurisdiction over health issues now have new chairmen.

Second, to reflect the 50-50 make-up of the Senate, Majority Leader Trent Lott (R-MS) and Minority Leader Tom Daschle (D-SD) have entered into a power sharing arrangement that equally allocates between Republicans and Democrats the number of committee slots. To advance any legislation, therefore, Republicans and Democrats will have to work out their differences on a bipartisan basis in committee or face potentially rancorous fights to break gridlock on the Senate floor.

Over the years, the AANS and CNS have established excellent relationships with many of the new “power brokers,” both through individual neurosurgeons and through the AANS/CNS Washington Office. These relationships will clearly help neurosurgery as it moves its agenda through the legislative and regulatory processes.

Alignment with the President
Healthcare continues to be a prominent issue on the national policy agenda, thus providing the AANS and CNS with the opportunity to get some needed legislative and regulatory changes that will benefit neurosurgeons. The issue that will most likely receive the most national attention will be Medicare reform, especially the addition of a new prescription drug benefit to the Medicare program. And while this may be the most visibly debated health policy issue over the next two years, it is unclear whether consensus will be reached given significant partisan differences that exist regarding the structure and costs of this new benefit, and indeed, how to reform the Medicare program as a whole.

Neurosurgery must clearly keep an eye on this debate, however, especially given the fact that policymakers are fond of paying for new Medicare benefits by reducing current Medicare provider reimbursement. The debate over this issue may also prove to be critical in terms of defining the political climate for all legislative activities in the Congress. If disagreements on this issue become particularly partisan and ugly, gridlock is likely to ensue and neurosurgery will find it difficult to move its priority issues through the legislative process.

Aside from Medicare reform, there are numerous other legislative and regulatory issues that will be on the front burner during this session of Congress. And while the Washington Committee has a broad agenda, monitoring legislative and regulatory activities on almost all healthcare issues, given its limited resources and “niche” in the healthcare system, neurosurgery must focus on those issues that are most important to neurosurgeons so we can allocate our resources accordingly. At the same time, it must be sensitive to those issues that are being debated by policymakers and stakeholders, so it can maximize opportunities for success. To this end, the Washington Committee will be working on monitoring issues for the upcoming two years, recognizing, of course, that the legislative and regulatory processes are fluid. Fortunately, it appears that many of neurosurgery’s priorities mirror those of President Bush and the majority of Congress, which will greatly enhance advocacy efforts.

Regulatory Relief
Shortly after taking the oath of office on January 20, 2001, in one of his first acts as president, President Bush issued a memorandum postponing for 60 days the implementation of regulations that were published in the Federal Register just before he took office. The memorandum also prohibits the publication of proposed or final regulations that have been sent to the Office of Federal Register, but have not yet been published, unless and until a Bush-appointed department or agency head reviews and approves it. The memorandum was intended to delay or prevent the implementation of a whole series of regulations (including several controversial Medicare policies) promulgated by former President Clinton in the 11th hour of his administration. Thus, the stage was set for implementing one of President Bush’s high priorities – regulatory relief.

Not to be outdone, members of Congress are likewise moving forward with their own regulatory relief proposals. High on the list of agencies needing major reform is the much-maligned HCFA. As most neurosurgeons well know, over the past decade HCFA has been responsible for implementing a number of regulations and policies that have had a negative impact on practicing neurosurgeons. Examples include reductions in Medicare reimbursement through unreasonable changes in the RBRVS, implementation of onerous and clinically irrelevant evaluation and management documentation guidelines, and the promulgation of unreasonable fraud and abuse regulations.

Throughout the year, there will be a series of congressional hearings on this topic, and the AANS and CNS are currently working closely with several members of Congress in drafting legislation that will address this problem. In addition, the Medicare Payment Advisory Commission (MedPAC) is preparing a report to Congress, which will evaluate the regulatory burdens of Medicare on all providers. The report is scheduled to be released in the fall and will make specific recommendations on solutions to the many problems experienced under the current regulatory system. Some areas that will be covered by the MedPAC review include:

• Coverage process (both local and national)
  
  
• Payment policies
  
  
• Enforcement and implications for non-compliance
  
  
• Beneficiary education and protection
  
  
• Different vehicles for regulation by different regulators (i.e., regulations issued not just from the federal government through the Federal Register but from carrier manual instructions, private insurers, states, Congress and multiple federal agencies)
  
  
• Regulatory process (i.e., actual process for developing regulations, including informal communication with stakeholders and compliance with such statutes such as the Administrative Procedures Act, Paperwork Reduction Act, etc.)
  
  
• Burden of regulations on providers (i.e., magnitude of regulations, implications for small vs. large practices, compliance with ever changing moving targets)

The AANS and CNS will work closely with MedPAC as the Commission works on this important report, which may ultimately serve as the blueprint for reform.

Patients’ Bill of Rights
The political environment for passage of a comprehensive managed care reform bill appears to have improved considerably. The issue proved to be a popular campaign theme for congressional candidates in last year’s elections and congressional leaders recognize the need to pass a meaningful Patients’ Bill of Rights. In addition, in the first month of his administration, President Bush, who signed into law similar legislation as Governor of Texas, signaled his strong commitment to this issue, pledging to complete work on a compromise bill by late spring. The President supports a bill that includes these principles:

• comprehensive patient protections such as access to emergency room and specialty care
  
  
• rapid medical review when claims are denied
  
  
• a review process that ensures doctors make medical decisions and patients receive timely care
  
  
• health plans are held accountable in court if they wrongly denied care
• patient protection laws encourage, not discourage, employers to offer healthcare
  
  

Simultaneous with the release of the president’s principles, Republicans and Democrats in both the House and Senate joined to introduce the “Bipartisan Patient Protection Act of 2001″. This bill is a slightly modified version for the legislation that overwhelmingly passed the House of Representatives in the 106th Congress. The key differences between the president’s principles and the Bipartisan Patient Protection Act remain: (1) the scope of the legislation, i.e., whether it apply to all Americans who currently have health insurance and (2) the ability to sue health insurers for injuries caused by delays and denials of care.

The AANS and CNS, through its leadership and participation in the Patient Access Coalition, are continuing to be key players in this debate. To this end, neurosurgery is working to ensure that any patient protection legislation includes the following key elements:

• Timely access to specialty care, both in-network and out-of-network
  
  
• Ability of patients to see the physician of their choice through the offering of a “point of service” option
  
  
• Coverage of emergency medical services under the “prudent layperson” standard
  
  
• Coverage of routine patient costs incurred for items and services furnished in connection with participation in approved clinical trials
  
  
• Timely internal and independent external appeals processes
  
  
• Ban on financial incentives to limit referrals to specialty care

Protections must apply to all patients in all health plans to the extent that they are not protected by stronger state laws.

The health insurance and business communities are once again gearing up to defeat a comprehensive patients’ bill of rights, although privately some industry representatives have acknowledged that passage of this legislation is inevitable.

Antitrust Relief
During the 106th Congress, organized medicine scored a tremendous victory with the overwhelming passage of HR 1304, the Quality Health Care Coalition Act (the “Campbell Bill”) in the House of Representatives. Unfortunately, this legislation was never considered by the Senate, and it died at the end of the session. The effort was not in vain, however, as it helped educate Congress on the need to “level the playing field” between health insurance companies and physicians by providing physicians with antitrust relief that would enable them to negotiate jointly with health plans.

This year the dynamics surrounding this legislation have changed. First, its principle sponsor, former Rep. Tom Campbell, lost his bid for the U.S. Senate, and is no longer a member of Congress. Second, due to the committee term limits, Henry Hyde (R-IL) is no longer the chairman of the House Judiciary Committee, replaced instead by James Sensenbrenner, who vocally opposed the Campbell bill last year. Finally, key leaders in the Senate remain opposed to a Campbell-style approach, once again creating a difficult political setting for passage of legislation that will give physicians an antitrust exemption for joint negotiations.

All hope is not lost, however. The AANS and CNS are continuing to work closely with the AMA and others to fashion a compromise proposal that will meet the needs of physicians, while at the same time satisfying those who opposed last year’s measure. Neurosurgery is considering an approach that has the following elements:

• Change the standard of review under the antitrust laws when two or more physicians jointly negotiate with health plans to a “rule of reason” standard rather than the current “per se” standard. If the conduct was found to be anticompetitive under the less onerous standard, damages would be limited to actual damages (rather than treble damages under the per se rule).
  
  
• Create a demonstration project in certain limited areas, conducted in conjunction with a study that would allow two or more to engage in such activities under the antitrust laws without challenge. The demonstration project could be modeled after the Campbell bill or some other approach.
  
  
• Increase scrutiny of health plans’ market power.
  
  

Former Rep. Tom Campbell continues to be committed to assisting physicians on this issue, and is working with neurosurgery and other medical specialties to achieve passage of this important legislation. Despite opposition by some congressional leaders, there is widespread support for providing physicians with some antitrust relief. In addition, as Governor of Texas, President Bush signed legislation that provided physicians with a limited ability to jointly negotiate with health plans. No final resolution of this issue will be likely in 2001, however.

Improving Trauma Care
Federal policymakers are beginning to understand that the Emergency Medical Services (EMS) system is in the midst of a growing crisis for a variety of reasons, including a recognized shortage of on-call specialists. In addition, there is a growing sensitivity to the fact that over the years the HCFA has inappropriately expanded the scope of the Emergency Medical Treatment and Labor Act (EMTALA). In recognition of this, there has been some initial government action related to improving the EMS system:

• Payment for On-Call Stipends. Last year’s budget bill included a provision allowing “critical access” hospitals to include on their Medicare cost reports the costs associated with paying on-call stipends.
  
  
• GAO Report to Congress. Last year Congress mandated that the General Accounting Office (GAO) conduct a review of EMTALA. The report will evaluate (1) reimbursement for EMTALA- mandated services (including on-call physician compensation), (2) the extent to which EMTALA is an “unfunded mandate”, and (3) whether the “scope” of EMTALA has been inappropriately expanded. A final report is expected later this spring.
  
  
• Proposed HCFA Regulations. HCFA had been preparing a new EMTALA regulation that would have significantly expanded the reach of EMTALA to apply not just to patient “transfers” but also to all “discharges.” This regulation is currently on hold, pending reconsideration by the Bush Administration.
  
  
• OIG Reports. In January, the HHS Office of Inspector General (OIG) issued two EMTALA related reports. “The Emergency Medical Treatment and Labor Act: Survey of Hospital Emergency Departments” describes the results of a mail and telephone survey of emergency department managers, doctors, nurses, and registration staff as well as on-call physicians. The OIG found, among other things, that managed care reimbursement practices create special problems in complying with EMTALA and that hospitals are having difficulty staffing on-call panels for some specialties because of a lack of payment for these services. Neurosurgery was listed as the number one specialty in which specialist coverage is a problem. The second report, “The Emergency Medical Treatment and Labor Act: The Enforcement Process,”: was critical of HCFA’s enforcement process, finding that the enforcement process is compromised by long delays and that EMTALA investigations vary widely by region. In addition, the OIG found that HCFA does not always obtain peer review before it considers terminating a hospital for EMTALA violations. Finally, despite HCFA instructions, the OIG found that state survey agencies don’t always use review physicians who are board-certified and actively practicing in the same medical specialty as the physician treating the patient whose case led to an alleged violation. The report recommended that HCFA establish an EMTALA technical advisory group that includes representatives from the medical specialty societies.
  
  
• Trauma Systems Funding. In the final FY 2001 appropriations bill, the Congress allocated $3 million for the Trauma Care Systems Planning and Development Act, which will assist states and localities to develop organized trauma systems.
  
  

At the request of the AANS/CNS Section on Neurotrauma and Critical Care, the Washington Committee has made improving neurotrauma care a high priority on our advocacy agenda. To this end, neurosurgery is working with the Section (and others in organized medicine) to develop an action plan that will build on the groundwork laid by these recent government actions. The plan will include suggested legislative and regulatory modifications to the EMTALA law and mechanisms and strategies for increasing trauma reimbursement (including reimbursement for on-call coverage). In addition, the plan will incorporate recommendations for trauma systems development, including increasing federal financial support. The timing for this initiative is ideal, and neurosurgery is hopeful that this will be an area with solid results that will significantly benefit all neurosurgeons.

Other Issues
The AANS and CNS will continue to be active on a whole series of other issues, which will likely require some action of one kind or another over the next two years. These include:

• Developing reasonable and clinically relevant Evaluation and Management Documentation Guidelines
  
  
• Improving Medicare reimbursement through changes to the RBRVS, increases in the conversion factor and accurate use of Correct Coding Initiative (CCI) edits
  
  
• Improving and updating CPT codes
  
  
• Ensuring reasonable application of fraud and abuse laws and regulations
  
  
• Ensuring the continued federal support for graduate medical education
  
  
• Promoting increased funding for biomedical research
  
  
• Passage of medical malpractice reform
  
  

What Will the Future Hold?
When President Clinton took office in 1993, he quickly went to work on a signature issue of his presidential campaign-healthcare reform. He appointed first lady Hillary Rodham Clinton and White House adviser Ira Magaziner to head a 500-person task force that sent a detailed bill to Congress for consideration. Members of Congress (including Democrats) and other key stakeholders were excluded from the decision-making process, and they did not appreciate being shut out. No legislation was ever brought to the House or Senate floors for a vote and during the mid-term elections of 1994 the Democrats lost control of the House of Representatives.

President Bush seems to be getting off to a much different start, although it is too early to draw any conclusions about how things will unfold. Unlike former President Clinton, President Bush appears willing to let Congress (both Republicans and Democrats) and stakeholders (such as physicians) play a prominent role in shaping healthcare legislation, even if it means compromising on some of his own ideas and positions.

In addition, President Bush is filling his staff roster with what seems to be a healthy mix of seasoned Washington “insiders” as well as individuals from outside the Beltway. Finally, House and Senate leaders have pledged to overcome past partisan divisions, which will facilitate the president’s agenda through Congress. The convergence of all of these elements should theoretically make for a productive two years in Washington. If these efforts fail, however, the 107th Congress may prove to be even more “do nothing” than its predecessors and the 2002 mid-term elections could result in yet another shift in the balance of power. Whatever the outcome, the next two years in Washington will certainly be worth watching.

Katie Orrico, JD, is Director, AANS/CNS Washington, D.C. Office.

Bipartisan Patients’ Bill Introduced
On Feb. 8, 2001, Senators John McCain (R-AZ) and John Edwards (D-NC) and Reps. Greg Ganske (R-IA) and John Dingell (D-MI) introduced the “Bipartisan Patient Protection Act of 2001.” Key provisions of the bill are:

• Patient Protections. Protections include access to emergency care, access to specialty care, access to non-formulary drugs, access to clinical trials, direct access to pediatricians and ob-gyns, continuity of care for those with ongoing healthcare needs and access to important health plan information.
  
  
• Appeals Process. The bill outlines criteria and time frames for initial claims review and internal appeals procedures. It establishes an independent, speedy external review process for patients dissatisfied with the results of the internal review. External appeals will be resolved by independent medical experts.
  
  
• Exhaustion Required. Patients must always exhaust internal and external appeals before going to court. The sole exception is when the death or irreparable injury has already occurred prior to completion of the appeals process. However, either party may request that the appeals process continue and the results of this process may be considered in court.
  
  
• Liability. The bill’s liability language draws a line between cases of injury or death involving administrative decisions, which would be heard in federal court, and cases which involve medically reviewable decisions, which would be heard in state court.
  
  
• Punitive Damages. For cases of personal injury or death pertaining to medically reviewable decisions (those heard in state court), state law would apply, including any caps on damages or other restrictions. Additionally, punitive damages are specifically prohibited in state court if the plan complies with the internal and external appeals process, unless clear and convincing evidence shows the plan acted with willful or wanton disregard for the rights and safety of others. However, in this instance, any state law caps on punitive damages would still apply. For cases of injury or death involving non-medically reviewable decisions (those heard in federal court), punitive damages are specifically prohibited. However, if a plan acts with bad faith and flagrant disregard to a patient’s rights, a court may assess a civil monetary penalty. This penalty cannot exceed five million dollars.
  
  
• Scope. The bill protects every American with private insurance. The bill allows states to develop their own patient protection laws and empowers the governors to certify that they are comparable to federal law.
  
  
• Employer Protections. Employers are protected against any liability, unless they directly participated in making the decision on a claim for benefits which resulted in personal injury or death.