Upcoming NCOA Event

Annual Membership Conference:
August 12–13, 2011 Renaissance Raleigh Hotel at North Hills, Raleigh, N.C.

For more information, go to www.ncoa-northcarolina.com.

NCOA Board of Directors 2011

President
Birgit A. Arb, MD
Hanover Medical Specialists

President–Elect
Linda Sutton, MD
Duke University Medical Center

Secretary/Treasurer/Member–at–Large
T. Flint Gray, III, MD
Seby Jones Regional Cancer Center

Immediate Past President
Jennie R. Crews, MD
Marion L. Shephard Cancer Center

Members–at–Large
Alan D. Kritz, MD
Cancer Centers of North Carolina

Glenn J. Lesser, MD
Wake Forest University School of Medicine

Michael J. Messino, MD
Cancer Care of WNC

Matthew E. Nielson, MD
University of North Carolina Department of Surgery

NCOA Corporate Partners

(as of 6/30/11)

Platinum

Celgene Corporation

Gold

Amgten Inc.
Astra Zeneca, LP
Boehringer Ingelheim
Genentech Inc.
GlaxoSmithKline
Lilly Oncology
McKesson Specialty Care Solutions/US Oncology
Merck & Co.
Millennium, The Takeda Oncology Company
Novartis Pharmaceutical Corporation
Sanofi Oncology

Thank you for the value you add to NCOA!

New Look!

We hope you enjoy our newly redesigned NCOA NewsLine. Please email us if you have any questions, comments, or news you'd like to see appear in the next NewsLine.

— Summer 2011 —

President's Message: See You in Raleigh August 12–13!
Birgit A. Arb, MD

Dear Colleague:

Greetings! I find that summer is one of the busiest times of the year as I try to balance new clinical information from ASCO, family vacations, and work pressures, and stay informed about the changes in healthcare economics and legislation. We, at the North Carolina Oncology Association (NCOA), recognize the difficulty in staying current in such diverse areas and have worked hard to focus our Fall Membership Conference agenda to facilitate the sharing of this knowledge. Specifically, we will focus on clinical updates in a range of solid tumors, recent advances in the care of malignant melanoma, as well as legislative and economic changes that are relevant to our practices.

New on the agenda for the Conference is the presentation of an Outstanding Fellow Recognition Award. This award will be presented to an outstanding fellow, chosen by his/her fellowship director, from each of the University fellowship programs. Each fellow will be awarded a plaque and a monetary award of $500.00. The three recipients will be honored on Friday evening at the networking reception. In addition, we will continue to have a fellow research presentation as part of our program on Saturday morning. We hope you will join us in our efforts to support and recognize our excellent statewide fellowship programs and their participants.

I hope you are planning to attend the Conference at the Renaissance Raleigh August 12–13. Please visit our website at www.ncoa-northcarolina.com for further details. See you there!

NCOA Legislative and Regulatory Report
Dana E. Simpson

The 2011 North Carolina General Assembly adjourned its regular session on Saturday, June 18th. This was the earliest adjournment for a legislative long session since 1973. Fortunately for the North Carolina Oncology Association (NCOA), and the medical community as a whole, legislative leaders were able to accomplish a lot in a short period of time. Specifically, the General Assembly passed two historic tort reform bills that will help lower the cost of healthcare, protected physician Medicaid rates despite a difficult budget situation, and made progress in developing a state–based health insurance exchange.

I. Historic Tort Reform Passes
The new Republican legislative leadership in Raleigh moved quickly to make good on its campaign promises to adopt medical liability reform this year. The House and Senate passed two important tort reform bills (SB 33—Medical Liability Reform; HB 542—Tort Reform) that include a number of legislative changes sought by the medical community for the past several decades.

Senate Bill 33, sponsored by Sens. Tom Apodaca (R-Henderson), Bob Rucho (R-Mecklenburg), and Harry Brown (R-Onslow), included a number of important medical liability reforms long supported by the North Carolina medical community. First, the legislation makes it more difficult to sue physicians providing emergency services mandated by EMTALA by requiring a plaintiff to prove negligence by “clear and convincing” evidence. Next, the bill requires courts to bifurcate trials in medical malpractice cases to prevent the medical damages of a plaintiff from unduly influencing a jury’s deliberation about a physician’s alleged negligence. The bill also includes important appeal bond reform that will allow physicians to appeal erroneous trial court rulings without forcing them to sell all of their belongings to post an appeal bond. Finally, SB 33 includes a $500,000.00 cap on non-economic damages. The non–economic damages cap was the most hotly debated provision in the legislation, with trial lawyers seeking to amend this provision to include a number of carve–outs that would have diluted its effectiveness. The final compromise negotiated between the House and Senate represents a fair balance without undermining the overall effectiveness of the cap.

In addition to SB 33, the General Assembly also approved general tort reform legislation (HB 542) that included the No. 1 tort reform goal of both the medical and business communities this year. Sponsored by Reps. Johnathan Rhyne (R-Lincoln) and Danny McComas (R-New Hanover), HB 542 includes an important reform specifying what evidence may be shown a jury regarding medical expenses. Under current law, juries in most trials (including medical malpractice, automobile, property cases, etc.) are only provided evidence of a plaintiff’s medical expenses based on the charges of the hospital and physicians providing care. As you know, such charges rarely represent the amount of payment actually incurred by the plaintiff or plaintiff's insurer in paying for such medical expenses. As a result, evidence based on medical charges is a fraud on the jury because it does not provide evidence of the plaintiff's actual medical damages. HB 542 will now limit evidence offered to prove past medical expenses to the amounts actually paid by the plaintiff, rather than inflated charges. Insurance actuaries have told the medical and business communities that this change will have an impact in lowering the cost of insurance in North Carolina.

The NCOA is pleased that both SB 33 and HB 542 were supported by strong bipartisan majorities in the General Assembly. HB 542 was approved in the House and Senate by wide margins and was signed by Gov. Perdue. SB 33 also received strong bipartisan support, passing the Senate by a 32-9 margin, with over one-third of the Democratic Caucus joining the entire Republican Caucus in voting for SB 33. In the House, 11 Democrats joined the Republican majority in approving SB 33 by a 62-44 margin. Eleven Republicans voted against the final bill. Unfortunately, Gov. Perdue decided to veto SB 33 due to her opposition to the proposed cap on noneconomic damages. The Senate voted to override the Governor's veto. As this newsletter goes to press, the House leadership is seeking a bipartisan coalition (60% of those voting) to override the veto.

II. State Budget/Medicaid
The General Assembly leadership faced a difficult task in developing a budget in the face of a fiscal deficit exceeding $2 billion. In the end, they were able to develop a budget that won the support of five House Democrats, allowing the Republican leadership to override the veto of Gov. Perdue.

From a Medicaid perspective, the NCOA and North Carolina Medical Society (NCMS) are very appreciative of the efforts of House and Senate leaders to protect physician Medicaid rates. While all other Medicaid providers received a 2% Medicaid rate cut, physician rates were held harmless and received no rate cuts in this year's budget. This lack of a rate cut was accomplished in part due to the willingness of the North Carolina Hospital Association (NCHA) to accept larger inpatient hospital cuts in exchange for avoiding physician rate cuts. Thanks to new Medicaid assessment legislation passed by the General Assembly in March, hospitals are better able to draw down federal funds to offset a portion of their inpatient Medicaid costs.

While the medical community avoided any additional Medicaid rate cuts on the frontend of the budget, the budget does require Community Care of North Carolina to achieve a daunting $90–million in savings through enhanced medical management activities. Community Care consists primarily of primary care physicians who contract with the Medicaid program to medically manage Medicaid patients in hopes of reducing utilization. North Carolina's Community Care Program is a national model in physician–driven medical management. The NCOA is currently working to develop an "oncology medical home" pilot project that will allow oncologists to participate in Community Care and help the state save costs from cancer care. It is important to note that the budget states that Lanier Cansler, Secretary of Health and Human Services, must either cut optional Medicaid services or further reduce Medicaid rates for all providers in the event that Community Care is unsuccessful in meeting its $90 million goal of cost savings. Thus, there is a risk of potential Medicaid rate cuts later in the fiscal year if Community Care's efforts are not successful.

III. Health Insurance Exchange Legislation
Under federal health reform, each state must develop a viable health insurance exchange (HIE) and have it up and operating by 2013, to avoid the federal government developing its own HIE for the state. The prospect of a federal takeover of North Carolina's health insurance market is problematic for the medical community because it could result in a federal exchange that does not follow North Carolina’s existing state insurance laws, including those laws that protect consumers and physicians from egregious health insurer behavior.

The NCOA worked with NCMS and NCHA this year to support bipartisan HIE legislation (HB 115), sponsored by Reps. Jerry Dockham, Harold Brubaker, Michael Wray, and Tom Murry. Consumer groups opposed portions of this legislation because it provides for two insurers to participate on the Board of the HIE. The NCOA and NCMS did not take a position on the makeup of the Board, but did support the version of HB 115 ultimately adopted by the House because it includes a clear requirement that any insurer participating in the state HIE must comply with all of North Carolina’s existing insurance laws. This provision is key to continued medical community support for the HIE. The House ultimately passed HB 115 by a bipartisan 83–34 vote. Unfortunately, the leadership of the Senate decided not to take up HB 115 this year. Instead, a provision was included in the budget specifying the state's intent to create a state–based exchange and allowing the Department of Insurance and the Department of Health and Human Services to begin working together on a joint IT system for such an HIE. The Senate leadership has promised the medical community that it is committed to passing health insurance exchange legislation in the 2012 short session once the federal government adopts final rules for such exchanges. We anticipate that passage of this legislation is likely to be the medical community’s top legislative priority next year.

IV. Scope–of–Practice
As always, a number of scope–of–practice bills were introduced this year.

Of particular interest to the NCOA was a legislative proposal to license naturopathic "doctors." This legislation was approved by the Senate Health Committee, but ultimately did not pass the full Senate after a number of questions were raised by the medical community, including the NCOA. As drafted, this legislation (SB 467, sponsored by Sens. Hartsell and Apodaca) raises concerns about the scope of naturopathic practice, including the ability to provide medical diagnoses and treatment of cancer, and be identified as "doctors" (which may be misleading to the public). NCMS, the North Carolina Academy of Family Physicians, and other specialty societies joined the NCOA in raising potential concerns about this legislation and have agreed to work with the sponsors before next year’s legislative session to address these patient safety concerns.

If you have any questions about the legislation or activities described above, please contact Dr. Jennie Crews, NCOA's Legislative Liaison, for further information.

Drugs in the News from NCOA Corporate Members

The FDA has approved ASTRAZENECA PHARMACEUTICALS' (www.astrazeneca-us.com) orphan drug vandetanib to treat adult patients with late-stage medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms. The first drug approved for medullary thyroid cancer, vandetanib is administered orally on a daily basis. A Risk Evaluation and Mitigation Strategy (REMS) is required for vandetanib due to the risks of QT prolongation, Torsades de pointes, and sudden death. Only prescribers who are certified through the vandetanib REMS program, a restricted distribution program, will be able to prescribe and dispense vandetanib. The use of vandetanib in patients with indolent, symptomatic, or slowly progressing disease should be carefully considered because of the treatment–related risks for vandetanib. (Oncology Issues, May/June 2011)

The FDA approved SCHERING CORPORATION'S (www.merck.com) Sylatron™ (peginterferonalfa-2b) for the treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy. The approval was based on a single trial, EORTC18991, an open label, multi–center trial enrolling 1,256 patients. The recommended dose and schedule for Sylatron is 6 mcg/kg/week, subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously. The maximum treatment period is 5 years (260 weeks). Sylatron is contraindicated in patients with a history of anaphylaxis to peginterferon alfa–2b or interferon alfa–2b, in patients with autoimmune hepatitis, and in patients with hepatic decompensation (Child-Pugh score >6 [class B and C]). (Oncology Issues, May/June 2011)

CELGENE CORPORATION (www.celgene.com) announced that the FDA has granted accelerated approval for its supplemental new drug application (sNDA) for an additional indication for Istodax (romidepsin) for injection for the treatment of peripheral T–cell lymphoma (PTCL) in patients who have received at least one prior therapy. Istodax is also approved for the treatment of cutaneous T–cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. (Celgene Corporation, Press Release, June 16, 2011).

The FDA approved Afinitor® (everolimus) Tablets (NOVARTIS PHARMACEUTICALS CORPORATION, www.novartis.com) for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. (Oncology Issues, July/August 2011)

For more information about North Carolina Oncology Association (NCOA)
go to www.ncoa-northcarolina.com or call 301.984.9496, ext. 218

You are receiving this message because you are affiliated with NCOA and we believe you will benefit from this information.