National Office

2461 South Clark Street 

Suite 640 

Arlington, VA 22202 

Phone: 703 414-7870 

Fax: 703 414-7874 

asts@asts.org 

www.asts.org 

President 

Michael M. Abecassis, MD, MBA 

Northwestern University 

Division of Transplantation 

676 North St. Clair Street, #1900 

Chicago, IL 60611 

Phone: 312 695-0359 

Fax: 312 695-1817 

mabecass@nmh.org 

President-Elect 

Mitchell L. Henry, MD 

Ohio State University 

The Division of Transplantation 

395 West 12th Avenue, Room 130 

Columbus, OH 43210 

Phone: 614 293-4627 

Fax: 614 293-4541 

henry.6@osu.edu 

Secretary 

Kim M. Olthoff, MD 

University of Pennsylvania 

Department of Surgery 

3400 Spruce Street - 2 Dulles 

Philadelphia, PA 19104 

Phone: 215 662-6136 

Fax: 215 662-2244 

kim.olthoff@uphs.upenn.edu 

Treasurer 

Alan N. Langnas, DO 

University of Nebraska 

983285 Nebraska Medical Center 

Omaha, NE 68198-3285 

Phone: 402 559-8390 

Fax: 402 559-3434 

alangnas@unmc.edu 

Immediate Past President 

Robert M. Merion, MD 

Past President 

John P. Roberts, MD 

Councilors-at-Large 

James D. Eason, MD 

Charles M. Miller, MD 

Peter G. Stock, MD, PhD 

R. Mark Ghobrial, MD, PhD 

Robert S. Higgins, MD, MSHA 

Elizabeth A. Pomfret, MD, PhD 

Stuart M. Flechner, MD 

David C. Mulligan, MD 

Lewis W. Teperman, MD 

Executive Director 

Katrina Crist, MBA 

American Transplant Congress • April 30 - May 3, 2011 • Philadelphia, PA katrina.crist@asts.org 

August 27, 2010 

Office of Consumer Information and Insurance Oversight 

Department of Health and Human Services 

Attention: OCIIO-9994-IFC, RIN 0991-AB69 

P.O. Box 8016 

Baltimore, Maryland 21244-1850 

Office of Health Plan Standards and Compliance Assistance 

Employee Benefits Security Administration, Room N-5653 

U.S. Department of Labor 

200 Constitution Avenue, NW 

Washington, DC 20210 

Attention: RIN1210-AB43 

Internal Revenue Service 

CC: PA: LPD: PR, Room 5025 

P.O. Box 7604, Ben Franklin Station 

Washington, DC 20044 

Attention: REG-120399-10 

Re: ASTS Comments on Interim Final Rules for Preexisting 

Condition Exclusions, and Lifetime and Annual Limits in Private 

Health Insurance (File Codes OCIIO-9994-IFC, RIN 0991-AB69/

RIN 1210–AB43/REG–120399-10)

Dear Sir or Madam: 

The American Society of Transplant Surgeons (ASTS) appreciates the 

opportunity to comment on interim final rules that implement provisions 

of the Patient Protection and Affordable Care Act (Affordable Care Act or 

“ACA”) regarding preexisting condition exclusions and lifetime and 

annual limits. We applaud the issuance of these interim final rules 

because their promulgation is an important step forward in protecting 

patients, especially transplant recipients and living donors, against some 

of the most egregious practices within the private health insurance market. 

ASTS worked hard during the legislative process to ensure that Congress 

prohibited discrimination in private health insurance based on organ 

donor status. We, therefore, provide the following comments for your 

consideration in strengthening the interim final rules. 
The ASTS is comprised of over 1700 transplant surgeons, physicians, scientists, advanced 

transplant providers and allied health professionals dedicated to excellence in transplant surgery 

through education and research with respect to all aspects of organ donation and transplantation 

so as to save lives and enhance the quality of life of patients with end stage organ failure. 

Prohibition of Preexisting Condition Exclusions 

We strongly support the interim final rules that prohibit preexisting condition exclusions in 

group health plans and health insurance coverage in the group and individual markets.1 These 

rules begin to implement the ACA’s prohibition against discrimination based on health or 

disability status.2 Once fully implemented in 2014, this reform will end the disincentive 

confronting many live organ donors who fear that their donor status will compromise their ability 

in the future to secure affordable private insurance coverage. 

There are currently over 109,000 people on the nation’s waiting lists for donor organs and over 

6,000 Americans die each year waiting for a donated organ. Living donors, who donate a kidney 

or a portion of another organ such as the liver, offer an alternative to such waiting lists. But when 

live organ donation is considered a preexisting condition, altruistic living donors are often 

confronted with the prospect of dramatically increased costs for health insurance coverage or the 

prospect of being considered uninsurable altogether. The fear of losing access to affordable 

private health care insurance can be a major barrier to potential live organ donors when 

contemplating the gift of life. In fact, the North American Transplant Coordinators Organization 

(NATCO) reports that 39% of transplant centers “had eligible donors decline donation due to 

fear of future insurance problems.”3

However, live organ donors are, in reality, very low health care risks because each undergoes a 

rigorous health evaluation before being considered a potential donor. To pass this testing, the 

donor must be healthy and without diabetes, hypertension, heart disease, or cancer. Since the 

majority of donors are under age 50, these healthy donors often have low health care costs for 

many years. Yet, even with these safeguards to ensure healthy donors, private insurance plans 

often treat an individual’s donor status as a preexisting condition. This creates a serious 

disincentive for living donation. 

The promulgation of the interim final rules will remove such barriers for living donors, 

beginning in 2014. ASTS greatly appreciates these protections and supports their full and 

effective implementation and enforcement on a timely basis. 

 

1

 The interim final rules are set forth at 26 CFR 54.9815-2704T, 29 CFR 2590.715-2704, 45 CFR 147.108. 

2

 The statutory prohibition is set forth at Sec. 2704 of the Public Health Service Act (PHS Act), which was added by 

section 1201 of the ACA. Section 2704 broadens current HIPAA provisions, which only apply to group health plans 

and group health coverage. 

3

 NATCO. Living Donor Health Care Coverage, Insurability and Follow-up. May 2006. Available at 

http://www.natco1.org/public_policy/documents/LivingDonorInsurability.pdf. 
Lifetime and Annual Limits 

We applaud the interim final rules that prohibit health plans from imposing lifetime limits as 

well as unreasonable annual limits until 2014 when such limits are prohibited all together.4 These 

restrictions on lifetime and annual limits only apply to “essential health benefits,” a term that is 

defined in the Affordable Care Act to include ten general categories, including hospitalization, 

physician services, and prescription drugs.5 We think the interim final rules could be improved in 

the following ways: 

 Regulations regarding “essential health benefits” should be issued as soon as practicable, 

but in the interim, according to the preamble of the interim final rules, health plans may 

use “good faith efforts” to determine the meaning of “essential health benefits.”6 This 

may lead to significant variations in the set of benefits subject to the rule and raises the 

concern that health plans may unduly narrow the scope of essential health benefits. In 

addition, the federal government’s definition of “essential health benefits” is, in part, to 

be based on a survey of what constitutes a “typical employer health plan.” 

ASTS is particularly interested in how health plans will define prescription drug 

coverage, including medications routinely used by organ transplant recipients. We 

believe that such coverage should be defined to include immunosuppressive drugs, which 

are necessary to prevent the immune systems of transplant recipients from rejecting 

donated organs. 

 The rules should also provide an objective definition of “good faith efforts” when health 

plans’ compliance with the lifetime and annual caps provisions is assessed. We also 

believe it may be helpful for the rules to provide illustrating examples of actions 

constituting “good faith efforts” for purposes of determining the meaning of essential 

health benefits. 

 The rules should further clarify how lifetime and annual limits will apply to large group 

and self-insured plans and at what point in time, because such plans will not be required 

to provide the essential health benefits package. Since the essential benefits package is 

inextricably linked to the operation of the lifetime and annual caps, the HHS Secretary 

should issue additional guidance on this important issue. 

 The interim final rules allow the HHS Secretary to waive restrictions on annual limits if 

compliance would result in a significant decrease in access to benefits or a significant 

increase in premiums. Consumer protections should be included to ensure that waivers do 

not have a negative, disproportionate effect on specific patient populations, especially 

those based on diagnosis or health status such as living donors. For example, the rules 

 

4

 The interim final rules are set forth at 26 CFR 54.9815-2711T, 29 CFR 2590.715-2711, 45 CFR 147.126. The 

interim final rules explicate the statutory provisions of Sec. 2711 of the PHS Act, which was added by Sec. 1001 of 

the ACA. 

5

 ACA, § 1302. 

6

 Patient Protection and Affordable Care Act: Preexisting Condition Exclusions, Lifetime and Annual Limits, 

Rescissions, and Patient Protections, 75 Fed. Reg. 37188, 27191(June 28, 2010). 
should allow the Secretary to rescind waivers if there is such a negative, disproportionate 

effect. 

ASTS believes that the interim final rules are a major step forward for transplant recipients and 

living donors, as well as anyone with a health care condition. Nonetheless, we believe that the 

rules could be strengthened in the manner described in this letter. If you have any questions, 

please feel free to contact me at 312-695-0359 or mabecass@nmh.org. Alternatively, you may 

also reach ASTS counsel, Peter W. Thomas, at 202-466-6550 or peter.thomas@ppsv.com. 

Thank you for your consideration of these comments. 

Yours sincerely, 

Michael M. Abecassis, MD, MBA 

President