Federal Register: February 4, 2005 (Volume 70, Number 23)
DOCID: FR Doc 05-1695
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Veterans Affairs Department
CFR Citation: 42 CFR Parts 413, 441, 486 and 498
CMS ID: [CMS-3064-P]
NOTICE: Part II
DOCUMENT ACTION: Proposed rule.
DATES: We will consider comments if we receive them at the appropriate address, as provided below, no later than 5 p.m. on April 5, 2005.
This proposed rule would establish new conditions for coverage for organ procurement organizations (OPOs), including multiple new outcome and process performance measures based on donor potential and other related factors in each service area of qualified OPOs. We are proposing new standards with the goal of improving OPO performance and increasing organ donation.
Health and Human Services Department, Centers for Medicare & Medicaid Services,
DOCUMENT BODY 2:
Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs)
Submitting Comments: We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS3064P and the specific ``issue identifier'' that precedes the section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. CMS posts all electronic
comments received before the close of the comment period on its public
Web site as soon as possible after they have been received. Hard copy
comments received timely will be available for public inspection as
they are received, generally beginning approximately 3 weeks after
publication of a document, at the headquarters of the Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4
p.m. To schedule an appointment to view public comments, phone 1800 7433951.
A. Key Statutory Provisions
The Organ Procurement Organization Certification Act of 2000 (section 701 of Pub. L. 106505) and section 219 of the Conference Report accompanying the Consolidated Appropriations Act, 2001 (Pub. L. 106554) contain identical provisions that amended section 371(b)(1) of the Public Health Service (PHS) Act (42 U.S.C. 273(b)(1)). The legislation directs the Secretary to establish regulations that include four major requirements. These are to:
1. Increase the recertification cycle for OPOs from 2 to at least 4 years.
2. Establish outcome and process performance measures based on
empirical evidence, obtained through reasonable efforts, of organ donor
potential and other related factors in each service area of qualified OPOs.
3. Establish multiple outcome measures.
4. Establish a process for OPOs to appeal a decertification on substantive and procedural grounds.
The recertification cycle was increased from 2 years to 4 years through an interim final rule with comment (December 28, 2001, 66 FR 67109), ``Emergency Recertification for Coverage for Organ Procurement Organizations (OPOs).'' The interim final rule recertified all 59 OPOs until December 31, 2005 and extended their agreements with us until July 31, 2006. Thus, the recertification cycle set forth in the interim final rule satisfies the first of the new criteria (that is, certification not more frequently than once every 4 years.) Our proposed rule addresses the remaining three requirements.
Section 1138 of the Social Security Act (the Act) (42 U.S.C. 1320b 8) provides the statutory qualifications and requirements that an OPO must meet in order for organ procurement costs to be reimbursed in hospitals and critical access hospitals under the Medicare or Medicaid programs. Section 1138(b) of the Act also specifies that an OPO must operate under a grant made under section 371(a) of the PHS Act or must be certified or recertified by the Secretary as meeting the standards to be a qualified OPO. Under these authorities, we previously established conditions for coverage for OPOs at 42 CFR 486.301, et seq. (May 2, 1996, 61 FR 19722).
Section 1102 of the Act gives the Secretary of Health and Human
Services the authority to make and publish such rules and regulations
as may be necessary to the efficient administration of the functions with which he is charged under the Act. This section of
the Act gives the Secretary broad authority to establish requirements for OPOs that are necessary for the efficient administration of the Medicare program.
B. Why We Are Proposing New OPO Regulations
OPOs are government contractors that play a crucial role in ensuring that scarce transplantable human organs are provided to seriously ill patients suffering from endstage organ failure. OPOs are responsible for identifying potential organ donors, informing families about their donation options, obtaining consent to donation, screening potential donors for infectious disease, clinically managing potential organ donors to maintain viability of their organs, placing the maximum number of organs possible with transplant centers, arranging for recovery, testing, and tissue typing of organs, and packaging and transporting organs to transplant hospitals. Clearly, OPO performance is one of the most critical elements of the nation's organ transplantation system. An OPO that is effective in procuring organs and delivering them safely to transplant centers will save more lives than an ineffective OPO. Therefore, under the broad authority in the statute, the Secretary has established performance standards for OPOs so that they excel in their critical mission.
The need for organ donors is acute and growing rapidly. While medical advances have made transplantation a viable treatment option for many patients suffering from endstage organ failure, the supply of organs has not kept pace with the number of patients who need them. Since 1996 when the current OPO regulations went into effect through the end of 2002, the number of patients waiting for organs increased by nearly 60 percent to more than 80,792, while the number of deceased donors grew by only 14 percent. As of June 23, 2003, there were 82,049 patients waiting for a transplant.
Various studies, including those by the Harvard School of Public Health, the Partnership for Organ Donation, and the Association of Organ Procurement Organizations (AOPO), have estimated that approximately 10,500 to 22,000 deaths occurring in the United States every year could yield suitable donor organs. (C Christiansen, S Gortmaker, J William, et al: A Method for Estimating Solid Organ Donor Potential by Organ Procurement Region, American Journal of Public Health, Vol. 88, No. 22, November, 1998. E Sheey, S Conrad, L Brigham, et al: Estimating the Number of Potential Organ Donors in the United States, The New England Journal of Medicine, 349:66774, August 14, 2003. E Guadagnoli, C Christiansen, C Beasley, Potential OrganDonor Supply and Efficiency of Organ Procurement Organizations, Health Care Financing Review, Vol. 24, No. 24, Summer 2003.) However, there were only 6,182 deceased donors in 2002 and only 18,244 transplants resulting from those donations. Based on these estimates, OPOs are recovering organs from, at most, only a little more than half the number of potential donors per year.
The study published in The New England Journal of Medicine found that of all potential organ donors reported in the study, only 42 percent became donors. Of those families who were asked to donate, only 39 percent agreed, and 16 percent of families were never asked whether they would agree to donation. The study published in the Health Care Financing Review found that of all potential organ donors reported in the study, only 35 percent became donors.
Over the years, many research studies have analyzed factors that impact donation rates, including health professionals' attitudes toward donation, the setting in which requests for donation are made, and medical examiner prohibitions on donation. Recently, researchers have increasingly turned their attention to the best practices of OPOs whose service areas have high donation rates.
In April 2003, the Health Resources and Services Administration (HRSA) began an ongoing ``Organ Donation Breakthrough Collaborative'' to bring best practices in organ donation to OPOs and hospitals, particularly to hospitals identified as having the greatest number of potential donors. More than threequarters of the 59 OPOs are participating in the Collaborative. By studying the practices of six of the bestperforming OPOs, the Collaborative's researchers have already identified several best practices for OPOs, as well as strategies for implementing them. Many of the best practices and associated strategies are discussed throughout this preamble to provide guidance for OPOs in implementing the requirements of the proposed rule.
Our proposals would fundamentally change the existing OPO regulations to emphasize quality and continuous quality improvement. The changes would ensure that each OPO utilizes best practices to improve its efficiency, effectiveness, and quality. While the requirements in the proposed rule apply to all OPOs, we have specifically targeted the requirements toward OPOs that may not understand the value of incorporating best practices into the structure of their organizations. Thus, our overall goal is to improve the functioning of poor performing OPOs, rather than simply to terminate them.
In April 2001, the Department of Health and Human Services (the
Department) launched ``The Secretary's Donation Initiative,'' a multi
pronged effort to increase all types of donationblood, marrow,
tissue, and organ. In his speech launching the Initiative, the
Secretary noted, ``The facts are just astounding. Someone dies every 96
minutes because there aren't enough organs to go around.'' The five
initial key elements of the Initiative were the Workplace Partnership
for Life, a new model donor card, a national forum on donor registries,
a national gift of life medal, and a drivers' education donation
curriculum. The Department promised that it would launch additional
elements under the Initiative in the future. The Organ Donation
Breakthrough Collaborative is the sixth key element of the Secretary's
Initiative. The Secretary believes promulgation of the multiple outcome
and process performance measures in this rule will improve OPO performance and, as a result, increase organ donation and
transplantation in the United States.
B. Overview of Key Proposed Provisions
1. Appeals and Competition Processes
In the congressional findings associated with section 219 of the Conference Report accompanying the Consolidated Appropriations Act, 2001 (42 U.S.C. 219(a)(2)) Congress found that the process for OPO re certification created a level of uncertainty among OPOs that interfered with their effectiveness in increasing organ donation. Therefore, Congress directed the Secretary to develop a process for OPOs to appeal a decertification on substantive and procedural grounds. (See section 219(c)(3) codified at 42 U.S.C. 273(b)(1)(D)(ii)(iv).) Under this authority, we are proposing a streamlined appeals process, in which an OPO facing decertification could appeal and receive a decision on its appeal before its service area is opened for competition from other OPOs. (See proposed Sec. 486.314.)
To further reduce the level of uncertainty identified by Congress,
we propose making certain changes in the current recertification
process. Although we would open every OPO's service area for
competition at the end of every recertification cycle as under the
current regulations, we would: (1) Permit OPOs to compete for open
areas only if they met certain specific objective criteria; (2) allow competition only for entire service areas; and (3) use
clear, objective criteria for determining which OPO would be designated for the service area (See proposed Sec. 486.316.)
A more extensive discussion of our proposal for the appeals and competition processes, as well as a description of other competition processes on which we are requesting comments, can be found in this preamble under proposed ``General Requirements.''
2. Proposed Multiple Outcome Performance Measures
When we published the current OPO regulations in 1996, population was the only measure readily available to assess donor potential. Therefore, we promulgated regulations that judge an OPO's performance based on the population in its service area (for example, the number of donors per million population). Subsequently, we began to investigate alternative methods for assessing donor potential in order to develop new outcome measures based on the organ donation potential in each OPO's service area. This preamble contains a discussion of our analysis of these alternative methods, as well as an explanation of the method we proposeusing potential donor data reported by OPOs to the Organ Procurement and Transplantation Network (OPTN) based on information from hospital referral calls to OPOs. A discussion of the proposed multiple outcome measures can be found in this preamble under ``OPO Outcome Performance Measures.'' The proposed regulatory text can be found at Sec. 486.318.
The proposed outcome measures would address two requirements of the Organ Procurement Organization Certification Act of 2000 and section 219 of the Consolidated Appropriations Act, 2001. The first requirement calls for promulgation of ``outcome* * *performance measures that are based on empirical evidence obtained through reasonable efforts of organ donor potential and other related factors in each service area of qualified organ procurement organizations.'' The second requirement calls for the use of ``multiple outcome measures as part of the certification process.''
3. Proposed Multiple Process Performance Measures
In addition to proposing multiple outcome measures, the Organ Procurement Organization Certification Act of 2000 and section 219 of the Consolidated Appropriations Act, 2001 require the Secretary to propose ``process performance measures that are based on empirical evidence obtained through reasonable efforts of organ donor potential and other related factors in each service area of qualified organ procurement organizations.'' In the congressional findings associated with section 219 of the Conference Report accompanying the Consolidated Appropriations Act, 2001 (Pub. L. 106554, 42 U.S.C. 219(a)(6)(B)), Congress urged us to ``improve the overall certification process'' by incorporating process as well as outcome performance measures. Congress noted that current OPO regulations do not permit consideration of outcome and process performance measures that ``would more accurately reflect the relative capability and performance of each organ procurement organization.''
Therefore, we propose to establish outcome and process performance related measures based on factors that affect an OPO's ability to provide the maximum number of healthy organs to transplant centers. The purpose of these measures is to improve OPO performance and increase organ donation by ensuring that OPOs attain the highest possible level of effectiveness and quality. The process performance measures we propose would require OPOs to develop performance protocols, monitor their own performance continuously, and make changes to improve the quality of their organizations.
The proposed new process performance measures are based on empirical evidence of organ donor potential and other related factors in each OPO service area derived from three bodies of knowledge: (1) Research into best practices in organ donation, (2) information about methods of maximizing organ donation based on our work with OPOs, and (3) accepted standards of practice and quality improvement strategies used by the larger health care community.
A review of the literature on best practices in organ donation provides empirical evidence that certain characteristics are common to successful OPOs. These characteristics include experienced leadership; efficient mechanisms for tracking activity; excellent communication with transplant hospitals; timely, onsite response to donor referrals; adequate experienced staff; datadriven decision making; inhospital coordinators; and targeted hospital development programs. We have incorporated findings from the literature into the proposed process performance measures. Discussions and citations of individual studies can be found in this preamble in ``Organ Procurement Organization Process Performance Measures.''
Our experience with topperforming OPOs supports the validity of the literature on best practices. In 1998, we developed four ``OPO Coordinator'' positions in the four CMS Regional Consortia (Midwest, West, South, and Northeast). The OPO Coordinator positions are unique; OPOs are the only Medicare providers or suppliers that have our staff assigned to work with them on an ongoing basis to improve their quality and outcomes. The Coordinators sponsor seminars, conduct conferences and workshops, provide education for OPO staffs, conduct site visits, meet with OPO directors and hospital development staffs, recommend interventions to increase OPO efficiency and quality, analyze OPO's voluntary quality improvement efforts, and act as liaisons between OPOs and hospitals and between OPOs and tissue banks to resolve problems and promote cooperation. (We would note that for ease of use, the term ``tissue bank'' when used in this preamble and in the proposed regulations text refers to all types of tissue banks, including those that recover only corneas and eyes, and the word ``tissues'' refers to all types of tissues, including corneas and eyes.)
The proposed process performance measures are based heavily on the Coordinators' extensive experience with all 59 OPOs. The Coordinators' experience with and knowledge about OPOs provide much of the empirical evidence that has enabled us to develop proposed process performance measures targeted specifically toward increasing OPO performance and quality.
As stated earlier, some of the proposed requirements are based on other factors such as accepted standards of practice for all health care organizations. For example, proposed Sec. 486.344 would require OPOs to use accepted standards of practice for testing donors to prevent transmission of the human immunodeficiency virus (HIV) and other infectious diseases. Proposed Sec. 486.348 is based on quality assessment and performance improvement (QAPI) programs that have been embraced by the health care community and that have been shown to increase quality and outcomes of care.
Therefore, the process performance measures we propose would
satisfy the second requirement in the Organ Procurement Organization
Certification Act of 2000 and section 219 of the Consolidated
Appropriations Act, 2001 for the Secretary to propose process
performance measures ``based on empirical evidence, obtained through
reasonable efforts, of organ donor potential and other related factors in
each OPO's service area.'' These include the following proposed requirements for OPOs:
In addition, we propose a number of other requirements based on the
Secretary's authority under section 1102 of the Act to establish
requirements necessary for the efficient administration of the Medicare
program. These requirements generally are related to (1) administrative
matters (because efficient administration by Medicare contractors such
as OPOs supports efficient administration of the Medicare program); (2)
OPOs' relationships with Medicare donor and transplant hospitals; and
(3) data collection, management, and reporting (because OPO data are
needed by other Medicare entities, by other agencies within the
Department, and by us for the certification of OPOs.) These proposed requirements include:
Some of the proposed process performance measurements have a dual role in that they both satisfy the requirements of the Organ Procurement Organization Certification Act of 2000 and section 219 of the Consolidated Appropriations Act, 2001 and are based on the Secretary's authority under section 1102 of the Act. For example, the requirement for OPOs to provide designated requestor training for hospitals can be linked to the Organ Procurement Organization Certification Act of 2000 and section 219 of the Consolidated Appropriations Act, 2001 because the requirement is based on empirical evidence that shows improved consent rates when the OPO and hospital collaborate in requesting consent. (Note that factors in each OPO's service area, such as the OPO's relationship with its hospitals, would determine whether hospitals would request, and OPOs would need to provide, designated requestor training). This proposed requirement also is necessary to the effective and efficient administration of the Medicare and Medicaid programs because under 42 CFR Sec. 482.45, hospitals must ensure that individuals who discuss donation with families of potential organ donors are trained in a course offered or approved by the OPO.
Finally, section 1138(b)(1)(A) of the Act requires an OPO to be a ``qualified'' OPO as described in section 371(b) of the PHS Act. A number of the requirements we propose (for example, arrangements to cooperate with tissue banks and membership composition and authority of OPO boards) are based on requirements for qualified OPOs under the PHS Act. (See Sec. 486.322 and Sec. 486.324.) Proposed requirements that relate to the PHS Act are noted in the broader discussion in this preamble under ``Proposed Process Performance Measures and Other Requirements.''
II. Provisions of the Proposed Regulations
For the reasons discussed above, we propose to reorganize and revise 42 CFR part 486, subpart G. Following is a discussion of the specific requirements contained in the proposed conditions. Proposed General Requirements
Basis and Scope (Proposed Sec. 486.301)
Section 486.301 (Basis and scope) would remain unchanged from the existing regulations except that we would add a reference to Sec. 1102 of the Act, and we would add the term, ``nonrenewal'' to Sec. 486.301(b)(3) to clarify that the scope includes nonrenewal of agreements.
Definitions (Proposed Sec. 486.302)
To reflect organizational changes in the regulations text, to remove obsolete material, and to provide further clarity to the regulations, we propose several amendments and additions to the definitions.
We propose amending the definition for ``certification'' to mean a Secretarial determination that an OPO meets (or has met) the requirements at 42 CFR 486.303 and is eligible for designation if it meets the additional requirements for designation.
We propose amending the definition of ``designation'' to clarify
that designation is the process of assigning geographic service areas to OPOs. Once an OPO is certified and assigned a
geographic service area, organ procurement costs of the OPO are eligible for Medicare and Medicaid payment under Sec. 1138(b)(1)(F) of the Act.
We propose amending the definition of ``entire metropolitan statistical area'' to state that we do not recognize consolidated metropolitan statistical areas (CMSAs) when making service area determinations.
We propose amending the definition of ``organ'' to clarify that the definition includes multivisceral organs only when they are transplanted with an intestine.
We propose eliminating ``potential donor'' and replacing it with ``organ donor potential.'' The definition of ``potential donor'' in the current regulations refers to causes and conditions of death that are ``generally acceptable'' for donation of at least one solid organ.'' In our definition for ``organ donor potential,'' we would include specific parameters for the cause and conditions of death that indicate medical suitability for organ donation. These parameters are discussed in this preamble under ``Proposed OPO Outcome Measures,'' section C3. We are particularly interested in public comments on this proposed definition.
We propose replacing ``transplant center'' with ``transplant hospital'' and have standardized the use of ``transplant hospital'' throughout this proposed regulation. A transplant hospital means a hospital that furnishes organ transplants and other medical and surgical specialty services required for the care of transplant patients. There may be one or more types of organ transplant centers operating within the same transplant hospital.
Additionally, we propose adding definitions for ``adverse event,'' ``agreement cycle,'' ``death record review,'' ``decertification,'' ``designated requestor,'' ``donor,'' ``donor document,'' ``potential donor denominator,'' and ``recertification cycle.''
We propose a definition for ``adverse event'' because we propose requiring an OPO to report those events to us so that we can monitor the OPO's response to the adverse event. An adverse event would mean an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof.
We propose definitions for ``agreement cycle'' and ``re certification cycle'' to clarify the difference between the two. The 4 year CMS/OPO agreement cycle runs from August 1 through July 31, unless it is extended according to Sec. 486.314. The 4year recertification cycle is based on the calendar year.
We have included a proposed definition for ``death record review'' because we would require OPOs to perform death record reviews as part of their QAPI programs.
We have included a definition for ``decertification'' to explain that decertification follows our determination that an OPO no longer meets one or more conditions for coverage (including, the outcome measures at Sec. 486.318 and the process performance measures and other requirements) or no longer meets the requirements for certification or designation. If an OPO's agreement with us is terminated or is not renewed, the OPO is decertified.
We propose adding a definition for ``designated requestor'' to explain the role of designated requestors in the donation process. We propose a definition for ``donor'' to ensure that OPOs'' reporting of donor data is standardized. (The definition of ``donor'' is not intended to limit acceptable donors.)
We are proposing a definition for ``donor document'' because we would require OPOs to ensure that, in the absence of a donor document, the individual or individuals with responsibility to make the donation decision are informed of their option to donate organs or tissues or to decline to donate.
We propose adding ``potential donor denominator'' to the definitions because we would use this term for the potential donor data OPOs would report to the OPTN. Those data would be used as the basis for the multiple outcome measures.
These definitions, as we propose to add or revise them, are
contained in the regulatory text section at the end of this document. Requirements for Certification and Designation
[If you choose to comment on this section, please include the caption ``Certification and Designation Requirements'' at the beginning of your comments.]
Requirements for Certification (Proposed Sec. 486.303)
The current regulations do not make a clear distinction between the requirements necessary for certification and the requirements necessary for designation, nor do they specify that an OPO must be certified before it is designated for a service area. Therefore, we propose adding a new section to specify the requirements an OPO must meet to be certified.
Following are the proposed requirements. After each proposed
requirement, we have listed the location of the requirement in the
statute or in current regulations. To be certified, an OPO must: (1) Have received a grant under 42 U.S.C. 273(a).
(2) Be a nonprofit entity that is exempt from Federal income taxation under Sec. 501 of the Internal Revenue Code of 1986. (See Sec. 486.306(a).)
(3) Have accounting and other fiscal procedures necessary to assure the fiscal stability of the organization, including procedures to obtain payment for kidneys and nonrenal organs provided to transplant hospitals. (See Sec. 486.306(b).)
(4) Have an agreement with the Secretary to be reimbursed under title XVIII for the procurement of kidneys. (See section 371(b)(1)(C) of the PHS Act.)
(5) Have been recertified as an OPO under the Medicare program from January 1, 2002 through December 31, 2005. (See Sec. 486.301(b)(4).)
(6) Have procedures to obtain payment for nonrenal organs provided to transplant centers. (See Sec. 273(b)(1)(E).)
(7) Agree to enter into an agreement with any hospital in the OPO's service area, including a transplant hospital, that requests an agreement. (See 486.304(b)(8).)
(8) Meet or have met the conditions for coverage, including the outcome measures and the process performance measures and other requirements. (See Sec. 486.314. This section states that an OPO's agreement with CMS may be terminated if the OPO does not meet the two conditions for coverage in the current regulations, as well as the requirements for qualifications for designation found in Sec. 486.306.)
We propose that these threshold requirements for certification must be met before an OPO can be designated, pursuant to our proposed Sec. 486.304.
Requirements for Designation (Proposed Sec. 486.304)
Provisions regarding general requirements for designation as an OPO
currently found in Sec. 486.304 (``General requirements'') and
requirements at Sec. 486.306 (``Qualifications for designation as an
OPO'') would be reorganized. Some requirements found in current Sec.
486.304 have been moved to proposed Sec. 486.303. Other requirements
judged to be burdensome or unnecessary have been removed. For example, we would no longer require
OPOs to submit a written application for designation.
Most requirements in the current Sec. 486.306 would be incorporated into other sections of the proposed rule. Specifically, requirements for OPO advisory boards and boards of directors have been moved to proposed Sec. 486.324 (``Administration and governing body''). Requirements for agreements with hospitals, critical access hospitals, and tissue banks can be found in proposed Sec. 486.322 (Relationships with hospitals, critical access hospitals, and tissue banks). Requirements for testing of donors and organs can be found in both proposed Sec. 486.344 (Donor evaluation and management and organ placement and recovery) and proposed Sec. 486.346 (Organ preparation and transport). Requirements for data reporting have been moved to proposed Sec. 486.328 (Reporting of data), and requirements for protecting privacy of data can be found in proposed Sec. 486.330 (Information management). Finally, requirements for professional education can be found in Sec. 486.326 (Human resources). Our rationale for these proposed changes is addressed later in this preamble in our discussion of the individual sections.
In addition, we propose requiring OPOs to file a cost report within 5 months following the end of the fiscal year, rather than the current 3 months. This would conform the OPO regulations to Sec. 413.24(f). OPO Service Area Size Designation and Documentation Requirements (Proposed Sec. 486.306)
The requirements contained in this section would be redesignated from the current Sec. 486.307, and many requirements would remain unchanged. We would no longer require OPOs to provide population data to us since population would no longer be used as a basis for OPO certification.
We propose retaining the requirement that an OPO must procure organs from an average of at least 24 donors per calendar year. We believe it is important to retain this requirement to assure that each OPO has ``a defined service area of sufficient size to assure maximum effectiveness in the procurement and equitable distribution of organs* * *'' as Congress intended. (See section 371(b)(1)(F) of the PHS Act.) In addition, we would change the current requirement for an average of 24 donors per calendar year in the 2 years before the year of re designation to a requirement for an average of 24 donors per calendar year in the 4 years before the year of redesignation because the re certification cycle has been increased from 2 years to 4 years.
However, we would no longer permit exceptions to the 24donor per year rule, including the exception for an OPO that serves an entire state. (See Sec. 486.307(d)(2)(ii).) When the current regulations were published in 1996, the average OPO recovered 77 donors per year. Because of a decrease in the number of OPOs and an increase in the number of donors recovered nationwide, the average OPO procured approximately 100 donors in 2002. Therefore, we believe that an OPO procuring fewer than 96 donors in a 4year period is too small to operate efficiently and effectively.
We propose removing language from the current regulations that refers to new entities or organizations becoming OPOs. Section 371(a) of the PHS Act provides authority for the Secretary to make grants to qualified OPOs that are described in subsection (b). However, given the provision in (b)(1)(D) added by the OPO Certification Act of 2000 (``notwithstanding any other provision of law, has met the requirements of this section and has been certified or recertified by the Secretary within the previous 4year period as meeting the performance standards to be a qualified organ procurement organization* * *''), it appears impossible for the Secretary to give a grant to an organization that was not one of the 59 OPOs that was certified by the Secretary as meeting the performance standards in the 4year period before January 1, 2000.
Therefore, we propose removing the language at Sec. 486.307(d)(2)(iv) that requires an entity to show that it can procure organs from at least 50 potential donors per year if it was not previously designated as an OPO. We also propose removing references related to designation of or requirements for entities or organizations that are not currently OPOs
Additionally, we would remove obsolete service area size standards
for periods during 1996 and before. We would change the current
requirement for submission of information about acute care hospitals
that have an operating room and the equipment and personnel to retrieve
organs to submission of information about hospitals that have both a
ventilator and an operating room, since we propose requiring OPOs to
have agreements with 95 percent of those hospitals. (See discussion in
this preamble of Sec. 486.322, Relationships with hospitals, critical
access hospitals, and tissue banks). Finally, we would increase the
designation period from 2 years to 4 years to conform the designation period to the recertification cycle.
Designation of One OPO for Each Service Area (Proposed Sec. 486.308)
Requirements for the designation of one OPO for each service area
would be moved from Sec. 486.316 to proposed Sec. 486.308. Many
requirements would remain unchanged. However, we propose replacing the
``tiebreaker criteria'' used to designate an OPO when two or more OPOs
apply for the same area with new criteria found in proposed Sec.
486.316 (``Recertification and competition processes''). (See
discussion of proposed Sec. 486.316 in this preamble for a discussion of the proposed criteria.)
Changes in Ownership or Service Area (Proposed Sec. 486.310)
The requirements for an OPO changing ownership or changing its
service area found in Sec. 486.318 would be moved to proposed Sec.
486.310. Many requirements would remain unchanged. However, we propose
requiring certain additional information if there is a change in
ownership of an OPO. The OPO would be required to provide information
specific to the board structure of the new organization to ensure that
all required representatives are included. In addition, the OPO would
be required to submit operating budgets, financial information, and
other written documentation we determine to be necessary for
designation to ensure that the OPO continues to meet the requirements for designation.
DeCertification (Proposed Sec. 486.312)
[If you choose to comment on this section, please include the caption ``Decertification'' at the beginning of your comments.]
Many of the requirements contained in Sec. 486.325 (``Termination of agreement with CMS'') would be moved to proposed Sec. 486.312, but the title of the section would be changed to ``Decertification,'' to reflect the fact that if an OPO's agreement with us ends (whether through voluntary or involuntary termination or nonrenewal of the OPO's agreement), we would decertify the OPO.
The paragraph titled ``Voluntary termination'' would remain
substantially unchanged, but the paragraph would be renamed ``De
certification due to voluntary termination of agreement.''
Additionally, we would add language to indicate that we would de
certify the OPO as of the effective date of the voluntary termination. The paragraph
titled ``Involuntary termination'' also would remain substantially unchanged, but the paragraph would be renamed ``Decertification due to involuntary termination of agreement.'' Additionally, we propose adding language to indicate that we would decertify the OPO as of the effective date of the involuntary termination.
We propose adding a paragraph titled, ``Decertification due to nonrenewal of agreement,'' which states that we will not renew an OPO's agreement if the OPO fails to meet the outcome measures at Sec. 486.318 based on data from the most recent recertification cycle or if the OPO is no longer designated for the service area. In that case, we would decertify the OPO as of the ending date of the agreement. We propose removing the paragraph titled, ``Appeal right,'' because we propose a new appeals process in Sec. 486.314.
In proposed Sec. 486.312(d), we have retained our general policy of providing an OPO with at least 90 days notice before a de certification would be effective. However, we propose that in cases of urgent need, notice of decertification would be given at least three days before decertification. We expect that cases where an OPO would need to be replaced based on urgent need would be extremely rare. Nevertheless, in unusual circumstances, this expedited time frame may be necessary to protect the public health. The notice to the OPO would specifically state the reason for decertification and the effective date. We propose changing the title of the paragraph, ``Effects of termination'' to ``Effects of decertification.'' We propose retaining the paragraph, ``Public Notice,'' but we would add language that states we would give public notice of involuntary termination or nonrenewal of agreement in local newspapers in the OPO's service area.
Finally, we propose eliminating the paragraph, ``Reinstatement''
because our proposed appeals process sets forth the process we would
use for an OPO whose decertification was reversed by a CMS hearing
officer. If a hearing officer upheld a decertification, we would not
voluntarily reinstate the decertified OPO. Thus the current language regarding reinstatement would no longer be needed.
Appeals (Proposed Sec. 486.314)
[If you choose to comment on this section, please include the caption ``Appeals'' at the beginning of your comments.]
Under existing regulations, an agreement with an OPO could be involuntarily terminated for failure to meet the conditions for coverage, and any resulting appeals were governed by regulations at 42 CFR part 498. If an OPO failed the outcome performance standards set forth in 486.310, we decertified the OPO as of August 1 of the year following the end of the recertification cycle. Although the OPO was given the right to appeal under part 498, it was not possible to complete the appeals process prior to expiration of our agreement with the OPO on August 1. Therefore, we opened the OPO's service area to competition from other OPOs as soon as the OPO was notified about the decertification. The existing time frame generally did not permit a decision to be made on an appeal prior to a successor OPO taking over the service area when the decertified OPO's agreement with us expired on August 1. In order to resolve this problem, we propose to make changes to the appeals process and alter the timing of the competition. Specifically, we would: (1) Delay competition until an appeal is completed; (2) expedite appeals by using a CMS hearing officer; and (3) extend an OPO's agreement beyond August 1 if necessary.
In the OPO Certification Act of 2000, Congress specified that we must propose a process whereby an OPO could appeal a decertification on substantive or procedural grounds. (See section 273(b)(D)(ii)(IV).) Therefore, we are proposing a process whereby an OPO facing de certification due to involuntary termination or nonrenewal of its agreement with us would be able to appeal the decertification on substantive or procedural grounds and receive a decision on its appeal before its service area was opened for competition from other OPOs. We believe the proposed appeals process would be both fair and expeditious.
An OPO would have 30 calendar days from the date on the notice of decertification to submit an appeal to a CMS hearing officer. In the appeal, the OPO would be given the opportunity to submit evidence to show why it should not be decertified. Appeals could be based on substantive and/or procedural grounds. Within 2 weeks of receipt of the OPO's appeal, the CMS hearing officer would schedule a hearing. The hearing officer would issue notice of his or her decision to the OPO by certified mail within 2 weeks following the date of the hearing.
In making an appeal on substantive grounds, an OPO could submit evidence of factors that negatively impacted organ donation in its service area and prevented it from meeting the outcome or process performance measures or other requirements. For example, an OPO might have evidence that its ability to obtain consent from families of potential donors was adversely affected by certain demographic factors in its service area, such as the presence of a significant number of citizens whose race, ethnicity, religion, or educational level may be associated with lower rates of consent to organ donation. As another example, an OPO might have evidence that its ability to recover and transport organs to transplant centers while they are still viable for transplantation was hampered by the remote location of many of its donor hospitals.
Since most OPOs have some factors in their service areas that work against organ donation, the failing OPO would need to demonstrate not only the specific factors that affected its ability to meet the outcome measures but also what it did to attempt to ameliorate the factors. For example, if an OPO provided data to show that it has a high minority population that historically has had a lower rate of consent to donation, the OPO would have to demonstrate what it did to address the situation (such as conducting targeted public education) and whether these efforts were successful.
Evidence submitted by an OPO about substantive factors could include, but would not be limited to, research studies, demographic studies, data from the OPO's QAPI program, and information on the OPO's public and professional education and hospital development activities.
In making an appeal on procedural grounds, an OPO could, for example, provide evidence that incorrect data were used by us to determine whether the OPO met the outcome measures.
We propose that if the hearing officer reversed our determination to decertify an OPO in a case involving the involuntary termination of the OPO's agreement, we would not decertify the OPO. An OPO that was successful in its appeal would have a right to compete for this service area for the next cycle.
If the decertification determination was upheld by the hearing officer, Medicare and Medicaid payment would not be made for organ procurement services the OPO furnished on or after the effective date of decertification. The unsuccessful OPO would not be permitted to compete for the service area, or any other service area.
As stated earlier, OPOs currently have the right to appeal a de
certification under part 498, which sets forth procedures for providers
and suppliers to appeal decisions that affect participation in the
Medicare program. Since this proposed rule includes an appeals process for OPOs that is
separate from the part 498 process, we propose that if a hearings officer denied an OPO's appeal, the OPO would have no further administrative appeal rights. Thus, we propose removing OPOs from the definition of suppliers found at Sec. 498.2.
However, we note that section 901 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) defines the term ``supplier'' to mean ``unless the context otherwise requires, a physician or other practitioner, a facility, or other entity (other than a provider of services) that furnishes items or services under this title [title XVIII].'' Nevertheless, the unique nature of OPOs and their special role in the Medicare program distinguishes them from other suppliers. Typically, suppliers furnish medical items and services directly to Medicare beneficiaries and obtain direct payment for Medicarecovered items and services from a Medicare carrier. A supplier may furnish one or more of the health care items included within the definition of ``medical and other health services'' that are defined in section 1861(s) of the Act and are included in the scope of the part B program. (See section 1832 of the Act.) Many suppliers do not have a formal participation agreement with the Secretary. (See section 1842(h) of the Act.) In contrast, an OPO is required to have an agreement with the Secretary. (See 42 U.S.C 273(b)(1)(C).) Moreover, many, if not most, organ donors are not Medicare beneficiaries, and many organs recovered by OPOs are not transplanted into Medicare beneficiaries.
Given this framework, and to ensure that Medicare pays appropriately for its share of organ acquisition costs, OPOs have payment rules and methodologies that differ from the payment rules and methodologies used for other suppliers. (See, for example, 42 CFR Sec. 413.200.) Among other differences, organ acquisition costs are not paid directly by a carrier to an OPO. Instead, the OPO is paid by the transplant hospital, subject to later adjustment (see 42 CFR 413.200(c)(iv)), and Medicare pays the transplant hospital for the organ acquisition costs. If necessary, Medicare payment to the OPO is adjusted after it files its yearly cost report; for example, if the OPO's costs to recover organs exceeded the payments it received for the organs, Medicare covers the additional costs, based on the percentage of organs that were recovered and transplanted into Medicare beneficiaries. However, for purposes of the adjustment, all organs provided by the OPO to Medicareapproved transplant centers are considered to be organs that were transplanted into Medicare beneficiaries. Since approximately 64 percent to 74 percent of extra renal organ transplant centers and approximately 100 percent of kidney transplant centers are Medicare approved, the Medicare program reimburses OPOs for their excess costs for most of the organs they recover. Thus, the legal relationship between an OPO and the Medicare program is different from other ``suppliers'' and reflects important statutory differences.
The MMA also requires the Secretary to establish in regulations a provider and supplier enrollment process that includes an appeals process. Section 936 of MMA states that suppliers ``whose application to enroll (or, if applicable, to renew enrollment) under this title is denied may have a hearing and judicial review of such denial under the procedures that apply under subsection (h)(1)(A) to a provider of services that is dissatisfied with a determination by the Secretary. Although the appeals process we propose for OPOs differs from the MMA appeals process, it specifically addresses the congressional findings associated with the OPO Certification Act of 2000 that the uncertainty of the current recertification interferes with the effectiveness of OPOs in raising the level of donation. This alternative appeals process is necessary because there is a limited time period from the date that the outcome performance measure data are available to the date when the OPO contract cycle ends. Therefore, to achieve the goals of the 2000 legislation, including providing an equitable process for appeals, OPO appeals must be expedited and completed before a replacement OPO is named in order to avoid disruption in organ procurement.
Under our proposed rule, if the hearing officer upheld a de certification determination, we would open the OPO's service area for competition from other OPOs. The decertified OPO would not be permitted to compete for the open area, and in most cases, the de certification would be effective as of the ending date of the OPO's agreement with us.
However, if the appeals process did not leave sufficient time for us to conduct a competition process for the open area and provide for a smooth transition of the service area to the successor OPO, we could, at our discretion, extend the OPO's agreement with us for a period of time not to exceed an additional 60 days.
We believe the appeals process we propose fully satisfies the
statutory requirement to provide a process for an OPO to appeal a de
certification on substantive and procedural grounds. Although the
process is streamlined to allow an OPO to receive a decision on its
appeal before the effective date of the decertification and before its
service area being opened for competition, it allows ample time for the
OPO to prepare and present evidence of the substantive or procedural
basis for its appeal. Furthermore, the process allows sufficient time
for a hearing officer to consider the evidence and make a fair decision
that affords all of the process that is due to the OPO, while
safeguarding our ability to remove and replace an OPO that has not performed well.
ReCertification and Competition Processes (Proposed Sec. 486.316) [If you choose to comment on this section, please include the caption ``Recertification and competition'' at the beginning of your comments.]
Congress stated in the congressional findings associated with section 219 of the Consolidated Appropriations Act, 2001 that the OPO recertification process ``created a level of uncertainty that is interfering with the effectiveness of organ procurement organizations in raising the level of donation.'' Under existing regulations at Sec. 486.310 and Sec. 486.316, the service area of every OPO was opened for competition at the conclusion of every recertification cycle, regardless of whether the OPO met the outcome performance standards for the prior recertification cycle. Any OPO that met the performance standards for the prior recertification cycle was eligible to compete for an open service area or a portion of an open service area.
Under existing OPO regulations, an OPO that failed to meet the outcome measures would lose its service area and be decertified. Its service area would be opened for competition from all OPOs that met the outcome performance standards. If no OPO that met the outcome performance standards was willing to accept responsibility for the service area, the OPO that failed the outcome performance measures would be redesignated for the service area if it submitted an acceptable corrective action plan to us.
Under existing regulations, if more than one OPO that met the
performance standards wanted to take over the service area or part of
the service area of another OPO, we used six ``tiebreaker'' criteria to
determine which OPO should be awarded the service area. The tiebreakers were: (1) Prior performance, including the previous
year's experience in terms of the number of organs retrieved and wasted and the average cost per organ; (2) actual number of donors compared to the number of potential donors; (3) the nature of relationships and degree of involvement with hospitals in the organization's service area; (4) bed capacity associated with the hospitals with which the organizations have a working relationship; (5) willingness and ability to place organs within the service area; and (6) proximity of the organization to the donor hospitals.
As stated earlier in this preamble, we propose opening every OPO's service area for competition at the end of every recertification cycle as we did under the existing regulations. However, we are proposing certain limitations that we believe would address the uncertainty in the recertification process that was noted by Congress. The limitations would ensure that: (1) The process can be completed expeditiously; (2) disruptions to service areas will be minimized; and (3) an OPO may compete for an open area only if it is likely to be able to improve organ donation in the service area.
The proposed competition process would differ somewhat, depending upon whether a service area was opened for competition because the incumbent OPO was decertified or because of the wider competition process taking place at the end of a recertification cycle. First, we would permit OPOs to compete for open areas only if they met certain specific objective criteria. These criteria would vary, depending upon whether the incumbent OPO was or was not decertified. Second, we would allow competition only for entire service areas. A service area could be divided only if the incumbent OPO was decertified and no OPO wanted to accept responsibility for the service area. In such case, we could, at our discretion, choose a single OPO to take over the service area or adjust the service area boundaries of two contiguous OPOs to incorporate the open area. Finally, we are proposing to use specific clear, objective criteria for determining which OPO would be selected for a service area.
The chart below shows how the process would differ. Following the chart is a more detailed explanation of our proposal.
Incumbent OPO Criteria OPOs must Incumbent OPO decertified? permitted to Can service area meet to compete Criteria CMS uses compete? be divided? for open area to choose OPO Yes............................. No................ Yes, at discretion 4 out of 5 outcome Acceptable plan to of CMS. performance increase organ measures at or donation in open above the mean. area. No.............................. Yes............... No................ 4 out of 5 outcome Acceptable plan to performance increase organ measures at or donation in open above the mean. area. Conversion rate (actual donors as a percentage of potential donors) at least 15 percentage points higher than incumbent's conversion rate. Competition When OPO Has Been DeCertified
We propose that if we notify an OPO that it will be decertified because its agreement will be terminated or will not be renewed and the OPO does not appeal within the time frame specified in Sec. 486.314(a) or the OPO appeals but the decertification is upheld (see Sec. 486.314(c)), we would open the OPO's service area for competition from other OPOs. An OPO's service area would not be opened for competition until the conclusion of the proposed appeals process.
Only OPOs that meet 4 out of 5 outcome performance measures at or above the mean for the preceding recertification cycle would be eligible to compete for the open service area of a decertified OPO. The decertified OPO would not be permitted to compete for its service area, or any other service area. Competing OPOs would be permitted to compete only for the entire service area.
By requiring an OPO to have attained the mean or greater in 4 out of the 5 outcome performance measures in order to compete for the open area of a decertified OPO, we would limit competition to OPOs that have performed significantly better than the failing OPO. That is, the overall performance of an OPO that meets 4 out of 5 outcome performance measures at or above the mean would be, at the least, approximately 25 percentage points higher overall than the performance of an OPO that is decertified because it did not meet 4 out of 5 outcome performance measures at 75 percent of the mean. We propose establishing the threshold at 100 percent of the mean for 4 out of 5 outcome performance measures because we believe that an OPO whose performance is at or above the mean would have the expertise needed to take over a failing OPO's service area and improve organ donation.
OPOs would be permitted to compete only for entire service areas. We have found that permitting competition for partial service areas provides an incentive for OPOs to attempt to ``raid'' portions of neighboring service areas for purely business reasons, with no regard to whether the OPO can increase organ donation in those areas. For example, an OPO may wish to take over counties in a neighboring service area where hospitals demonstrate high conversion rates, which would improve the competing OPO's overall outcome performance measures but lead to no actual increase in organ donation. An OPO with a tissue bank may want a section of another OPO's service area that has particularly high tissue donation potential in hopes of expanding its tissue bank into the area. Because of the problems created by allowing competition for partial service areas, we believe it is critically important to require OPOs to compete for entire service areas.
If no OPO applied to compete for the service area of a decertified OPO, we could select a single OPO to take over the entire open area or adjust the service area boundaries of two or more contiguous OPOs to incorporate the open area. CMS would select an OPO based on the OPO's success in meeting the process performance standards during the preceding recertification cycle
Competition When OPO Has Not Been DeCertified
We propose that all OPO service areas would be opened for
competition at the end of every recertification cycle. Once we
determined that an OPO met the outcome measures at Sec. 486.318 for
the previous recertification cycle and was found to be in compliance
with the process performance measures and other requirements at Sec. Sec. 486.320
through 486.348, CMS would open the OPO's service area for competition from other OPOs.
To compete for open areas, OPOs would be required to meet certain criteria based on data from the preceding recertification cycle. An OPO would be required to meet the following: (1) 4 out of 5 outcome performance measures at or above the mean; and (2) a conversion rate of potential donors to actual donors at least 15 percentage points higher than the conversion rate of the OPO currently designated for the service area. (The conversion rate is the first of the five outcome performance measures.) OPOs would be required to compete for an entire service area. The incumbent OPO would be permitted to compete for its own service area.
To illustrate how this process would work, we provide the following example:
OPO A's service area is opened for competition. The OPO met 4 out of 5 outcome performance measures at or above the mean for the preceding recertification cycle. Its conversion rate was 109 percent of the mean. A survey of the OPO determined that it met all process performance measures. Two OPOs would like to compete for OPO A's service area. Both OPOs met 4 out of 5 outcome performance measures at or above the mean and both met all process performance measures. OPO B's conversion rate was 117 percent of the mean, and OPO C's conversion rate was 125 percent of the mean. OPO C is permitted to compete for OPO A's open area because its conversion rate is 16 percentage points higher than OPO A's conversion rate. OPO B is not permitted to compete for the open service area because its conversion rate is only 8 percentage points higher than OPO A's conversion rate. In selecting an OPO for the service area, we would consider each OPO's success in meeting the pr
FOR FURTHER INFORMATION CONTACT
Marcia Newton, (410) 786-5265. Diane Corning, (410) 7868486.