OAH 16-0900-21786-1
Governor’s Tracking No. AR 380
STATE OF
OFFICE OF
ADMINISTRATIVE HEARINGS
FOR THE DEPARTMENT HEALTH
|
In the Matter of the Proposed Amendments to Rules of the
Department of Health Governing the |
REPORT OF THE ADMINISTRATIVE LAW JUDGE |
Administrative Law Judge (ALJ) Manuel
J. Cervantes conducted a hearing concerning the above rules on the morning of March
17, 2011, at the Minnesota Department of Health,
The Hearing and this Report are
part of a rulemaking process governed by the Minnesota Administrative Procedure
Act.[1] The legislature has designed the rulemaking
process to ensure that state agencies have met all of the requirements that
The rulemaking process includes a hearing when a sufficient number of persons request that a hearing be held. The hearing is intended to allow the agency and the Administrative Law Judge reviewing the proposed rules to hear public comment regarding the impact of the proposed rules and what changes might be appropriate. The Administrative Law Judge is employed by the Office of Administrative Hearings, an agency independent of the Department.
Patricia Winget, Attorney for the Department of Health (Department or Agency),
and Dr. Sally Bushhouse, Director of the Department’s Minnesota Cancer
Surveillance System (MCSS), appeared at the rule hearing on behalf of the Department.
Approximately 14 people signed the hearing register and six interested persons spoke at the hearing. The proceedings continued until all interested persons, groups or associations had an opportunity to be heard concerning the proposed amendments to these rules.
After
the hearing ended, the record remained open until March 24, 2011, to allow
interested persons and the Department an opportunity to submit written
comments. Following the initial comment
period, the record remained open for an additional five working days to allow
interested persons and the Department the opportunity to file a written
response to the comments submitted. The
OAH hearing record closed on March 31, 2011.
All of the comments received were read and considered.
Based on the testimony, exhibits and written comments, the Administrative Law Judge makes the following:
Nature of the Proposed Rules
1.
The
Minnesota Cancer Surveillance System (MCSS) is a program within the Minnesota
Department of Health’s Section of Chronic Disease and Environmental
Epidemiology that was authorized by the Legislature in 1987.[2] The purpose of the MCSS is to monitor
incidence trends of cancer and predict risk to public health; target
intervention resources for communities; inform health professionals and
citizens about risks, early detection, and treatment of cancers that are
occurring in their communities; and promote high quality research.[3]
2.
Every
state in the
3.
The
Department first adopted rules regarding the MCSS in 1988, which are codified
in Chapter 4606 of the Minnesota Rules.[5] In this rulemaking, the Department seeks to
update the rules to reflect the scientific advances that have occurred in the
last 15 to 20 years, and proposes modifications in the following areas:
4.
The
proposed amendments have received written support from the Minnesota Medical
Association, the Mayo Clinic Cancer Registry, the
5. Under Minn. Stat. § 14.14, subd. 2, and Minn. Rule 1400.2100, a determination must be made in a rulemaking proceeding as to whether the agency has established the need for and reasonableness of the proposed rule by an affirmative presentation of facts. In support of a rule, an agency may rely upon legislative facts, namely general facts concerning questions of law, policy and discretion, or it may simply rely upon interpretation of a statute, or stated policy preferences.[7] The Department prepared a Statement of Need and Reasonableness (SONAR) in support of the proposed rules. At the hearing, the Department primarily relied upon the SONAR as its affirmative presentation of need and reasonableness for the proposed rule. The SONAR was supplemented by comments made by Department representatives at the public hearing and in written post-hearing submissions.
6.
The
question of whether a rule has been shown to be reasonable focuses on whether
it has been shown to have a rational basis, or whether it is arbitrary, based
upon the rulemaking record.
7. The Minnesota Supreme Court has further defined an agency’s burden in adopting rules by requiring it to “explain on what evidence it is relying and how the evidence connects rationally with the agency’s choice of action to be taken.”[11] An agency is entitled to make choices between possible approaches as long as the choice made is rational. Generally, it is not the proper role of the Administrative Law Judge to determine which policy alternative presents the “best” approach since this would invade the policy-making discretion of the agency. The question is rather whether the choice made by the agency is one that a rational person could have made.[12]
8. In addition to need and reasonableness, the Administrative Law Judge must also assess whether the rule adoption procedure was complied with, whether the rule grants undue discretion, whether the Agency has statutory authority to adopt the rule, whether the rule is unconstitutional or illegal, whether the rule constitutes an undue delegation of authority to another entity, or whether the proposed language is not a rule.[13]
9. On September 7, 2010, the Department published in the State Register a Request for Comments on the proposed rules. The Request for Comments was published at 35 S.R. 396.[14]
10.
By letter dated January 20, 2011, the Department
asked the Commissioner of
11. By letter dated January 5, 2011, the Department requested that the Office of Administrative Hearings schedule a hearing on the proposed rules and assign an Administrative Law Judge. Along with the letter, the Agency filed a proposed Dual Notice, a copy of the proposed rules, and a draft of the Statement of Need and Reasonableness (SONAR). The agency also requested that the Office of Administrative Hearings give prior approval of its Additional Notice Plan.
12. Administrative Law Judge Manuel J. Cervantes was assigned to the rule hearing. In a letter dated January 12, 2011, Judge Cervantes approved the Department’s Dual Notice, as modified, and Additional Notice Plan.
13. On January 24, 2011, the Department mailed copies of the Dual Notice and proposed rules to the Chairs of the Senate Health and Human Services Budget Committee, House Health Care and Human Services Reform Committee, and the House Health Care and Human Services Finance Committee. On the same date, the Department also mailed copies of the Dual Notice and proposed rules to the Director of the Legislative Coordinating Commission and Chairs of several other legislative committees.[16]
14. On January 24, 2011, the Department mailed a copy of the Dual Notice and the proposed rules to all interested parties on its rulemaking mailing list.[17]
15.
Between January 24 and 26, 2011, the Department
mailed via
16. On January 26, 2011, the Department electronically mailed a copy of the SONAR to the Legislative Reference Library as required by law.[19]
17. On January 31, 2011, a copy of the Dual Notice and proposed rules was published in the State Register at 35 S.R. 1156.[20]
18. On the day of the hearing the Department placed the following documents in the record:
·
The
Request for Comments on Possible Amendment to Rules Governing the Minnesota
Cancer Surveillance System, published in the State Register on September 7, 2010, at 35 SR 396. (Ex. 1);
·
A copy
of the proposed rules with Revisor’s approval, dated August 5, 2010 (Ex. 3);
·
The Statement
of Need and Reasonableness (SONAR) (Ex. 4);
·
A copy
of the transmittal letter and a Certificate of Mailing the SONAR to the
Legislative Reference Library on January 26, 2011 (Ex. 5);
·
A copy
of the Dual Notice as mailed and as published in the State Register 35 S.R. 1156 (Ex. 6a and 6b);
·
Certificate
of Mailing the Dual Notice to the Rulemaking Mailing List on January 24, 2011,
and Certificate of Accuracy of the Mailing List (Ex. 7a and 7b);
·
Certificate
of Mailing the Dual Notice to individuals and organizations pursuant to the
Additional Notice Plan between January 24 and 26, 2011 (Ex. 8);[21]
·
Written
public comments in support of and in opposition to the proposed rules received during
the public comment period (Ex. 9a and 9b);
·
Letter
to MMB dated January 20, 2011, regarding fiscal impact of proposed rules (Ex.
11a);
·
Letters
in support of proposed rules from the Minnesota Medical Association, the Mayo
Clinic Cancer Registry, the University of Minnesota Masonic Cancer Center, and
the Minnesota Cancer Registrars Association (Ex. 11b);
·
Email
sent to those who requested a hearing, stating that the hearing would take
place as scheduled in the Dual Notice (Ex. 11c); and
·
Certificate
of Mailing the Dual Notice and the SONAR to Legislators on January 24, 2011
(Ex. 11d).[22]
19. The Agency’s responses and written comments from Citizens Council for Health Freedom (CCHF), received after the hearing, were also placed in the record.
20.
Under
Minn. Stat. § 14.116, an agency is required to give notice of proposed rules to
both the chairs and the ranking
minority members of the legislative policy and budget committees with
jurisdiction over the subject matter of the proposed rules. Here, the Department certified that it
provided proper notice to the chairs of those committees, but did not provide
any evidence that it gave notice to the ranking minority members. The Department’s failure to provide notice of
the proposed rules to the ranking minority members constitutes a procedural
defect in these rules.
21.
The ALJ
requested an extension to complete his report so that the Department could cure
the procedural defect. The Chief ALJ
granted the request by Order dated May 2, 2011.
The Order required the Department to provide the Dual Notice, proposed
rules, and SONAR to the ranking minority members of the appropriate committees,
and re-open a 30-day comment period for these legislators. The Order further required the Department to
provide to the ALJ, by June 7, 2011, evidence that it complied with the notice
requirement, copies of any comment received from the legislators, and any
responses made by the Department to those legislators.
22.
A procedural defect can be considered a harmless
error under Minn. Stat. § 14.15, subd. 5, if:
“(1) the failure did not deprive any person or entity of an opportunity
to participate meaningfully in the rulemaking process; or (2) the agency has
taken corrective action to cure the error or defect so that the failure did not
deprive any person or entity of an opportunity to participate meaningfully in
the rulemaking process.”
23.
Under
the circumstances, the Administrative Law Judge concludes that the Department has
taken corrective action to cure the defect.
Accordingly, this error is harmless under Minn. Stat. § 14.15, subd. 5
(2).
24. Minnesota Statutes §§ 14.131 and 14.23, require that the SONAR contain a description of the Agency’s efforts to provide additional notice to persons who may be affected by the proposed rules. The Agency submitted an additional notice plan to the Office of Administrative Hearings, which reviewed and approved it by letter dated January 12, 2011. In addition to notifying those persons on the Agency’s rulemaking mailing list for these proposed rules, the Agency represented that it would mail or electronically mail the Dual Notice to:
● Designated contact persons at each facility that submits reports to the MCSS;
●
●
●
●
●
● Physicians to whom MCSS has, within the past
year, sent a letter asking for more information about a specific cancer patient;
● Individuals who replied to the Request for
Comments;
● Pathologists, via the listserve of the
Minnesota Society for Pathology (MSP);
● Physicians who are members of the Minnesota
Medical Association (MMA), via the MMA’s listserve;
● Cancer registrars, via the Minnesota Cancer
Registrars Association (MCRA) listserve;
● Department staff in cancer control;
● Members of the MCSS Advisory Group and MCSS
Peer Review Committee; and
●
Cancer epidemiology faculty at the
25. A copy of the proposed rules, SONAR, the Dual Notice, and a Q&A regarding the proposed rules were also posted on the Department’s rulemaking webpage.
26. The Administrative Law Judge finds that the Department fulfilled its additional notice requirement.
27. Minn. Stat. § 144.672 gives the Department general authority to collect “cancer incidence information, analyze the information, and conduct special studies designed to determine the potential public health significance of an increase in cancer incidence.”
28. Minn. Stat. § 144.672 directs the Commissioner to adopt rules “to administer the system, collect information, and distribute data.” The rules must include, among other things, the type of data to be reported, the standards for reporting specific types of data, and criteria for contracts made with outside entities to conduct studies using the data collected by MCSS.
29. The Administrative Law Judge finds that the Department has the statutory authority to adopt the proposed rules. The issue of whether the proposed rules are consistent with the governing statutes is addressed in the part-by-part analysis below.
Regulatory Analysis in the SONAR
30. The Administrative Procedure Act requires an agency adopting rules to consider seven factors in its Statement of Need and Reasonableness. The first factor requires:
(1) A description of the classes of persons who
probably will be affected by the proposed rule, including classes that will
bear the costs of the proposed rule and classes that will benefit from the
proposed rule.
The proposed rule amendments
will affect hospitals that do not have a cancer registry because they will need
to submit electronic files containing discharge diagnoses or uniform billing
data to the Department. Also affected
will be physicians who diagnose and treat cancer patients outside of hospital
settings. They will need to initiate
cancer reports when no diagnostic specimen was submitted to a laboratory that
reports to the MCSS. Hospitals with a
cancer registry will be affected in that they will need to report cancer cases
diagnosed without microscopic confirmation.[23]
According to the Department, all
Minnesotans will indirectly benefit from this rule change because the
Department will be able to describe treatment disparities and target cancer
control programs more accurately. The
Department suggests that broadening the data collected to non-microscopically diagnosed
cancer will pull in information from economic and cultural classes whose data
are not currently represented in the MCSS. Minnesotans will better understand how the
cancer rates and survival in
(2) The probable costs to the
Agency and to any other agency of the implementation and enforcement of the
proposed rule and any anticipated effect on state revenues.
The Department states that its costs related to the implementation and enforcement of this rule will increase because it is expanding the types of cancer diagnoses that it will track. Specifically, the Department estimates that the additional, ongoing work to collect non-microscopically confirmed cancers will require approximately 1.25 full-time employees at a rate of about $80,000 per year. The Department has secured federal funding to support this activity. The MCSS software will need to be updated to receive this new information, but the Department projects that the software costs will be absorbed by the existing MCSS development team.[25]
Additionally, the Department asserts that changing the method by which it notifies reporting entities of the required data items will reduce costs to the Department because it is less expensive to publish a notice in the State Register that it is to modify the rules.[26]
According to the Department, the balance of the proposed rules will not affect the Department’s costs of running the MCSS; nor will they affect costs to other agencies or state revenues.[27]
(3) The determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule.
The Department addressed this issue by subject matter.
Case report definition: If the Department continued to collect data on only clinically-diagnosed cancers identified by death certificate review or reported by hospital-based registries, it would save money. But the current approach does not achieve the goal of broadening the data in the MCSS and the resulting research.[28]
Specify required data items by publication in State Register: The Department asserts that the proposed rules are the least-cost alternative because the rules enable the Commissioner to keep the list of required data items consistent with national standards as those standards are updated. Further, these proposed changes allow the Department to publish the changes in the State Register without going through the formal lengthy rulemaking process.
Follow-up information: According to the Department there is no less costly alternative to collecting information regarding survival rates and outcomes because the proposed changes do not require facilities to report information that they do not have or that they do not already collect as required by other law.[29]
Additional conditions under which cases may be approached without physician consent: The Department states that the least costly way to contact patients would be to not require physician consent at all. The Department acknowledges, however, that this method would be contrary to Minn. Stat. § 144.69, and an intrusion on patient privacy.[30]
Cease collection of all in situ neoplasms of uterine cervix: The Department is eliminating all possible costs and intrusions because they are proposing to no longer collect this information.[31]
Update terminology: There is no cost involved with these proposed changes.
(4) A description of any alternative methods for achieving the purpose of the proposed rule that were seriously considered by the agency and the reasons why they were rejected in favor of the proposed rule.
The Department states that there are limited ways to accomplish the necessary changes. The only alternative seriously considered by the Department was to forego making the changes to the rules. The Department declined to pursue that alternative because it would not be able to run an effective MCSS program if it was out of compliance with national standards.[32]
(5) The probable costs of complying with the proposed rules, including the portion of the total costs that will be borne by identifiable categories of affected parties, such as separate classes of governmental units, businesses, or individuals.
As stated under Item (1) above, the proposed rules affect hospitals without cancer registries, physicians who diagnose or treat a clinically diagnosed cancer patient, and hospitals with cancer registries.
Hospitals without cancer registries: These hospitals will bear some costs associated with the collection of non-microscopically confirmed cancers. The Department believes that its plan to screen electronic billing or discharge data files submitted by these hospitals for cancer diagnosis codes should minimize the costs to these hospitals. Non-registry hospitals may need to make some modifications to existing computer software and in-house support, which could cost up to $5,000.[33]
Physicians who diagnose or treat clinically diagnosed cancer patients: The cost to these physicians would be the time required to complete a 1-2-page reporting form and submit it to MCSS. The Department estimates that each form can be completed in 20-60 minutes, or approximately $42 to $175 per non-microscopically confirmed case. These reports are only required for patients who are not being seen at a hospital and for whom no diagnostic pathology report has been submitted to MCSS. These physicians may also be contacted by the Department slightly more frequently regarding patient eligibility for research studies since MCSS will be receiving data on more patients under the proposed rules.[34]
Hospitals with cancer registries: These hospitals should experience very little change in costs for complying with the revised reporting rules. In fact, the Department suggests that hospitals with cancer registries may notice a decrease in costs due to updated rules and more consistent standards. Hospital registries already collect follow-up information and would incur costs only if their registry vendor required payment to begin including new information in the submission to the MCSS. According to the Department, most registry vendors provide updates to meet state reporting standards as part of their maintenance agreements.[35]
(6) The probable costs or consequences of not adopting the proposed rule, including those costs borne by individual categories of affected parties, such as separate classes of governmental units, businesses, or individuals.
According to the Department, if the proposed rule
amendments are not adopted, the continued exclusion of non-microscopically
confirmed cancer cases would perpetuate anomalies in
(7) An assessment of any differences between the proposed rules and existing federal regulations and a specific analysis of the need for and reasonableness of each difference.
The Department reports that there are no existing federal regulations
that govern cancer reporting. To receive
federal funds for cancer registration, however, the Department must conform to
federal standards.[37]
The Administrative Law Judge finds that the Agency has adequately considered the cost of its proposed amendments and it has adequately considered the other factors in the regulatory analysis required by Minn. Stat. § 14.131.
31. The Administrative Procedure Act[38] also requires an agency to describe in its SONAR how it has considered and implemented the legislative policy supporting performance based regulatory systems. A performance-based rule is one that emphasizes superior achievement in meeting the agency’s regulatory objectives and maximum flexibility for the regulated party and the agency in meeting those goals.[39]
32. The Department states that the proposed rules emphasize superior achievement in meeting its agency goals by specifying national standards for cancer reporting. The proposed rules afford the regulated entities flexibility in that the MCSS accepts reports in a variety of media. Physicians and registries are also not required to report information that they do not have, and the Department will work with non-registry hospitals to ease the transition to the new reporting requirements.[40]
33. The Administrative Law Judge finds that the Agency has met the requirements set forth in Minn. Stat. § 14.131 for assessing the impact of the proposed rules, including consideration and implementation of the legislative policy supporting performance-based regulatory systems.
Consultation with the Commissioner of Finance
34. Under Minn. Stat. § 14.131, the Agency is also required to “consult with the commissioner of management and budget to help evaluate the fiscal impact and fiscal benefits of the proposed rule on units of local government.”
35.
The Department consulted with MMB by letter
dated January 20, 2011.[41] MMB did not respond to the Department’s
submission.
36. The Administrative Law Judge finds that the Department has met the requirements set forth in Minn. Stat. § 14.131.
Compliance Costs to
Small Businesses and Cities
37. Under Minn. Stat. § 14.127, state agencies must “determine if the cost of complying with a proposed rule in the first year after the rule takes effect will exceed $25,000 for: (1) any one business that has less than 50 full-time employees; or (2) any one statutory or home rule charter city that has less than ten full-time employees.”[42] Although this determination is not required to be included in the SONAR, the agency must make this determination before the close of the hearing record, and the Administrative Law Judge must review the determination and approve or disapprove it.[43]
38.
In the SONAR, the Department states that it has
determined that the cost of complying with the proposed rule amendments in the
first year after the rules take effect will not exceed $25,000 for any one
small business or small city. The Department asserts that small cities
will have no costs associated with the proposed rules because none of them owns
a hospital or pathology laboratory. As
for small businesses, such as independent clinics with one or two physicians or
dentists, the Department claims that their costs would exceed $25,000 only if
the practice diagnosed at least 625 cancer cases in the first year. According to the Department, this is
extremely unlikely.[44]
39. The Administrative Law Judge concludes that the Department has met the requirements set forth in Minn. Stat. § 14.127 for determining whether the cost of complying with the proposed rules in the first year after the rules take effect, will exceed $25,000 for any small business or small city. The ALJ approves that determination.
Adoption
or Amendment of Local Ordinances
40.
Under
Minn. Stat. § 14.128, the agency must determine if a local government
will be required to adopt or amend an ordinance or other regulation to comply
with a proposed agency rule. The agency must make this determination
before the close of the hearing record, and the Administrative Law Judge must
review the determination and approve or disapprove it.[45]
41.
The
Department concludes that the proposed rules do not necessitate local
government action because the rules contain no provisions that would affect the
law or regulations of a town, home rule charter or statutory city. The affected groups are hospitals, clinics,
and physicians, the majority of which are individuals or privately-owned
entities. To the extent that hospitals
and clinics are publicly-owned, local governments do not have a role in the
reporting of data to the MCSS. All data
collection functions are performed within the Department. Accordingly, the Department asserts that the
proposed rules would not require a county to adopt or amend an ordinance to
comply with the rules.[46]
42. The Administrative Law Judge finds that the agency has made the determination required by Minn. Stat. § 14.128, and approves that determination.
Analysis of the Proposed Rules
General
43. This Report is limited to discussion of the portions of the proposed rules that received significant comment or otherwise required close examination. Several sections of the proposed rules were not opposed by any member of the public and were adequately supported by the SONAR. Accordingly, this Report will not address each comment or rule part. When rules are adequately supported by the SONAR or the agency’s oral or written comments, a detailed discussion of the proposed rules is unnecessary.
44. The Administrative Law Judge finds that the Agency has demonstrated the need for and reasonableness of all rule provisions not specifically discussed in this report by an affirmative presentation of facts. Further, the Administrative Law Judge finds that all provisions not specifically discussed are authorized by statute and there are no other problems that would prevent the adoption of the rules.
Part 4606.3300 Purpose
45.
The Department proposes the following changes to
this rule part:
The purpose of
parts 4606.3300 to 4606.3309 is to establish a process and assign
responsibility for:
A.
collecting data from pathology laboratory reports
and other demographic data on the occurrence and outcomes of cancer
in the state; and
B.
investigating the occurrence of cancer.
46.
The current rule limits data collection to cancers diagnosed
by examining tissue. The Department,
however, wishes to collect data for cancers that are diagnosed clinically (i.e.
by means other than looking at cells through a microscope).[47] Accordingly, the Department proposes to
delete the language regarding pathology lab reports and other demographic data. This additional information updates the MCSS
so that it is collecting the same types of information collected by other
cancer registries around the world.[48]
47.
The Department also seeks to amend this rule part to
include cancer patient outcome data in the MCSS. According to the Department, reporting
entities are already collecting outcome data, and this information would make
the information distilled from the MCSS more meaningful. The Department asserts that it does not know
how the survival rate in
48.
Dr. James Cerhan, Chair of the Mayo Clinic’s
Epidemiology Division and the Associate Director of the Mayo Cancer Registry,
supported both amendments to part 4606.3300.
Dr. Cerhan explained that oncology is constantly changing and that more
cancers are being diagnosed through imaging.
According to Dr. Cerhan, failure to include these types of cancer
diagnoses will result in skewed population-based estimates and faulty
conclusions.[50] Regarding the collection of outcome data, Dr.
Cerhan asserts that it is important to understand how different treatments
affect different cancer survivors so that the quality of life of cancer
patients can be improved. Dr. Cerhan
believes that cancer survivors want to be studied so that future cancer
patients can benefit from the data and research.[51]
49.
Twila Brase, on behalf of Citizens’ Council for
Health Freedom (CCHF), objected to both amendments to rule part 4606.3300. CCHF questions the Department’s motives in
collecting clinically diagnosed cancers because often these diagnoses do not
turn out to be cancer. CCHF is concerned
that the Department readily admits that cancer diagnoses without tissue
confirmation are not always accurate. CCHF
believes the MCSS has no authority to collect data on people who do not have
cancer.[52]
50.
As to the outcomes data collection issue, CCHF
asserts that the Department is not authorized by statute to collect outcome
data, only cancer incidence data. CCHF
is concerned that the MCSS will be allowed to collect data on cancer patients
“in perpetuity,” and that some of those cancer patients may object to this
governmental intrusion into their privacy.[53]
51.
Donald Lee expressed concern about imposing new reporting
requirements on already overburdened doctors, nurses, and health care staff.[54]
52.
The Department’s response to CCHF’s concerns about
collecting data on clinically diagnosed cancers is that Minn. Stat. § 144.672
gives the Department broad rulemaking authority to collect and analyze cancer
incidence information, and to determine the potential public health
significance of an increase in cancer.
The Department argues that the MCSS was originally limited to
pathology-based diagnoses of cancers because that was the most efficient way to
identify the majority of cancers in 1988.
As science has progressed and other states have begun collecting
clinically diagnosed cancer data, the Department is seeking to keep the MCSS
current and viable. The Department argues
that it must be able to collect cancer data regardless of the diagnostic method
used and claims that its rulemaking authority is broad enough to encompass all
of those methods.[55]
53.
The Department’s response to CCHF’s concerns about
collecting outcome data, in addition to incidence data, is that Minn. Stat. §§
144.671 and 144.672 must be read together.
The purpose of the MCSS is to “more accurately target intervention
resources for communities and patients and their families” and to “promote high
quality research to provide better information for cancer control.”[56] The Department also cites the U.S. National
Cancer Institute’s position regarding cancer surveillance. “The core functions of cancer surveillance
are the measurement of cancer incidence, morbidity, survival, and mortality for
persons with cancer. . . . It also includes the assessment of genetic
predisposition, environmental and behavioral risk factors, screening practices,
and the quality of care from prevention through palliation.”[57] The Department asserts that it would be
remiss in not collecting and studying cancer outcomes.
54.
The Administrative Law Judge finds the proposed amendments
to part 4606.3300 to be needed and reasonable.
The decision to collect data on clinically diagnosed cancers and data on
cancer patient outcomes is a rational choice by the Department that is
supported by their statutory authority.
Part 4606.3304, subpart 1a Reports – Data items
55.
Rule part 4606.3304 details the information that
must be included in the case reports to the MCSS. The current rule, at subpart 1, contains a
detailed listing of required case information, which changes on a regular
basis. The Department proposes to pare
this information down to seven general categories. Rather than maintain a detailed listing in
the rule language, the Department proposes to add a new subpart 1a, as follows:
The commissioner
shall, at least once per year and by publication in the State Register and
electronic notice on the Minnesota Cancer Surveillance System Web site, provide
a list of the data items to be reported under part 4606.3303, subpart 1, and
specify the format to be used for electronic reports. The list will be revised according to
national cancer reporting standards.
The
national cancer reporting standards referred to in the proposed language are
incorporated by reference in the proposed language at subpart 1b.
56.
According to the Department, the national standard
setters (the Centers for Disease Control and Prevention’s National Program of
Cancer Registries (NPCR); the American College of Surgeons’ Commission on
Cancer; the National Cancer Institute’s Surveillance, Epidemiology, and End
Results (SEER) system; and the North American Association of Central Cancer
Registries (NAACCR)) modify their data collection standards annually to ensure
that the collected data remains useful for assessing progress in cancer
diagnosis and treatment.[58] The Department asserts that the proposed
language at subpart 1a will add administrative flexibility and efficiency by
allowing MCSS to bring data submission requirements up to date by publishing
changes in the State Register and the
MCSS website, instead of through formal rulemaking.[59]
57.
CCHF is troubled by the Department’s proposal to
modify the rules without going through the formal rulemaking procedures of Minnesota
Statutes, chapter 14 and Minnesota Rules, chapter 1400. CCHF also objects to replacing the list of
specific required information in subpart 1, with general categories of data. According to CCHF, these proposed changes give
the Commissioner of Health great discretion to modify the types of data
collected regarding cancer patients. It
also argues that the proposed rule robs the general public of the ability to
participate in the revision of the rules and to object to potential action by
the Department that might exceed its statutory authority (i.e. data on
individuals who do not have cancer).
CCHF believes that the Department is superseding the rights of
58.
In response, the Department asserts that its
authority under Minn. Stat. § 144.672, subd. 1 (1) permits it to adopt rules
that specify the type of data to be reported.
The Department states that the proposed changes were prompted by “MCSS’s
need for a more flexible structure to keep pace with the modern rate of change
in science and medicine.”[61]
The national standards to which the
Department will adhere are incorporated by reference into the rule and readily
available to the public. Several of the
standards are already incorporated by reference in the current rule. The Department argues that the public is
protected from over-reaching by the Department because its statutory authority
limits its data collection to cancer-related information. According to the Department, the use of the State Register and the MCSS website to
announce changes to the information reporting standards allows the Department
the flexibility to respond quickly to changes in medicine with no loss of
transparency.[62]
59.
The Administrative Law Judge finds the Department’s
proposed amendments to part 4606.3304 are needed and reasonable. The Commissioner’s discretion is
appropriately contained by the national standards incorporated by reference
into the rule, as well as the Department’s statutory authority.
Part 4606.3306, subpart 2 Physician Consent - Approach without
consent
60.
Part 4606.3306 requires the Commissioner to attempt
to locate and obtain the consent of the attending physician or a personal
representative before undertaking epidemiologic studies on cancer patients
whose information appears in the MCSS.
Subpart 2 of this part describes when the Commissioner may go forward
with studies on patient data without consent.
The Department seeks to add to subpart 2 as follows:
The commissioner
may approach a case named in a report or a person representative of a deceased
case . . . without the consent of the attending physician as identified in the
case report in order to conduct epidemiologic investigations if the attending
physician is deceased, is no longer licensed in the state, is no longer
practicing, or cannot otherwise be located, or is no longer caring
for the case and is unable to identify the case’s current attending physician.
61.
The Department’s justification for this change is
that it has not been able to participate in studies involving long-term cancer
survivors, in part, because of the current constraint of having to acquire
physicians’ consent to contact the patients.
The Department proposes this change to account for the instances where a
cancer survivor becomes eligible for a study and a physician can no longer be
identified. In that instance, the
proposed change gives the Department authority to contact a patient directly,
or a personal representative, if the patient is deceased. The Department believes that most cancer
survivors welcome the opportunity to participate in studies that will benefit
future cancer patients.[63]
62.
CCHF objects to this amendment because the group
does not believe that the legislature intended to let the government track
every cancer patient from diagnosis to death.
CCHF does not believe that the proposed rule protects cancer patients
and survivors who may not want to be approached by the government over their
entire lifetime. CCHF questioned the
Department’s assertion that the majority of cancer patients welcome the
opportunity to participate in cancer studies.
Instead, CCHF suggests that some cancer patients may feel coerced by the
government to participate in cancer studies.
CCHF goes so far as to question whether the Department’s requests might
be overtly coercive or repetitive, relying on guilt or obligation to make
patients participate in the studies.
CCHF believes that the doctor provides an important “buffer” between the
Department and the patient.[64]
63.
The Department responded that it takes seriously its
obligation to protect the data on individuals collected by the MCSS. Pursuant to
64.
In addition, Minn. Stat. § 144.69 speaks directly to
the issue of obtaining physician consent prior to contacting patients: “Except
as provided by rule, and as part of an epidemiologic investigation, an
officer or employee of the commissioner of health may interview patients named
in any report, or relatives of any such patient, only after the consent of the
attending physician or surgeon is obtained.” (Emphasis added.)[66]
65.
The Administrative Law Judge finds the Department’s
proposed amendment to part 4606.3306 is needed and reasonable and a rational
policy choice. Minn. Stat. § 144.69
clearly supports the Department’s ability to make rules regarding approaching
cancers patients without physician consent.
Other concerns
66.
CCHF raised many questions regarding how the MCSS functions. The group requested that the Department place
information in the rule record regarding, for example, who decides what type of
research will occur, if the Department gives or receives compensation for the
data in the MCSS, who at the Department contacts patients or doctors to request
participation in research and what process or materials are used in that
contact, how many patients refused to participate in research studies, and
whether the Department ever waives consent requirements.[67]
67.
In response, the Department stated that many of
CCHF’s questions were outside the scope of the changes proposed in the
rules. The Department did, however, give
an overview of how MCSS functions and how research is conducted and consent is
obtained. The Department emphasized that
stringent rules apply to private health data received by MCSS, and that MCSS
takes seriously its obligations regarding patient privacy.[68]
68.
At the hearing, several individuals expressed fear
over potential government rationing of health care, government intrusion into
their private lives without their consent, and the manner in which the
Department conducts its statistical sampling.[69]
69.
The Administrative Law Judge acknowledges these
concerns but finds that they are outside the scope of this rulemaking
proceeding.
Based on the Findings of Fact,
the Administrative Law Judge makes the following:
1. The Department gave proper notice of the hearing in this matter.
2. The Department has fulfilled the procedural requirements of
Minnesota Statutes § 14.14 and all other procedural requirements of law or rule,
with one exception. This procedural
defect was subsequently found to be harmless error, as noted in Findings 20-24.
3. The Department has demonstrated its statutory authority to
adopt the proposed rule and has fulfilled all other substantive requirements of
law or rule within the meaning of Minn. Stat. §§ 14.05, subd. 1, 14.15, subd.
3, and 14.50 (i) and (ii).
4. The
Department has documented the need for and reasonableness of its proposed rule
with an affirmative presentation of facts in the record within the meaning of
Minn. Stat. §§ 14.14, subd. 2, and 14.50 (iii).
5. Any Findings that might properly be termed Conclusions and any Conclusions that might properly be termed Findings are hereby adopted as such.
Based on the Conclusions, the
Administrative Law Judge makes the following:
IT IS RECOMMENDED that the proposed rules be adopted, as finally proposed.
Dated:
June _10_, 2011
|
/s/
Manuel J. Cervantes |
|
MANUEL J. CERVANTES |
|
Administrative Law Judge |
Transcript
Prepared.
NOTICE
The Agency must make this
Report available for review by anyone who wishes to review it for at least five
working days before the Agency takes any further action to adopt final rules or
to modify or withdraw the proposed rules.
If the Agency makes changes in the rules, it must submit the rules,
along with the complete hearing record, to the Chief Administrative Law Judge
for a review of those changes before it may adopt the rules in final form.
When the rule is filed
with the Secretary of State by the Office of Administrative Hearings, the
Agency must give notice to all persons who requested that they be informed of
the filing.
[1]
[2]
Statement of Need and Reasonableness (SONAR) at 1. See,
[3]
[4] Tr. at 13-14, 16 (Sally Bushhouse); 22 (James Cerhan).
[5] The Department amended Chapter 4606 in 1997. See, SONAR at 2.
[6] Ex. 11b.
[7] Mammenga v. Department of Human Services,
442 N.W.2d 786 (
[8] In
re Hanson, 275 N.W.2d 790 (
[9] Greenhill v. Bailey, 519 F.2d 5, 19 (8th Cir. 1975).
[10] Mammenga, 442 N.W.2d at 789-90; Broen Memorial Home v. Department of Human Services, 364 N.W.2d 436, 444 (Minn. Ct. App. 1985).
[11] Manufactured Housing Institute, 347 N.W.2d at 244.
[12] Federal Security
[13]
[14] Ex. 1.
[15]
Ex. 11a;
[16]
Ex. 11d. See
[17] Ex. 7a.
[18] Ex. 8.
[19] Ex. 5.
[20] Ex. 6b.
[21] This document was erroneously entitled “Certificate of Mailing the Request for Comments.”
[22] This rulemaking was not initiated in response to a Petition for Rulemaking (Ex. 2), and the Department did not seek permission to omit the text of the proposed rules from publication in the State Register (Ex. 10).
[23] SONAR at 4.
[24]
[25]
[26]
[27] SONAR at 5-6.
[28]
[29]
[30]
[31]
[32] SONAR at 7.
[33]
[34]
[35]
[36] SONAR at 9-10.
[37]
[38]
[39]
[40] SONAR at 10.
[41] Ex. 11a.
[42]
[43]
[44] SONAR at 13.
[45] Minn. Stat. § 14.128, subd. 1.
[46] SONAR at 12-13.
[47] Transcript (Tr.), at 16.
[48] SONAR, at 14-15.
[49] SONAR at 17-18.
[50] Tr. at 23.
[51] Tr. at 25.
[52] Tr. at 27-28; see also, CCHF’s Rebuttal Comments (CCHF Rebuttal), dated March 31, 2011, at 1.
[53] Tr. at 26-27; see also, CCHF Rebuttal, at 1-2.
[54] Tr. at 44-45.
[55] Department’s Post-hearing Response to Comments (Department’s Response), dated March 24, 2011, at 1-2.
[56] Department’s Response, at 4.
[57] Department’s Response, at 4; see also, http://surveillance.cancer.gov/about/.
[58] SONAR at 17.
[59]
[60] Tr. at 28-30; see also, CCHF Rebuttal, at 1.
[61] Department’s Response, at 3.
[62]
[63] SONAR at 18-19.
[64] Tr. at 31-35.
[65] Department’s Response, at 5-6.
[66]
[67] CCHF’s Post-Hearing Comments, dated March 24, 2011.
[68] Department’s Rebuttal Comments (Department’s Rebuttal), dated March 31, 2011.
[69] Tr. at 38-40 (Wayne King); 40-41 (Thomas Roman); 41-43 (Martin Kellogg).