Number

Adopted Recommendation

Committee Action

1

Publish a final rule on the previously proposed rule on Conditions of Participation (COPs) for home health agencies (HHAs) currently in the queue.

Adopted 
May 2002

2

Announce removal of the Proposed Rules on HHA COPs from the docket if the proposed rule remains dormant for more than six months from the date of adopting this recommendation.

Adopted 
May 2002

3

Eliminate or modify the definitions of branch office and sub-unit contained within Medicare’s COPs for HHAs to reflect current technology and accepted practices.

Adopted 
May 2002

4

Allow Medicare+Choice Organizations (M+COs) to access State and county codes and input changes to that data element during the summer of 2002 for payment reconciliation of special status Medicare enrollees. (Direct access to proprietary information held in Federal databases would be limited in accordance with the Privacy Act.)

Adopted 
May 2002

5

Determine new procedures for processing working aged enrollments for M+CO payment reconciliation purposes and establish pilot. Analyze systems issues with ESRD enrollments and propose workarounds.

Adopted 
May 2002

6 *

Adopted 
May 2002

7

Provide additional comprehensive training for auditors concerning the development of ACR proposals in order to decrease the occurrence of erroneous and incorrect findings; include industry experts in the faculty for the training sessions. Consult with industry experts in the design of the training.

Adopted 
May 2002

8

Convene a work group whose goal is to pursue alternative methods of determining a M+COs compliance with Medicare’s regulations, such as by data-driven and "focused review"-based, biennial monitoring visits. (Plans with good performance should not be subject to total review.) Implement work group’s recommendations no later than January 1, 2004.

Adopted 
May 2002

9 *

Continue to standardize and streamline the process of reviewing M+CO marketing materials, including nationwide use of "use & file" standards; establish uniform performance standards that do not exceed statutory requirements and provide training prior to their use by all CMS Regional Offices (ROs).

Adopted 
May 2002

10

Establish a policy wherein joint training is conducted for M+CO CMS Regional Office (RO) and Central Office (CO) staff in one setting regarding major initiatives and issuance of significant changes in existing M+C policy.

Adopted 
May 2002

11

Establish a policy to provide sufficient notice to M+COs to implement major CMS information systems’ changes allowing M+COs to adequately budget for said changes, many of which occur when M+COs are in the midst of implementing other statutory system upgrades, such as Year 2000 and HIPAA.

Adopted 
May 2002

12

Establish a Special Election Period (SEP) for current M+CO members who wish to enroll in a zero-premium plan offered by the same M+CO in 2002 consistent with the "lock-in" requirement.

Adopted 
May 2002

13

Establish a policy that allows M+C plans to default members to replacement plans based on the member’s primary care physician choice.

Adopted 
May 2002

14

Review and revise the language of its template on Medicare Health Plan Compare in situations where there is a $0 premium or $0 co-pay. The fill-in-the-blank default template language does not make sense for situations where the dollar amount is greater than $0. The result is confusing, misleading, and possibly contradictory language as to financial liability.

Adopted 
May 2002

15

Clarify the 36-month payment reconciliation rule to ensure that the 36-month window runs from the time an M+CO submits its information or claim rather than the time CMS acts on and enters the information or claim into the system.

Adopted 
May 2002

16

Publish regulations in a timely fashion. States are left in limbo or held financially responsible for unclear policies. (For example, finalize and publish the newest revision of Medicaid and School Health: A Technical Guide for States; clarify the policy related to payment for these services. [The "old" version of the Technical Guide still references Medicaid as a payer of last resort for health-related services. The transmittal of May 2000 indicates the opposite.])

Adopted 
May 2002

17

Modify the definition of "hospital property" to be only the emergency department and any other health facility that holds itself out to the public as being available to provide emergency or urgent care, as well as the "immediate vicinity" to the hospital property (such as the hospital lawn, parking lot, waiting room, or similar location) in situations where someone seeking emergency care is physically unable to proceed to the actual emergency department or urgent care facility.

Adopted May 2002,
with dissent from
Mr. Martin.

18

Issue immediate interpretive guidance that use of community-based Emergency Medical Service (EMS) protocols, including established 911 protocols, is not a violation of the Emergency Medical Treatment and Active Labor Act (EMTALA).

Adopted 
May 2002

19 *

Exclude from the purview of EMTALA patients who are referred to the emergency department for diagnostic or scheduled therapeutic services, unless the diagnosis is part of the EMTALA-required screening or the treatment is part of the EMTALA-required stabilization.

Adopted 
May 2002

20 *

Resolve the Medicare coverage issues underlying the need for advanced beneficiary notices (ABNs) to have to be provided in the emergency room. Consider waiving the requirement for ABNs and the associated denial of coverage in emergency room and other urgent care settings.

Adopted 
May 2002

21

Adopted 
May 2002

22

Review, update, and clarify in regulation and interpretive guidance what is mandated by EMTALA for the physician; clearly distinguish physician medical staff responsibilities from hospital responsibilities. In particular, Centers for Medicare & Medicaid Services (CMS) guidance should provide an explanation as to whether there is a recommended threshold for the application of EMTALA as it relates to the number of specialists and type of specialists on staff who are available to be "on-call" at a particular hospital (e.g., identify safe harbors when physician specialists who are in short supply are "on-call" at more than one hospital at the same time).

Adopted 
May 2002

23

Require that hospitals be notified when EMTALA investigations are completed, regardless of the outcome.

Adopted
May 2002

24

Make Quality Improvement Organization (QIO) review mandatory early in the process and improve training of regional offices and State Agencies to improve performance and consistency of review of complaints. (CMS’ Atlanta Regional Office procedures should be used as a model.)

Adopted 
May 2002

25

Develop, fund and implement a comprehensive, ongoing communications plan that will be coordinated among HHS, CMS and its contractors, as recommended by the Advisory Panel on Medicare Education, to aggressively reach specific segments of the audience, using the appropriate channels including radio, TV, 1-800-MEDICARE, web and print media, as well as other strategies supported by research results.

Adopted 
May 2002

26

Continuously improve efforts to educate elderly individuals and/or individuals with disabilities approaching Medicare eligibility.

Adopted 
May 2002

27

Add the 1-800 MEDICARE phone number and website address to the beneficiary’s Medicare card.

Adopted 
May 2002

28

Eliminate overly burdensome Medicare Secondary Payer requirements.

Adopted 
May 2002

29

Research, consumer-test, and evaluate the current Medicare Summary Notice (MSN) and incorporate those enhancements that result in improved beneficiary understanding of the content. Incorporate reasons for noncoverage or denial of service on MSNs in plain language and refer beneficiaries to relevant regulations regarding the noncoverage or denial.

Adopted 
May 2002

30

Improve and consistently update the Medicare Plan Finder (which includes original Medicare and Medicare+Choice).

Adopted 
May 2002

31

Develop/implement performance standards for CMS’program of beneficiary education and communication efforts so that the program can be implemented consistently by CMS and all its agents and partners.

Adopted 
May 2002

32

Develop shorter versions of the Minimum Data Set (MDS) (e.g., one of the quarterly assessments forms) for Medicare and Medicaid resident assessment, to the maximum extent possible. Define the specific uses of any data elements prior to retaining any element on the form as part of an overall streamlining process. Delete or revise all MDS data elements whose reliability is below generally accepted statistical standards.

Adopted 
May 2002

33

Clarify with interpretive guidance that the MDS is a source document and does not require supporting documentation to justify coded responses.

Adopted 
May 2002

34

Automate the Resident Assessment Protocols (RAPs) process at the facility level to free up more time to meet patient care needs.

Adopted 
May 2002

35

Update the Coverage Manual relevant to Medicare Part A (e.g., who can be covered, authorized benefit periods, breaking the spell of illness, and other administrative issues).

Adopted 
May 2002

36

Integrate updates of the MDS Manual and Resident Assessment (RAI) User Guide and documentation into one manual, distribute the updated guide as soon as possible, and keep the one manual up-to-date. Revise the current manual to incorporate all interpretive guidance and answers to frequently asked questions. Keep a downloadable, up-to-date manual available on the CMS website and publish an annual print edition each year on a set date which incorporates all life-to-date regulation and guidance. Post quarterly updates on interpretive guidance to the CMS website.

Adopted 
May 2002

37

Continue to develop the MDS 3.0, which will include an analysis of the clinical relevancy of its contents and the capability to capture short stay assessment data, with an expected release date of 2004.

Adopted 
May 2002

38

Adopt a continuous quality improvement process to keep the MDS tool and the RAI process current with medical practice and changing delivery systems. Establish a scientific and technical advisory panel to guide MDS use (measure work-ups, interpretation of data quality, and interpretation of results, quality reporting, assessment of need for new measures).

Adopted 
May 2002

39

Give providers joint property rights to any data submitted as part of the MDS process. (This will allow the provider to access backup copies and may reduce the need for providers to warehouse redundant manual versions of the data.)

Adopted 
May 2002

40

Develop facility-specific analytic reports that allow facilities to compare their own performance in relation to local, regional and national trends. Develop reports and other tools to share aggregate data with all persons.

Adopted 
May 2002

41

Shorten the interval from when MDS data were originally collected to when the reports of those data are made public. The older the data are, the less relevant the application and inferences to be drawn from those data.

Adopted 
May 2002

42

Enhance CMS’ investment in education related to the use of the Minimum Data Set (MDS), including web-based training tools, such as the Medicare Learning Network. Update the skilled nursing facility (SNF) section of the Medicare Learning Network to include a detailed tutorial on MDS.

Adopted 
May 2002

43

Eliminate data elements that are not used for payment, quality measurement, or survey purposes for those resident assessments performed solely for the purpose of complying with Medicare payment requirements.

Adopted 
May 2002

44

Consolidate the number and timing of all MDS assessments to those that are required for care planning purposes, to the maximum extent possible. Refine the time frames for MDS assessments so that payment and quality cycles coincide and such cycles require the least number of assessments during short periods of time.

Adopted 
May 2002

45

Add case mix/risk adjustment to quality indicators, as appropriate.

Adopted 
May 2002

46

Improve the legend of key terms on the Nursing Home Compare website.

Adopted 
May 2002

47

Further automate the Minimum Data Set (MDS) process, including the design of publicly available software with "interview wizards" and other intuitive data accumulation methods.

Adopted 
May 2002

48

Improve the balance of nursing home comparative data available for the public to include both quality of life and quality of care measures.

Adopted 
May 2002

49

Standardize the investigative protocols of HHS and State survey teams. Increase training for State survey teams. Focus training on the proper interpretation of the regulatory compliance requirements placed on nursing facilities.

Adopted 
May 2002

50*

Use the Health Insurance Portability and Accountability Act (HIPAA) mandate as the basis to standardize terminology and identify common data elements used by payers, programs, providers, and suppliers of care and to determine whether the Resident Assessment Protocols (RAPs) are confidential and if any access protections are needed.

Adopted 
May 2002

51

Develop a standard instrument for the assessment of the health and functional status of patients receiving post acute services as mandated by the Benefit Improvement and Protection Act (BIPA); integrate, to the extent feasible, communication standards adopted under the Consolidated Health Information (CHI) eGov initiative as part of the development of this tool.

Adopted 
May 2002

52

Seek greater partnerships and outreach to the full continuum of academic medical, nursing, and other allied health care training programs in order to expose all health care professionals (not just specialists) to the value of training in gerontology and participation in interdisciplinary teams, and to the utility of clinical patient care data sets in the process of care planning.

Adopted 
May 2002

53*

Establish an appeal process for default Resource Utilization Group (RUG) payments with a specified time frame for the appeal. Establish clear and reasonable rules concerning submission of the MDS instrument so that providers are not penalized with default RUG payments for legitimate, minor delays in completing an MDS assessment.

Adopted 
May 2002

54

Adopted 
May 2002

55

Eliminate separate form for significant change in condition when it occurs in the 5-day window of the follow-up assessment.

Adopted 
May 2002

56

Adopted 
May 2002

57

Share the Outcome and Assessment Information Set (OASIS) risk-adjustment methodology with all users; make the information available on the CMS website.

Adopted 
May 2002

58

Provide access to the studies on the validity of OASIS data, adverse event measurements, and the University of Colorado study on OASIS quality and outcomes.

Adopted 
May 2002

59

Adopted 
May 2002

60

Consider the impact of HIPAA on HHAs with respect to the timing of any changes to the OASIS.

Adopted 
May 2002

61

Adopt a continuous quality improvement process to keep the OASIS tool current with medical practice and changing delivery systems. Establish a scientific and technical advisory panel to guide OASIS use (measure work-ups, interpretation of data quality, interpretation of results, quality reporting, assessment of need for new measures).

Adopted 
May 2002

62

Field test new OASIS measures before they are put into use.

Adopted 
May 2002

63

Clarify the definition of "significant change." Consider using re-hospitalization as a proxy for "significant change."

Adopted 
May 2002

64

Conduct an independent evaluation of the cost-benefit of using the OASIS form.

Adopted 
May 2002

65

Adopted 
May 2002

66 *

Seek legislation that would require all insurance companies and other government payers to recognize the validity of the Medicare enrollment process and prohibit them from developing their own processes. (For provider enrollment.)

Adopted 
May 2002

67

Create and maintain one central repository of forms required or allowed by HHS or its principal components from all of the various HHS websites.

Adopted 
May 2002

68

Create a continuous review process for all forms with an eye to constantly improving and streamlining existing forms and eliminating obsolete forms.

Adopted 
May 2002

69

Redesign all forms and data requirements to seamlessly interface with the Information Technology (IT) architecture of HHS so as to minimize human intervention and optimize IT output. Do not publish new forms until IT issues have been addressed.

Adopted 
May 2002

70

Eliminate Medicare credit balance reporting.

Adopted 
May 2002

71

Eliminate forms HCFA 1513 and HCFA 1514.

Adopted 
May 2002

72

Incorporate form HCFA 2572 into CMS 855.

Adopted 
May 2002

73

Adopted 
May 2002

74

Adopted 
May 2002

75

Use Generally Accepted Accounting Principles-based cost reporting for providers who no longer receive cost reimbursement; continue to use a simplified and streamlined version of the MCR for cost-based providers.

Adopted May 2002, with dissent from
Ms. Pattee

76

Issue clear directions to carriers and State Agencies that observations made on the MDS, OASIS, and other HHS-approved survey instruments do not require redundant manual documentation to support the observations.

Adopted 
May 2002

77

Connect data instruments and acquisition efforts so data can be transferred and applied to another use or another site of service.

Adopted 
May 2002

78

Provide resources to meet the January 1, 2005, deadline set by Congress for the development of standard patient assessment instruments as mandated by BIPA. Involve providers and patients in this process.

Adopted 
May 2002

79

Adopt protocols for joint ownership of data thus eliminating the need for manual backup copies of data.

Adopted 
May 2002

80

Establish a task force funded to address specific issues related to current practices, whereby a single provider or health plan may be reviewed/surveyed/audited by numerous State and Federal entities (especially those under the auspices of the Secretary of HHS), none of which are required to be coordinated. The task force should also address regulatory oversight. The task force will be established no later than December 31, 2002 and it will have a six-month time frame for recommendations to be submitted.

Adopted 
May 2002

81

Simplify the authorization process by adopting the Notice of Proposed Rulemaking (NPRM) proposal at 45 CFR § 164.508 that would permit a single, relatively straightforward form to cover all authorization settings.

Adopted 
May 2002

82

Adopted 
May 2002

83

Adopted June 2002;
Re-adopted
September 2002, with dissent from Dr. Olsen, Ms. Ryan, Mr. Toby

84

Clarify in the rule, or at least in the preamble to the rule, that an activity that the Privacy Rule characterizes as "not marketing" may still be marketing regulated by other applicable Federal and State laws, such as FDA regulations, CMS rules addressing Medicare+Choice (M+C) materials, and the anti-kickback and anti-influencing laws (Social Security Act §§ 1128A(a)(5), 1128B(b)). HHS Office of Civil Rights (OCR) should coordinate the final "marketing" provisions of the Privacy Rule with the HHS Office of Inspector General, FDA, and other appropriate Federal agencies to ensure consistency in regulatory provisions among these agencies.

Adopted June 2002;
Re-adopted
September 2002, with dissent from Dr. Olsen, Mr. Toby

85

Clarify that incidental use and disclosure is permitted (45 CFR §§ 164.502(a), 164.530(c)) by adopting the NPRM provisions that specify that uses and disclosures reasonably incidental to permitted uses and disclosures of medical information are not violations of the Privacy Rule.

Adopted 
May 2002

86

Adopted 
May 2002

87

Another potential solution is to allow a health plan to warn in its notice of privacy practices that requests for confidential communications may not prevent the insured under a health plan from receiving other information, such as explanations of benefits for others covered by the insured’s policy or benefits plan, that may alert the insured that the individual requesting confidential communications obtained health care. Yet another is to permit a health plan to inform an individual requesting confidential communication that the individual may have to pay for the care to avoid the health plan providing information to the insured through other explanations of benefits or similar communications that may alert the insured that the individual obtained health care in confidence.)

Adopted June 2002;
Re-adopted
September 2002, with dissent from Dr. Olsen, Ms. Ryan

88

"(4) Review of denial requested. If the individual or the individual’s personal representative requests review of a denial of access under paragraph (a)(3) of this section, the covered entity must designate a licensed health care professional to review the decision to deny access. This designated reviewing official must not have been directly involved in the denial and must be qualified by training or experience to make an informed evaluation whether withholding the protected health information to which access has been denied is in the best interest of the individual or others. The covered entity must promptly refer the request for review to such designated reviewing official. The designated reviewing official must determine, within a reasonable time, whether to deny or grant the access requested based on the designated reviewing official’s professional judgment, exercised in the best interest of the individual or others. The covered entity must promptly provide written notice to the individual or the individual’s personal representative of the determination of the designated reviewing official, and take all action required by this section to carry out the designated reviewing official’s determination.")

Adopted June 2002;
Re-adopted
September 2002, with dissent from Dr. Olsen, Ms. Ryan and Mr. Toby

89

Allow an additional year for covered entities to conform pre-existing contracts with business associates to the Privacy Rule’s requirements and issue the model business associate terms suggested by the NPRM.

Adopted 
May 2002

90

"(ii) For a business associate who is not a covered entity, obtaining a written contract or other written agreement or arrangement with the business associate that meets the applicable requirements of § 164.504(e) of this subpart.")

Adopted 
May 2002

91

Adopt the NPRM proposal at 45 CFR §§ 160.202, 164.502(g) to clarify that parents’ access to the medical information of their unemancipated children is controlled by State law, and when State law is silent, by the covered entity’s professional judgment.

Adopted
May 2002

92

The effect will be that the health care components, and the components serving them in a business associate capacity, may not disclose their protected health information to, or allow their protected health information to be used by, non-health care components unless the Privacy Rule allows such disclosure or use. For example, a health care component will not be allowed to disclose its protected health information to the covered entity’s human resources personnel performing non-covered employment functions. It also means that individually identifiable health information held by the covered entity’s non-health care components [e.g., health information in the human resources department is not protected health information subject to the Privacy Rule.])

Adopted May 2002; Re-Adopted September 2002 with dissents from Dr. Olsen and Mr. Toby

93

Adopt the NPRM proposal at 45 CFR §164.501 ("Protected Health Information") that would exclude employment records from the protected health information definition.

Adopted May 2002, with dissent from
Dr. Olsen

94

Adopt the NPRM proposal at 45 CFR § 164.504(f) to explicitly state that a health plan may disclose enrollment data to the employer or other sponsor of the group health plan, even if the sponsor does not qualify under the Privacy Rule to perform plan administration functions.

Adopted 
May 2002

95

Adopt the NPRM proposal at 45 CFR § 164.514(b)(2)(i)(R) that would make clear that a re-identification code or key under 45 CFR § 164.514(c) does not have to be deleted to de-identify data.

Adopted 
May 2002

96

"(ii) The covered entity determines, after documented inquiry of those of its components that may be reasonably expected to know, that it has no actual knowledge that the information could be used alone or in combination with other information available outside of the covered entity to identify an individual who is a subject of the information.")

Adopted 
May 2002

97

(This recommendation assumes that the nature of modifications will vary from year to year. In some years, changes may be minor in nature, while in others may be far-reaching.)

Adopted May 2002; Re-adopted November 2002

98

Establish a Privacy Rule advisory panel either within the National Committee on Vital and Health Statistics or as a separate advisory committee or task force, to concentrate on improving the operation and consumer privacy protections of the Privacy Rule and to advise HHS on the modification, additions, and deletions to the Privacy Rule’s standards and implementation specifications for the defined annual Privacy Rule Modification cycle. The advisory panel or task force should be comprised of health industry representatives, patients, and health plan enrollees with significant operational experience in the delivery and financing of health care and representative of various government agencies, including FDA, DOL, OIG, Department of Justice, State Medicaid programs, etc. that regulate activities affecting health care delivery or financing.

Adopted 
May 2002

99

CMS should eliminate the Evaluation & Management documentation guidelines.

Adopted May 2002, with dissent from Dr. Olsen

100

Encourage skilled nursing facilities (SNFs) certified to participate in Medicare to use the new shorter assessment form (called the Medicare Payment Assessment Form) to update a Medicare beneficiary’s condition on days 5, 14, 30, 60 and 90 of the person's stay in the nursing home. Maintain the policy that SNFs complete the full MDS to assess resident status on admission, annually and upon significant change in resident status thereafter. (Note: the requirement that the admission MDS is to be completed no later than l4 days after the resident’s admission would continue in force.)

Adopted 
June 2002

101

Consider the efficacy of making the collection of OASIS mandatory for Medicare patients only.

Adopted June 2002 with dissent from Dr. Olsen, Mr. Fay, and Mr. Bloom

102*

Establish incentives to encourage State Medicaid programs to discontinue requiring forms HCFA 1513, HCFA 1514, HCFA 1561, HCFA 2572 and other forms no longer used by CMS.

Adopted 
June 2002

103

Expand the J Code system to more accurately define the package size used. If available package sizes are 100 mg, 200 mg, and 1 gram, have separate codes for each of those sizes, with corresponding reimbursements.

Adopted 
June 2002

104

Further clarify the HIPAA final transaction rules to allow providers to make changes in the event the National Drug Code (NDC) system is going to remain a part of the initial HIPAA transactions codes implementation.

Adopted 
June 2002

105

Clearly define covered drug products instead of broadly defining what may qualify as self-administered.

Adopted 
June 2002

106

Use patient-specific modifiers that may move drugs into a covered category for patients with limited mobility and/or capability to understand therapeutic schedules.

Adopted 
June 2002

107

Implement a drug coding system that is standard, updates electronically, and specifically states the product administered. (Currently, the only such coding system that exists is the NDC coding system.)

Adopted 
June 2002

108

Follow the GAO’s February 2002 recommendation that CMS NOT establish its own separate review program, distinct from State efforts, to ensure the accuracy of MDS data for payment purposes. Reorient CMS’ proposed MDS accuracy program and confine its monitoring activities to determining the adequacy of each State’s efforts to ensure MDS accuracy and providing guidance and technical assistance to individual States, as needed.

Adopted 
June 2002

109

Adopted 
June 2002

110 *

Consolidate existing definitions of "rural" into one communicable definition. (Currently "rural" can mean one thing for a hospital and another for a rural health clinic.)

Adopted 
June 2002

111

Disaggregate data describing rural health care delivery from data describing urban health care delivery to ensure accurate representation of resources and expenses for the purposes of rule-making and rate-setting.

Adopted 
June 2002

112

Eliminate the ceiling regarding the maximum number of surgeries a rural hospital can perform in order to bill Part A for Certified Registered Nurse Anesthetist (CRNA) services instead of Part B, to eliminate the burden of having to get Part B provider numbers for rural CRNAs.

Adopted 
June 2002

113 *

Establish a Part A fee schedule for CRNA services. (This schedule could be used to reimburse rural hospitals in lieu of the pass-through cost of CRNA services.)

Adopted 
June 2002

114

Allow hospitals, skilled nursing facilities, and other affected entities to file an annual, renewable, three-year, geographic, reclassification application. Consult with the Office of General Counsel and industry legal experts to determine if the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 does indeed permit the filing of renewable, three-year, geographic, reclassification applications. Accept the first renewable application by September 1, 2003, if it is determined that three-year, renewable, geographic, reclassification applications are permitted by statute.

Adopted 
June 2002

115 *

Adopted 
June 2002

116

Develop a pilot certification survey process for Critical Access Hospitals (CAHs) that would entail a single survey to examine all aspects of a hospital’s operations and allied health services.

Adopted 
June 2002

117 *

Develop a legislative proposal with Congress for a single certification survey process for all providers of rural health services, including hospitals, skilled nursing facilities, home health agencies, rural health clinics, community health centers, etc., based on the results of the single survey process for CAHs.

Adopted 
June 2002

118

Urge the National Advisory Committee on Rural Health to advise HHS on a process whereby HHS works with knowledgeable representatives of rural America to analyze the impact of a new statute or regulation on the rural delivery system before it is enacted.

Adopted 
June 2002

119 *

Develop a legislative proposal with Congress to address the current fragmented approach to rural Medicare payment policy (e.g., Sole Community Hospitals, CAHs, bonus payments for rural primary care physicians, etc.) with an eye toward replacing this fragmented approach with a system that recognizes the unique operating characteristics of rural providers in all settings.

Adopted 
June 2002

120 *

Limit the application of the Medicare’s Home Health COPs based on certain payers (e.g., apply to Medicare patients only) and service criteria (e.g., the criteria would exclude services that do not meet the definition of "home health services" in the Social Security Act, Section 1861, such as those that are custodial in nature or considered personal care and may not result from a signed physician order).

Adopted June 2002, with dissent from Dr. Olsen

121

Revise the CMS Interpretive Guidance on Medicare’s HHA COPs (the State Operations Manual – Provider Certification, Section 2183, "Separate Entities") to give all agencies more flexibility in managing their operations, such as the requirements for separate policies and procedures for admission, separate clinical records, separate licensure (unless required by the State), separate timesheets and personnel records, and separate budgets. (The Interpretive Guidance contains directions to State surveyors for recognizing and qualifying an organization as a "separate entity" so that they can properly certify that an HHA meets Medicare’s COPs. The surveyors would not apply the COP requirements to the patients served by the "separate entity.")

Adopted June 2002, with dissent from Dr. Olsen

122

Establish a coordinated annual schedule for CMS-related on-site audits/reviews of M+COs to ensure that oversight activities are coordinated to the greatest extent possible for those M+COs that wish to have their routine periodic and scheduled reviews take place at the same time. (Unannounced reviews or visits would not be affected by this provision.)

Adopted 
June 2002

123

Establish a process for making timely changes to the standardized Summary of Benefits (SB) language so that beneficiaries can rely on it to make informed choices. Permit limited variations from the standardized language when they are needed for accuracy and are made in a way that does not undermine the utility of the SB for plan-to-plan comparison.

Adopted 
June 2002

124

Examine Social Security Administration (SSA) disenrollment forms and Medicare & You Handbook information to ensure that the text does not stimulate an unintended disenrollment that triggers the "lock-in."

Adopted 
June 2002

125

Explore the feasibility of permitting members of employer group health plans or individuals who have access to a personal computer to enroll and disenroll electronically from M+C plans, and begin a pilot to test said procedures, respecting security, privacy, and other related matters.

Adopted 
June 2002

126

Clarify the policy that in the event that a Medicare+Choice Organization (M+CO) becomes insolvent, and can no longer pay the provider network, the beneficiary is still responsible for any pre-determined obligations (e.g., co-pays, etc.) but should not be balance-billed for any unpaid services beyond that obligation.

Adopted 
June 2002

127

Make the changes necessary to implement the M+C enrollee health risk adjustment methodology with the M+C program on a budget-neutral basis, without increasing or decreasing total funding for the M+C program, as intended by Congress.

Adopted June 2002 with dissent from Ms. Ryan, Mr. Fay, Ms. Pattee, Dr. Olsen and Ms. Martin

128

Reduce the number of pages of referring telephone numbers in the next publication of the Medicare & You Handbook by focusing on 1-800 MEDICARE so as to avoid overwhelming readers. Ensure that all transferred callers from 1-800-MEDICARE are connected expeditiously with a "live" person at the connected number. Furthermore, work with consumer testing groups to determine the best content and organization of the Medicare & You Handbook, if not currently doing so.

Adopted 
June 2002

129

Improve communication between CMS and States, including the clarity and consistency of Medicaid policy interpretations across CMS by conducting centralized training for all RO and CO staff to ensure uniformity.

Adopted 
June 2002

130 *

Seek administrative solutions within statutory parameters to reduce Transitional Medical Assistance (TMA) reporting requirements from quarterly to annually, until such time as the statutory parameters are addressed. (Currently, families receiving transitional Medicaid coverage must report requested information quarterly, and they lose eligibility if the information is not submitted.)

Adopted 
June 2002

131

Adopted 
June 2002

132

Create an Emergency Services Cooperative Project that would follow the format of the Diabetes and Cardiovascular Quality Improvement Project. This should be developed and implemented with a scientific and technical advisory board of emergency physicians, hospitals, first responders, emergency transportation specialists, consumers and other advisers. This group should also guide development of future regulations that would assure availability of effective emergency services in all parts of the country. This group would include on-call physicians (medical and surgical specialists who provide care for emergencies) as part of the scientific and technical advisory board for the Emergency Services Cooperative Project. In the future, this group should take on thorny issues such as reimbursement mechanisms for EMTALA-related services when patients don’t have insurance; foster appropriate consultation with and involvement by QIOs; appropriate due process for hospitals and health care professionals before CMS can issue a public notice of termination and proceed with a termination letter.

Adopted 
June 2002

133

Adopted 
June 2002

134

Expand contractual relationships to community-based organizations (in addition to SHIP programs, organizations with whom Regional Education About Choices in Health (REACH) currently works) for translation services, information/education services, and outreach to individuals with Limited English proficiency (LEP), persons with disabilities, and beneficiaries in rural areas. Consider the Request for Proposal (RFP) process as a means of establishing these relationships.

Adopted 
June 2002

135

Improve the accuracy and effectiveness of beneficiary counseling and assistance programs (e.g., State Health Insurance Assistance Program [SHIPs]) by fully integrating them into regional and local outreach activities and by providing consistent training to these programs. Training programs should be based on national standards with implementation tailored to community needs.

Adopted 
June 2002

136*

Encourage and/or incentivize State Medicaid plans to provide reimbursement to community agencies providing education and outreach activities.

Adopted 
June 2002

137

Simplify beneficiary forms, use plain language in forms, and use peer focus groups to rigorously re-test the clarity of communication on an ongoing basis. Test the effectiveness of targeting communications literacy to the fourth grade level. (Currently, Medicare policy targets a sixth grade literacy level.)

Adopted 
June 2002

138*

Simplify the Medicare application using plain language and encourage States to develop their own simplified, universal application for Medicaid and other services.

Adopted 
June 2002

139

Continually evaluate and improve education and communication strategies to ensure that beneficiaries find materials easy to access and understand so they can make informed decisions about their rights, options, and obligations.

Adopted 
June 2002

140

Implement education and training of fiscal intermediaries (FIs) and carrier call centers regarding the rules for disclosing beneficiary-specific information to others (as covered in Transmittal AB-01-87). Publish these guidelines in plain language for the general public on the Medicare.gov website.

Adopted 
June 2002

141

Enhance provider education efforts by ensuring that comprehensive communication plans are coordinated among HHS, CMS, and its contractors to aggressively reach the various provider communities (including physician, nurses, and other provider groups.) These communication plans should include how to use local and national educational campaigns and advisory committees in the most effective way possible and be responsive to the needs of all provider groups.

Adopted 
June 2002

142

Simplify communications to providers using plain language and using formats that are accurate and easy to use by the provider groups on an ongoing basis. Target communications appropriately and include an executive summary of key points in all bulletins, updates, and instructions. (For example, develop a simplified "executive summary" set of instructions for physicians and staff to use the new advanced beneficiary notices.)

Adopted 
June 2002

143

Maximize the use of technology-based educational initiatives (for example, MedLearn), targeting content to the different types of providers, including non-physician providers and suppliers of care.

Adopted 
June 2002

144

Consult with advisory panels or groups of providers to provide real-time review of new communication strategies or materials in a proactive manner. Use focus groups of the intended audiences to rigorously test clarity of communications and educational programs.

Adopted 
June 2002

145

Ensure that interpretations of regulations are consistent within all manuals and that every program memorandum clearly describes the modifications or introductions of regulations. Require carriers to give answers based on regulations and CMS guidelines and not on their own interpretations. Eliminate penalties or denial of payment to providers for errors due to incorrect advice from carriers or FIs.

Adopted 
June 2002

146

Continuously improve the development of a central repository of information (i.e., MedLearn) so that general information for providers and rules/regulations are disseminated from CMS and not individual carriers, while being cognizant of regional sensitivities.

Adopted 
June 2002

147

Survey FIs and carriers and publicize the results of what are discovered to be the contractors’ "best practices" relating to provider education and communication.

Adopted 
June 2002

148

Compile, publish, and distribute widely a yearly report of provider best practices to serve as guidance for compliance. Give specific emphasis to best practices of rural health programs, clinics or providers among the rural health care community using most effective national and regional outreach methods. Periodically focus CMS teleconferences and listening sessions with various communities of interest on sharing best practices addressing problematic rules and regulations.

Adopted 
June 2002

149

Ensure that carriers are meeting with the medical community and stakeholders when systemic problems are identified and that such meetings are used as a basis for provider education programs.

Adopted 
June 2002

150

Require carriers/FIs to report the specific reasons for their denial of claims in plain language, explain what additional information is needed, and reference the specific regulation, policy memorandum or Local Medical Review Policies (LMRP), upon which the denial was based. Appeals to decisions should be reviewed and responded to within 45 days.

Adopted 
June 2002

151

Conduct outreach with the hospice and nursing home industries so that both better understand how Medicare beneficiaries living in nursing facilities can access hospice services.

Adopted 
June 2002

152

Develop and continuously improve provider educational initiatives programs to address systemic misperceptions and confusion that exist in the home care and long-term care industry about CMS’ policies and requirements (e.g., on OASIS, MDS, and "homebound status.")

Adopted 
June 2002

153

Involve all stakeholders early in the course of policy development to ensure that subsequent regulations and interpretations will be understandable and workable in diverse settings.

Adopted 
June 2002

154

Assess the effectiveness and publish results of the evaluations of provider educational materials, including but not limited to the new Resident and New Physician Training Manual.

Adopted 
June 2002

155

Establish a workgroup to evaluate the impact and feasibility of standardized medical review policies.

Adopted 
June 2002

156

Streamline the frequency of communication output, particularly rules and regulations, by ultimately moving to an annual publication of CMS regulations (Medicare Provider Manual) with quarterly updates for new technologies, treatments, and coverage decisions. Make this available online and in easy-to-update paper format.

Adopted 
June 2002

157

Provide assistance for small rural communities to learn and apply for competitive requests for proposals. Provide account service representatives to rural health clinics/providers.

Adopted 
June 2002

158

Market/publicize regional technical assistance workshops and train-the-trainer programs to assist rural health care providers and programs in each State.

Adopted 
June 2002

159

Intensify outreach efforts to educate rural health clinics and providers about the specific programs that focus on rural communities and invest in rural "best practices." Develop a rural health care section on relevant HHS websites for providers that will include all appropriate resources, technical and financial assistance programs, and best practice models for rural communities.

Adopted 
June 2002

160

Develop models to educate people from rural communities to become health care practitioners and provide incentives for these practitioners to remain in their own rural communities.

Adopted 
June 2002

161

Convene focus groups to continue to improve the clarity of the advance beneficiary notice (ABN) for both beneficiaries and providers. Emphasis should include the minimizing of any question of medical judgment.

Adopted 
June 2002

162

Continue to improve the LMRP web site so it is more user-friendly.

Adopted 
June 2002

163 *

Evaluate the potential for CMS to develop an automated prior authorization system that could, using computer edits similar to those used by insurance companies in their current claims processing systems, efficiently determine whether most claims will or will not be covered; develop a pilot program to test use of such a system in Medicare; determine the extent to which additional resources beyond computer edits may be needed for accurate prior coverage determinations; implement and evaluate the pilot program, focusing on the benefits perceived by beneficiaries and providers and the potential to minimize costs to the program; and based upon lessons learned in the pilot program, develop and implement a full national Medicare system to furnish prior coverage determinations to both beneficiaries and providers.

Adopted 
June 2002

164

Exclude from Medicare LMRP those diagnostic services ordered by a qualified medical professional when medically necessary pursuant to satisfying the Hospital’s EMTALA obligations; and require FIs and carriers to pay for diagnostic services when ordered and provided in connection with satisfying the hospital’s EMTALA obligation.

Adopted 
June 2002

165

Simplify and clarify the Clinical Laboratory Improvement Act (CLIA) requirements using plain language whenever possible to assist laboratory and physician office laboratory (POL) staff in understanding and complying with CLIA guidelines.

Adopted 
June 2002

166

Provide information to POLs about training opportunities by the State Survey Agencies (SAs) and other accrediting bodies, such as the College of American Pathologists (CAP) and the Commission on Office and Laboratory Accreditation (COLA) to assist with interpretation and implementation of new CLIA requirements.

Adopted 
June 2002

167

Update and make more user friendly CMS’ CLIA website; include links to the Centers for Disease Control and Prevention’s National Laboratory Training Network.

Adopted 
June 2002

168

Include a plain-language version of the CLIA requirements as well as a basic laboratory practices document tailored to the POL’s test system menu for moderate complexity tests, as part of the CLIA application package.

Adopted 
June 2002

169

Help laboratories to interpret the new CLIA requirements by offering training and simplified guidelines at meetings of laboratory professionals, accreditation bodies, and medical organizations.

Adopted 
June 2002

170

Develop protocols of compliance surveys for waived POLs that use criteria established in consultation with accrediting agencies and physician organizations. Perform compliance surveys when indicated on waived laboratories according to CLIA guidelines and using criteria established in consultation with accrediting agencies and physician organizations.

Adopted 
June 2002

171

Modify the Alternate Quality Assessment Survey (AQAS) self survey form as an educational tool to facilitate the survey and certification process.

Adopted 
June 2002

172

Increase the number of POL representatives serving on the Clinical Laboratory Advisory Committee (CLIAC) to more accurately reflect the number of POLs being regulated.

Adopted 
June 2002

173

Develop an educational brochure for POLs containing a plain-language interpretation of the regulatory requirements by having CMS and CDC collaborate.

Adopted 
June 2002

174

Provide open forums with professional, medical, and accreditation laboratory organizations to solicit feedback on ways to improve outreach to POLs and to increase understanding of the CLIA program among physicians.

Adopted 
June 2002

175

Solicit interest in developing an educational "Clearinghouse" on the CLIA website that includes a multimedia educational program package from interested parties, including: CMS; other Federal agencies; professional, medical, and accreditation laboratory organizations; and the CLIAC. Design methods for evaluating the effectiveness of educational programs.

Adopted 
June 2002

176

Collaborate with States and private laboratory organizations to develop and promote self-assessment tools for laboratories, as well as other types of educational programs. Include in these efforts an evaluation of the effectiveness of such educational programs.

Adopted 
June 2002

177

Stress to CMS staff the importance of collegiality and clarity in communication with providers and incorporate these factors into employee performance evaluations.

Adopted 
June 2002

178

Address program integrity problems with a general understanding that most providers want to comply with program rules and that targeted education is the best way to address problems. Reserve other approaches for instances when targeted education efforts have failed or there is clear evidence of intentional misconduct.

Adopted 
June 2002

179

Strengthen efforts to increase and improve provider education on an ongoing basis, with a new emphasis on incorporating feedback from providers into continuous quality improvement efforts. Develop mechanisms to routinely obtain and evaluate such feedback, such as focus groups, surveys, and other methods.

Adopted 
June 2002

180

Ensure that CMS has staff with well-developed talent for explaining complex matters in plain language, and work with policy experts to ensure that written communications to providers are clear, concise, and collegial. Hire and/or train staff extensively to achieve the relatively high skill levels needed to explain complex Medicare policies clearly.

Adopted 
June 2002

181

Eliminate the practice of having contractors and ROs rewrite materials from CMS’ central office, allowing exceptions only when required by unique local conditions.

Adopted 
June 2002

182

Publish annual reports that establish a baseline and track progress over time of efforts to improve the clarity and collegiality of communications.

Adopted 
June 2002

183

Evaluate the impact of newly revised materials to determine if they reduce the number of beneficiaries who make inappropriate decisions based on a misunderstanding of their rights and options.

Adopted 
June 2002

184

Evaluate whether instructing newly eligible beneficiaries to call 1-800-MEDICARE for questions about Medicare Part B eligibility is more effective in helping them to become accustomed to this resource than instructing them to call a toll-free SSA online number, which is current practice.

Adopted 
June 2002

185

(This recommendation assumes that the nature of modifications will vary from year to year. In some years, changes may be minor in nature, while in others may be far-reaching because of proposals for new transactions, replacing clinical code sets, etc.)

Adopted 
June 2002; Re-adopted November 2002

186

Require the definition of every standard transaction (45 CFR §§ 162.1101 162.1801) to include a "sender" specification and a "receiver" specification. (For example, revise the "health care claims status" and "referral certification and authorization" standard transactions to add "sender" and "receiver" requirements to their definitions.)

Adopted 
June 2002

187

Eliminate or define in a useful manner the meaning of "Within the Same Covered Entity" (45 C.F.R § 162.923(a)). (For example, if the intent of this provision is to require that transactions between health care components doing different covered functions that are part of the same corporate entity ought to be in standard formats, then apply the concepts of "hybrid entity," "covered functions," "multiple-function covered entity," and "health care components" [now applicable only to the HIPAA Privacy Rule] to all of the HIPAA rules, including the Transactions Rule. The "within the same covered entity" provision could then be redefined to apply only to transactions that are between a covered entity’s health care components that do different covered functions.)

Adopted 
June 2002

188

Issue clearer rules, including more meaningful compliance guidance, for covered entities regarding conduct of Direct Data Entry (DDE) Transactions (45 CFR § 162.923(b).)

Adopted 
June 2002

189

Work with the Office of Management and Budget to recognize that budget neutrality is measured across Medicare and all benefit programs under the purview of the Secretary of the Department of Health and Human Services, not solely Medicaid. A specific situation to apply the recognition is when determining whether waiver services are cost-effective, CMS should uniformly clarify or adopt the policy that "cost-effective" means waiver services will cost no more to the Medicare and Medicaid programs combined than the combined costs of providing Medicare and Medicaid services on a fee-for-service basis to the same population.

Adopted 
June 2002

190

Give States greater flexibility in developing their programs by stating the purpose of the programs (for example, providing health care for low-income individuals) and giving the States the ability to design their own programs, in compliance with Federal law, while holding States accountable for achieving the outcomes in accordance with pre-established criteria. (Do not specify how States should meet those criteria.)

Adopted 
June 2002

191

Work with States when drafting State Medicaid Letters and solicit States’ input prior to the letter being formally issued.

Adopted 
June 2002

192

Convene by September 1, 2002, with recommendations by July 1, 2003, and have a pilot ready to implement by September 1, 2003, an interagency working group consisting of CMS, State Medicaid Directors, and the Social Security Administration (SSA) to work on an improved system for timely and accurate identification, enrollment, and notification of dual eligibles.

Adopted 
June 2002

193*

Identify the best practices of States that have been most successful in identifying and enrolling dual eligible beneficiaries (QMBs, SLMBs, QI-1s, QI-2s), including through electronic data matches, and encourage through incentives, use of those best practices in other States that are not as successful. Develop pilot studies and other demonstrations of innovative methods to integrate Medicare and Medicaid data on a near real-time basis, so that States could be provided continuous ability to access and analyze their dual eligibility data on a command basis.

Adopted 
June 2002

194

Institute in those 15 States where there is no electronic information exchange to identify dual eligibles, data match agreements between the State, and CMS and/or SSA. Until those data match agreements have been operationalized, develop or refine interim working agreements between States and CMS and/or SSA to ensure timely notification about dual eligibility and enrollment. Work to continuously improve the quality and accuracy of the Medicaid eligibility data States bring to CMS and/or SSA for new and existing electronic information exchanges to identify and enroll dual eligibles.

Adopted
June 2002

195

Determine what barriers exist to State Medicaid Agencies complying with Federal timelines for enrolling qualified Medicare beneficiaries into premium assistance programs, and seek remedies (e.g., best practices for technical problems, information technology improvements, etc.) to remove those barriers. (The timelines apply only after an individual has filed an application through the State Medicaid Agency.)

Adopted 
June 2002

196

Institute immediately a policy requiring States to exempt lump sum Medicare Part B premium refunds, currently allowed to be deducted from the Social Security benefit payments of a dually eligible beneficiary during the period in which the beneficiary’s initial Medicaid eligibility is being determined, from being counted as an asset in determining the beneficiary’s continuing eligibility for Medicaid.

Adopted 
June 2002

197 *

Look at States that have enacted a single enrollment form for all eligible programs such as the District of Columbia. Develop a simplified, model, "one-stop-shop" application form that constitutes a formal beneficiary enrollment into all eligible Federal/State entitlement or assistance programs (for example, Medicaid, food stamps, Women, Infants and Children (WIC), housing, etc.). To the maximum extent possible, work with relevant agencies to standardize the form in order to develop an electronic enrollment process. Immediately have HHS look at those State programs that are most successful in enrolling dual eligible beneficiaries into all eligible Federal/State entitlement or assistance programs (especially those programs under the auspices of the Secretary of HHS).

Adopted 
June 2002

198

Determine if States provide assistance to individuals who require assistance to complete beneficiary enrollment applications for Federal/State entitlement or assistance programs, consistent with applicable Federal, State and local laws, requirements, and established policies, including but not limited to those regarding individuals with Limited English Proficiency (LEP) and the Americans with Disabilities Act. Work with States to eliminate any technical barriers they may encounter to meeting those requirements and share best practices that demonstrate effective methods of doing so.

Adopted 
June 2002

199

Work in coordination with States on development of appropriate educational materials for dual eligibles that are equal in quality to those published for all Medicare beneficiaries, to assist dual eligibles in understanding the programs (including the core set of Federally mandated Medicaid services) to which they are entitled and their financial responsibility in those programs. Use these materials as part of outreach efforts with this population.

Adopted 
June 2002

200

Evaluate for best practices the State of Connecticut’s 211 system for beneficiary information, called "Info Line" (www.infoline.org). Determine the extent to which other States are using this model and encourage the use of systems like "Info Line" by States as a model for all Medicare & Medicaid beneficiaries.

Adopted 
June 2002

201

Clarify in the State Operations Manual (SOM) section(s) dealing with "Medicare-Medicaid Certification – Distinct Part Designation" that any reference to particular examples (mentioned either in relevant Instructions, Survey Procedures, Interpretive Guidelines, or Forms) is intended only to be EXEMPLARY of how compliance may be achieved, but does not constitute the only configurations that are allowed for compliance with the statute or regulations. Clarify for State surveyors that in the absence of a facility complying with one or more examples that are mentioned, the facility must still be able to demonstrate how it complies with the regulation or statute. Provide guidance and training to surveyors and providers. Follow up and monitor consistency in application. (Recommendation refers to just SNF/NFs.)

Adopted 
June 2002

202*

Require FIs to render decisions on demand bills within 45 days after receiving all medical records documentation required by the FI to support the original decision made by the SNF. If the FI decision is not rendered by 90 days, require FIs to pay the SNF automatically. Require administrative law judges (ALJs) to render a decision within a 90-day period of time after an appeal is filed at the ALJ level. Allow payment without "prejudice" during the appeals period.

Adopted 
June 2002

203

Adopted 
June 2002

204

Adopted 
June 2002

205 *

Adopted 
June 2002

206

Issue a revised policy declaring that due to the national nursing shortage, we are in a period of "extraordinary circumstances." Due to this problem, contracting for nursing services for continuous care is allowed. The statement should restate the responsibility of hospice when contracting for services, located in 42 CFR § 418.80.

Adopted 
June 2002

207

Convene relevant stakeholders to work with CMS to revise the threshold definition of "harm" as applied in the SNF/NF enforcement process and operationalize item-specific criteria for decision making at each relevant survey requirement. Publish the results of this collaboration in a Notice of Proposed Rulemaking (NPRM) and revise relevant regulations as needed. Implement the final rule; develop guidance for survey and enforcement; provide training to surveyors and providers; and require CMS to monitor its application by surveyors.

Adopted 
June 2002

208

Convene relevant stakeholders to work with CMS to amend the threshold definition of "repeat deficiency" as applied in the SNF/NF enforcement process; insure that the more serious remedy associated with a repeat deficiency can only be applied in the presence of a repeat occurrence of the same problem, and/or a repeat deficiency of the same subordinate requirement within the larger regulatory group. (For example, under the larger regulatory grouping, "Quality of Care," there might be a citation related to wound care on one survey, and a citation related to personal grooming found on a subsequent survey. For purposes of the Advisory Committee’s recommendation, the latter citation would not constitute a "repeat deficiency" of wound care, and hence the more serious penalty would not be imposed.) Issue an NPRM adding the revised definition from above at 42 CFR § 488.401 and related requirements as needed; publish a final rule; develop and issue corresponding instructional guidance in SOM Chapter, 7, Section 7516, and (C) (3). Provide training to surveyors and providers; require CMS to monitor its application by surveyors.

Adopted 
June 2002

209

Convene relevant stakeholders to define and clarify the criteria for when a determination of a "quality of care" deficiency rises to the threshold level of "abuse and neglect." Publish an NPRM incorporating these criteria and related requirements; amend the SOM Guidance to include and implement these new definitions; and provide training to ROs, States, and providers.

Adopted 
June 2002

210

Implement the final rule; issue revised instructions and guidance; and provide training to surveyors, States and providers.

Adopted 
June 2002

211

Issue an NPRM modifying the regulation at 42 CFR § 498 to permit providers the opportunity to (1) appeal noncompliance whether or not a remedy is actually imposed; (2) to challenge severity and scope determinations; and (3) to challenge choice of remedies recommended or imposed, including modification to related citations. Implement the final rule; issue instructional guidance; and provide training to ROs, States and providers.

Adopted 
June 2002

212

Strengthen the quality of SOM communications (e.g., survey procedures, interpretive guidance, written instructions, etc) written for the primary audience of SAs and surveyors, by infusing it with a more positive, less provider-adversarial tone and stance. Include specific instructions and guidance that suggest or favor increased communication between surveyors and providers, including allowing surveyors to exchange information with providers on best or innovative practices. Design training programs for surveyors and providers that implement these types of less adversarial, more collegial types of changes.

Adopted 
June 2002

213 *

Issue an NPRM that would allow CMS to grant waivers to SAs to test and implement alternatives to the survey and enforcement process currently required to assess Federal quality of care and resident outcome requirements. Implement a final rule, develop criteria and guidance to States in making application to CMS for such waivers; issue guidance for survey and enforcement purposes; provide training to States, surveyors, and providers; evaluate the efficacy of waivers that have been granted, in relation to the efficacy of CMS’ current survey process, in terms of overall improvement to quality and care and resident outcomes.

Adopted 
June 2002

214 *

Issue an NPRM modifying the enforcement regulation in order to defer the ability of the SAs to suspend a facility’s nurse aide training programs pending the final results of an appeal; implement the final rule issue required instructional guidance; and provide training to ROs, States, and providers.

Adopted 
June 2002

215

Modify existing regulations in order to allow providers the option to utilize electronic images, transmittals, and automated vendor file exchange data receipts as evidence to support costs claimed for reimbursement in place of the currently required "hard copy" originals of such evidence.

Adopted 
June 2002

216

Convene relevant stakeholders to modify and operationalize the definition of "substandard quality of care" and defining the exclusive set of the subordinate requirements/survey tags whose citation can constitute the threshold determination of substandard quality of care (i.e., only those requirements that deal with the provision and quality of care and/or to the training of nurse aides, but NOT to the citation of other SNF/NF requirements, e.g., having sufficient closet space, etc.) Issue an NPRM to this effect; publish and implement a final rule; issue revised instructional guidance; provide training to the surveyors and providers.

Adopted 
June 2002

217

Issue an NPRM modifying 42 CFR § 488.318(b)(2) so that when inadequate survey performance (e.g., "failure to cite only valid deficiencies, failure to use Federal standards, protocols, and the forms, methods, procedures, policies, and systems as specified by [CMS]…") is demonstrated/established to have contributed to the citation of a deficiency, that the CMS Regional Office or SA must conduct follow-up (including on-site investigation, if necessary) to validate the presence of the deficiency, if a corresponding remedy is to be applied. Implement the final rule; and require CMS to monitor its application.

Adopted 
June 2002

218

Issue an NPRM modifying the regulation at 42 CFR § 488.331 to include criteria for "timeliness" (so that it applies to timely transmission of both the CMS Form 2567 [Statement of Deficiencies] and the notice to the facility of its opportunity to request an IDR). Until such time as a regulation can be promulgated, issue instructional guidance to State and Federal survey agencies establishing preliminary criteria for timely response to IDR requests. Implement final regulation; and provide guidance and training to ROs, States and providers.

Adopted 
June 2002

219

Develop a database for practitioners, patients, and caregivers to help prevent known potential adverse interactions between and among drugs, foods and dietary supplements. Once a patient, caregiver, or any medical professional enters a patient’s complete drug regimen into this database, the program would alert the patient to the level of risk and/or benefit of any known potential interactions. (For this recommendation, the term "drug" includes prescription and over-the-counter medications, and the term "dietary supplements" include but are not exclusive to herbal and nutritional supplements. An existing example can be found on the web at www.aidsmeds.com.)

Adopted 
June 2002; Re-Adopted September 2002

220

Publicize the user-friendly, drug-food-dietary supplement interactions database to mitigate any increases in health care costs due to adverse events. (For this recommendation, the term "drug" includes prescription and over-the-counter medications, and the term "dietary supplements" include but are not exclusive to herbal and nutritional supplements.)

Adopted 
June 2002; Re-Adopted September 2002

221

Immediately launch an educational and information campaign to educate patients and all health care professionals about the MedWatch system (an adverse event reporting system operated by the FDA) to increase the reporting of adverse events until an improved, automatic information technology system is established.

Adopted 
June 2002

222

Create an FDA/HHS working group of all affected stakeholders to look at the current IT systems that have automatic reporting for adverse events, adverse drug reactions, and medical errors; study the feasibility of developing a National Automatic System. (An existing example can be found on the web at www.PRHI.org.)

Adopted 
June 2002

223

Use the Centers for Education and Research on Therapeutics (CERTs) for collection of adverse event information from all health care providers, both public and private. Use CERTs to develop a central repository of drug adverse event reports from all health care providers. CERTs should conduct Phase IV Trials when, in consultation with the FDA, it has been decided that a Phase IV Trial may be necessary to answer new questions that arise from newly reported adverse events.

Adopted 
June 2002

224

Design and implement, as soon as possible, a demonstration project to deploy Medicare smart cards to selected beneficiaries. Include a chip on the card that would contain basic beneficiary data in a write-protected form so it could not be altered by an unauthorized user. Ensure that the smart card can be used by providers, beneficiaries, and the industry to store information. (Note: the long-term goal of this initiative is to create an electronic medical record.)

Adopted
September 2002; Re-adopted November 2002

225

226 *

Use the Medicare smart card as a tool for integrating medical information across the continuum of care over the long term. For example, allow for the integration of data from future electronic standard assessment instruments, enrollment forms, and medication administration records into smart card technology.

Adopted
September 2002

227

Issue written guidance to surveyors stating that 42 CFR § 418.88b, which requires as a COP for hospice providers that dietary counseling by qualified individuals is available and does not preclude nurses or other qualified health professionals from providing dietary counseling (could be implemented with a memorandum).

228

Revise the hospice COPs to provide an exception to the twenty-four (24) hour nursing services standard in the hospice COPs when respite care is provided (without undermining basic health and safety standards for hospice patients).

Adopted
September 2002

229

Collaborate with States to ensure that State Plan Amendments and State waiver requests (for example, 1115 waivers) are approved in a manner that is timely, significantly decreases unnecessary documentation, and fosters State program innovation. CMS should adopt a reasonable, workable, preset schedule for completing State requests for plan amendment approvals and waivers. (This would enable States to promptly provide a continuum of services to all beneficiaries in the least restrictive setting, regardless of whether those beneficiaries have disabilities.)

Adopted
September 2002 with dissents from Mr. Bloom, Ms. Osborne Shafer and Ms. Pattee

230

Issue immediately a written statement that "Medicare hospice providers must recognize the individual’s right to self-determination at the end of life and hospice staff should be prepared to provide CPR for hospice patients that request to be resuscitated or do not have a DNR or advance directive."

Adopted
September 2002

231

Adopted
September 2002

232

Require that Medicare FIs and carriers pay claims in review for longer than 45 days for unresolved situations in which Medicaid or Medicare may be obligated to pay. Develop systems for Medicare to ensure the timely recoupment of payments that are determined to be the responsibility of Medicaid upon final review.

Adopted
September 2002

233

Develop an online, real-time claims adjudication system for Medicare that gives payors information relating to coverage, reimbursement, and COB at the point of service whenever possible.

Adopted
September 2002

234

Promote the broadest dissemination of the "Best Pharmaceuticals for Children Act" mandate for a 1-800-Toll-Free number for reporting of adverse drug events when promulgating a final rule under P.L. 107-109. The toll-free number should appear in an easily identifiable location. The Committee also recommends that manufacturers voluntarily begin placing this number on unit of use or ready-to-dispense prescription packages to minimize the impact on pharmacy.

Adopted
September 2002

235

Adopt safe labeling practices for all FDA-regulated products to improve patient safety and decrease avoidable adverse drug events. For example, adopt labeling standards with respect to label format, information placement, information presentation and standardized definitions (and measurements.)

Adopted
September 2002

236*

Issue a Memorandum of Understanding (MOU) between the FDA and CMS that considers the interest of stakeholders and defines the process the two agencies will employ to permit the exchange of information and support collaboration relative to their respective reviews of innovative medical device technologies while maintaining the confidentiality of trade secrets and other proprietary data. Propose regulations to achieve specific elements of this recommendation, as needed.

Adopted
September 2002

237

Formally promote and encourage the implementation of processes to expedite FDA notification of CMS when an Investigational Device Exemption (IDE) designation, i.e., Category A or B, has been granted, and ensure complete and timely CMS transmittal of such notification to local carriers and fiscal intermediaries.

Adopted
September 2002

238*

Shift from doing name safety testing, in most cases, to reviewing data from sponsors who follow protocols designed to evaluate the potential for look-alike and sound-alike errors with generic and proprietary names prior to approval of FDA-regulated drugs. Use information gathered from the name safety research to improve patient safety by minimizing post-marketing medication errors linked to name similarity and practitioner confusion.

Adopted
September 2002

239

Encourage all relevant parties (FDA, other HHS agencies, consumer groups, industry, and pharmacy groups) to issue educational materials on the reporting of adverse events targeted to the patient and health care provider audiences. Such materials should be designed to encourage reporting of appropriate adverse events by patients and health care providers.

Adopted
September 2002

240*

Issue regulations that would require all appropriate FDA-regulated products to be packaged to take full advantage of appropriate administration and patient identification technologies, and, consequently, to prevent medical errors.

Adopted
September 2002

241*

Establish a process, with input from affected stakeholders, to enable early coordination between FDA and CMS and, when appropriate, permit parallel reviews during the design of clinical trials for medical device technologies, thereby promoting more timely patient access to innovative therapies without slowing down the FDA approval process.

Adopted
September 2002

242*

Announce publicly and promote through outreach to stakeholders the process (e.g., relevant structures and time frames) for the implementation of recommendations relating to FDA/CMS coordination related to new medical device technologies.

Adopted
September 2002

243

244

Determine processes for timely review of FDA-regulated combination products by dedicating staff to the development of appropriate policies or establishing a new Office of Combination Products.

Adopted 
September 2002

245

Encourage electronic submission of applications to market new FDA-regulated products, including all relevant information that can be furnished electronically.

Adopted 
September 2002

246*

Add information on clinical trials for IDEs to the clinical trial database for drugs and biologics. Seek stakeholder input in this process, while ensuring confidentiality of proprietary information. Establish, as a priority, the implementation of this database for all FDA-regulated products.

Adopted 
September 2002

247

Develop separate MedWatch forms for pharmaceutical products and medical devices.

Adopted 
September 2002

248

Support government-wide efforts to simplify and harmonize requirements related to human subject research; maintain strong human subject protections and balance individual medical privacy rights with the societal health benefit that results from effective medical research.

Adopted 
September 2002

249

Support the activities of the HHS Working Group to respond to the National Bioethics Advisory Commission report, Ethical and Policy Issues in Research Involving Human Participants.

Adopted 
September 2002

250

Issue proposed, interim final, and final CMS regulations on one business day of every month, unless another date is necessary to comply with the law or is contrary to public interest. Issue interpretive guidance on a biweekly schedule that coincides with the promulgation of all related final regulations.

Adopted 
September 2002

251

Adopted 
September 2002 with dissent from Dr. Olsen

252

Adopted 
September 2002

253

Examine ways to expedite approval timelines and procedures to get products, services, processes or benefits to market faster to respond to evolving consumer needs.

Adopted 
September 2002

254 *

Implement a process to continually review and update current regulations against statutes, policies and guidance to ensure relevancy and consider either an automatic review or sun setting process for particular regulations or categories of regulations.

Adopted 
September 2002

255

Examine the processes and procedures that ensure the Department’s agencies use the most current and reliable data in the rulemaking and interpretive guidance processes, including performance standards or guarantees with contracting entities.

Adopted 
September 2002

Page modified as of January 28, 2003 .