Summary of Public Comments - CMS-10185.30 day comment summary_2012 Part D RR_07212011

Reporting Requirements
Organization	Reporting Section	Description of Issue or Question	Suggested Revision/Comment	CMS ACTION	REASON FOR ACTION
HealthSpring	Appeals	Clarify if C31 and C32 include both member and provider appeals.	Clarification.	Clarify	Guidance will be given to clarify that this reporting should only include member appeals.
Med-Impact	Coverage Determinations and Exceptions	Suggest replacing 'made' with processed.	Replace 'made' with 'processed.'	Do not accept	The current terminology was requested by other Sponsors, and does not require change.
Blue Cross and Blue Shield of North Carolina	Coverage Determinations and Exceptions	Recommend element A be further refined to specify the types of pharmacy transactions that should be included. Please clarify the rationale for reporting multiple transactions for the same beneficiary, same drug, same pharmacy, same rejection reason on the same date of service.	Revise data element A.	Do not accept	CMS will use data element A to determine the rate of reversal; therefore, multiple transactions should be included in this reporting.
Blue Cross and Blue Shield of North Carolina	Coverage Determinations and Exceptions	All the following elements use the word “made” in the reporting period.  Please clarify what they mean by “made?”  Is it CMS’ expectation that cases be reported when they are decided and not when they are requested?	Clarification.	Clarify	Guidance will be given to clarify that it is CMS' expectation that cases be reported when they are decided and not when they are received/requested.
Blue Cross and Blue Shield of North Carolina	Coverage Determinations and Exceptions	For elements C, F, I , L, the sponsor suggests language clarification “Total number of [PA, UM, tier, formulary] determinations made in the reporting period”. Please clarify if a review that is fully favorable but is within the 24 hrs of the expiration of the timeline as allowed in Chapter 18 would be included in the number of favorable exceptions H,K,N. While this is used rarely it could impact numbers.	Clarification.	Clarify	Guidance will be given to clarify data elements for this reporting section.
Independent Health	Coverage Determinations and Exceptions	Seeking more clarification/definition in the reporting requirements or technical specs as to what is included in each data element. For example, in the timely decision fields (elements D., G., J., M.), are we looking to include the number that were approved or denied within the time frames?	Clarification.	Clarify	Guidance will be given to clarify data elements for this reporting section.
BCBS of Minnesota	Enrollment and Disenrollment	Recommend removing references to transaction types 60, 62 and 71 because they no longer exist after the relesse of CMS' enrollment processing changes eff 4/18/11.	Remove references to 60, 62 and 71.	Accept	An update was made to the Reporting Requirements document to remove references to transaction types 60, 62 and 71 due to changes in the MARx system effective 4/18/11.
United	Enrollment and Disenrollment	State that elements K and L are duplicative to data already available to CMS.	Remove data elements K and L.	Accept	An update was made to the Reporting Requirements document to remove data elements K and L because they are duplicative of data already available to CMS.
United	Enrollment and Disenrollment	Request clarification for element P. For element P, does this refer to a beneficiary who moves to a new Part C and Part D Sponsored Plan due to another Sponsor's contract nonrenewal, plan termination or service area reduction? Or, is this element capturing a current member of a plan who is moved internally to another plan within the same organization, due to contract nonrenewal, plan termination or service are reduction? For current members who are moved internally (reasons previously mentioned) are considered disenrollments and not enrollments, and are sent to CMS using "X-administrative change." In this instance then, CMS has access to the data and reporting for this data element would then be duplicative.	Clarification.	Clarify	Guidance will be given to clarify that data element P may include a beneficiary who moves to a new Part C and Part D Sponsored Plan due to another Sponsor's contract nonrenewal, plan termination or service area reduction. Due to revisions of other data elements in this section, data element P has been renamed data element O.
SCAN Health Plan	Enrollment and Disenrollment	Suggest elections instead of "enrollments". Clarification if OEC enrollments should be included as a new element.	Replace "enrollments" with "elections." Clarify if OEC enrollments should be included as a new element.	Accept	CMS will retain the term "enrollments" as the term "elections" is too generic. An update was made to the Reporting Requirements to include OEC enrollments as a new data element. The order of data elements has been revised. This data element has been named data element J.
Kaiser	Enrollment and Disenrollment	Request elements 1.K and 1.L are deleted as they duplicate data already available to CMS.Confirm if internet printouts that are mailed should be included in element 1G, instead of 1.I.	Remove data elements K and L. Clarify how internet printouts should be reported.	Accept	An update was made to the Reporting Requirements document to remove data elements K and L because they are duplicative of data already available to CMS. The order of data elements has been revised. Guidance will be given to clarify reporting for this data element.
AHIP	Enrollment and Disenrollment	Proposed element O would require sponsors to report enrollment transactions “using the SEP Election Period code ‘S’ that coordinates with the Medicare Advantage Disenrollment Period” (MADP). If we understand this language correctly, it appears that it may be in error, because no enrollments will be permissible under the MADP and therefore no code “S” enrollments would be associated with the MADP. Recommend CMS revise or delete this element.	Revise data element O.	Accept	An update was made to the Reporting Requirements document to add language to this data element to make plans aware that this element is only applicable to stand-alone PDPs. The order of data elements has been revised. Data element has been renamed data element N.
AHIP	Enrollment and Disenrollment	Exclusion for 800 series plans, and employer/union direct contract plans. We also note that in the proposed CY 2012 Part C Reporting Requirements, CMS is proposing to add an Enrollment/Disenrollment section, similar to the Part D Reporting Requirements. The currently applicable Part D Technical Specifications (CY 2010, which also apply for CY 2011) indicate that EGWPs and all 800 series plans are waived from this requirement (see pages 10 – 11). However, the proposed Part C requirement would apply to these plans. Recommend CMS retain the waiver under Part D and recommend that it also be included in the proposed Part C reporting requirements.	Exclude 800 series plans and employer/union direct contract plans from reporting Enrollment and Disenrollment section for Part C.	Accept	CMS will clarify in the Part C Reporting Requirements that 800 series plans and employer/union direct contracts will be excluded from this reporting in order to be consistent with Part D.
United	Fraud, Waste and Abuse Compliance Programs	Recommend reporting deadline be moved to 5/31.	Move reporting deadline to 5/31.	Do not accept	This reporting is optional for Plans; and therefore, the reporting deadline will not be changed.
United	General	Recommend a guide to the technical requirements and uploading edits that are in place would reduce the amount of error messages when uploading extensive data on the measures and conserve HPMS Helpdesk resources.	Recommend a guide to the technical requirements and uploading edits for HPMS.	Do not accept	This comment is outside of the scope of this PRA package, however CMS will review current technical guides and provide additional clarification.
United	General	Request additional technical instructions re: data submission.	Request additional technical instructions re: data submission.	Do not accept	This comment is outside of the scope of this PRA package, however CMS will review current technical guides and provide additional clarification.
PerformRx	General	Suggest improvements for communicating technical instruction changes and providing RR training.	Suggest improvements for communicating technical instruction changes and providing RR training.	Do not accept	This comment is outside of the scope of this PRA package, however CMS will review current technical guides and provide additional clarification.
HealthSpring	Grievances	Provide clarification on a few exceptions such as accepting Grievances by members whose eligibility date is post dated, and clarify on reporting Part D Grievances for LIS beneficiaries & LIS statues at the time of reporting.	Clarification.	Do not accept	CMS has already provided clarification re: categories of grievances and LIS statuse for reporting purposes. Sponsors should retain documentation if necessary.
HealthPartners	Grievances	Suggest CMS provide definitions of various grievance types to ensure plans are properly categorizing all grievances.	Provide definitions of various grievance types.	Do not accept	This comment is outside of the scope of this PRA package, however CMS will review current technical guides and provide additional clarification.
United	Licensure and Solvency	Suggest CMS consider deleting this report from the 2011 reporting requirements to clearly define Part D reporting from other plan reporting.	Remove this reporting from 2011 reporting requirements.	Do not accept	This comment is outside of the scope of this PRA package, however CMS will review current technical guides and provide additional clarification.
United	LTC Utilization and Waste	Under LTC Waste reporting, Data Element D, there appears to be a typographical error in "The total ingredient cost of total reported in B." We believe should state "The total ingredient cost of total reported in C."	Edit LTC Waste data element D,	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
United	LTC Utilization and Waste	Defer LTC Waste reporting until 01/2013.	Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
Blue Cross and Blue Shield of North Carolina	LTC Utilization and Waste	Defer LTC Waste reporting until 2013.	Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
Blue Cross and Blue Shield of North Carolina	LTC Utilization and Waste	Recommend removing LTC Waste reporting.	Remove LTC waste elements.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
Capital BlueCross and Aetna / Horizon Blue	LTC Utilization and Waste	Recommend that the LTC Waste reporting elements be built into the NCPDP transaction in the same manner it was for electronic prescribing. When the waste component of this report measure is implemented, please confirm if the data in elements 2.a – 2.E.12 should be reported based on the drug costs and formulary status at the time the claim is adjudicated. Recommend CMS continue to report the 2011 requirements for LTC Utilization until standards for the industry can be established. Until the waste standards can be implemented, recommend that the current timeline of reporting LTC Utilization be retained.	Remove LTC waste elements.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
Tufts	LTC Utilization and Waste	Defer reporting to 2013, "Appropriate Dispensing Prescription Drug in LTC Facilities under PDPs and MA-PD Plans" provision in the ACA, the Final Rule indicates compliance is required by 1/1/13.	Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
Silverscript	LTC Utilization and Waste	Defer to 2013.	Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
Omnicare	LTC Utilization and Waste	State many concerns about the draft data elements, and recommend deferring until 1/2013 to allow for industry development/consensus.	Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
NCPDP	LTC Utilization and Waste	State many concerns about the draft data elements, and recommend deferring until 1/2013 to allow for industry development/consensus.	Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
Med-Impact	LTC Utilization and Waste	Defer to 2013.	Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
AHIP	LTC Utilization and Waste	Retain current LTC reporting requirements for the LTC Utilization as well as current reporting deadline. Defer new LTC Waste reporting requirements until 2013. Continue to work with NCPDP and utilize the standard transaction as the basis for the reporting requirement.	Retain current LTC Utilization reporting requirements and current reporting deadline. Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012. The Reporting Requirements document will retain LTC Utilization data elements. Reporting deadline will not be changed and will remain bi-annual.
NCPA	LTC Utilization and Waste	Defer LTC Waste reporting until 01/2013. Recommends CMS allow sufficient time to create a HIPPA compliant transaction that adequately addresses reporting of unused medications. Requests clarification to the effect that pharmacies making good-faith efforts to educate the facilities they service will not be held responsible for the minor imprecision introduced by situations such as those described above. Suggests that more pharmacies would be compelled to take part in the early adoption of 7-day-or-less dispensing methodology if unused medication reporting was based at the prescription or facility level. Asks that CMS incentivize this method of dispensing methodology by exempting these reused medications from the reporting requirements.	Defer LTC Waste reporting until 2013.	Accept	An update was made to the Reporting Requirements document to remove all LTC Waste data elements because this reporting is not appropriate for CY2012.
Med-Impact	Medication Therapy Management Programs	Recommend data element P is deleted because it is administratively burdensome. Request clarification for data element Q, states it is subjective.	Remove data element P. Clarify data element Q.	Do not accept	CMS will not remove data element P. This data element is necessary for CMS' monitoring of MTM programs. Guidance will be given to clarify reporting for data element Q.
Kaiser	Medication Therapy Management Programs	Recommend element Q is expanded to include initiation of drug therapy.	Revise data element Q.	Accept	An update was made to the Reporting Requirements document to revise data element Q. Data element Q now states: Number of changes to drug therapy made as a result of MTM interventions. Changes include, but are not limited to, dosage changes, therapeutic or generic substitutions, and discontinuation or addition of therapy.
Independent Health	Medication Therapy Management Programs	For Data elemetn H: Data of MTMP enrollment. Is using the date of the enrollment letter acceptable?	Clarification.	Clarify	Guidance will be given to clarify reporting for data element H.
Independent Health	Medication Therapy Management Programs	For Data element I: Date of MTMP opt-out, if applicable. Are there any restrictions on this date? Can it be after the date the CMR was offered or received?	Clarification.	Clarify	Guidance will be given to clarify data element I.
Independent Health	Medication Therapy Management Programs	For Data element K: Offered annual comprehensive medication review. Does this only count if it's after the Opt-out?	Clarification.	Clarify	Guidance will be given to clarify data element K.
Independent Health	Medication Therapy Management Programs	For Data element L: If offered, date of (initial) offer. Can this be the same as the date of enrollment? Can this be the same or before the date of opt-out?	Clarification.	Clarify	Guidance will be given to clarify data element L.
Independent Health	Medication Therapy Management Programs	For Data element M: Received annual comprehensive medication review (CMR). Must the CMR actually include the conversation with member or only the offer for that conversation?	Clarification.	Clarify	Guidance will be given o clarify data element M.
Independent Health	Medication Therapy Management Programs	For data element Q: Number of changes to drug therapy made as a result of MTM interventions. Changes include dosage changes, therapeutic or generic substitution, and discontinuation of therapy. Can this include changes made as a result of the conversation with the patient and not the prescriber, so this number could be higher than "P. Number of prescriber interventions"?	Clarification.	Clarify	Guidance will be given to clarify data element Q.
Blue Cross and Blue Shield of North Carolina	Pharmacy Support of Electronic Prescribing	Recommend that CMS eliminate the need for plan sponsors to report this information. It would be more efficient if CMS received this information from a central source such as NCPDP since pharmacies that support electronic prescribing would do so for all Plan Sponsors for which the pharmacy is a network participant.  This capability is not a Plan Sponsor specific capability.	Remove this reporting section.	Do not accept	CMS will not remove this reporting section. While this reporting could be performed by groups other than Plans, CMS sees the relationships between Sponsors and pharmacy networks as unique for promoting the use of electronic prescribing, and hopes this continued reporting will help further promote these practices.
HealthSpring	Plan Oversight of Agents - Parts C and D	Would like to see a list of categories for types of allegations/complaints that have to be counted.	Provide a list of categories for types of allegations/complaints.	Do not accept	This comment is outside of the scope of this PRA package, however CMS will review current technical guides and provide additional clarification.
Independent Health	Prompt Payment by Part D Sponsors	Would like detailed specifications for this reporting section clearly documented for 2012.	Provide detailed specifications.	Do not accept	This comment is outside of the scope of this PRA package, however CMS will review current technical guides and provide additional clarification.
HealthSpring	Redeterminations	Please clarify what data element B covers.	Clarification.	Clarify	Guidance will be given to clarify data element B.
Blue Cross and Blue Shield of North Carolina	Retail, Home Infusion, and Long Term Care Pharmacy Access	Please confirm if the template will be the same or similar to the template that they are currently using for the Application process in February.	Confirm if the template will be the same.	Do not accept	This comment is outside of the scope of this PRA package, however CMS will review current technical guides and provide additional clarification.