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Table of Contents
                            7.2.1 Table of Contents
7.2.2 Transmittal Letter
7.2.3 Checklist and Cross-References
7.2.4 Executive Summary
	Qualifications to Serve as the IME Contractor for the Project
	Online, real-time Point of Sale (POS) pharmacy claims adjudication
	Drug utilization management
	CMS and Supplemental Rebate management
	Preferred Drug List (PDL) management
	Drug Prior Authorization Committee and DUR Board support
	Focused clinical pharmacy services, including Drug Class Reviews
	Prior Authorization (PA), and other related programs
	Multi-State Pool for Supplemental Rebates
	Pharmacy/Physician Help Desks to support POS and PA
	Medical Prior Authorization Services (beginning in 2010 for the Maine Medicaid Program)
	Robust reporting systems for our clients – including standard, ad hoc, decision support systems and pharmacy data “marts”
	Interfacing with Medicaid Management Information Systems(MMIS) and /or POS vendors;  and
	Consultation and implementation of cost containment and legislative proposals
	GHS is the transparent Medicaid Pharmacy Vendor.  All aspects of our services, including supplemental rebate pricing data, is presented to, and controlled by, our state Medicaid agency clients;
	We are an experienced Medicaid Pharmacy Benefit Services Administrator (PBSA) with proven results as the full PBSA vendor in the State of Iowa, as well as in both the States of Maine and Wyoming; and
	GHS is a service-oriented healthcare management company, offering a package that is capable of expanding services when additional programs are needed.
7.2.5 General Requirements
	6.1 General Requirements for All Components
	6.1.1 Staffing Named Key Personnel Key Personnel Requirements Key Personnel Resumes Key Personnel References Department Approval of Key Personnel Changes to Contractor’s Key Personnel Special Staffing Needs
	6.1.2 Facilities Permanent Facilities Contractor Responsibilities Courier Service
	6.1.3 Contract Management Performance Reporting and Quality Assurance Contractor Responsibilities Performance Standards Reporting Deadline Documentation Annual Performance Reporting Pharmacy Medical Services
	6.1.4 Training
	6.1.5 Operational Procedures Documentation
	6.1.6 Security and Confidentiality
	6.1.7 Accounting
	6.1.8 Banking Policies
	6.1.9 Payment Error Rate Measurement (PERM) Project
	6.1.10 Subcontractors
	6.1.11 Regulatory Compliance
	6.1.12 Audit Support
	6.1.13 No Legislative Conflicts of Interest
	6.1.14 No Provider Conflicts of Interest
7.2.6 Professional Services Requirements
	6.3 Pharmacy Medical Services
	6.3.1 RetroDUR Contractor Responsibilities Performance Standards
	6.3.2 Pharmacy Prior Authorization Contractor Responsibilities Performance Standards
	6.3.3 Preferred Drug List (PDL) and Supplemental Rebate Program Contractor Responsibilities Contractor Responsibilities
			GHS will provide the Department with a fresh PDL baseline analysis within the ten day time frame noted. Since we manage other states, some with different PDL designs, it may be most beneficial for Iowa if we compare Iowa to other states across common ...
			It is our overall belief that a PDL needs to provide a selection of preferred drugs that allows primary care physicians to care for the majority of their patients without prior authorization requests being necessary on a daily basis. The driving force...
			Whenever we partner with a State, we continuously reassess the existing PDL each quarter. As the incumbent vendor providing Preferred Drug List and Supplemental Rebate services to the IME, we already have extensive knowledge of the current PDL, utiliz...
			GHS will provide complete financial modeling scenarios for the therapeutic categories identified for discussion. The models will include separately, identified CMS and supplemental rebates and the resultant net drug costs. The model will demonstrate t...
			Most PDL categories do not require complex pharmaco-economic modeling. When comparator drugs are already available, similar in terms of daily dosing and similar in terms of expected outcomes (no proven inferiority or superiority) then the model is sim...
			Some drug categories are more important than others by virtue of their fiscal significance. The mental health drugs and the antidiabetic classes are two examples of drug categories that warrant close attention all the time. These two areas required sp...
			We first modified these models during the SR negotiation process that we currently perform in our other role as the negotiation vendor for the SSDC pool this past summer. Initially we created a model using large scale pool data to determine comparativ...
			The first pharmaco-economic model, shown in Figure 10, on the next page, concerns the TZD class. Actos has always displayed disproportionate variations in CMS rebates across its three strengths. Over time the Actos 15mg tab has become much cheaper per...
			We can also perform financial modeling that shows the recent utilization with all CMS rebates, supplemental rebates and net costs clearly identified. Then we demonstrate how these variables might change under different sets of assumptions and their pr...
			The SNRI antidepressants cost over $7 million annually or nearly 3% of the state drug budget. The Legislature’s restrictions imposed on this class make it difficult to curb overly expensive chemically unique antidepressants. Since Venlafaxine ER is th...
			GHS will continue to provide supplemental rebate negotiations and saving analyses of specific drugs/drug categories on a mutually acceptable schedule. We will present estimated savings in a manner agreeable to the Department. This will involve estimat...
			It is important for the model to emphasize that the sum of SR dollars or the percent of the drug budget that they represent are not necessarily the best indicators of success. The best indicator is net cost. The Department should judge the success of ...
			At a detailed level, the cost analyses are performed to arrive at comparisons of net costs. We take your pharmacy reimbursement rate(s), FULs, and SMACs and then subtract out CMS rebates (and eventually supplemental rebates) to arrive at net costs. We...
			The last major component of the cost analysis relates to market share. The committee members need to know how many people are on (tentatively) preferred and non-preferred drugs. They also need to know if any data exists that would help predict the pro...
			In the more complex analysis, we use a predictive pricing approach to estimate the final budget impact of PDL decisions after accounting for all rebates, prescribing alterations, and offsetting administrative costs. We have attached the initial step o...
			One limitation with the financial model is that it is only concerned with the choices being presented to the Committee and not what is unavailable. The model does not account for what you had last year compared to this year. It does not compare betwee...
			Every therapeutic class will be reviewed at least once per calendar year. Additional indications and off-label abuse must be considered. Trends toward or away from specific drugs must be identified. Supplemental contracts may run from one to three yea...
			GHS is prepared to continue to represent the Department in public relations matters and to coordinate with other agencies, groups, boards and individuals regarding the program at the request of the Department. GHS has provided representatives to testi...
			As part of these duties in the past, we have been requested to create tailored Power Point presentations and handouts. The State would typically give us specific instructions on their needs and we would then clear the materials beforehand with State p...
			On behalf of the Department, GHS will accept and handle all contract discussions and inquiries from manufacturers. If GHS should no longer be the negotiating agent for the SSDC pool, we will conduct any contract discussions with manufacturers as expre...
			GHS will maintain all original SR agreements and provide the Department with access to copies and related documentation within 24 hours of a request. We will make certain that the original agreements are preserved safely. GHS will also create and keep...
			GHS assures the Department that it will keep their contracts confidential and hold their agreements separated physically from those of any other clients. We have been the vendor for the states of Maine, Iowa, and now the Sovereign States Drug Consorti...
			The agreements will be kept separate from those of our other clients. The paper copies will be stored in a separate, locked file cabinet devoted to the State of Iowa. The electronic agreement copies will be stored in a well-protected and separate elec... Performance Standards
7.2.7 Project Plan
7.2.8 Project Organization Organization Charts Staffing Key Personnel Subcontractors
7.2.9 Corporate Qualifications Corporate Organization Corporate Experience
		Other Experience with Governmental Healthcare Programs Corporate References Felony Disclosures Certifications and Guarantees
	Attachment C: Certification of Independence and No Conflict of Interest
	Attachment D: Certification Regarding Debarment Suspension Ineligibility and Voluntary Exclusion
	Attachment E: Authorization to Release Information
	Attachment F: Certification Regarding Registration, Collection and Remission of State Sales and Use Taxes
	Attachment G: Certification of Compliance with Pro-Children Act of 1994
	Attachment H: Certification Regarding Lobbying
	Attachment I: Business Associate Agreement
	Attachment J: Proposal Certification of Available Resources
	GHS project plan OPERATIONS.pdf
	GHS IME Pharmacy Task and Work Estimates
	GHS Iowa Transition Plan
		1 Introduction
		2 Scheduling and Timeline
		3 Delivery Method
		4 Resources and Responsibilities
			4.1 GHS
			4.2 IME
		5 Deliverables
			5.1 Business Rules
			5.2 Pharmacy Prior Authorization (PA)
			5.3 RetroDUR
			5.4 Preferred Drug List (PDL) and Supplemental Rebate (SR)
			5.5 Operational Documentation
			5.6 Reports
			5.7 Paper Files
			5.8 Archived Historic Data
		6 Data Record Layouts
			6.1 Data Feed Formats
		7 Summary
		page 5.pdf
		project plan back
	GHS Certificate of Authority.pdf
	Professional Licenses
Document Text Contents
Page 1

Goold Health Systems
45 Commerce Drive, Suite 5
PO Box 1090
Augusta Maine, 04332-1090

800-832-9672 (p)
207-623-5125 (f)

Submitted on December 10, 2009
© 2009 Goold Health Systems


Small Company. Big Results.

Quality Partnerships.



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This proposal has been formatted for double-sided printing.

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Iowa Medicaid Enterprise
RFP MED-10-001: Professional Services Request for Proposal 7.2.6 Professional Services Requirements

Page 112

will have PDL information available on our website. Patient specific information (personal
health information or PHI) would not be available via the web, to prevent a HIPAA PHI

j. Ensure that Medicaid providers have accurate, timely and complete information about all drugs on the PDL. The

contractor shall make this information available through various sources, such as written materials and on the
web site. The minimum notification to providers is 30 days prior to implementation.

GHS fully understands that provider access to accurate, complete and timely information on the
PDL is vital for success. This is our standard practice to facilitate and dampen the volume of
unnecessary PAs by ill-informed providers. We are able to utilize electronic and paper
newsletter, email, fax, and mail. All of this information will also be prominently posted on the
website. All public disseminations will be approved by the Department and will follow the
Department’s minimum notification timeframe policies of thirty (30) days.

In certain situations, such as positive additions to the PDL after implementation, drugs can be
become preferred with simultaneous notification. In this case, dispersed information would not
meet the 30-day requirement. In cases like these, GHS would seek written approval from the
Department before implementing a change that would fail to meet the information dispersion
requirements. Any changes proposed to the PDL will be highlighted. PDL drugs with proposed
status changes or PA criteria changes are highlighted in blue. New drugs are highlighted in pink
to attract significant attention.

The PDL manages several thousand drugs. This is a high-maintenance activity. We currently
post, on average, six to eight updated PDLs on the website each year. Beyond this there are many
specialized PDL lists that must be periodically updated to keep providers current. These include
covered OTC drugs, preferred cough and cold drugs, brands preferred over generics and
Medicare Part D excluded drugs.

k. Receive claims files (on a schedule to be determined) from the appropriate IME contractors to support evaluation

and management of the PDL program.

GHS is aware that claims files will need to be shared and analyzed periodically to support PDL
evaluation and management. These extracts will enable us to perform the many elements of
evaluation and management critical to the well-being of this program. We have developed
considerable proficiency in this area. We have had no issues with receiving data from IME’s
other claims/data vendors. We currently receive medical claims data and SMAC data with great
frequency. On the PDL side we use the SMAC data to make timely decisions on preferring
brands or generic versions. The medical claims data is extremely important when PA exemptions
or grandfatherings are planned based on diagnoses. We also use the diagnostic data in analyses in
preparing for P&T meetings where we need to know the size of a population that will be affected
by drug PDL decisions. The medical data is also crucial when trying to determine the extent that
a drug is being used for specific FDA approved indications or for off-label conditions. One very
important example was the anticonvulsant class where it was easily demonstrated that less than
25% of most use was directed toward seizures. This type of information also helps us to estimate
the cost associated with exempting certain people (diagnoses, ages) from PDL requirements.

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Iowa Medicaid Enterprise
RFP MED-10-001: Professional Services Request for Proposal 7.2.6 Professional Services Requirements

Page 113

l. Support the management and coordination of all activities related to the maintenance of the PDL, including
presentation of ongoing efforts to the Department and the P&T committee as appropriate. Activities include but
are not limited to the following:
1. Clinical review of new brand drugs for clinical safety and efficacy including a cost analysis.
2. Clinical review of new generic drugs or clinical safety and efficacy including a cost analysis.
3. Clinical review and cost analysis of existing drugs for new indications, changes to indications and/or safety

4. Review of new products forms and strengths and associated cost analysis.
5. Development of and changes to PDL criteria based on new information.

PDL maintenance is not simple. A PDL needs constant attention as it is constantly evolving.
Some drugs become too expensive and must be removed. New drugs are added, previously
preferred drugs are removed and as more information becomes available, some previously non-
preferred drugs are moved into more advantageous positions. As time passes we must constantly
assess new drugs and their variants:

• Drugs become unavailable due to shortages or discontinuation
• New products, new forms, new strengths and new package sizes enter the market

incessantly and require prompt attention
• Generics become available but are often financially unattractive initially
• New FDA approved indications appear nearly weekly and necessitate revisions of

existing criteria
• Warnings are released on drugs and corresponding alterations must be made in the PDL
• Prices drop and prices increase (mostly)

Over the past five years we have developed a fairly simple but thorough process to flag and rate
new drugs. The weekly drug file is reviewed and new drugs/new NDCs are identified and scored
using a four part key to create an initial PDL status recommendation. The key includes logic that
determines if a new drug should be treated like an existing drug or if it really requires a new drug
assessment. Many new drugs can be automatically rated using the key as a guide.

Truly new drugs require clinical monographs that elaborate on efficacy and safety. The drug
must be rated to its closest comparators, both financially and clinically. To the extent that it is
available we try to gather and include Number Needed to Treat (NNT) and Number Needed to
Harm (NNH) data. When comparing side effects and only placebo controls have been used we
will adjust side effect rates for brands by subtracting the placebo rates from the brand rates.

Generic drugs are somewhat easier to review since the primary clinical issue relates to AB
ratings and automatic substitution concerns. If the brand remains available then the cost review is
primarily concerned about which version costs less after rebates. Some brands have accumulated
massive CMS rebates due to price inflation interest and best price penalties. A good general rule
is that any exclusive generic will remain more expensive than the corresponding brand for the
first six months.

New brand product forms and strengths are almost always uniformly more costly to the State. It
is rare for these types of new drugs to be recommended as preferred on the PDL unless the cost
is controlled by a SR contract. These versions of “new” drugs typically shed the large CMS
rebates associated with the existing versions and become comparatively expensive.

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