Saturday, May 19, 2007

THIS BLOG IS MOVING

Please direct your blog pointers to:

http://www.markfrisse.com/erx/blog.html

A face page will be at:

http://www.markfrisse.com/erx/index.html

Sunday, May 13, 2007

Prescription Drug Pricing: MAC can make you Wacky

To understand the pricing of prescription drugs, one must wade through a number of acronyms and concepts that have evolved over time and, in this writer's opinion, obfuscate rather than clarify pricing. Understanding the history of prescription drug pricing seems important if one is to develop a transparent pricing approach. But here is an irony, although CMS has the authority to ensure that where applicable manufacturer's sales information on average manufacturer price and best price are correct (see below), the Social Security Medicare Part D legislation requires that this information be kept confidential and hence it is not publicly available.

Terms

Average Wholesale Price (AWP).

"The AWP has often been equated with a “sticker price” or “list price,” as those terms are used in the automobile industry. It has become an important prescription drug pricing benchmark for payers throughout the health care industry. Payments are typically based on AWP minus some percentage. Despite its name, however, the AWP is not an accurate reflection of actual market prices for drugs. As noted, it is a price derived from self-reported manufacturer data for both branded and generic drugs. There are no requirements or conventions that the AWP reflect the price of any actual sale of drugs by a manufacturer, or that it be updated at established intervals. It is not defined in law or regulation, and it fails to account for the deep discounts available to various payers, including certain federal agencies, providers, and large purchasers, such as HMOs. Consequently, the AWP has been the subject of great criticism and scrutiny." (Source: Wikipedia)

Wholesale Acquisition Cost (WAC).

The price a wholesaler pays to a manufacturer for a drug. It is a published price that does not include rebates or discounts. Sometimes called the "catalog price." (Source: Gencarelli)

Average Manufacturer’s Price (AMP).

The average price paid to manufacturers by wholesalers (less discounts) for a particular dosage form and strength of a prescription drug distributed solely to the retail pharmacy class of trade. The AMP is not a published price. It is calculated by the manufacturer and submitted to CMS for purposes of calculating the Medicaid rebate. (Source: Gencarelli)

Maximum Allowable Cost (MAC).

The highest price a health plan or other intermediary will pay for medications. This cost figure becomes most relevant when there are more than two generic options available for the drug. Maintaining a list of these costs across all drugs is, as one document describes it, "tedious and expensive."

Federal Supply Schedule (FSS).

Obtained from market transaction data reported by manufacturers. In general, FSS may not be higher than the lowest price charge by the manufacturer for non-federal purchasers. That is, the federal government should never pay more than any other plan or intermediary. Some federal bodies (e.g., the VA) set price according to FSS.

Federal Upper Limit (FUL).

This is a ceiling paid when there are more than three generic options available. It is set at 150% of the least costly therapeutic equivalent that can be purchased by pharmacies in quantities of 100 tables. (Source Gencarelli)

Estimated Acquisition Cost (EAC).

This is the other upper limit complementing the FUL. EAC is a state's estimate of price paid by providers for a drug. It is often used for single-source (e.g., "brand") drugs. Most states use AWP to calculate EAC.

Average Sales Price (ASP).

The average of all final sales prices charged for a prescription drug in the United States to all purchasers (including mail order pharmacies) excluding those sales that
are exempt from inclusion in the “best price” for Medicaid drug rebate
purposes. Defined by the OIG-mandated corporate integrity agreement with TAP pharmaceuticals.

Usual and Customary Charge.

The common charge to the public for a prescription drug.

References


AWP (Wikipedia)

Medicaid Prescription Reimbursement by State (CMS). A comprehensive Web resource.

Follow the Pill: Understanding the U.S. Commercial Pharmaceutical Supply Chain. Health Strategies Consultancy for the Kaiser Family Foundation (March, 2005)

Dawn M. Gencarelli (June_7, 2002). "Average Wholesale Price for Prescription Drugs: Is There a More Appropriate Pricing Mechanism?" (pdf). National Health Policy Forum. Includes definitions of all terms. Appendix 1 contains Medicaid dispensing and cost sharing as of 2002 for each state. It is instructive.

Office of the Inspector General (2002). Actual acquisition costs of generic prescription drug products.

Office of the Inspector General (2002). Additional analysis of the actual acquisition cost of prescription drug products.

Abramson, et. al. Generic Drug Cost Containment in Medicaid: Lessons from Five State MAC Programs. Health Care Financing Review. Spring 2004. 25 (3), 25-34.

HHS Office of the Inspector General (October, 2003). State Strategies to Contain Medicaid Drug Costs (OEI-05-02-00680).

HHS Center for Beneficiary Choices. Lower Cash Pricing (October 11, 2006). Describes the CMS approach to Wal-Mart $4 generics and similar programs.

HHS Center for Beneficiary Choices. Scope of work: State-to-State Plan Reconciliation (July 7, 2006). Describes the data fields (including "usual and customary charge") that will be submitted by states to Public Consulting Group (PCG) to study costs incurred by states for dual-eligible and low-income subsidy entitled beneficiaries during their transition to Medicare Part D. States will then work with CMS and its contrator to establish reimbursement parameters based on eacch state's liability for either primary or secondary payment under Part D claims.



How this works.



First, a state determines a dispensing fee. Examples abound.
Second, a state determines a reimursement for ingredient costs. This is often AWP less some percent (usually 5-15%) or WAC + some percent (around 5%) - whichever is lower.

Remember that the federal government pays some portion of the charge, depending on the state. (Follow this link to the Kaiser Family Foundation's table of federal matching rates.) The rate in Tennessee for 2007 is 63% and the rate in Florida is 58%.

States or other intermediaries then receive rebates from manufacturers equal to some percentage of the AMP. It is higher (15% a good number) for "sole source" drugs (e.g., "brand names) and a bit lower (around 10%) for multi-source drugs (e.g., generics). Sometimes the rebate is the difference between the AMP and the best price. Sometimes it is further increased if prices exceed the CPI or other inflation indicators. The Federal rebate amount is the same for all states and established by 42 U.S.C. 1296r-8(a).

Tuesday, April 17, 2007

CMS releases e-prescribing pilot reports

CMS released the evaluation report from their five e-prescribing projects. The five pilot sites are among the leading experts in the field of e-prescribing: RAND, Ohio KePRO/UHMP, Brigham and Women's Hospital, SureScripts, and Achieve Healthcare. A summary of their results as well as additional analyses and recommendations is included in the evaluation report.

This writer had the opportunity to contribute to this effort with Chelle Woolley, Kevin Johnson, Adil Moiddudin, and many others.

Follow this link for the summaries:
Follow these links for the individual evaluations:

Tuesday, April 03, 2007

e-Prescribing needs work: Are we surprised?

In the most recent Health Affairs, Grossman and colleagues discuss the limitations of e-prescribing from the perspective of the physician office practice. Two thirds of those interviewed used eRX in the context of a more comprehensive EMR.
Their semi-structured interviews raised the following concerns:

First the good news:
  • Practitioners uniformly believed this technology leads to better care. Although they seem to disregard the many early adopters and discarders when they say that their subjects "did not want to go back to paper."
  • They relate documentation benefits and believe more legible prescriptions decrease call-backs and believe the ease of accessing lab data in the many who use integrated EMR/e-Rx decreases chart pulls.
  • They believe that formularies (when available) made choices "somewhat easier." Those few who submitted electronically reported additional time savings.
  • Most could not point to staff cuts but believed the technology freed staff to do other things. They believe efficiency gains were offset by costs.

Now the less positive news.
  • Most were not able to availa themselves to update a medication history
  • Eligibility checks were erratic because the limited number of PBMs and a conservative matching algorithm.
  • Some noted that adjudicated claims data did not necessarily correspond to an active medication list.
  • Clinical decision support was limited because of integration.
  • Many had difficult getting formulary data. ("Over half of the practices did not have acess to the formulary data electronically....either because their systems lacked the feature or the practice had chosen not to enable it.
  • Those respondends seeking formulary information found it from 25-90%.
  • There was limited connectivity to pharmacies (retail and mail).
  • Many believed their states precluded electronic transmission (largely, this is so only for controlled substances).
  • Local pharmacies' lack of readiness was cited as a barrier to full electronic transmission.
  • "Most practices using electronic fax or EDI reported spending substantial time educating local pharmacies about e-prescribing. This included both informing pharmacies that electronic transmissions were legal and making sure that pharmacies routinely checked their fax machine or computer system for the transmissions. Respondents reported that it took a couple of months of daily communication about individual patients for pharmacies to begin to treat electronic transmissions as routine. Until that point, practices reported that pharmacies regularly called when patients arrived to pick up medications because they could not find the prescriptions."
  • Two industry experts "believed, however, that pharmacies typically must reach a critical mass of electronic prescriptions to successfully incorporate checking these new sources into their workflow."

Saturday, March 10, 2007

Rhode Island Publishes List of True e-Prescribers

One of the leading states in e-prescribing has elevated the discourse on this topic by publishing a list of physicians who do true e-prescribing. Based on Rhode Island Board of Pharmacy documents, e-prescribing is defined as:
  • The electronic entry of a prescription by a clinician (e.g., physician or nurse practitioner);
  • The secure electronic transmission of the prescription to a pharmacy;
  • The receipt of an electronic message (not a fax) by the pharmacy;
  • The electronic approval of prescription renewal requests from pharmacies.
Rhode Island's goals for achieving e-prescribing adoption are:

  • 75% prescriptions (new and renewal) that are eligible to be e-prescribed are completed electronically.
  • 67% of prescribers are using e-prescribing mechanism for new or renewal prescriptions in the last 90 days.
  • 100% of pharmacies are capable of accepting electronic prescriptions

SureScripts Press Release

During the annual HIMSS meeting, SureScripts, LLC announced its safe Rx awards. Their awards are based on the use of e-prescribing as a fraction of total scripts eligible for electronic routing. This is defined as true digital communication between prescriber and pharmacy - not faxing.

As the release points out, "There remains a sizable opportunity to increase the adoption and utilization of e-prescribing across the country – including in all the top 10 Safe-Rx states."

What this means is that the actual number of e-prescriptions is relatively small. One concern is that many prescribers use e-Rx software to write scripts but the transmission to pharmacies remains via fax. The unknown: what percentage of the claimed safety and financial benefits are realized when scripts are written using digital systems but faxed? Given the relative lack of integrated, interoperable systems, it is highly likely that many of the safety and financial benefits will not be realized until pharmacy, medical practice, and data integrator systems (including laboratory systems) are all tightly coupled and focused on comprehensive review and interaction checking.

Monday, February 26, 2007

RxHub Accomplishments

ON February 23, RxHub announced its accomplishments for the past year (2006) and the plans for the coming year. Quoting from the press release (this writer's comments are in blue text):

in 2006:
  • Access to more than 160 million patient prescription information records for consenting patients, via payers and PBMs, through the growing list of RxHub certified technology partners. Contracts with payers and PBMs were executed representing additional access to more than 50 million patients though RxHub.
  • An increase in transaction volumes of 50% from 29 million transactions in 2005 to more than 43 million transactions in 2006. These transactions were real-time requests for patient eligibility and benefits, formulary, and medication history information, made at the point-of-care in the ambulatory and acute care settings from clinicians across the United States. (blogger note: 43 million transactions - but there were over 3 billion scripts filled last year)
  • A ten-fold increase in true electronic prescriptions, which includes the transmission of patient-specific clinical decision support information at the point of prescribing, to retail and mail order pharmacy locations of the patient’s choice. (note: the % of true eRx still is estimated to be well under 5% of total transactions)
  • Involvement in three of the four nationwide health information network (NHIN) prototypes defined by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology.
  • Participation in four of the five year-long ePrescribing pilots that were funded by the Centers for Medicare and Medicaid Services (CMS) in collaboration with the Agency for Healthcare Quality and Research (AHRQ). RxHub provided the underlying infrastructure for the pilots to test a variety of e-prescribing standards, including RxHub’s medication history and formulary and benefits standards that were made available to the industry last year. The pilots also tested a new standard for electronic prior authorization (ePA) and a new use of electronic prescribing standards to meet the unique needs of the long-term care environment. All pilots have successfully completed their obligations and submitted final reports, which identify successes as well as opportunities for improving the ePrescribing process.

During 2007, RxHub will address these opportunities through focus groups, workgroups, product enhancements, and standards development.

Their proposed activities for this year include:

  • RxHub will actively continue the growth of PBM and payer participation and expand its current Master Patient Index (MPI) coverage to more than 200 million covered lives which will increase the already impressive value it brings to the prescribing industry as well as the patients it represents nationwide. (note: Since the American population is just around 300 million, does this really mean that the participating plans cover 2/3 of the people in the United States? It would be interesting to know how many duplicates are in these data)
  • RxHub will conduct a partner satisfaction survey to poll participants on current services and additional offerings necessary to enable further physician adoption of ePrescribing.
  • RxHub will host the Second Annual RxHub Symposium focused on payer sponsored ePrescribing initiatives and pay-for-performance programs in the United States. Results of the findings and outcomes will be published following the Symposium in May.
  • RxHub has retained the services and expertise of Maria Friedman as part of the RxHub team focused on Public strategies related to electronic prescribing. Dr. Friedman is a former senior advisor to CMS.
  • RxHub is in the final stages of receiving full accreditation by the Electronic Healthcare Network Accreditation Commission (EHNAC). This milestone reinforces the dedication to quality RxHub strives for in its daily operations and provides partners with continued commitment to excellence.

How Two Rights Can Make a Wrong

In a February 25, 2007 NY Times article entitled "How Two Rights Can Make a Wrong," Howard Markle, MD does a fantastic job if describing the perils of prescription drugs. Added to this well-referenced article is a graphic that describes the complexity in a new way.
He has a more current, 2005 number for prescription drugs - 3.6 billion (2004 was 3.38 billion). His source is the Kaiser Family Foundation. (source - June 2006 Prescription Fact Sheet)

Mentioned as well is the October 18, 2006 survey of emergency departments published in JAMA by Budnitz et. al. (PubMed Source; JAMA abstract). They performed active surveillance from January 1, 2004, through December 31, 2005, through the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project. They found that over the 2-year study period, 21,298 adverse drug event cases were reported, producing weighted annual estimates of 701,547 individuals.

The Sloan Epidemiology Center is cited as a source for prescription drug use. They claim:
  • 75% of Americans over 65 years of age took roughly four prescription drug on a daily basis
  • the average 75-year old swallowed 8 different prescription medications each day
  • 82 percent of the united states population reported using at least one prescription drug, over-the-counter meds, or dietary supplement in the previous week.
A fascinating report by the Columbia University Center for Addiction and Substance Abuse entitled "Under the Counter: the Diversion and Abuse of Controlled Substances in the US" states that:
  • 34% of pharmacists do not have time to check a patient's full medication history at the time of dispensing
  • 28% do not regularly validate the prescriber DEA number and 10% rarely or never do so.
  • Only about half (54%) of physicians in the survey regularly call or obtain records from patient's previous (or other treating) physicians before prescribing long-term controlled drugs.

Monday, February 19, 2007

Calculating dispensing costs and the value of e-prescribing

What does it cost to fill a prescription?

Depends on what you measure.

One valuable source are the Medicaid cost data prepared by firms like Myers and Stauffer, LLC.

A 2002 study prepared for Texas, for example, showed a weighted median cost per prescribing of $5.95.

The dispensing fee is one of two major components of drug fees (the other is the ingredient cost). The dispensing, or professional, fee is paid to pharmacies to cover their overhead and labor costs. Federal regulations at 42 CFR 447.331-333 require states to establish a reasonable dispensing fee for their Medicaid pharmacy programs and to document their pharmacy reimbursement methodology in their state plan. (the requirement is for reasonable, but evidently not for perspicuous). These studies are a mother lode of information. They demonstrate some obvious trends (for example, the relationship between prescription volume and unit cost).

Pharmacy costs are also dictated by the amount of compounding and intravenous drugs delivered. These specialty areas skew data and hence lead to calculations of median rather than mean values.