Martin Sipkoff
MANAGED CARE December 2009. ©MediMedia USA

The Centers for Medicare and Medicaid Services will make the Part D reporting process more difficult and complex

In 2008, the Centers for Medicare and Medicaid Services conducted an extensive evaluation of the medication therapy management (MTM) component of its Part D program.

Then it decided to increase access to MTM for Part D beneficiaries and to decrease the eligibility restrictions for beneficiaries. The new requirements, in effect Jan. 1, aim to strengthen the interactions between Part D sponsors and beneficiaries while requiring detailed quarterly and yearly records.

There are four target areas associated with these significantly expanded requirements:

  • Aggressive enrollment
  • Targeting on basis of appropriateness
  • Improved interventions
  • Expanded outcomes reporting

“This has made the entire MTM reporting process more difficult and rigorous,” says Denise Kehoe, vice president for development at PharmMD in Brentwood, Tenn., one of several MTM service vendors. “The most difficult element will be to manage the much [enlarged] group of enrolled beneficiaries receiving MTM services.”

What she is referring to is that Part D sponsors now must use an opt-out method for MTM enrollment. Beneficiaries who qualify are enrolled automatically unless they choose to opt out. Enrolled beneficiaries may refuse individual services and still remain in the program. If an enrollee opts out of the MTM program, the sponsor must still continue to apply the patient’s existing drug utilization management program.

All Part D health plans, including PBMs, received their new instructions in a CMS letter last spring. It included detailed policies and procedures on how Part D sponsors must design and implement required MTM services. Since the start of Medicare Part D in 2006, drug plan sponsors have been required to offer MTM programs to members who take what the rules describe simply as multiple drugs for multiple chronic conditions and whose Part D drug costs are expected to exceed $4,000 annually.

Until 2010, Part D sponsors were left alone to experiment with various MTM plan designs, and beneficiaries could opt into MTM programs, often run by pharmacists within an organization.

But starting in 2010 — with data management and communication products that several companies have been designing for two years — Part D sponsors must:

  • Lower the qualifying drug-cost threshold from $4,000 to $3,000
  • Target beneficiaries at least quarterly
  • Offer a minimum level of MTM services, including interventions for both beneficiaries and providers
  • Measure and report details of the number of comprehensive and targeted medication reviews, provider interventions, and changes in therapy resulting directly from the interventions

New level of complexity

“This is a new level of complexity,” says Nancy England, RPh, director of product and quality assurance for IMS Health’s Payer Solutions group, which offers MTM and other performance-related services for health plans and PBMs. “This can be challenging for payers, many of whom are not typically geared toward building the technology tools to support such programs.”

England outlines the information technology system changes that payers need to adopt to meet the CMS changes that capture year-to-year data:

  • Quality measurements for identifying medication-related problems
  • Outcomes measurements for utilization of drugs , utilization of medical services, financial impact on pharmacy and medical costs, and patient satisfaction
  • Instantaneous data to complete targeted and comprehensive medication reviews
  • Patient histories and interview responses
  • Drugs administered outside of prescription benefits and new types of drugs, herbal treatments, and samples included in MTM
  • Intervention results/histories, including changes in therapy
  • Program beneficiary opt-outs

“It’s not too late to be fully compliant,” says England. “Sponsors need to leverage technology and good workflow to make this job easier. CMS of course is going to continue to evaluate MTM services to see what is working, so we believe flexibility and scalability are key. Tools that capture all the targeted medication review information for reporting are a necessity for assessing outcomes.”

Centrally located database

All this information should be in one database, England adds, and the results should be readily assessable so metrics, action plans, and outcomes can be reported at many levels.

Kehoe agrees. She points to the fact that the new requirement for a comprehensive medication review (CMR) includes a review of all medications, all offers of interactive consultation, and detailed consultation summaries. “The medication review must be detailed enough and rigorous enough to identify any potential medication-related problems.”

Dan Malloy, general manager of IMS Payer Solutions, says that in reality, the new requirements should run parallel to case management protocols. “That would be an efficient maximization of a sponsor’s return on investment,” he said.

Kehoe points to the fact that the intervention component itself is much more complicated for 2010. Interventions may be for use of a single drug or relate to the interaction of multiple medications. The interventions may be provided by pharmacists or other qualified providers.

The interventions must include continued monitoring and follow-up. Sponsors must offer to provide an interactive person-to-person consultation to each targeted beneficiary that is face to face or through another interactive method, such as by telephone. It must assess information that may be outside of the claims data, such as OTC medications, herbal/dietary supplements, health status, adverse events, and other health-related concerns.

“The number of beneficiaries participating in 2010 is simply unknown,” says Kehoe.

Contributing editor Martin Sipkoff can be reached at

Major changes to MTM requirements

Changes in the Centers for Medicare and Medicaid Services requirements for 2010 include the following:

  1. Enroll targeted beneficiaries using an opt-out method (beneficiaries will be in the program unless they refuse to be)
  2. At least once a quarter, attempt to enroll beneficiaries who have multiple chronic diseases, targeting:
    1. People who have at least four of these seven core chronic conditions: hypertension, heart failure, diabetes, dyslipidemia, respiratory disease, bone disease (arthritis), and/or mental health problems
    2. Are taking multiple Part D drugs, and
    3. Are likely to incur annual costs for covered Part D drugs that exceed $3,000
  3. Offer a minimum level of MTM services, including interventions for providers and for beneficiaries that include an annual comprehensive medication review (CMR), interactive person-to-person consultation, individualized written summary of interactive consultation, and quarterly targeted medication reviews
  4. Measure and report details on the number of CMRs, targeted medication reviews, provider interventions, and the changes in therapy resulting directly from the interventions

Source: CMS

Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.