The Impact Of Health Technology Assessments On Reimbursement

By Edward Black, founder and principal, Reimbursement Strategies

By Nancy Kolb, Reimbursement Strategies, LLC

Health Technology Assessments (HTAs) are used by many organizations to create policy. Regulatory agencies use them to help determine commercial use, professional healthcare societies use them to assist with clinical practice guidelines development, and health care networks and group purchasing organizations use them to inform buying decisions.

Within the medical device industry, companies may use HTAs to focus on future product development, and investors may look at HTAs to guide funding decisions for promising innovations. Another use for HTAs is to do “horizon scanning” — looking for emerging technology trends that could have significant impact on health care outcomes or the delivery of healthcare.

This article will define HTAs and examine how they performed, by whom, and the implications for reimbursement and coverage. Its guidance builds upon previous articles, in which we discussed the need for good clinical data that show statistically significant outcomes (as well as clinically significant outcomes), and how a health economic analysis can become part of a successful reimbursement strategy.

Who Performs HTAs, And Why?

HTAs offer a comprehensive assessment of available clinical data about a medical device or procedure, including, but not limited to:

• Technical properties — e.g., design and reliability
• Safety — probability/severity of an adverse event
• Clinical efficacy — how well it delivers on expected health outcomes
• Health economics impact — Does the expense justify improved health outcomes?
• Societal impacts — dissemination across various geographies and social classes
• Legal and ethical effects — access for all patients, or only those who can afford to pay?

Summed up, the HTA includes four main factors: whether the technology works, for whom it works, at what cost, and how it compares to other alternatives. While HTAs usually are undertaken to determine the effectiveness of a health technology, practice, or procedure, one possible outcome is a determination that the technology is not effective. Some examples of practices that have been demonstrated ineffective include gastric freezing for peptic ulcer disease, frontal lobotomy for depression, and having healthy babies sleep on their stomachs, rather than on their backs.

Each HTA is undertaken systematically, by an interdisciplinary group, as a structured analysis. It uses an analytical framework to evaluate a health technology for its direct and indirect effects (unintended consequences), and most often is performed to influence the technology’s use – by patients, health care professionals, healthcare institutions, or within government healthcare programs. HTAs are based upon processes designed to be unbiased and scientific, with a defined and transparent methodology. Additionally, HTAs frequently are used by payers to assess an existing or new medical device or procedure, in order to make policy coverage decisions. 

Multiple private and public entities perform HTAs: national government agencies, hospital networks for internal use, non-profit groups, and for-profit firms. However, access to HTAs performed by these groups may depend upon how they are organized.

For example, publicly available HTAs developed by the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) make recommendations to CMS that are used to influence national coverage policies. Also available publicly are HTAs performed by the Agency for Healthcare Research and Quality (AHRQ), which are submitted by Evidence-Based Practice Centers that contract with AHRQ to create HTAs.  The Cochrane Collaboration is composed of work groups of expert volunteers from around the world, who evaluate health technologies and post their reports online. In the UK, the National Institute for Health and Care Excellence (NICE) creates HTAs that include an economic component, used by National Health Service (NHS) hospitals to help determine adoption based upon budgetary concerns.

Other US-based vendors of HTAs include, the Blue Cross and Blue Shield Association Center for Clinical Effectiveness (CCE), ECRI Institute, Hayes, Inc., the Institute for Clinical and Economic Review (ICER) Center for Medical Technology Policy (CMTP), the Institute for Clinical Systems Improvement (ICSI), and the Oregon Drug Effectiveness Review Project.

HTA Methodologies

There are various methods to create HTAs, but all have several characteristics in common. The first task is to select a topic based upon some characteristic that makes the HTA of interest — for example, how often the health condition occurs, societal costs, prevention strategies, new innovations within a continuum of care, controversial treatments, therapies that have been quickly adopted with little clinical data support, or technologies that have widespread support. A systematic review of peer-reviewed, published clinical literature is conducted, using set criteria to judge the quality of the evidence for the inclusion of studies to be reviewed. For example, the HTA may only consider randomized controlled trials (RCT) with large populations, meta-analyses, or well-designed case control series.

A table for level of evidence grades the quality of the studies. It ranges from the most robust, credible evidence downward: a systemic review of RCTs, individual RCTs, a review of non-randomized cohort studies, individual cohort studies, prospective or retrospective observational studies, systemic review of case control studies, evidence from a single case control study, evidence from a case series and, finally, expert opinion.

After carefully selecting and reviewing the available published clinical evidence, findings are collated and a report containing recommendations is written. Dissemination of the findings depends entirely upon the organization that has performed the HTA. A public agency will make the results available via its website, in open publications, or within a professional journal. An internal organization will disseminate findings through established internal communication channels. A subscription service will make findings available to its members, or reports from private groups may require payment of a one-time fee.

The “Payoff”

HTAs may be used to improve quality of care by indicating the degree to which a technology is expected to increase health outcomes, adding additional therapies to an existing continuum of care, or demonstrating that an existing therapy may not produce desired results. HTAs also may show that a health technology has clinical significance, in that outcomes are achieved that have practical meaning to patients and caregivers. A study may show that an intervention has statistically significant results, but reflect only a small difference between control and active treatment groups. The practical impact for patients may be minimal, with no practical importance in their daily lives. On the flip side, clinical improvements that do not reach statistical significance in small studies may be important to patients. 

Furthermore, many payers use HTAs to assist with formulation of their coverage policies.  Medical policy analysts within payer organizations may perform their own investigation of the clinical literature supporting use of a technology. As part of this process, the analysts review HTAs to which they have access; for example, many third-party payers use the Blue Cross/Blue Shield Association CCE reports to guide policy development.  These assessments look at a technology’s effectiveness and the patient population for whom the technology works best.

This information is important to a payer, who may realize that a technology’s best outcomes occur for patients who do not fit the organization’s beneficiary profile. For example, private payers insure those who are under the age of 65, while the Medicare program insures those over 65.  Payers also may determine how a new technology fits into the continuum of care for a disease, and then create criteria to limit its use. An example of this approach is a nutrition and exercise program prescribed for weight loss prior to approval for bariatric surgery.

HTAs are becoming more commonplace as government agencies, third-party payers, healthcare professionals, patients, and consumers expect — and outright demand — more information about the impact of healthcare technologies. Medtech entrepreneurs must understand and appreciate the rigor by which new technologies are judged, or risk developing a solution that cannot find its way into medical coverage policy.

About The Author

Nancy Kolb, MSN, is a senior advisor at Reimbursement Strategies, LLC. She has worked in the international medical device community for 30 years, serving in reimbursement, marketing, and executive positions.

Ms. Kolb specializes in strategic business and marketing plans that incorporate reimbursement issues for entrepreneurial and established companies. Prior to joining Reimbursement Strategies in 2014, her roles included VP of Marketing & Reimbursement at Uroplasty, Inc., VP of Marketing at Inlet Medical, and various business unit positions at Gyrus Medical.

Ms. Kolb has authored, co-authored and supported publication of over 30 manuscripts in professional journals.  She is one of the founders of the Society of International Gastroenterological Nurses and Associates, a past president of the U.S. Society of Gastroenterology Nurses and Associates, and a member of the Society of Urology Nurses Association.