Regulatory

Robert Henry: Our editorial focus is on balancing the clinical, business, and regulatory criteria that guide the US healthcare system. As a new administration is taking over, we would like to ask you what you think those involved in healthcare, especially payers, can expect from this new environment.

Dan Mendelson: The new administration will look at the relationship between health plans and the government in a fundamentally different way from the previous administration.

Health Policy in the New Administration

F. Randy Vogenberg: There have been attempts to look at large claim databases (eg, WellPoint's) of patients receiving erythropoiesis-stimulating agents (ESAs). News about the cutback on ESA use was accompanied by reports about the rise in the number of transfusions. At the same time, articles published in pharmacy and hospital journals were advocating the use of ESAs to avoid transfusions. So, the message is mixed. What people are doing in an inventory environment is not the same as what they are doing in an institutional inpatient environment.

The Clinical and Economic Complexity of Biologics

We are in the final stretch of the presidential elections, and both the Democratic and Republican conventions are now behind us. After the August break, Congress was back in Washington for only 3 weeks starting September 8, making it unlikely for any new healthcare legislation to be passed until after we have a new administration.

Health Reform and the Next President

Robert Henry: Our goal is to draw on your current position at the Center for Medical Technology Policy (CMTP), as well as your previous experience at the Centers for Medicare & Medicaid Services (CMS), to discuss private payer initiatives for medical technologies research and development (R&D) and the role of evidence in developing new technologies.

Policy Considerations in Evidence-Based Coverage Decisions

The Medicare Part D Prescription Drug Program was enacted on December 8, 2003, as part of the Medicare Prescription Drug Improvement and Modernization Act of 2003 and was implemented on January 1, 2006. Because the program was the largest major enhancement of Medicare since its inception in 1965 and was controversial in its original design, Congress chose not to amend the legislation until last summer.

Part D under the Medicare Improvements for Patients and Providers Act of 2008

On March 1, 2001, the Institute of Medicine (IOM) released its report, "Crossing the Quality Chasm: A New Health System for the 21st Century," in response to alarming rates of medical errors that led to thousands of unnecessary deaths. The report called for changes within information technology (IT), payment policies, and the medical workforce. By stressing a "new paradigm for healthcare delivery," the IOM identified 15 medical conditions for which improvements could be made to improve the delivery of patient care.1

The Many Challenges of Pay-for-Performance Programs

For the past 25 years, manufacturers of orphan drugs have faced few obstacles to reimbursement from private or public insurers, despite prices that can amount to hundreds of thousands of dollars annually in treatment cost. However, payer sensitivity appears to be rising, as the launch rate of orphan drugs accelerates amid increasing pressure to contain costs.

Orphan Drugs: The Potential Impact of Generic Biologics

Many of today's healthcare concerns focus on the concept of value, which can be defined as a composite of cost, quality, and access. Expanding access through affordable healthcare insurance will only be possible if healthcare costs are contained through a focus on quality.1 Poor care quality results in costly errors, complications, and re-work. Conversely, high-quality care, namely, the right treatment at the right time, results in more cost-effective care.

The Missing Quality Standard for Medication Adherence

The decision-making process in many aspects of the healthcare delivery system is often complicated and detailed, requiring many considerations before arriving at a course of action in patient care. Increasingly today, the perspectives of each healthcare stakeholder should be considered, which often leads to confusion and controversy in decisionmaking. For example, what is of value to a patient may not be of value to a provider, and what medical evidence determines to be of value may be very limited or subject to interpretation because of the paucity of definitive evidence.

Potential Benefits of Prediction Models from Large Electronic Databases
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