Weekend Update

Congress is out of session this week of Presidents' Day.

The healthcare information trade association HIMSS is calling on the Health and Human Services Secretary to maintain the current October 1, 2013, implementation date for the ICD-10 code set. According to the association's press release,

While HIMSS understands and recognizes that there are providers facing resource challenges to meet the compliance date, the conversion to ICD-10 code sets will affect more positive outcomes for patients. To that end, the Society offers a comprehensive and credible portfolio of ICD-10 related tools, resources, education, and community for health providers. Today, HIMSS and AHIMA will be releasing its “ICD-10 Critical Pathway to Getting Started – 2012 and Beyond.” This readiness tool is designed to help providers, just starting on the ICD-10 conversion effort, to achieve the October 1, 2013 deadline.

The solid point that HIMSS makes is that delaying the ICD-10 code set for some HIPAA covered entities but not for others will increase costs for those covered entities, such as health plans, that will have to employ both the ICD-9 and the ICD-10 code sets.

Earlier this month, the Food and Drug Administration issued "three guidance documents providing the FDA’s current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products to the agency." Biosimilars are generic versions of specialty biologic drugs that are typically injectable and expensive. The European Union created such a pathway about ten years ago, and there are about a dozen biosimilar drugs on the market there according to the Wall Street Journal. It appears that the FDA will open a pathway here soon as authorized by the Affordable Care Act. The Wall Street Journal article points out that

Many of the knockoffs will be classified as comparable to branded biologics, but not copies that a pharmacist could automatically substitute. As a result, manufacturers expect they will have to do more than sell the therapies based on price, as companies do with traditional generics. They will have to promote biosimilars to doctors, as they do for brand-name drugs.

The essence is not going to be a typical generics business," said Michael Kamarck, who's heading Merck's biosimilars effort. He said the brief history of biosimilars in Europe, where the medicines are approved, showed the need for "actively promoting" the medicines in order to get them used.

The Affordable Care Act created a 12 exclusivity period for biologic drugs. The Obama administration in its recent budget documents has sought to reduce that period to seven years to PhRMA's dismay.

The Society for Human Resource Management discussed a recent CIGNA study of claims from 1.1 million insureds finding that "When American workers engage in health-smart habits offered in consumer-driven health plans (CDHPs), they reduced their health risks and lowered their total medical costs an average of $9,700 per employee over five years."