News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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CMS’s ‘Innovation Center’ May Be the Affordable Care Act’s Lasting Legacy, Particularly as It Works to Replace Fee-for-Service Payments with New Reimbursement Models

Clinical laboratories and pathology groups feel the impact of many of the Center’s demonstration projects that move healthcare toward value-based reimbursement

One perennial criticism of this nation’s healthcare system is that it is slow to innovate. Technologies and management principals widely adopted by many industries may take a decade or longer to gain acceptance by hospitals, physicians, and clinical laboratories.

To encourage faster adoption by useful technologies and innovations by providers, the Affordable Care Act (ACA) has a section that is not well known. This part of the law, passed in 2010, created  the Center for Medicare & Medicaid Innovation.

The Innovation Center was included in the ACA legislation for the purpose of testing “innovative payment and service delivery models to reduce program expenditures … while preserving or enhancing the quality of care” for Medicare, Medicaid, or Children’s Health Insurance Program (CHIP) beneficiaries.” (more…)

23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services

FDA’s assertion of power to regulate genetic tests is a familiar argument to pathologists and clinical laboratory scientists, but does create problems for 23andMe

It has been national news since November 22, when the Food and Drug Administration (FDA) sent a letter to 23andMe ordering it to stop the sale of direct-to-consumer genetic tests. The FDA said that 23andMe had failed to prove the validity of its genetic tests and gave the company 15 days to respond and  identify the steps it would take to address  FDA concerns.

This event has fulfilled the predictions of many pathologists and clinical laboratory professionals. Having dealt with the FDA throughout their careers, experienced medical laboratory scientists knew that the FDA would eventually take enforcement action against 23andMe, if the company did not provide adequate scientific information to support the clinical validity of its genetic tests. (more…)

23andMe Submits Genetic Test Applications with the FDA

23andMe executives want the credibility that FDA clearance provides for its DNA tests and declared their intent to eventually support more clinical laboratory test applications

Offering genetic tests directly to consumers is a controversial subject among some pathologists and healthcare ethics experts, who question both the science of these tests and whether consumers will do the right thing with the information.

Now that debate is likely to heat up, because direct-to-consumer genetic testing company 23andMe recently submitted an application to the Food & Drug Administration (FDA) to review and clear its personalized DNA test for market.

On July 30, 23andMe delivered its first round of 510(k) documentation to the FDA. This is a first for the direct-to-consumer genetic testing industry. At the same time, by seeking FDA clearance for its genetic tests, 23andMe will raise interesting issues for the traditional clinical laboratory testing profession. (more…)

Federal Government Agrees to Open Access to Medicare Data about Individual Doctors

Experts predict employers will use this data to create “report cards” on individual physicians

In a big step forward for public access to data about provider outcomes, the Department of Health and Human Services (HHS) will make its enormous Medicare claims database more broadly available to the public. Both the press and the public will be able to search for information about individual physicians. It is likely that information about pathologists will be searchable in this manner.

Specifically, Medicare will relax its restrictions on the release of information about individual doctors who participate in Medicare. This development was reported recently by The Wall Street Journal, which played a role in getting HHS to make physician data available to the public.

“This is a giant step forward in making our health care system more transparent,” stated Marilyn Tavenner, Medicare’s Acting Administrator. (more…)

Senate Votes to Advance its Health Reform Bill, But Fails to Extend Universal Health Coverage to Millions of Americans

News Reports Estimate as many as 25 Million Americans Would STILL Lack Coverage

With its vote on Saturday, the United States Senate advanced its version of a healthcare reform bill one step further. Now, in both the House and Senate, full floor debate will begin on the different healthcare reform bills that have reached the floor in each body.

Looming in the background, however, is the failure of each of these 2,000-page proposed bills to extend universal coverage to all residents of the United States. This is notable fact, since, over the course of 2009, advocates of an immediate legislative overhaul of the healthcare system in the United States declared their goal was to extend health coverage to all of the estimated 46 million Americans who currently lack health coverage.

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