ADVANCE Outlook: Lab Professionals : Legislation

Signs of the Times

Matthew T. Patton — Fri, 13 Nov 2009 18:46:00 GMT

Acknowledging healthcare reform has been controversial would definitely be an understatement. Almost everywhere I've traveled lately I've heard highly emotional and passionate positions for both sides of the debate. This past weekend, a large group of...(read more)

CLC Writes the Senate

Amanda Koehler — Fri, 28 Aug 2009 12:43:00 GMT

ADVANCE received the following press release from ASCLS: "The Clinical Laboratory Coalition, of which ASCLS is a member, has written the Senate Finance Committee after learning a 20 percent Medicare laboratory co-pay was being proposed by the Senate Finance...(read more)

Obama Repeals Order

Kerri Penno — Mon, 09 Mar 2009 18:59:00 GMT

Today President Obama repealed an order signed by former President Bush back in 2001 restricting federal funding for embryonic stem cell research. The executive order lifts some of the limitations on the types of embryonic stem cell research receiving...(read more)

"Octomom" Sparks Action

Kerri Penno — Fri, 06 Mar 2009 15:54:00 GMT

In the past few weeks, media coverage and public opinion has surrounded Nadya Suleman, who recently gave birth to octuplets, bringing her brood to a whopping 14 children. While the celebrity gossip magazines have focused on Suleman's family's disapproval,...(read more)

Council Elects Leadership Team

Amanda Koehler — Fri, 06 Feb 2009 17:51:00 GMT

We recently received the following press release from AACC:

"The member organizations of the Coordinating Council on the Clinical Laboratory Workforce (CCCLW) have elected Susan Gross, the representative of the American Association for Clinical Chemistry (AACC), to a 2-year term as Chair of the CCCLW. She replaces Paula Garrott of the American Society for Clinical Laboratory Science (ASCLS), who had chaired the coalition for the last 3 years. Gross works for UCSF at San Francisco General Hospital.

Joining Gross on the newly elected leadership team are Vice-Chair Rick Panning, the ASCLS representative and vice president for Laboratory Services for Allina Hospitals and Clinics in Minnesota; and two at-large Steering Committee members: Cheryl Caskey of the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), and Gary Gill of the American Society of Cytopathology (ASC). The steering committee also includes workgroup leaders Paul Epner of the Clinical Laboratory Management Association (CLMA), Elissa Passiment of ASCLS, and Garrott.

The Coordinating Council on the Clinical Laboratory Workforce is a coalition of clinical laboratory organizations, government and regulatory agencies, and industry partners that have been working together since 2000 to address the clinical laboratory workforce shortage. The CCCLW members believe clinical laboratory stakeholders will have a broader and greater impact in addressing the clinical laboratory workforce shortage when working collectively. The Coordinating Council's mission is to represent a united voice of clinical laboratory organizations and stakeholders focusing their collective efforts to increase the number of qualified clinical laboratory professionals, increase public awareness of laboratorians' value in achieving positive patient outcomes and enhancing the image of clinical laboratory professionals.

The current member organizations of the CCCLW include: Abbott Diagnostics, AACC, American Medical Technologists, ASCLS, American Society for Clinical Pathology, American Society for Cytotechnology, American Society for Microbiology, ASC, Association of Genetic Technologists, Association of Public Health Laboratories, CLMA, College of American Pathologists, Commission on Accreditation of Allied Health Education Programs, NAACLS, National Credentialing Agency, Veterans Administration's National Pathology and Laboratory Service Program."

Rightful Place

Kerri Penno — Fri, 23 Jan 2009 16:36:00 GMT

"We will restore science to its rightful place, and wield technology's wonders to raise healthcare's quality and lower its cost."

President Barack Obama made this promise just 3 days ago during his inauguration address and, as with his plans to examine spending and realign military actions in Guantanamo Bay and Iraq, we're already seeing results.

Today, the FDA cleared a human clinical trial of embryonic stem cell based therapy in patients with acute spinal injury.

Geron Corp., Menlo Park, CA, received approval of its Investigational New Drug application for GRNOPC1. The company will initiate a phase 1 multi-center trial to establish the drug's safety in patients with complete American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.

"This marks the beginning of what is potentially a new chapter in medical therapeutics--one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells," said Thomas Okarma, PhD, MD, Geron's president and CEO.

"The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."

The stem cells are derived from the H1 human embryonic stem cell line, created before Aug. 9, 2001, when former President Bush banned government funding for research using embryonic stem cells.

If successful, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA grade B or C) injuries to enable access to the therapy for a broader population.

Breaking News

Kerri Penno — Thu, 17 Jul 2008 12:39:00 GMT

Competitive bidding has been repealed. Congress has voted to override President Bush's veto of H.R.6331, the Medicare Improvements for Patients and Providers Act. This effectively ends the San Diego competitive bidding demonstration and prevents all future demonstrations.

The bill will also replace the scheduled 10.6 percent cut in the Medicare Physician Fee Schedule with a 1.1 percent increase, and extend the technical component grandfather provision for 18 months retroactively from the July 1 cutoff, according to the College of American Pathologists STATLINE report.

Joint Commission's 2009 Safety Goals

Frank Fraser — Thu, 19 Jun 2008 19:24:00 GMT

The Joint Commission announced on June 17 the 2009 National Patient Safety Goals and related requirements for its accreditation programs and Disease-Specific Care Certification Program

Of the Joint Commission's 16 total goals-three of which have been retired since the requirements were incorporated into the standards-the following four apply to the Laboratory Accreditation Program:

Goal 1: Improve the accuracy of patient identification
Goal 2: Improve the effectiveness of communication among caregivers
Goal 7: Reduce the risk of healthcare associate infections
Goal 13: Encourage patients' active involvement in their own care as a patient safety strategy.

Each year, the Sentinel Event Advisory Group works with the Joint Commission to review literature and databases to identify potential new goals and requirements.

Find a complete list of goals and related requirements for the Laboratory Accreditation Program here.

Frank Fraser is an editorial intern at ADVANCE.

Genetic Nondiscrimination

Kerri Penno — Wed, 14 May 2008 22:26:00 GMT

Earlier this month, the House passed H.R. 493, the Genetic Information Nondiscrimination Act, by a vote of 414 to 1. The legislation aims to prevent insurance companies and employers from discriminating against employees based on their genetic information. The act is designed to offer protection and encouragement to those hoping to discover more about their health through genetic tests and personalized medicine.

Francis S. Collins, MD, PhD, director, National Human Genome Research Institute,
National Institutes of Health, made this statement, "This is a great gift to all Americans. It will make it safe for Americans to benefit from the medical results of the Human Genome Project, in which they invested so much. It will make it safe to have their genes examined without fear that they may be discriminated against in employment or health insurance. This is a great day."

Competitive Bidding Halted

Kerri Penno — Wed, 09 Apr 2008 19:08:00 GMT

United States District Judge Thomas J. Whelan has granted a preliminary injunction blocking implementation of the competitive bidding demonstration project in the San Diego Area.

Here is an excerpt from a CLMA e-mail alert:

This is a huge victory for Medicare patients in San Diego, the three plaintiffs in the case, and the entire laboratory profession.

The original lawsuit was filed by Sharp HealthCare, Scripps Health and Internist Laboratory of Oceanside against U.S. Department of Health and Human Services (HHS) Secretary Michael Leavitt on January 29, 2008.

CMS had already accepted bids on laboratory services and was about to announce bid winners on April 11, 2008. Judge Whelan's order means CMS cannot proceed with implementation of the demonstration project in San Diego, cannot announce the winning bidders on April 11, 2008, and cannot disclose information on any bids submitted.

The injunction will stay in place until further order of the court, which likely means until there is a full trial on the merits of the case. Further, the judge agreed that the plaintiffs had shown irreparable harm and found there was substantial economic injury to the laboratories and to patients. He also noted that hospital laboratories would have to set up costly procedures to determine which tests were included in the demonstration and which tests were not.

The judge agreed that the balance of hardships falls "sharply" in favor of the plaintiffs and finds that the laboratories are likely to succeed on the merits of the case. He agreed that the HHS Secretary should have gone through rulemaking, that the Secretary incorrectly interpreted the definition of "face-to-face encounter," and that specimen collection should not have been included in the demonstration because it is not a laboratory test.

Although the order will likely only delay implementation for a matter of months, the decision allows valuable time for Congress to provide a permanent solution with legislation to permanently repeal the competitive bidding demonstration project.

Don't let this major victory go to waste! Please immediately contact your Senators and Representative and urge them to co-sponsor legislation to repeal the competitive bidding demonstration project and permanently stop CMS from implementing it.

Personal Politics

Kerri Penno — Fri, 14 Mar 2008 13:25:00 GMT

Last month, HHS secretary Michael Leavitt (or Mike, as he goes by in his blog) posted a comment about the urgent state of Medicare, which accounts for 56 percent of the HHS budget. Left as is, Medicare is just 11 years from going broke, Mike pointed out.

And that's not the only issue facing the nation's healthcare system, as I'm sure you are painfully aware. With the remaining Democratic Presidential candidates descending on Pennsylvania in anticipation of our April 22 primary, politics are on the brain right now.

It certainly seems the upcoming presidential election is garnering more interest than usual, for a variety of reasons I won't delve into in this forum. My question to you is, how does your position as a healthcare professional impact your personal politics? Are you following the candidates' platforms in regard to healthcare policy? Post your comment below and let us know.

Competitive Bidding Halt Denied

Kerri Penno — Mon, 25 Feb 2008 20:23:00 GMT

On February 14, federal court Judge Whelan issued an order denying a temporary restraining order (TRO) to plaintiff laboratories Sharp HealthCare, Scripps Health and Internist Laboratory of Oceanside, in their complaint against the HHS for implementing a competitive bidding process for clinical laboratory services.

The complaint sought to halt the bidding process imposed on clinical labs serving Medicare beneficiaries in the San Diego, Carlsbad, and San Marcos communities.

The court denied the TRO based on the government argument that any challenge to the Lab Project was premature as winners have not yet been announced.

CLC Files Lawsuit Against Government

Matthew T. Patton — Wed, 30 Jan 2008 00:00:00 GMT

We received this press release today from CLMA:

The Clinical Laboratory Coalition (CLC), of which CLMA is an active member, announced its support for a lawsuit filed today by San Diego area clinical laboratories and health systems in an attempt to stop the federal government from moving forward in its plan to limit San Diego laboratory services.

Filed by Internist Laboratory of Oceanside, Sharp Healthcare of San Diego, and Scripps Healthcare of San Diego against the HHS Secretary Michael Leavitt, the lawsuit also seeks to require public notice and comment on this project, as mandated by federal law. CMS, as part of the Medicare Prescription Drug, Improvement and Modernization Act of 2003, chose San Diego as the first of two demonstration project locations to use so-called "competitive bidding" for clinical laboratory services. The agency will accept bids on laboratory services and select only a very limited number of labs to perform tests that will be reimbursed under Medicare Part B services. Those labs that don't win the bid can not bill for reimbursement of Medicare lab testing services. Rather than creating competition, it will result in fewer labs, less competition and the government in essence picking winners and losers. Bids are due to CMS by Feb. 15, 2008.

"Although a lawsuit is an unusual approach, we believe it is important to use every avenue available to stop competitive bidding from going forward because of the potential negative impact on patient care," said Dana Procsal, CLMA's CEO. "CLMA stands solidly behind this action."

"CLMA stands committed behind the more than 4,000 clinical laboratory managers and leaders it represents in their efforts to protect their laboratories and health care systems from a government mandate which could do serious harm," said JoAnne Milbourn, President of CLMA. "Competitive bidding threatens the viability of our nation's laboratories and their capacity to provide needed services to the very patients they exist to serve.

"CLMA believes a more rational approach to the financial difficulties facing government programs such as Medicare and Medicaid will best preserve the clinical laboratories ability to deliver the type of care our beneficiary population deserves."

Internist, Sharp HealthCare and Scripps Healthcare are fighting to be able to continue to serve San Diego residents. These laboratories will either be forced to shut down all together or close their laboratory outreach services if they aren't selected as winning bidders. The lawsuit was filed in the United States District Court for the Southern District of California. The Clinical Laboratory Coalition is comprised of the following organizations: Advanced Medical Technology Association (AdvaMed), American Association of Bioanalysts (AAB), American Association for Clinical Chemistry (AACC), American Clinical Laboratory Association (ACLA), American Medical Technologists (AMT), American Society for Clinical Laboratory Science (ASCLS), American Society for Clinical Pathology (ASCP), American Society for Microbiology (ASM), Clinical Laboratory Management Association (CLMA), College of American Pathologists (CAP), and National Independent Laboratory Association (NILA).

Dolly for Dinner?

Kerri Penno — Wed, 16 Jan 2008 18:49:00 GMT

When dining out, we choose our wines by variety, and the year and region in which they were produced. How would you like to choose your steak the same way? If you think 2007 was a particularly good year for beef, you're in luck.

The FDA has deemed meat and milk from cloned cattle, swine and goats as safe to eat as conventionally bred animals. It looks like Dolly and her descendants are in the clear, however, as there was inconclusive evidence to approve sheep and other less traditionally eaten animals.

Some snippets of the press release appear below:

"Because clones would be used for breeding, they would not be expected to enter the food supply in any significant number. Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace.

"Due to their cost and rarity, clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding.

"The risk assessment finds that meat and milk from clones of cattle, swine, and goats, and food from the sexually reproduced offspring of clones, are as safe to eat as food from conventionally bred animals."

Just about 1 year ago, in an Opinion Poll question, we asked, "Would you eat meat from a cloned animal?" The results: 42 percent of respondents said "No," while 39 percent said, "Yes." With the FDA deciding not to require labeling of cloned food products, it looks like we may not have a choice.

Stem Cell Breakthroughs

Kerri Penno — Wed, 12 Dec 2007 20:00:00 GMT

In November, a team of researchers reported they had genetically reprogrammed human skin cells to create cells indistinguishable from embryonic stem cells. Time magazine recently called this and other stem cell breakthroughs the top scientific discovery of 2007.

The team, led by University of Wisconsin-Madison biologist James Thomson and Junying Yu of the Genome Center of Wisconsin and the Wisconsin National Primate Research Center, found the induced cells did everything embryonic stem cells do, without the problems of immune rejection.

"They are probably more clinically relevant than embryonic stem cells," Thomson said. While more testing is necessary, and Thomson cautioned it is hardly time to discontinue embryonic stem cell research, he did say this about their discovery: "It's going to completely change the field."

What do you think? Are skin-based stem cells a welcome solution to the ethical debate surrounding embryonic stem cells? Or is this a win for conservative politicians, potentially leading to more political control over science in the future?