American Society for Clinical Pathology

July 30, 2008

Congress

Congress Overrides President’s Veto of Medicare Bill

Competitive Bidding Repealed, Additional Positive Changes for Laboratory Community

On July 15th both the U.S. House of Representatives and the Senate voted overwhelmingly to override the President’s veto of H.R. 6331, the “Medicare Improvements for Patients and Providers Act of 2008.” The action was a spectacular victory for ASCP members (see related article about ASCP member advocacy below) and the laboratory community. By itself, repeal of the clinical laboratory competitive bidding demonstration project is a significant win but add the lifting of the freeze on CPI updates to the clinical laboratory fee schedule, the extension of the technical component grandfathering provisions and the reversing of the projected 10.6 percent cut in the physician fee schedule, and you’ve got yourself a really important piece of legislation.

Here’s a recap of some of the most important provisions affecting clinical laboratories:

  • Most important, the House Medicare law repeals the clinical laboratory competitive bidding demonstration project. The demonstration project initially would have affected only two geographic areas, one of which was San Diego; the other was not announced due to a court injunction. Data from the project, however, could have been used to rebase reimbursement under the clinical laboratory fee schedule, most likely at a significant discount to its current levels. Among the concerns raised by ASCP with federal policymakers was the impact this could have on quality testing and patient care.

    Repealing the demonstration project was one of ASCP’s top policy priorities and was achieved with Congress’ veto override. In addition to numerous meetings with federal legislators, ASCP issued numerous action alerts resulting in almost 15,000 letters being sent to federal policymakers urging the demonstration project’s repeal. These messages have been heard. ASCP also helped fund a successful lawsuit challenging certain aspects of the demonstration program.
  • In addition, under H.R. 6331 the “freeze” on the clinical laboratory fee schedule has been lifted. Congress imposed a five-year freeze on the clinical laboratory fee schedule in 2004, blocking the fee schedule from inflationary updates (based on the Consumer Price Index). The freeze is set to expire December 31, 2008. Lifting the freeze on the fee schedule was another ASCP advocacy priority. In 2009 the Clinical Laboratory Fee Schedule is expected to receive a 4.5 percent update, the first significant update in more than a decade.
  • Another item of importance to the laboratory community concerns the extension of the technical component grandfathering provision for independent laboratories, thus enabling certain laboratories to continue receiving Medicare reimbursement for the technical component (TC) of pathology services provided to hospital inpatients and outpatients. The bill extends the grandfathering provision through December 31, 2009.
  • The provision of H.R. 6331 that may have garnered the most attention in the press concerned the 18-month Medicare physician payment fix. That provision reverses the 10.6 percent cut in the Medicare physician fee schedule for the remainder of 2008, plus it reverses an estimated 5 percent cut projected to go into effect in 2009. In place of these cuts, the Medicare bill provides a positive 0.5 percent update for 2008 and a 1.1 percent update for 2009. As previously noted in ASCP’s e-Policy, the now-reversed 2008 and 2009 cuts come as a result of the flawed sustainable growth rate (SGR), which is intended to contain Medicare spending. ASCP has urged Congress to reform the SGR.

House Passes ASCP-Supported Senate PEPFAR Bill

Next Step: President’s Signature

On July 24, the U.S. House of Representatives passed the Senate version of the Lantos/Hyde Leadership Against AIDS, TB, Malaria Act of 2008, which provides funding for the President's Emergency Plan for AIDS Relief (PEPFAR). This legislation reauthorizes PEPFAR, which was passed by the Congress in 2003. The President is expected to sign the legislation within the next few days.

This ASCP-supported legislation is important because it provides integrated prevention, diagnostic and treatment programs to address HIV/AIDS, tuberculosis and malaria in Africa and other developing countries. In addition, the legislation will help these countries develop systems to provide accurate, reliable and timely clinical laboratory testing for HIV and related diseases.

Since its implementation in 2003, PEPFAR has been responsible for 1.4 million men, women and children receiving life-saving antiretroviral therapy; 33 million people have received counseling and testing; and more than 6 million people have received HIV related care. To read the Society’s statement on funding for the PEPFAR initiative, click here.

Congress Moving Ahead on Informatics Legislation

House, Senate Wrangle over HIT Details in Hopes of Passage

Subcommittees of the House Energy and Commerce and Ways and Means committees as well as the Senate Finance Committee are ironing out details of health information technology (HIT) legislation and hope to have something passed and ready for a full Congressional vote this year.

Although moving to electronic health records and creating an automated system in which health information can be shared is seen as beneficial, the creation and implementation of such present challenges. Key among them are the need to protect patient privacy, the financial investment of establishing the framework, the compatibility of systems as well as education in the use of these systems. These are some of the issues legislators are now tackling.

The House Energy and Commerce committee is looking at H.R. 6357, the "Protecting Records, Optimizing Treatment and Easing Communication through Healthcare Technology Act of 2008," or PRO(TECH)T Act.” The bill was introduced by Committee Chairman John D. Dingell (D-MI) and approved by the Subcommittee on Health on June 25 by voice vote.

The legislation proposes to create a structure for the adoption of HIT standards by developing a system that looks toward openness and transparency, and provides grants and loans for the establishment of electronic systems. In addition, the legislation tries to address privacy issues through patient consent, limited data set and lack of disclosure to health plans.

The House Ways and Means Subcommittee is also meeting to discuss health information technology. The focus of these talks will be the adoption and use of a secure, clinically comprehensive and fully interoperable system. Subcommittee Chair Pete Stark (D-CA) described the U.S. health care system as the most advanced in the world, with a 19th-Century method of medical recordkeeping. Rep. Stark maintains that the implementation of health information technology could improve quality of care while also reducing costs. “It’s a win-win situation,” he said. “But the lack of progress to date shows the need for strong federal leadership and real investment in order to realize those benefits.

The Senate Finance Committee also met recently to discuss strategies to encourage the adoption of a nationwide electronic health record system, coinciding with other proposals aimed a creating a national system to move through Congress.

It has been reported that the Congressional Budget Office (CBO) will release two reports in December that will outline Congressional policy options regarding electronic health records and will address potential changes to the health care and health insurance industries.

ASCP has adopted a policy in support of health information technology, believing it to be the catalyst that links clinical laboratories to other components of the health care delivery system as well as a tool for providing accurate and timely information to diagnose and treat patients. Implementation of a program that includes health information technology is a priority issue of the Bush Administration. In 2004, under the auspices of the Department of Health and Human Services, the Administration established a 10 year plan to transform both public and private health care systems.

Federal

ASCP Provides Recommendations to CMS on New CLFS Tests

ASCP recently provided its reimbursement recommendations to CMS on a slate of new clinical laboratory tests that are being added to the Clinical Laboratory Fee Schedule (CLFS) for 2009.

ASCP provided recommendations on the following new codes: CPT Codes 8372X, Myeloperoxidase; 8395X Oncoprotein; des gamma-carboxy-prothombin, 85XXX, coagulation and fibrinolysis, functional activity, not otherwise specified (e.g. ADAMTS-13), each analyte; 879XX, Infectious agent enzymatic activity other than virus (e.g. sialidase activity in vaginal fluid); 8874X1, Hemoglobin, quantitative, transcutaneous, per day; carboxyhemoglobin; 8874X2, Hemoglobin, quantitative, transcutaneous, per day; methemoglobin.

For a copy of ASCP’s reimbursement recommendations, click here.

State

NY Revises Personnel Licensure Law

Has New York fixed its personnel licensure law? That is indeed the question. On July 7th, New York Governor David A. Paterson signed into law legislation modifying the state’s laboratory personnel licensure law. The bill includes some appropriate fixes to the old law, but significant problems remain.

Among the problems with the revised version is that, like the previous law, it fails to provide for appropriate licensing of most categorical laboratory personnel, such as pathologist assistants, histotechnologists, and most categorical technologists. Acceptance of on-the job training or work experience as a means to satisfy the state clinical training requirements for licensure is not considered neither is the recognition of accredited clinical training programs, particularly those located outside of New York. In ASCP’s advocacy with New York state legislators, the Society urged fixes to these problems. ASCP also issued several advocacy alerts, which resulted in several hundred letters being sent to New York state legislators.

On the upside, the recently enacted legislation establishes licensure for histotechnicians and revamps and extends the state’s grandfathering provisions, allowing laboratory practitioners who either did not previously apply or qualify for licensure another opportunity for licensure. Grandfathering provisions provide, for a limited time, the opportunity to apply for licensure under more lenient requirements, such as several years of acceptable work experience. Individuals interested in working in New York, particularly those who did not complete an accredited training program, may want to consider applying for licensure prior to the January 1, 2009, expiration of the grandfathering provisions.

The new law goes into effect on August 7, 2008. For more detailed information on the new law, click here.

Society News

The Advantages of ASCP Member Advocacy
Participation in Political Process Yields Results, Promotes Sense of Pride

By Shaun Hill, Senior Manager, Advocacy

How often have we heard friends, colleagues or family members utter, “My vote doesn’t count” or “ I can’t communicate with my Member of Congress”? Perhaps we’ve even shared these sentiments ourselves. But not only can we, we must, for only through participation in the political process can we facilitate social and economic change.

Advocacy has its roots in our nation’s history; after all, grievances with the government are at the core of America’s founding. But the most telling argument for the legitimacy of advocacy is that it nets results. Case in point: ASCP over the course of several years has urged its members to take action, writing to federal agencies, Congress and the President. The membership responded by the thousands and the work paid off in a major legislative victory.

Hours after President Bush vetoed the ASCP-supported Medicare Bill, both the House of Representatives and the Senate voted to override the President’s veto, making the bill a law once and for all. The law reverses a previously pending 10.6 percent cut in the physician fee schedule, repeals the clinical laboratory competitive bidding demonstration project, lifts the freeze on the clinical laboratory fee schedule, and extends the technical component grandfather provisions. More than 15,000 letters have been generated on these very issues using ASCP’s e-Advocacy Center; moreover, during the height of the activity over the Medicare package, more than 5,000 letters went to Capitol Hill and the White House within a week and a half.

The sheer volume of messages generated was phenomenal, to have legislators or the President receive so many letters articulating the same request sends a powerful message that cannot be ignored. You spoke and they not only listened, they acted.

The passage of the Medicare package is huge. The process has been a long one. However, what ultimately netted results was the legislative community hearing from the laboratory community. Job well done!

The groundwork has been laid for an active and vibrant advocacy community among ASCP’s membership. There still remains a great deal of work to do. Will you be ready to pick up the mantle to advocate on behalf of the laboratory community?

Health Workforce Shortage is a Worldwide Crisis

The United States is far from alone in seeking solutions to workforce shortages in the health sector. The World Health Organization (WHO) estimates that 57 countries worldwide are experiencing a critical shortage of health care workers, equivalent to a global deficit of about 4 million physicians, nurses, midwives, pharmacists, laboratory technologists, and other health workers. Thirty-six of these 57 grossly understaffed countries, defined by the WHO as having fewer than 2.3 health care professionals per 100,000 people, are in Africa.

The critical shortage of health workers not only causes suffering for thousands of people in some of the poorest countries in the world, but it could potentially have just as devastating an impact on the United States and the rest of the world. Not having sufficient numbers of well-trained health professionals impedes the abilities of those countries affected to contain diseases that could become global pandemics. Solving this crisis will require a determined and sustained commitment from governments, educators, international development partners and donors, local partners, and the public and private sector.

Read more about the global shortage of health care workers, including ASCP’s efforts to strengthen pre-service training programs in some of the hardest-hit countries, in the October issue of Critical Values.

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