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December 16, 2011

2011

Washington Letter
December 16, 2011
Newsletter of the American Thoracic Society's Washington Office

1150 18th Street NW
Suite 300
Washington, D.C. 20036
Telephone:(202) 296-9770
advocacy@thoracic.org

HEADLINE

Government Stays Open, But SGR Unresolved

This weekend, Congress wrapped up an omnibus spending bill to keep the federal government operating through the remainder of fiscal year 2012. However, at press time, Congress still had not resolved a number of pressing tax and entitlement issues, including a temporary fix for the Medicare sustainable growth rate factor (SGR).  Over the weekend, it appeared that House and Senate leaders had reached a two-month extension of several tax provisions and a two-month patch for the Medicare physician payments.  However, the deal quickly unraveled as members of the House Republican Caucus strongly opposed a two-month extension.  With only 13 days left before the 27.4 percent Medicare physician payment cuts take effect (along with ending unemployment insurance and a payroll tax cut), it is unclear how Congress will resolve the stalemate. 

While details of the Omnibus Appropriations Bill are still emerging, below are key programs of interest to the American Thoracic Society.

NIH Funding
The Omnibus Appropriations Bill provides a +$299 million, or 1 percent, increase for NIH, putting the NIH budget at $30.7 billion in FY2012.

CDC Funding
The omnibus provides a $38 million, or 0.6 percent, , increase for the CDC, putting FY2012 funding for the agency at $6.1 billion.

CDC Asthma Program
The President’s FY2012 budget had proposed merging the Asthma Program with the Lead and Healthy Homes programs and cutting funding by almost 50 percent. The ATS worked with the Asthma and Allergy Foundation and other partners to protect the program. As a result of our efforts, the omnibus maintains asthma as a separate program, providing $24.5 million, a $3 million cut from FY2011.

VA Research Funding
Congress provides $581 million for the VA Research Program, which is the same funding level as FY2011.

Tuberculosis
The omnibus provides $225 million for USAID’s Tuberculosis Program , which is level funding with FY2011.

EPA Funding
Funding for the EPA was cut $233 million for a total budget of $8.4 billion.  A number of legislative riders preventing the EPA from moving forward with Clean Air Act standards were removed from the final bill.  Other legislative riders on regulating mountaintop mining wastes and light bulb efficiency standards were part of the final bill.

While the ATS is pleased that legislative riders on the Clean Air Act were removed from the Omnibus Appropriations Bill, there is still talk of adding legislative riders on the pending tax bill.  The ATS will continue to oppose Congressional efforts to undermine the Clean Air Act. 

RESEARCH

CMS Releases Physician Payment Sunshine Rules

This week, the Centers for Medicare and Medicaid Services released proposed rules for collecting and public reporting of industry payments made to physicians and teaching hospitals.  The rules--often referred to as the Physician Payment Sunshine Rules ---were called for in the Affordable Care Act. 

Under the proposed rules, industry will need to collect and report payments or other “transfers of value” made to physicians or teaching hospitals. The data will be made publically available and is intended to allow the public to evaluate potential conflicts of interest their physicians may have. 

In general, the rule requires all transfers of value that exceed $10, or cumulatively exceed $100 in a calendar year, to be reported by industry.  Research grants, contacts, consulting, honoraria and speakers fees are all reportable under the proposed rule.  Certain exchanges are exempted, including those less than $10 (that do not exceed $100 in a calendar year), patient education materials, transfers administered by a  third party in which the industry does not know who received the transfer and drug samples .

Because of the impact this rule may have on ATS members and their interactions with the drug and medical device industry, the ATS will carefully review and comment on the proposed rules.  It is expected that industry will need to collect and report partial year data for 2012, and the data will become available in 2013.

CLINICAL PRACTICE

ATS Urges FDA to Take Action to Alleviate Drug Shortages

This week, the ATS sent a letter to the FDA urging the agency to take action to alleviate current drug shortages and prevent future widespread occurrences. The United States is experiencing an unprecedented national shortage of many medications, including chemotherapy drugs, anesthetics and sedatives. In late October, President Obama issued an executive order concerning shortages, however, the effect of this action is limited because the president lacks authority to require drug companies to give advance notice of supply issues.

The ATS letter to FDA Commissioner Margaret Hamburg, MD, calls attention to national shortages of many drugs commonly used for treatment of respiratory diseases, critical illnesses and sleep disorders, including the sedative propofol and the anesthetic fentanyl and persistant shortages of drugs used to treat drug resistant tuberculosis. In the letter, ATS President Nicholas S. Hill, said, “The unavailability of these medications means physicians must delay treatment or rely on alternative therapeutics that may not be as effective or may have more side effects.”

Dr. Hill continued, “We are concerned that continued drug shortages are compromising care for patients with respiratory diseases, critical illnesses and sleep disorders.” While applauding the president for issuing the executive order, the ATS urged the FDA to take the following measures:

  • Expand the Strategic National Stockpile to include medications essential to treating patients with critical illness;
  • Maintain a database of foreign and domestic manufacturers of critical drugs; and
  • Determine and communicate alternative treatments to hospitals and providers more quickly.

In the letter, the ATS also expresses support for passage of legislation that would provide the FDA with the authority to require drug manufacturers to provide advance notice of supply problems, entitled the Preserving Access to Life-Saving Medications Act, H.R. 2245/S. 296, sponsored by Sen. Klobuchar (D-MN) and Rep. DeGette (D-CO). While the legislation is not yet scheduled for Congressional action, the Senate Finance Committee recently held a hearing on drug shortages. Witnesses, including an oncologist and representative from the American Society of Health-System Pharmacists, testified that while there is no magic bullet for short-term relief of shortages, there are steps that can be taken to prevent future large-scale shortages. These include revisions to Medicare’s reimbursement system for generic drugs, incentives for generic manufacturers and enactment of the Preserving Access to Life-Saving Medications Act so that the FDA can have advance notice of manufacturing problems and develop plans for alternative supplies of drugs.

The ATS Washington Office will continue to monitor drug shortages in pulmonary, critical care and sleep medicine and work with the FDA to address them. We will also work with the Congressional sponsors of the Preserving Access to Life-Saving Medications Act to support enactment of this legislation.

 

 

 


The Washington Letter is written by the American Thoracic Society government relations office and emailed to all ATS members living in the United States. The letter keeps clinicians, scientists, and patients abreast of legislative, judicial, and regulatory issues in pulmonary, critical care, and sleep medicine. Each week's edition is archived on the ATS Web site, www.thoracic.org. If you have any questions or one more information about becoming involved in advocacy, please contact the ATS Washington office at 202-296-9770.