12.19.13
Here we are again. As part of recent budget negotiations struck between Democrats and Republicans from both houses of Congress, medical device tax repeal is on the table again--sort of. The language in the bill to repeal the device tax, however, is non-binding. In the text of the proposed budget legislation, the medical device tax is included as a "revenue-neutral device tax repeal reserve fund." In non-inside-the-Washington-beltway speak, the inclusion of a reserve fund in a budget resolution, more or less, does nothing. It’s essentially like a wish list inserted by members of Congress to get a project they're interested in on record. But it doesn’t require any policy action to be taken. Translation: The device tax is still in place.
The bigger news this time around is the user fees—but for a relatively short time.
The deal, negotiated on Dec. 10 by House Budget Committee Chairman Paul Ryan (R-Wis.) and Senate Budget Committee Chairman Patty Murray (D-Wash.)— ahead of the Dec. 13 deadline — includes language that calls for a repeal of the medical device tax, as well as an agreement that allows the U.S. Food and Drug Administration to access the full amount of user fees paid by industry for fiscal years 2014 and 2015.
If approved, the overall budget deal likely would prevent a government shutdown in mid-January. The House of Representatives voted on Dec. 12 to approve the budget. The Senate voted on Dec. 18 to approve the deal and send it to the president's desk for his signature.
Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), commended lawmakers for crafting a bipartisan budget agreement that “replaces the sequester, allows FDA to access the full amount of user fees paid by industry for FYs 2014 and 2015, and calls for repeal of the medical device tax. AdvaMed is encouraged that the budget deal preserves language from the Senate Budget Resolution calling for repeal of the medical device tax. We look forward to working with lawmakers on both sides of the aisle moving forward to achieve repeal of this tax which continues to cost our country jobs and to stifle medical innovation."
Because of the sequester, the Center for Devices and Radiological Health in the U.S. Food and Drug Administration (FDA) device center lost access to $2.9 million in industry user fees in fiscal year 2013, according to Ubl.
“While the budget deal spares user fees for the next two years, unless a permanent solution is found, the agency stands to lose significantly more user fee funds in FY 2016 and beyond,” Ubl added. “For that reason, AdvaMed strongly supports bipartisan legislation introduced by Sens. Mark Pryor (D-Ark.) and Roy Blunt (R-Mo.) and Reps. Leonard Lance (R-N.J.) and Anna Eshoo (D-Calf.) that would address this situation. AdvaMed believes user fees paid by industry to FDA should not be treated the same way as taxpayer dollars. We urge Congress to advance a permanent solution in January to allow FDA to access all user fees paid by industry, and we support efforts to release those FY 2013 user fees the agency has been unable to use.”
Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), also weighed in on the deal.
“MDMA applauds the continuing bipartisan support for putting an end to the medical device tax. With each passing day, this onerous policy impedes innovation, thwarts patient care and destroys jobs. We have much more work to do, but MDMA and medical technology innovators will work tirelessly with all stakeholders to achieve this bipartisan goal,” he said. “In addition, it is crucial that FDA has access to all industry provided user fees so that it can provide a more reasonable and predictable regulatory framework. Sequestration of these privately paid user fees was an unfortunate consequence that needs to be fully addressed to help ensure America's medical technology industry can continue to be the global leader.”
In an official estimate released Dec. 10, the nonpartisan Congressional Budget Office (CBO) said the budget measure would reduce deficits by $85 billion over the next decade by reducing taxpayer contributions to federal-worker pensions, requiring private companies to pay higher premiums for federal insurance of their pensions and increasing security fees for airline travelers, among other changes.
Of that $85 billion, the CBO said $62 billion would go toward rolling back parts of the sequester in fiscal 2014 and 2015, with the Pentagon and domestic programs benefiting equally. The rest of the savings, roughly $23 billion, would go toward trimming deficits over the next decade.
If approved by both houses of Congress, members of the House and Senate appropriations committees then would work over the holidays to prepare funding bills for individual agencies, which are likely to be combined into a single measure known as an omnibus.
While the agreement between Ryan and Murray lessens the odds of another shutdown when a temporary spending bill expires Jan. 15, the omnibus must pass before that deadline to keep the government open.
That would give Congress relatively clear sailing on the budget until the fall of 2015—except for the need to raise the federal debt limit, probably sometime in late February or early March.
"Today's bipartisan budget agreement is a good first step," President Barack Obama said in a statement. "I want to call on members of Congress from both parties to take the next step and actually pass a budget based on this agreement so I can sign it into law."
The president praised elements of the deal, saying the modest rollback of the across-the-board sequester spending cuts would ease a drag on economic growth. He called the measure "balanced" because it increases government revenues and includes spending cuts he said would not hurt the economy.
The bigger news this time around is the user fees—but for a relatively short time.
The deal, negotiated on Dec. 10 by House Budget Committee Chairman Paul Ryan (R-Wis.) and Senate Budget Committee Chairman Patty Murray (D-Wash.)— ahead of the Dec. 13 deadline — includes language that calls for a repeal of the medical device tax, as well as an agreement that allows the U.S. Food and Drug Administration to access the full amount of user fees paid by industry for fiscal years 2014 and 2015.
Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), commended lawmakers for crafting a bipartisan budget agreement that “replaces the sequester, allows FDA to access the full amount of user fees paid by industry for FYs 2014 and 2015, and calls for repeal of the medical device tax. AdvaMed is encouraged that the budget deal preserves language from the Senate Budget Resolution calling for repeal of the medical device tax. We look forward to working with lawmakers on both sides of the aisle moving forward to achieve repeal of this tax which continues to cost our country jobs and to stifle medical innovation."
Because of the sequester, the Center for Devices and Radiological Health in the U.S. Food and Drug Administration (FDA) device center lost access to $2.9 million in industry user fees in fiscal year 2013, according to Ubl.
“While the budget deal spares user fees for the next two years, unless a permanent solution is found, the agency stands to lose significantly more user fee funds in FY 2016 and beyond,” Ubl added. “For that reason, AdvaMed strongly supports bipartisan legislation introduced by Sens. Mark Pryor (D-Ark.) and Roy Blunt (R-Mo.) and Reps. Leonard Lance (R-N.J.) and Anna Eshoo (D-Calf.) that would address this situation. AdvaMed believes user fees paid by industry to FDA should not be treated the same way as taxpayer dollars. We urge Congress to advance a permanent solution in January to allow FDA to access all user fees paid by industry, and we support efforts to release those FY 2013 user fees the agency has been unable to use.”
Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), also weighed in on the deal.
“MDMA applauds the continuing bipartisan support for putting an end to the medical device tax. With each passing day, this onerous policy impedes innovation, thwarts patient care and destroys jobs. We have much more work to do, but MDMA and medical technology innovators will work tirelessly with all stakeholders to achieve this bipartisan goal,” he said. “In addition, it is crucial that FDA has access to all industry provided user fees so that it can provide a more reasonable and predictable regulatory framework. Sequestration of these privately paid user fees was an unfortunate consequence that needs to be fully addressed to help ensure America's medical technology industry can continue to be the global leader.”
In an official estimate released Dec. 10, the nonpartisan Congressional Budget Office (CBO) said the budget measure would reduce deficits by $85 billion over the next decade by reducing taxpayer contributions to federal-worker pensions, requiring private companies to pay higher premiums for federal insurance of their pensions and increasing security fees for airline travelers, among other changes.
Of that $85 billion, the CBO said $62 billion would go toward rolling back parts of the sequester in fiscal 2014 and 2015, with the Pentagon and domestic programs benefiting equally. The rest of the savings, roughly $23 billion, would go toward trimming deficits over the next decade.
If approved by both houses of Congress, members of the House and Senate appropriations committees then would work over the holidays to prepare funding bills for individual agencies, which are likely to be combined into a single measure known as an omnibus.
While the agreement between Ryan and Murray lessens the odds of another shutdown when a temporary spending bill expires Jan. 15, the omnibus must pass before that deadline to keep the government open.
That would give Congress relatively clear sailing on the budget until the fall of 2015—except for the need to raise the federal debt limit, probably sometime in late February or early March.
"Today's bipartisan budget agreement is a good first step," President Barack Obama said in a statement. "I want to call on members of Congress from both parties to take the next step and actually pass a budget based on this agreement so I can sign it into law."
The president praised elements of the deal, saying the modest rollback of the across-the-board sequester spending cuts would ease a drag on economic growth. He called the measure "balanced" because it increases government revenues and includes spending cuts he said would not hurt the economy.