Business & Economy
Grassley and Kohl Urge Action on Sunshine Law PDF Print E-mail
News Releases - Business & Economy
Written by Grassley Press   
Tuesday, 04 October 2011 07:56

WASHINGTON – U.S. Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) are pressing the Centers for Medicare and Medicaid Services (CMS) on missing a deadline for drafting regulations for the Physician Payment Sunshine Act (Sunshine Act), a new law requiring public disclosure of the financial relationships between physicians and the pharmaceutical, medical device and biologics industries.

“Prompt federal guidance is urgently needed to ensure a smooth path toward increasing disclosure, eliminating conflicts and ultimately providing patients with the tools they need to make informed health choices,” Grassley and Kohl wrote in a letter to CMS Administrator Dr. Donald Berwick.

The Sunshine Act requires manufacturers to report all payments to physicians, including consulting fees, honoraria, travel and entertainment, and for the Department of Health and Human Services (HHS) to publicly disclose the identity of the manufacturer, physician, and the drug or device associated with the payment on the internet. Additionally, the law requires manufacturers and group purchasing organizations (GPOs) to report all ownership or investment interests held by physicians or members of their family, and for making that information public. The law required HHS to establish guidance on how manufacturers submit information and how the information would be made available to the public no later than October 1, 2011.

The Sunshine Act was developed by Grassley and Kohl after numerous investigations and hearings revealed that large sums of money were going to physicians for sometimes questionable purposes. Some of these payments were the subject of a federal criminal inquiry which resulted in $400 million in fines and legal costs paid by the major orthopedic medical device manufacturers. Ultimately, Congress passed the Sunshine Act as part of the health care reform law in response to growing concerns over industry payments to physicians and their potential negative effects on patient care and the need to restrain health care costs.

In their letter, Grassley and Kohl also asked why CMS failed to meet the statutory deadline and requested a timeline on establishing regulations.

Manufacturers and GPOs are required to start complying with the law by collecting payment data beginning January 1, 2012, and must begin reporting this information to the government on March 31, 2013. Starting September 30, 2013, the details of these payments must be made available to the public. Violations of the disclosure requirements can result in civil monetary penalties ranging from $1,000 to $100,000.

 

The text of the letter follows.

October 3, 2011

Donald Berwick, M.D., M.P.P

Administrator

Centers for Medicare and Medicaid Services

200 Independence Avenue, S.W.

Washington, D.C. 20201

 

Dear Administrator Berwick:

As authors and sponsors of the Physician Payments Sunshine Act (Sunshine Act), which was included in the Patient Protection and Affordable Care Act, we write today to express our severe disappointment in the Centers for Medicare and Medicaid Services (CMS) for failing to meet the October 1, 2011, deadline to draft the regulations mandated by the health care reform law.

While many interactions between the pharmaceutical and medical device industries and medical professionals are beneficial to medical science and lead to innovation, the Sunshine Act was developed after numerous investigations and hearings revealed that large sums of money were going to physicians for sometimes questionable purposes.  Some of these payments were the subject of a federal criminal inquiry which resulted in $400 million in fines and legal costs paid by the major orthopedic medical device manufacturers.  Ultimately, Congress passed the Sunshine Act in response to growing concerns over industry payments to physicians and their potential negative effects on patient care and efforts to restrain healthcare costs.

Under the provisions of this law, manufacturers are required to report to the Secretary of the Department of Health and Human Services (HHS) all payments to physicians, including consulting fees, honoraria, travel, and entertainment, for public disclosure by the Secretary.  The Secretary is then instructed to include the identity of the manufacturer, the physician, and the drug or device associated with the payment on the internet.  An additional provision requires manufacturers and group purchasing organizations (GPOs) to report all ownership or investment interests held by physicians or members of their family, also for public reporting by the Secretary.  It is our understanding that the Secretary has delegated implementation of this provision to CMS.

Manufacturers and GPOs are required to start complying with the law by collecting data beginning January 1, 2012, and must begin reporting this information to the government on March 31, 2013.  Beginning on September 30, 2013, the details of these payments are to be made available to the public.  Violations of the disclosure requirements can result in civil monetary penalties ranging from $1,000 to $100,000.

In order to ensure that manufacturers had adequate time to comply, the law required that the Secretary establish procedures not later than October 1, 2011, describing how manufactures are to submit information and how the information will be made available to the public.  In addition, in establishing these procedures the Secretary was required to “consult with the Inspector General, affected industry, consumers, consumer advocates and other interested parties to ensure that the information made available to the public is presented in the appropriate context.”

The deadline for establishing procedures has passed and there has not been, to our knowledge, adequate consultation with either industry representatives or consumer advocates.  Therefore, we are concerned that CMS’s failure to implement the statutory provisions on time with clear guidance, standards and definitions will create confusion among both manufacturers and consumers, potentially placing taxpayer dollars at risk.

Although many of the large pharmaceutical and medical device manufacturers, universities, and even the National Institutes of Health (NIH) have already begun to implement disclosure policies voluntarily, we are concerned that smaller companies are waiting for clarity and direction from CMS and will find the lack of timely guidance burdensome and costly.  Prompt federal guidance is urgently needed to ensure a smooth path toward increasing disclosure, eliminating conflicts, and ultimately providing patients with the tools they need to make informed health choices.

In a conference call with our staff on Friday, September 23, 2011, your agency assured us that you have sent the proposed rule over to the Office of Management and Budget (OMB) for review. So that we may better monitor this progress, please answer the following questions in writing no later than October 14, 2011:

(1)   What is your timetable for implementing the Sunshine Act?

(2)   When did you originally send the proposed rule to the Office of Management and Budget (OMB)?  Please include any dates that follow-up was conducted and for what reason.

(3) Why have you failed to meet the statutory deadline?

(4) What is the anticipated release date of the preliminary regulations?  How long will the regulations be open for comment as required by the statute? What is your timeline for issuing final regulations?

In addition to your written response, please have the appropriate CMS officials contact our staff no later than October 7 to schedule an in-depth briefing on these issues and an open discussion on a path forward that allows both a timely implementation and a robust comment period.

Should you have any questions regarding this letter, please contact Erika Smith of the Senate Judiciary Committee staff at (202) 224-5225 or Jack Mitchell of the Senate Special Committee on Aging staff at (202) 224-5364. Thank you for your immediate attention to this important matter.

Sincerely,

 

Charles E. Grassley                       Herb Kohl

Ranking Member                         Chairman

Committee on the Judiciary                      Senate Special Committee on Aging

 
Morthland Proposes Sales Tax Exemptions for IL Farmers PDF Print E-mail
News Releases - Business & Economy
Written by Rich Morthland   
Monday, 03 October 2011 14:28

Moline, IL...State Representative Rich Morthland (R-Cordova) has filed legislation offering sales tax exemptions for Illinois farmers. House Bill 3817 exempts the sales tax imposed on fence posts, fencing, and farm gates. House Bill 3818 exempts the sale tax imposed on baling twine, baling wire, plastic bags, plastic sleeves, and plastic sheeting

Representative Morthland, a seventh generation Illinois farmer, explained that farmers cross the Mississippi River to Iowa to make agricultural supply purchases because Iowa has a more favorable tax structure.

"Every time a farmer crosses the river to buy agricultural products, the State of Illinois loses employment potential and revenue opportunities on all of the purchases made that currently do not qualify for the sales tax exemption," Morthland said.

Morthland's legislation requires that the purchaser certifies the items will be used for farm production.

"Sales taxes on agricultural production goods act like a cumulative value added tax which, incidentally, Illinois rejected under Rod Blagojevich," Morthland said. "Some people will look at this like, 'it's just fence materials and twine,' but to the Illinois farmer who buys in bulk, these taxes can be burdensome."

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Baucus, Grassley Uncover Gaming of the Medicare System by For-PROFIT Home Health Companies PDF Print E-mail
News Releases - Business & Economy
Written by Grassley Press   
Monday, 03 October 2011 14:11
Finance Senators Release Report Showing Companies Intentionally Increased Frequency of Home Health Visits to Manipulate Reimbursement Rates

Washington, DC – Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior Finance Committee Member Chuck Grassley (R-Iowa) today released a Finance Committee staff report showing tactics used by major for-profit home health companies to game Medicare.  The result has been waste of taxpayer dollars and the delivery of what could be medically-unnecessary patient care to increase the companies’ profits.  Baucus and Grassley initiated the investigation into the improper practices as part of the Committee’s oversight role of the Medicare and Medicaid programs and the Senators’ ongoing commitment to protect patients and taxpayer dollars from waste, fraud and abuse.

“The gaming of Medicare represents serious abuse of the home health program,” said Baucus.  “Elderly patients in the Medicare system should not be used as pawns to increase a company’s profits. Especially in these tough economic times, taxpayers simply cannot afford for their dollars to be wasted on unnecessary care.  We are going to continue to crack down on these companies to ensure taxpayer dollars are used efficiently and Medicare patients are protected.”

“The reimbursement policy encourages gaming, and gaming is what’s occurred.   Companies are doing everything they can to make as much money as possible, whether the patients need the care or not.  The federal government needs to fix the policy that lets Medicare money flow down the drain.  This can’t wait until tomorrow.  It should have been done yesterday.  The longer this kind of policy continues, the more Medicare’s budget balloons, and the bigger the burden on taxpayers,” Grassley said.

In May 2010, Baucus and Grassley began their investigation into home health therapy practices at Amedisys, LHC Group, Gentiva, and Almost Family in response to a media report that these home health companies took advantage of the Medicare therapy payment system by providing medically-unnecessary patient care.

The Committee staff report released today examines documents provided by the companies which show how therapists were encouraged to target the most profitable number of therapy visits, even when patient need may not have required such visits.  In addition, therapy visit records for each company showed concentrated numbers of therapy visits at or just above the point at which a “bonus” payment was triggered by the Medicare program.

Internal documents from three of the four companies, Amedisys, LHC Group and Gentiva, provided evidence of top-down strategies to game Medicare.  Highlights from the report include:

  • Managers encouraged therapists to meet a 10-visit target that would have increased their payments from Medicare.
  • An “A-Team” tasked with developing programs to target the most profitable Medicare therapy treatment patterns.
  • Therapists and regional managers that were pressured to follow new clinical guidelines developed to maximize Medicare reimbursements.
  • Top managers instructed employees to increase the number of therapy visits provided in order to increase case mix and revenue.
  • A competitive ranking system for management aimed at driving therapy visit patterns toward profitable levels.
  • Evidence that management discussed increasing therapy visits and expanding specialty programs to increase revenue.

The Medicare Part A program pays out an estimated $19 billion yearly for home health care.  Fraud, waste and abuse in the health care system cost Americans an estimated $60 billion a year, approximately three percent of total health care spending.

Baucus and Grassley have led numerous major investigations of the health care industry to protect consumers and taxpayer dollars.  Earlier this year, when their investigation found that the drug company Sanofi interfered in the approval of generic alternatives to its blood-thinner drug Lovenox, the Finance leaders called on the Food and Drug Administration (FDA) to help guarantee consumers have access to affordable generic medications.  Last December, Baucus and Grassley released a report detailing the relationship between Abbott labs and a Maryland doctor who allegedly implanted nearly 600 unnecessary cardiac stents into his patients, costing the federal government as much as $3.8 million in overpayments.  The specific stent case highlighted in the Senators’ report is indicative of a widespread, national problem of unnecessary stenting.  The Senators also spearheaded a two year inquiry which revealed undisclosed side effects of the diabetes drug Avandia.  This resulted in the FDA restricting use of the drug, ensuring that patients and doctors have the information they need to make safe, informed decisions about their medication.

The Committee’s full report is available here.

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Morthland's Gas Tax Report Released PDF Print E-mail
News Releases - Business & Economy
Written by Rich Morthland   
Monday, 03 October 2011 14:08

Moline, IL...State Representative Rich Morthland's (R-Cordova) House Resolution 328 directed the Illinois Commission on Government Forecasting and Accountability to conduct an objective, non-political examination of the State's policy of charging "ad valorem" Illinois sales taxes on motor fuel. This report revealed various factors contributing to the price of gas sold in Illinois.

"Our gasoline sales tax of 6.25% makes Illinois the 3rd highest total tax on fuel in the nation," Morthland said. "This tax has a compounding effect as it increases when gas prices increase. This contributes to flight to Iowa and other states that don't have such a punitive tax structure." Morthland continued, "When we buy our gas in Iowa, it's not uncommon to pick a few groceries or other items there." 

The COGFA report speculates that this tax structure has a negative on business in Illinois.

"It's nice to have the income, but it's not necessarily a good dollar in if it's hurting our state and derailing Illinois jobs by pushing sales across state borders," Morthland said. "I am working on a form of tax relief for border communities in Illinois to restore our competitive edge."

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Iowa Farm Bureau Study Estimates Missouri River Flooding at $207 Million in Crop and Economic Losses PDF Print E-mail
News Releases - Business & Economy
Written by Iowa Farm Bureau   
Monday, 03 October 2011 14:06

IOWA FARM BUREAU STUDY ESTIMATES MISSOURI RIVER FLOODING TO CAUSE $207 MILLION IN CROP AND ECONOMIC LOSSES

WEST DES MOINES, IOWA – Oct. 3, 2011 – This year’s devastating flooding on the Missouri River caused an estimated $207 million in lost crop sales and related economic activity in six western Iowa counties that border the river, according to a new study commissioned by the Iowa Farm Bureau Federation (IFBF).

The flooding began in late June when the U.S. Army Corps of Engineers opened up a series of dams in the Dakotas to release water caused by heavy snows and record rains. Farmers are finally seeing the floodwaters recede and assessing the damage which includes severely damaged roads and the destruction of several hundred thousand acres of corn and soybean fields.

The study focused on Fremont, Pottawattamie, Mills, Woodbury, Harrison and Monona counties and analyzed the direct and indirect economic impacts from crop losses from flooded fields, said Dave Miller, IFBF director of research and commodity services. The study also factored in the impact of lost wages as the income of the lost crops won’t circulate in the western Iowa communities.

“This study shows the repercussions of the lost cropland and economic activity in these counties,” added Miller. “On a business level, farmers won’t be purchasing machines or inputs such as fertilizer for land. But there is also a household effect with reduced expenditures in those counties.”

For the farmers in the six-county region, the flooding cost $46.1 million in net income compared to pre-flood estimates.  That total included losses on flooded acres that can’t be harvested, as well as yield losses from affected crops that were within a mile of the flooded area. The study also factored in the cost of seed, fertilizer and other inputs that farmers had already invested in their 2011 corn and soybeans before the fields were damaged or wiped out by flooding.

The study also accounted for potential crop insurance indemnity payments that farmers will receive because their crops were destroyed, as well as payments from the U.S. Department of Agriculture’s Supplemental Revenue Assistance payments (SURE) program, which provides financial assistance for crop production and or quality losses due to a natural disaster.

Fremont County suffered the highest losses, at an estimated $52.2 million; with $43.9 million in direct crop income loss and $8.3 million indirect losses from the damaged fields. Harrison County suffered $36.7 million in crop and other economic losses, and Monona County lost $32.3 million.

Losses in the remaining Missouri River counties were: Pottawattamie at $31.2 million; Mills at $22.2 million and Woodbury at $14.7 million.

Miller emphasized that the study measured losses of economic activity from lost crop sales and didn’t factor in losses to personal property, or the steep cost of rebuilding roads, levees and other infrastructure damaged or destroyed by the months of flooding.

“This is really just the tip of the iceberg on economic losses from the flooding,” Miller said. “But we hope this study will provide valuable information to help farmers, community leaders and lawmakers as they rebuild the region and push for policies to prevent or minimize flooding in the future.”

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