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What Can You Expect from Congress the Remainder of the YearWhat Can You Expect from Congress for the
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What Can You Expect from Congress for the Remainder of the Year?

Cynthia Blankenship, Esq., IACP VP Government Affairs

One does not have to look very far here in Washington, DC to know that we are in an election year.  The upsets have already started to shake each party to the core leaving the entire legislative agenda in both the House and Senate in question.  With the shocking double-digit loss of House Majority Leader Eric Cantor in his Primary to a lesser known (and significantly less funded) Tea Party challenger, the Republican House was not only left scrambling to identify their new leadership, but also to determine what is “safe” to place on the legislative agenda for the months remaining before the election.  

The Cantor upset was not the first shock of this election year and it will not be the last.  One thing is clear - with FL holding a special election in the 19th Congressional District to replace Republican Rep. Radel who resigned after pleading guilty to buying cocaine from a federal law enforcement officer; Senator Thad Cochran (R-MS), who has served six terms, facing a Tea Party challenger in his Primary runoff; longtime heavyweight and former House Ways and Means Chairman, Rep. Charles Rangel (D-NY), who has served 22 terms, facing his own challenges in his Primary in New York’s 13th Congressional District; Senator Tom Coburn (R-OK) retiring in Oklahoma; and long-term Democratic fixtures in the House, John Dingell (D-MI) and Henry Waxman (D-CA), both retiring and leaving the make-up of the House Energy and Commerce Committee in limbo –there will be many new faces on the Hill come January of next year.  

While every media outlet in DC struggles to predict the turnout of this election year and the winners and losers of the Primary elections, the agenda for the House and Senate are just as in flux.  It might be tempting to look at the calendar and conclude that Congress has months until the elections and thus plenty of time to conclude everything on the agendas. However the House and Senate are set to adjourn for the July 4th recess on June 27th and June 30th respectively.  Both Chambers will not return until the second week of July giving each chamber just shy of four weeks before they adjourn for the month-long August recess.  

After August, as election years normally go, full focus will turn to the elections at-hand with bipartisan efforts on anything becoming a rarity and votes being scheduled to provide political cover in the ever approaching elections but with little to no chance of actually becoming law.  Therefore, the hard realization is that Congress is simply running out of time to conclude all the business listed on the agenda for this year and only must-pass items like appropriations measures will be addressed before Congress enters campaign mode.   So, what can pharmacists expect to see from now until the election?

Fraud, Waste, and Abuse:  Increased Focus on Billing, Reimbursement, and Data Transparency

Leading up the election, pharmacists can expect a broad focus on fraud, waste, and abuse as well as transparency from both parties.  The Administration has undertaken the initiative to identify and decrease what the Administration deems fraud, waste, and abuse within the health care industry.  These efforts were codified within the Affordable Care Act and gave Agencies an unprecedented amount of tools to fight fraud, waste, and abuse and increased funding for “Health Care Fraud and Abuse Control Fund” by approximately $250 million over the next decade.

Demonstrated in recent months by the releasing of physicians’ Medicare and Medicaid reimbursement amounts, it is clear that data transparency also fits within the Administration’s efforts and will likely be seen for more practitioners within the health care industry.  Thus, the Democrats will likely unveil a broad fraud, waste, and abuse strategy leading up to the election year including releasing reimbursement data, billing data, fraudulent activities, wasteful spending, etc. for health care practitioners in order to attempt to demonstrate the success of the provisions found within the Affordable Care Act.  To the contrary, the Republican Party will likely focus on fraud, waste, and abuse, in an attempt to demonstrate the opposite – that the Affordable Care Act is not working and there is widespread fraud, waste, and abuse still in existence.

To continue the ongoing efforts around fraud, waste, and abuse, the House Energy and Commerce Committee is holding a hearing this week on Medicare Program Integrity:  Screening out Errors, Fraud, and Abuse where representatives from Centers of Medicare and Medicaid Services (CMS), Office of Inspector General (OIG), and Government Accountability Office (GAO) are expected to testify.  The Senate Finance Committee has announced the intent to focus on Data Transparency and is currently soliciting comments from stakeholders and the public until August 12, 2014 regarding ways to make data more transparent.  Previously, Chairman Wyden and Senator Grassley introduced the Medicare Data Access for Transparency and Accountability Act which would make the Medicare claims database available to the public online at no cost.  Following the introduction of this legislation, CMS took steps on its own to open the payment database to the public and released over 9 million rows of data on more than 880,000 physicians and other providers including data on the number of services, average submitted charges, average allowed amount, average Medicare payment, and number of unique beneficiaries treated.

In this realm, pharmacists are seeing a tremendous increase on the focus on compounding reimbursement and billing as well as relationships shared with other providers.  Pharmacists can expect to see this increased focus to continue well into the remainder of this year and 2015.

Fiscal Year 2015 Appropriations

The general deadline for action on all appropriations is the start of the fiscal year on October 1 of each year.  The last time that all appropriations legislation was completed by the October 1st deadline was 1996.  Therefore, if one or more appropriations bills aren’t completed by the fiscal year deadline, either a government shutdown can occur or some form of a short-term funding vehicle (i.e. continuing resolution or ominibus) can be utilized.

As IACP previously reported, the President’s Budget requested $25 million for FDA to “improve oversight of compounding pharmacies.”  IACP was successful in getting language included within both the Senate FDA Appropriations legislation and the House FDA Appropriations to cut this funding request in half and place restrictions on how FDA can utilize any funding received from the Appropriations process.  Specifically, the House FDA Appropriations legislation grants FDA $12 million and the House and Senate FDA Appropriations place restrictive language on FDA requiring FDA to meet with pharmacists on the implementation of the DQSA while only authorizing FDA to have oversight of 503B facilities and making clear 503A pharmacies remain under the jurisdiction of State Boards of Pharmacy.  

The House and Senate FDA Appropriations have made it out of their respective Subcommittee and Full Committee Mark-ups with the language protecting compounding pharmacists intact.  Both are awaiting Floor action.  Regarding the timing of Floor action, after seeing a decrease in polling numbers after the Government shutdown last year, the House has committed to passing all appropriations bills this year before the Fiscal year deadline of October 1, 2014.  Despite this commitment, the current timeframe makes the passage of all twelve appropriations bills individually and with an open amendment process on the House Floor almost impossible.  

The House attempted to reach an agreement on the controversial nutrition sections within the FDA Appropriations last week.  The House just announced that it will not take up FDA Appropriations this week before leaving for the July 4th recess.  The earliest the House will consider the FDA Appropriations is the week of July 8th but it likely will require more time for the House to reach an agreement on the controversial sections.

In an attempt to meet the October 1 deadline, the Senate tried to take up three Appropriations bills together in a minibus.  The minibus included the FDA Appropriations, but the Senate was unable to reach an agreement on the amendment process for this minibus.  Thus, the FDA Appropriations were sidelined until after the July 4th recess.

Overall, it is very unlikely that both Chambers can pass all 12 Appropriations bills and conference each bill before the October 1, 2014 deadline.  It is more likely that while we may see some of the 12 Appropriations bills go through the process before the deadline, passing a Continuing Resolution (CR), or shot-term funding vehicle, is very likely.  It is likely that Congress will agree to a CR in order to prevent a government shutdown and provide short-term funding beyond the election.  IACP continues to work diligently to try to get the FDA Appropriations legislation scheduled for the House and Senate Floors and to keep the language protecting compounding pharmacists intact.

Tax Extenders for Businesses and Individuals

Tax breaks for businesses as well as individuals expired at the end of last year.  Therefore, both Chambers are considering a tax extenders package that would include these expired tax breaks.  The Senate Finance Committee recently passed its $85 billion tax renewal package earlier this month and House Ways and Means Committee held a hearing regarding this issue.  Thus, both the House and Senate are addressing this area.  

It’s left to be seen whether the House will produce its own tax extenders package as taking up the Senate package is not likely.  If both Chambers act on this issue, it will be before the election.

Letters to FDA Regarding the Implementation of the DQSA

While FDA Appropriations is currently stalled on the House and Senate Floors, Congress continues to provide guidance to FDA on the implementation of the DQSA in the form of letters to the FDA.  Representatives Morgan Griffith (R-VA), Gene Green (D-TX), Diana DeGette (D-CO), and Gus Bilirakis (R-FL) will be sending letters to FDA.  All letters are currently open as House sign-on letters and collecting as many signatures as possible in the House.  Both letters will close before Congress heads out for the July 4th recess on Thursday, June 26, and will be sent out to FDA shortly thereafter.

While Congress stalls on budget and spending issues, pharmacists can expect to see more uptick in overall Agency activities as well as letters sent from Congress.  Drafting letters addressed to the Agencies is a way for Congress to act when gaining bipartisan support and thus passage in both Chambers is difficult. Congress can provide instruction as to legislative intent or in this case ask for immediate response and explanation from the Agency on its current actions.  
Pharmacists can expect to see more communication from Congress with the Agencies in the form of Congressional letters providing guidance to the Agencies, requiring responses and explanations from the Agencies, and stating concern with the actions of the Agencies.

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