Jeffrey J. Kimbell and David C. Rudloff , Jeffrey J. Kimbell & Associates Inc.07.26.18
Of particular interest to the life sciences industry are a series of recent efforts by the U.S. Congress to expand the scope of the Physician Payments Sunshine Act—a 2010 law that requires transactional transparency between drug and device manufacturers and their customers or providers.
On June 12, the U.S. Senate Finance Committee voted unanimously to advance the Helping to End Addiction and Lessen Substance Use Disorders (HEAL) Act of 2018. The legislative package contains a measure that would expand Sunshine Act provisions by requiring drug and device manufacturers to publicly disclose the payments they make to nurse practitioners and physician assistants for promotional talks, consulting, and other interactions. The Sunshine Act already requires such transparency for payments made to physicians and academic medical centers.
Some members of Congress have proposed going even further in expanding the law. Senator Claire McCaskill (D-MO) filed an amendment to the HEAL Act that would greatly expand the scope of the Sunshine Act. McCaskill’s original amendment would have required drug manufacturers to publicly disclose payments made to patient groups and advocacy organizations such as a professional society of healthcare providers or pharmacists; a patient or consumer advocacy organization; a patient education organization; a provider of continuing education; a clinical trial organization; an educational accreditation organization; and a co-pay assistance organization or any organization providing financial assistance to patients. However, during the Senate Finance Committee markup of the HEAL Act on June 12, Senator McCaskill offered, and later withdrew, a modified version of her original amendment. The modified amendment would have required only opioid manufacturers to publicly report payments made to patient groups and advocacy organizations, in the same manner in which they currently report payments to physicians and teaching hospitals under the Sunshine Act. After withdrawing her amendment, McCaskill stated that she is working with Senators Chuck Grassley (R-IA) and Bill Cassidy, M.D., (R-LA) on compromise modifications to her amendment that she is negotiating to be included in the final text of the bill on the Senate floor. In the markup, Senator Cassidy added there should be transparency in what pharmaceutical companies give to patient advocacy groups because of potential conflicts of interest. Senator Cassidy stated that he had received assurances from the Committee that this matter will be discussed in a separate future hearing on drug costs.
In the same vein as Senator McCaskill’s modified amendment, on the House side, U.S. Rep. Jan Schakowsky (D-IL), a notable supporter of single-payer healthcare, introduced an amendment to H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Like the McCaskill amendment, Schakowsky’s would expand Sunshine Act provisions to require opioid manufacturers to publicly disclose any payments made to patient groups and advocacy organizations. Schakowsky’s amendment was not included in the bill, but serves as a warning sign that members of Congress are considering changes to the Sunshine Act.
While some of these proposals do not affect the medical device industry directly, it is important to monitor the increased scrutiny Congress is giving to the relationship between manufacturers and advocacy groups. Senator McCaskill and Rep. Schakowsky’s amendments would have created yards of unnecessary red tape and reporting requirements for manufacturers as well as making industry collaboration with stakeholders more difficult. As members of the life sciences community, it is important that we collaborate with groups representing the patients and physicians who use our products. These groups provide important advocacy bridges from the manufacturer to the public and help make our voices heard in an increasingly challenging regulatory environment. Judging by the recent activity with this issue, we will continue to see more criticism of these relationships, especially if Congress changes hands next year.
2018 Midterm Elections Update
Much has happened on the campaign trail since our previous update. Over half of the states have held their primary elections, allowing us to get a better glimpse of what the races will look like in November. On May 8, businessman Mike Braun won a heated Republican primary for the Senate race in Indiana. By pegging himself as a true Washington outsider, Braun was able to defeat two sitting U.S. Congressmen, Reps. Luke Messer (R-IN) and Todd Rokita (R-IN) with 41 percent of the total vote. Braun now faces incumbent U.S. Senator Joe Donnelly (D-IN) in a state where President Trump won by 19 percentage points. We expect this race to be competitive, but give Braun the edge given the popularity of the President in ruby-red Indiana.
In North Dakota, incumbent Senator Heidi Heitkamp (D-ND) faces U.S. Rep. Kevin Cramer (R-ND) in what is seen as one of the bigger pick-up opportunities for Republicans. Heitkamp has voted as a moderate, but it will be hard for her to distance herself from her party in this polarized climate when Trump won North Dakota by over 35 points in 2016. The President has been active on the campaign trail and hosted a large rally in Fargo on June 27 to support Cramer.
Another competitive race ensues in West Virginia, where incumbent Senator Joe Manchin (D-WV) will take on Republican challenger Patrick Morrissey. Morrissey, the current Attorney General of West Virginia, won a heated three-way primary defeating sitting U.S. Rep. Evan Jenkins (R-WV) and coal baron Don Blankenship in the process. Trump won West Virginia by 42 percentage points, the largest margin of victory for any presidential election in the state’s history; however, Manchin remains popular as a moderate “blue dog” Democrat. This race will be competitive but, perhaps seeing the writing on the wall, Manchin recently stated that he regrets voting for Hillary Clinton and would be open in 2020 to supporting Trump.
Montana poses another potential blue-to-red pickup for the GOP. On June 5, Montana State Auditor Matt Rosendale won a contested four-way Republican primary to take on sitting Senator Jon Tester (D-MT). Montana is another red state that Trump won by a large margin, but unlike some of his moderate Democratic cohorts, the former rancher Tester has bona fide blue-collar credentials. It is important to note, however, that Tester has never won a race with over 50 percent of the vote. We expect this race to be decided by less than 20,000 votes.
For Democrats, their biggest opportunity to steal a red Senate seat will be Nevada, where incumbent U.S. Senator Dean Heller (R-NV) will face Congresswoman Jacky Rosen (D-NV) in the November Senate election. Nevada is a purple state, but has been trending blue in recent elections. Barack Obama won Nevada in 2008 and 2012, and in 2016 Hillary Clinton won the state by over two percentage points. In the 2012 Senate race, Heller won by a razor thin margin of just 10,000 votes. The challenger Rosen will also be sure to take advantage of the fact that President Trump has a net disapproval rating of negative two in Nevada. Democrats certainly see Nevada as one of their best pickup opportunities and this race will be decided by less than 25,000 votes.
On the House side, the generic ballot lead for the Democrats has evaporated to just three percentage points, which is within the margin of error. According to the latest June 22 Gallup poll, so has the so-called “enthusiasm gap.” Voter enthusiasm previously favored heavily toward the Democrats, but now the percentage of Democrats and Republicans who are “absolutely certain to vote” in 2018 has evened to around 65 percent for both parties. The party out of power usually has more motivation going into midterm elections, but these recent poll numbers reflect the painstakingly hyper-partisan nature of the current political climate.
These midterms are especially difficult to predict because analyses by different electoral indicators point to swings in the opposite direction. The economy, by all indications, is doing extraordinary well so far under Trump’s presidency. As expected, the party in power typically gets credit during good economic conditions, which would bode well for the Republicans. Fittingly so, according to FiveThirtyEight’s analysis, if you forecasted the 2018 midterms based on the public’s view of the economy, the GOP would actually gain 55 seats. However other indicators, such as presidential approval, are not favorable for the GOP. President Trump’s approval rating sits around 43 percent which, if forecasted according to FiveThirtyEight’s methodology, would cause the Republicans to lose 68 seats in the elections.
A third set of indicators are the results of recent special elections. Democrats have over performed by an average of nine points in every federal special election since President Trump took office. A nine-point swing for Democrats would put the 2018 elections on par with the “wave” elections of 1994 and 2010, but the current generic ballot suggests Democrats should not be as optimistic. Of course, you cannot predict elections based on one set of factors since voters have different and, sometimes, contradictory reasons for voting, but these indicators will be especially interesting to watch looking toward November. Democrats need to flip 23 seats to take back the House and Las Vegas has their odds set at 50/50. Today, we anticipate the GOP losing between 12 to 16 seats in the House and picking up a net of plus two seats in the Senate.
Jeffrey J. Kimbell, president and founder of Jeffrey J. Kimbell & Associates Inc., represents over 35 clients in the life sciences community seeking legislative and policy remedies in Washington. Founded in 1998, the firm provides strategic solutions to hand-selected clients seeking creation, modification, or proper implementation of public law.
David C. Rudloff is a manager of government relations at Jeffrey J. Kimbell & Associates Inc. He previously worked as a litigation paralegal at Covington & Burling in Washington, DC. David graduated from Davidson College in 2016 with a B.A. in political science.
On June 12, the U.S. Senate Finance Committee voted unanimously to advance the Helping to End Addiction and Lessen Substance Use Disorders (HEAL) Act of 2018. The legislative package contains a measure that would expand Sunshine Act provisions by requiring drug and device manufacturers to publicly disclose the payments they make to nurse practitioners and physician assistants for promotional talks, consulting, and other interactions. The Sunshine Act already requires such transparency for payments made to physicians and academic medical centers.
Some members of Congress have proposed going even further in expanding the law. Senator Claire McCaskill (D-MO) filed an amendment to the HEAL Act that would greatly expand the scope of the Sunshine Act. McCaskill’s original amendment would have required drug manufacturers to publicly disclose payments made to patient groups and advocacy organizations such as a professional society of healthcare providers or pharmacists; a patient or consumer advocacy organization; a patient education organization; a provider of continuing education; a clinical trial organization; an educational accreditation organization; and a co-pay assistance organization or any organization providing financial assistance to patients. However, during the Senate Finance Committee markup of the HEAL Act on June 12, Senator McCaskill offered, and later withdrew, a modified version of her original amendment. The modified amendment would have required only opioid manufacturers to publicly report payments made to patient groups and advocacy organizations, in the same manner in which they currently report payments to physicians and teaching hospitals under the Sunshine Act. After withdrawing her amendment, McCaskill stated that she is working with Senators Chuck Grassley (R-IA) and Bill Cassidy, M.D., (R-LA) on compromise modifications to her amendment that she is negotiating to be included in the final text of the bill on the Senate floor. In the markup, Senator Cassidy added there should be transparency in what pharmaceutical companies give to patient advocacy groups because of potential conflicts of interest. Senator Cassidy stated that he had received assurances from the Committee that this matter will be discussed in a separate future hearing on drug costs.
In the same vein as Senator McCaskill’s modified amendment, on the House side, U.S. Rep. Jan Schakowsky (D-IL), a notable supporter of single-payer healthcare, introduced an amendment to H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Like the McCaskill amendment, Schakowsky’s would expand Sunshine Act provisions to require opioid manufacturers to publicly disclose any payments made to patient groups and advocacy organizations. Schakowsky’s amendment was not included in the bill, but serves as a warning sign that members of Congress are considering changes to the Sunshine Act.
While some of these proposals do not affect the medical device industry directly, it is important to monitor the increased scrutiny Congress is giving to the relationship between manufacturers and advocacy groups. Senator McCaskill and Rep. Schakowsky’s amendments would have created yards of unnecessary red tape and reporting requirements for manufacturers as well as making industry collaboration with stakeholders more difficult. As members of the life sciences community, it is important that we collaborate with groups representing the patients and physicians who use our products. These groups provide important advocacy bridges from the manufacturer to the public and help make our voices heard in an increasingly challenging regulatory environment. Judging by the recent activity with this issue, we will continue to see more criticism of these relationships, especially if Congress changes hands next year.
2018 Midterm Elections Update
Much has happened on the campaign trail since our previous update. Over half of the states have held their primary elections, allowing us to get a better glimpse of what the races will look like in November. On May 8, businessman Mike Braun won a heated Republican primary for the Senate race in Indiana. By pegging himself as a true Washington outsider, Braun was able to defeat two sitting U.S. Congressmen, Reps. Luke Messer (R-IN) and Todd Rokita (R-IN) with 41 percent of the total vote. Braun now faces incumbent U.S. Senator Joe Donnelly (D-IN) in a state where President Trump won by 19 percentage points. We expect this race to be competitive, but give Braun the edge given the popularity of the President in ruby-red Indiana.
In North Dakota, incumbent Senator Heidi Heitkamp (D-ND) faces U.S. Rep. Kevin Cramer (R-ND) in what is seen as one of the bigger pick-up opportunities for Republicans. Heitkamp has voted as a moderate, but it will be hard for her to distance herself from her party in this polarized climate when Trump won North Dakota by over 35 points in 2016. The President has been active on the campaign trail and hosted a large rally in Fargo on June 27 to support Cramer.
Another competitive race ensues in West Virginia, where incumbent Senator Joe Manchin (D-WV) will take on Republican challenger Patrick Morrissey. Morrissey, the current Attorney General of West Virginia, won a heated three-way primary defeating sitting U.S. Rep. Evan Jenkins (R-WV) and coal baron Don Blankenship in the process. Trump won West Virginia by 42 percentage points, the largest margin of victory for any presidential election in the state’s history; however, Manchin remains popular as a moderate “blue dog” Democrat. This race will be competitive but, perhaps seeing the writing on the wall, Manchin recently stated that he regrets voting for Hillary Clinton and would be open in 2020 to supporting Trump.
Montana poses another potential blue-to-red pickup for the GOP. On June 5, Montana State Auditor Matt Rosendale won a contested four-way Republican primary to take on sitting Senator Jon Tester (D-MT). Montana is another red state that Trump won by a large margin, but unlike some of his moderate Democratic cohorts, the former rancher Tester has bona fide blue-collar credentials. It is important to note, however, that Tester has never won a race with over 50 percent of the vote. We expect this race to be decided by less than 20,000 votes.
For Democrats, their biggest opportunity to steal a red Senate seat will be Nevada, where incumbent U.S. Senator Dean Heller (R-NV) will face Congresswoman Jacky Rosen (D-NV) in the November Senate election. Nevada is a purple state, but has been trending blue in recent elections. Barack Obama won Nevada in 2008 and 2012, and in 2016 Hillary Clinton won the state by over two percentage points. In the 2012 Senate race, Heller won by a razor thin margin of just 10,000 votes. The challenger Rosen will also be sure to take advantage of the fact that President Trump has a net disapproval rating of negative two in Nevada. Democrats certainly see Nevada as one of their best pickup opportunities and this race will be decided by less than 25,000 votes.
On the House side, the generic ballot lead for the Democrats has evaporated to just three percentage points, which is within the margin of error. According to the latest June 22 Gallup poll, so has the so-called “enthusiasm gap.” Voter enthusiasm previously favored heavily toward the Democrats, but now the percentage of Democrats and Republicans who are “absolutely certain to vote” in 2018 has evened to around 65 percent for both parties. The party out of power usually has more motivation going into midterm elections, but these recent poll numbers reflect the painstakingly hyper-partisan nature of the current political climate.
These midterms are especially difficult to predict because analyses by different electoral indicators point to swings in the opposite direction. The economy, by all indications, is doing extraordinary well so far under Trump’s presidency. As expected, the party in power typically gets credit during good economic conditions, which would bode well for the Republicans. Fittingly so, according to FiveThirtyEight’s analysis, if you forecasted the 2018 midterms based on the public’s view of the economy, the GOP would actually gain 55 seats. However other indicators, such as presidential approval, are not favorable for the GOP. President Trump’s approval rating sits around 43 percent which, if forecasted according to FiveThirtyEight’s methodology, would cause the Republicans to lose 68 seats in the elections.
A third set of indicators are the results of recent special elections. Democrats have over performed by an average of nine points in every federal special election since President Trump took office. A nine-point swing for Democrats would put the 2018 elections on par with the “wave” elections of 1994 and 2010, but the current generic ballot suggests Democrats should not be as optimistic. Of course, you cannot predict elections based on one set of factors since voters have different and, sometimes, contradictory reasons for voting, but these indicators will be especially interesting to watch looking toward November. Democrats need to flip 23 seats to take back the House and Las Vegas has their odds set at 50/50. Today, we anticipate the GOP losing between 12 to 16 seats in the House and picking up a net of plus two seats in the Senate.
Jeffrey J. Kimbell, president and founder of Jeffrey J. Kimbell & Associates Inc., represents over 35 clients in the life sciences community seeking legislative and policy remedies in Washington. Founded in 1998, the firm provides strategic solutions to hand-selected clients seeking creation, modification, or proper implementation of public law.
David C. Rudloff is a manager of government relations at Jeffrey J. Kimbell & Associates Inc. He previously worked as a litigation paralegal at Covington & Burling in Washington, DC. David graduated from Davidson College in 2016 with a B.A. in political science.
