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U.S. Election Forecast on Congressional Leadership Changes

With the election less than a week away, we conducted in-depth analysis of possible House and Senate committee leadership changes, including committees that effect energy technology policies. Leadership of a number of House and Senate committees is bound to change due to term-limits, retirements, and perhaps election results, including the Energy and Commerce and Natural Resources House committees, and the Energy and Natural Resources and Environment and Public Works Senate committees. We have outlined those potential changes in either a Republican- or a Democratic-controlled House and Senate. To read more about these potential Congressional leadership changes, read on!

Among Republicans on the House Energy and Commerce committee, Rep. John Shimkus (IL) and Rep. Greg Walden (OR) are expected to run for Chair/Ranking Member because Rep. Fred Upton (MI) is term-limited. Rep. Shimkus has more seniority on the committee than Rep. Walden, but Walden is completing his second term leading the Republican National Congressional Committee. Both are well-liked within the Republican Caucus and are adept fundraisers. Rep. Joe Barton (TX) has the most seniority on the committee and could also choose to run for Chairman or Ranking Member. Sources are indicating that should the Democrats gain control of the House, Rep. Barton would be less interested in running for Ranking Member. Additionally, Rep. Barton is already term-limited as the top Republican on the committee and would have to seek a waiver to serve as the next Chair or Ranking Member. On the Democrats’ side, Rep. Frank Pallone (NJ) would likely remain the Ranking Member if the Republicans control the House and would likely become Chairman if the Democrats control the House.

On the House Natural Resources committee, Republican Rob Bishop (UT) would likely remain the Chairman if the Republicans control the House and would likely become the Ranking Member if the Democrats took control. For the Democrats, Rep. Raul Grijalva (AZ) could remain the Ranking Member if the Republicans retain the House and could become Chairman if the Democrats win control. However, Rep. Grijalva could choose to run for Chair/Ranking Member of the Education and the Workforce Committee if Rep. Bobby Scott (VA) is appointed to the Senate to replace Vice Presidential candidate Tim Kaine. It is unclear who would run for or become Chair/Ranking Member of Natural Resources in that scenario.

In the Senate, Republican Sen. Lisa Murkowski (AK) would likely remain Chairwoman of the Energy and Natural Resources committee if the Republicans win the Senate. However, if the Democrats control the Senate, Sen. John Barrasso (WY) could become the Ranking Member because Sen. Murkowski is term-limited as Ranking Member of Energy and Natural Resources. Sen. Barrasso could also choose to become the Ranking Member of Environment and Public Works, in which case, Sen. Jim Risch (ID) could become the Ranking Member of Energy and Natural Resources. However, sources are indicating that Sen. Barrasso, who represents a Western coal state, would likely choose to become the Ranking Member of Energy and Natural Resources, in part because it would allow Sen. Shelley Moore Capito (WV), a rising female star in the GOP who hails from an Eastern coal state, to become the Ranking Member of Environment and Public Works. For the Democrats, Sen. Maria Cantwell (WA) would likely remain the Ranking Member if Republicans remain in control or become the Chairwoman for Energy and Natural Resources if the Democrats win the Senate. Though highly unlikely, there is a scenario in which, Sen. Jack Reed (RI) becomes the Chair/Ranking Member of Appropriations and Sen. Bill Nelson (FL) then takes over as Chair/Ranking Member of Armed Services. In that unlikely case, Sen. Cantwell could choose to become the Chair/Ranking Member of Commerce, opening up the top Democratic slot on Energy and Natural Resources to Sen. Bernie Sanders (VT). (Sen. Ron Wyden (OR) would be next in line after Sen. Cantwell on Energy and Natural Resources, but Sen. Wyden will remain the Chair/Ranking Member of Finance.)

Among Republicans on the Senate Environment and Public Works committee, Sen. Barrasso could become the Chairman because Sen. James Inhofe (OK) is term-limited as Chairman and Sen. David Vitter (LA) is retiring. If the Democrats control the Senate, Sen. Barrasso could become the Ranking Member because Sen. Inhofe is again term-limited and Sen. Vitter is retiring. However, as discussed above, Sen. Barrasso would likely choose to become the Ranking Member of Energy and Natural Resources, in which case Sen. Capito could become the Ranking Member of Environment and Public Works. For the Democrats, if the Republicans or Democrats control the Senate, Sen. Tom Carper (DE) could become Chair/Ranking Member of Environment and Public Works because Sen. Barbara Boxer (CA) is retiring. According to sources, Sen. Carper is indeed preparing to take over as the top Democrat on this committee. However, Sen. Carper could choose to remain the Chair/Ranking Member of Homeland Security, in which case Sen. Ben Cardin (MD) could become the Chair/Ranking Member of Environment and Public Works. Sen. Cardin could also choose to remain the Chair/Ranking Member of Foreign Relations unless Sen. Robert Menendez (NJ) is cleared of ethics violations and is reinstated, which is unlikely in the near future. If Sen. Cardin remains the Chair/Ranking Member of Foreign Relations, which is nearly certain as long as Sen. Menendez is under indictment, Sen. Sanders could become the Chair/Ranking Member of Environment and Public Works.

ARTICLE BY David J. Leiter, Sarah Litke & Matthew Miller of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Three Employee-Friendly Bills That May Be Affected By Upcoming Elections

In the past few years, Democratic members of Congress have introduced several decidedly pro-employee bills, none of which have yet passed, but which may be impacted by the elections in November. Such bills were first introduced in the 113th Congress when Republicans controlled the House of Representatives and Democrats controlled the Senate. Versions of these bills were reintroduced in the 114th Congress, although Republicans control both the House and the Senate. The November election not only will decide the next President, but also may change the balance of power in both houses of Congress.

Healthy Families Act

Would allow employees of an employer with 15 or more employees to earn 7 days of sick time per year after 60 days of employment.
113th Congress: Introduced to the House and Senate on March 20, 2013. Co-sponsored by 134 Democrats in the House and 23 Democrats in the Senate.
114th Congress: Introduced to the House and Senate on February 12, 2015. Co-sponsored by 145 Democrats in the House and 31 Democrats and 2 Independents in the Senate.

Family and Medical Insurance Leave Act

Would create a trust fund within Social Security to collect fees and provide compensation to employees on FMLA.
113th Congress: Introduced to the House and Senate on December 12, 2013. Co-Sponsored by 101 Democrats in the House and 6 Democrats in the Senate.
114th Congress: Introduced to the House and Senate on March 18, 2015 with 134 Democrats co-sponsoring in the House and 20 Democrats and 1 Independent co-sponsoring in the Senate.

Family and Medical Leave Enhancement Act

Most recent version of this Act would extend FMLA coverage to employees at worksites with 15-49 employees, including part-time workers. The Act would also protect (1) parental involvement leave to participate in school activities or programs for children or grandchildren and (2) parental involvement leave to care for routine medical needs including: (a) medical and dental appointments of an employee’s spouse, child, or grandchild, and (b) needs related to elderly individuals, such as nursing and group home visits.
A version of this bill has been introduced to Congress each session since 1997.
The most recent version was introduced to the House on June 16, 2016 with 7 Democrats co-sponsoring.

Following the elections later this year, employers should be on the lookout for versions of these bills being reintroduced, potentially in a political climate where they have a stronger chance of passing.

ARTICLE BY LaToya Alexander of Polsinelli PC

Congress Passes GE Labeling Standard

On July 14, 2016, the U.S. House of Representatives passed a genetically engineered (GE) labeling standard with bipartisan support. The bill is identical to S. 764, which passed the Senate last week, and represents a compromise brokered by Sens. Debbie Stabenow and Pat Roberts. The White House has indicated that President Obama will sign the legislation into law.

Significantly, the legislation sets a national standard that preempts current and future attempts by states to require labeling of foods containing genetically modified ingredients, including Vermont’s mandatory labeling standard that went into effect July 1.

The legislation establishes a mandatory disclosure standard that applies to all food products intended for human consumption containing bioengineered ingredients. Food companies may satisfy the disclosure requirement through text, a symbol, or by use of certain embedded electronic or digital links, such as a QR Code.

Animal-based products such as beef, pork, poultry, eggs and milk are prohibited from being considered bioengineered foods solely because the animal consumed feeds containing GE ingredients. The legislation does not require animal feed to comply with the disclosure requirement.

Under the legislation, the Secretary of Agriculture is required to promulgate rules that implement the national standard within two years. The legislation requires the Secretary to provide additional flexibility for small food manufacturers in the regulations, including additional disclosure options and more time to comply with the standard. Some very small food manufacturers will be exempt under the regulations.

White House press officials indicated that the administration was pleased with the Roberts–Stabenow compromise effort. “While there is broad consensus that foods from genetically engineered crops are safe, we appreciate the bipartisan effort to address consumers’ interest in knowing more about their food, including whether it includes ingredients from genetically engineered crops,” spokeswoman Katie Hill told reporters in an e-mail.

The federal standard comes just days after Vermont’s standard, passed in 2014, went into effect and follows failed attempts to mandate labeling in states such as Colorado, Oregon, and California. Food manufacturers expressed concern that a patchwork of state laws would make compliance difficult and potentially reduce consumer choice if manufacturers elected to pull products off store shelves rather than implement costly labeling requirements. After being signed into law, the focus will quickly turn to the U.S. Department of Agriculture’s implementation of the legislation and how the agency will define key terms that directly impact applicability (for example, the definition of “small” and “very small” food manufacturers).

ARTICLE BY Seth A. Mailhot & Leah Hurtgen Ziemba of Michael Best & Friedrich LLP

Congress to Vote on Short-Term FAA Reauthorization This Week

This week, Congress will vote on a short-term Federal Aviation Administration (FAA) authorization that will reauthorize FAA programs through September 30, 2017. The short-term authorization includes some policy changes, but avoids many significant changes the House and Senate had been pursuing. While the Senate passed a long-term FAA reauthorization bill this year, the FAA Reauthorization Act of 2016 (S. 2658), the House did not take up the bill reported out of the Transportation and Infrastructure Committee, the Aviation Innovation, Reform, and Reauthorization (AIRR) Act of 2016 (H.R. 4441). Both the House and Senate are expected to pass the highly-negotiated short-term extension, before FAA authorization expires on July 15.

The short-term extension does include provisions related to safety and security, as well as some unmanned aircraft systems (UAS) provisions. Among the policy changes, the bill will increase funding for bomb-sniffing dog teams, direct FAA to detect and mitigate UAS operation near airports, and require airlines to refund baggage fees if luggage is delayed or lost, among other provisions.

It appears that House Transportation and Infrastructure Committee Chairman Bill Shuster (R-PA) successfully kept many policy changes out of the short-term extension, in order to keep pressure up on Congress to pass a long-term extension next year that includes Chairman Shuster’s controversial air traffic control reform proposal.

This Week’s Hearings:

On Tuesday, July 12, the Senate Commerce, Science, and Transportation Subcommittee on Surface Transportation and Merchant Marine Infrastructure, Safety, and Security will hold a hearing titled “Intermodal and Interdependent: The FAST Act, the Economy, and Our Nation’s Transportation System.” The witnesses will be:
- Patrick J. Ottensmeyer, Chief Executive Officer, Kansas City Southern Railway Company;
- Major Jay Thompson, Arkansas Highway Police; President, Commercial Vehicle Safety Alliance;
- David Eggermann, Supply Chain Manager, BASF; and
- Stephen J. Gardner, Executive Vice President and Chief of NEC Business Development, Amtrak.
On Wednesday, July 13, the Senate Commerce, Science, and Transportation Subcommittee on Space, Science, and Competitiveness will hold a hearing titled “NASA at a Crossroads: Reasserting American Leadership in Space Exploration.” The witnesses will be:
- William H. Gerstenmaier, Associate Administrator of Human Exploration and Operations, NASA;
- Mary Lynne Dittmar, Executive Director, Coalition for Deep Space Exploration;
- Mike Gold, Vice President of Washington Operations, SSL;
- Mark Sirangelo, Vice President of Space Systems Group, Sierra Nevada Corporation; and
- Professor Dan Dumbacher, Professor of Engineering Practice, Purdue University.
On Tuesday, July 12, the Senate Foreign Relations Subcommittee on Department and USAID Management, International Operations, and Bilateral International Development will hold a hearing titled “Public-Private Partnerships in Foreign Aid: Leveraging U.S. Assistance for Greater Impact and Sustainability.” The witnesses will be:
- Eric G. Postel, Associate Administrator, U.S. Agency for International Development; and
- Daniel F. Runde, William A. Schreyer Chair and Director, Project on Prosperity and Development, Center for Strategic and International Studies.

ARTICLE BY Timothy W. Drake & Patricia Doersch of Squire Patton Boggs (US) LLP

Congress Just Says No—to Banking Services for Marijuana Businesses

Yet another attempt has failed to pass legislation shielding banks that provide services to marijuana-related businesses from regulatory action or other penalties. Late last week, the US House of Representatives appeared likely to approve an amendment to the House Financial Services and General Government appropriations bill (the Amendment) that would prevent financial institutions from being penalized if they provided services to state-sanctioned marijuana-related businesses. A similar amendment had already been approved by the Senate Appropriations Committee and appeared likely to be approved by the US Senate.

Under recently passed procedures, the House Committee on Rules must approve all amendments to appropriations bills. On June 20, Representative Denny Heck (D-WA) and Representative Ed Perlmutter (D-CO) filed the bipartisan Amendment with the Committee on Rules. They emphasized that, without banking services, marijuana businesses are forced to conduct business and pay salaries in cash, which increases the risk of money laundering and theft. The Committee on Rules declined to consider the Amendment for a vote, effectively blocking it from further consideration in connection with the appropriations bill.

The Amendment is the latest effort by members of Congress to bring some certainty to banks that wish to provide banking services for marijuana-related businesses. Although both the US Department of Justice and the Financial Crimes Enforcement Network have provided guidance that allows banks to provide services to legal marijuana businesses, marijuana is still illegal under federal law, and banks have been reluctant to rely on such guidance, which they generally have concluded provides insufficient regulatory and law enforcement certainty.

Although marijuana businesses that seek traditional banking services will not see any relief in the current appropriations process, a number of bills that have been introduced in the Senate and House remain that would offer clarity for banks that wish to offer banking services to marijuana businesses. Even though none of those bills have passed the initial stages of the legislative process, these efforts, which are generally bipartisan in nature, are expected to continue and may at some point be successful. In any event, the legal marijuana industry is expected to continue to grow, and more states are likely to authorize recreational and medical use of marijuana. Meanwhile, the issue of providing legal certainty to banks that wish to offer banking services to marijuana business will continue to be debated.

ARTICLE BY Melissa R. H. Hall of Morgan, Lewis & Bockius LLP

Senate, House Continue on with Appropriations Work

Senate Legislative Activity

The Senate will convene on Monday, June 20, at 3:00pm. Following any Leader remarks, the Senate will resume consideration of H.R.2578, Commerce, Justice, Science, and Related Agencies Appropriations Act. The pending cloture motions on amendments will ripen at 5:30pm, at which time the Senate will have up to four roll call votes:

Grassley amendment #4751;
Murphy amendment #4750;
Cornyn amendment #4749; and
Feinstein amendment #4720

If cloture is invoked on any of these amendments, there will be up to 30 hours of debate on each amendment on which cloture is invoke prior to a vote on that amendment, after which the Senate will move on to a cloture vote on the next amendment.

House Legislative Activity

On Monday, June 20, the House will meet at 2:00pm in pro formasession, with no votes expected.

On Tuesday, June 21, the House will meet at 12:00pm for morning hour and at 2:00pm for legislative business, with votes postponed until 6:30pm. The following legislation will be considered under suspension of the rules:

H.R. 5525 – End Taxpayer Funded Cell Phones Act of 2016;
H.R. 4369 – To authorize the use of passenger facility charges at an airport previously associated with the airport at which the charges are collected;
H.R. 5388 – Support for Rapid Innovation Act of 2016;
H.R. 5389 – Leveraging Emerging Technologies Act of 2016;
S. 2133 – Fraud Reduction and Data Analytics Act of 2015;
H.R. 4902 – To amend title 5, United States Code, to expand law enforcement availability pay to employees of U.S. Customs and Border Protection’s Air and Marine Operations;
H.R. 2395 – Inspector General Empowerment Act of 2016, as amended;
H.R. 4639 – Thoroughly Investigating Retaliation Against Whistleblowers Act, as amended;
H.R. 4372 – To designate the facility of the United States Postal Service located at 15 Rochester Street, Bergen, New York, as the Barry G. Miller Post Office;
H.R. 2607 – To designate the facility of the United States Postal Service located at 7802 37th Avenue in Jackson Heights, New York, as the “Jeanne and Jules Manford Post Office Building”;
H.R. 4010 – To designate the facility of the United States Postal Service located at 522 North Central Avenue in Phoenix, Arizona, as the “Ed Pastor Post Office”;
H.R. 4777 – To designate the facility of the United States Postal Service located at 1301 Alabama Avenue in Selma, Alabama as the “Amelia Boynton Robinson Post Office Building”;
H.R. 4925 – To designate the facility of the United States Postal Service located at 229 West Main Cross Street, in Findlay, Ohio, as the “Michael Garver Oxley Memorial Post Office Building”;
H.R. 4960 – To designate the facility of the United States Postal Service located at 525 N Broadway in Aurora, Illinois, as the “Kenneth M. Christy Post Office Building”;
H.R. 5028 – To designate the facility of the United States Postal Service located at 10721 E Jefferson Ave in Detroit, Michigan, as the “Mary Eleanora McCoy Post Office Building”;
H.R. 4590 – Fiscal Year 2016 Department of Veterans Affairs Seismic Safety and Construction Authorization Act, as amended;
H.R. 5317 – To designate the Department of Veterans Affairs health care center in Center Township, Butler County, Pennsylvania, as the “Abie Abraham VA Clinic”;
H.R. 3936 – VET Act, as amended;
H.R. 5170 – Social Impact Partnerships to Pay for Results Act, as amended;
H.R. 5447 – Small Business Health Care Relief Act of 2016;
H.R. 5452 – Native American Health Savings Improvement Act; and
H.R. 5456 – Family First Prevention Services Act of 2016

ARTICLE BY Brandon C. Roman of Squire Patton Boggs (US) LLP

November Election and Estate Planning

The Presidential election is around the corner. What does that mean for estate planning? Probably nothing, particularly if the Executive Branch and Congress remain split among the parties. In the past four years, a Democratic President and Republican Congress has resulted in no significant estate tax legislation. Thus, after 10 years or so of uncertainty and change that preceded 2012, there has been an estate planning calm.

It is unlikely the calm changes in 2017 if there is President Clinton and a Republican Congress. Hillary favors the same provisions as President Obama, which are reducing the estate tax exemption from $5 million per person, indexed for inflation, to $3.5 million, and increasing the estate tax rate from 40% to 45%. But as with President Obama, it is unlikely these proposals will go anywhere, unless Democrats take control of the House and Senate.

Conversely, President Trump wants to eliminate the estate tax, similar to former President Bush. Perhaps a big push to eliminate the estate tax would result if large Republican majorities controlled the House and Senate. But even with a Republican President and Congress it is more likely current law, allowing married couples to protect $10.9 million from estate tax, adjusted annually for inflation, would continue.

Of less concern to most, but significant for the relatively wealthy few, is the Obama Administration’s desire to eliminate or reduce advanced planning techniques, such as GRATS, gift/sales to intentionally defective trusts, dynasty trust planning, and intra-family discounting. A new President and Congress may also address these strategies.

Article By John P. Dedon of Odin, Feldman & Pittleman, P.C.

New Federal Law Will Provide First-Ever Civil Claim for Theft of Trade Secrets

On April 27, 2016, the U.S. House of Representatives approved the Defend Trade Secrets Act, S. 1890, by a vote of 410-2. The Senate approved an identical bill 87-0 on April 4, 2016. President Obama is expected to sign the DTSA into law in short order. Once effective, the DTSA will create a federal, civil cause of action for trade secret misappropriation for any act that “occurs on or after the date of the enactment” of the law. In addition to providing plaintiffs an opportunity to obtain injunctive relief and monetary damages, the DTSA will further allow for ex parteseizures of misappropriated trade secrets.

The DTSA borrows from the Uniform Trade Secret Act (the “UTSA”). For example, the DTSA’s misappropriation, improper means, and three-year limitations provisions are all copied from the UTSA. At the same time, the DTSA does not preempt state trade secret law or other sections of the U.S. code pertaining to trade secret misappropriation. Finally, the DTSA directs government officials to report on exterritorial trade secret misappropriation.

The DTSA’s seizure provision is a notable addition vis-à-vis the UTSA. It allows courts to issue an ex parte order to seize property as “necessary to prevent the propagation or dissemination of the trade secret that is the subject of the action.” To obtain such an order, a party must meet eight distinct prerequisites—including showing that a temporary restraining order is inadequate, that immediate and irreparable injury will occur if the seizure is not approved, and that the harm to the applicant outweighs the legitimate interests of any party from whom material is seized. The party seeking an ex parte seizure order must post security and is subject to a claim for any damage caused by a wrongful seizure. The raft of requirements intentionally set a high bar to issuance of an ex parte seizure order. It is a powerful tool, but also susceptible to abuse absent strict controls. The DTSA’s ex parte seizure requirements strike the right balance between need and caution.

The DTSA provides district courts with “original jurisdiction of civil actions brought under” the DTSA. The DTSA does not contain any specific venue provisions and therefore an aggrieved party must look to the general venue statute for civil actions in deciding choice of venue in a federal district court. In addition, plaintiffs may be able to bring a claim alleging a violation of Section 337 of the Tariff Act of 1930 in the U.S. International Trade Commission, depending on the circumstances. Plaintiffs deciding upon a venue in which to bring a DTSA claim should analyze differences between the DTSA and any potential state law or other federal claim.

The DTSA explicitly applies to “interstate or foreign commerce.” While the DTSA does not expand upon “foreign commerce” in any meaningful way, Section 4 of the DTSA requires various governmental officials to report on trade secret misappropriation experienced by U.S. companies that occurs abroad. In particular, one year after the DTSA is enacted, and every two years thereafter, the Attorney General, the Intellectual Property Enforcement Coordinator, and the Director of the USPTO must submit a report to the House and Senate Judiciary Committees pertaining to trade secret theft occurring abroad.

The DTSA is an important development in U.S. law, as it provides the first-ever federal law providing a private civil claim for trade secret misappropriation. The rationale for the DTSA is the belief by Congress, the Obama Administration, and stakeholders that the current patchwork of state laws is inadequate to address trade secret misappropriation and the concomitant damage it causes to trade secrets rights holders and to the U.S. economy. Time will tell whether the law achieves its intended purposes.

Article By John J. Thuermer, Steven M. Auvil & David Elkins

Congress Awaits Health Provisions in President’s Budget

Health Bills Slated for House Floor Consideration; SAMHSA Releases Proposed Rule Focused on Confidentiality of Substance Use Disorder Patient Records

Legislative Activity

Congress Awaits Health Provisions in President’s Budget

On Tuesday, February 9, President Barack Obama will submit his FY 2017 Budget Request to Congress, which is expected to include several large-scale investments for the nation’s health. Last week, the White House released a “sneak preview” of the Budget, which includes: $755 million for cancer research as part of the “moonshot” to cure cancer; a legislative proposal to provide any state that takes up the Medicaid expansion option the same three years of full federal support that states that expanded in 2014 received; a commitment to changes in the excise tax on high-cost employer-sponsored health coverage, otherwise known as the “Cadillac Tax”; and $1 billion in mandatory funding over two years to address prescription drug abuse and heroin use.

On Wednesday, February 10, U.S. Department of Health and Human Services (HHS) Secretary Sylvia Mathews Burwell will provide testimony on the Budget to the House Committee on Ways and Means. The next day, she will also address the Budget in her testimony to the Senate Committee on Finance.

Health Bills Slated for House Floor Consideration

House Majority Leader Kevin McCarthy (R-CA) has announced that several health care bills will be considered on the floor this week.

On Tuesday, the following pieces of health legislation are expected to be considered under suspension of the rules: H.R. 3016, the Veterans Employment, Education, and Healthcare Improvement Act, as amended, which clarifies the role of podiatrists in the Department of Veterans Affairs (VA); H.R. 3106, the Construction Reform Act of 2016, which makes certain changes in the administration of Department medical facility construction projects; H.R. 3262, To provide for the conveyance of land of the Illiana Health Care System of the Department of Veterans Affairs in Danville, Illinois; H.R. 4056, To authorize the Secretary of Veterans Affairs all right, title, and interest of the United States to the property known as “The Community Living Center” at Lake Baldwin Veterans Affairs Outpatient Clinic, Orlando, Florida, as amended; H.R. 4437, To extend the deadline for the submittal of the final report required by the Commission on Care; H.R. 3234, the VA Medical Center Recovery Act, which establishes within the VA an Office of Failing Medical Center Recovery; and H.R. 2915, the Female Veteran Suicide Prevention Act, which directs the Secretary of the VA to identify mental health care and suicide prevention programs that are effective in treating women veterans.

Later in the week, the House is expected to consider H.R. 2017, the Common Sense Nutrition Disclosure Act of 2015, which seeks to improve and clarify disclosure requirements for restaurants and other retail food establishments.

Senate HELP Committee to Mark Up Health Legislation

On Tuesday, February 9, the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a markup to consider several health care bills. In January, Committee Chairman Lamar Alexander (R-TN) announced the Committee’s schedule for the “step by step” consideration of biomedical innovation bills. This process, aimed at legislation that is somewhat similar to language in the House-passed 21st Century Cures Act (H.R. 6), begins with this markup.

Legislation to be considered on Tuesday includes: S. 2030, the Advancing Targeted Therapies for Rare Diseases Act of 2015, which allows the sponsor of an application for the approval of a targeted drug to utilize data and information from the sponsor’s previously approved targeted drugs; S. 1622, the FDA Device Accountability Act of 2015, which requires the Food and Drug Administration (FDA) to ensure training on least burdensome requirements for employees who review premarket submissions of medical devices; S. 2014, the Next Generation Researchers Act, which seeks to demonstrate a commitment to our nation’s scientists by increasing opportunities for the development of future researchers; S. 800, the Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act, which seeks to improve, coordinate, and enhance National Institutes of Health (NIH) rehabilitation research; S. 849, the Advancing Research for Neurological Diseases Act of 2015, which provides for systematic data collection and analysis and epidemiological research regarding neurological diseases; S. ___, the Preventing Superbugs and Protecting Patients Act; and S. ___, the Improving Health Information Technology Act.

This Week’s Hearings:

Tuesday, February 9: The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a markup of health care bills, as described above.
Wednesday, February 10: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Examining Medicaid and CHIP’s Federal Medical Assistance Percentage.”
Wednesday, February 10: The House Committee on Veterans’ Affairs will hold a hearing titled “U.S. Department of Veterans Affairs Budget Request for Fiscal Year 2017.”
Wednesday, February 10: The House Committee on Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations and Subcommittee on the Western Hemisphere will hold a joint hearing titled “The Global Zika Epidemic: Emerging in the Americas.”
Wednesday, February 10: The House Committee on Ways and Means will hold a hearing titled “Department of Health and Human Services’ (HHS) Fiscal Year 2017 Budget Request.”
Wednesday, February 10: The House Committee on Rules will meet on H.R. 2017, the Common Sense Nutrition Disclosure Act of 2015.
Wednesday, February 10: The Senate Committee on the Judiciary will hold a hearing titled “Breaking the Cycle: Mental Health and the Justice System.”
Wednesday, February 10: The Senate Special Committee on Aging will hold a hearing which “will unveil and examine a new, troubling scam by global drug traffickers perpetrated against our nation’s seniors.”
Thursday, February 11: The House Committee on Veterans’ Affairs Subcommittee on Health will hold a hearing titled “Choice Consolidation: Improving VA Community Care Billing and Reimbursement.”
Thursday, February 11: The House Committee on Homeland Security Subcommittee on Emergency Preparedness, Response, and Communications will hold a hearing titled “Improving the Department of Homeland Security’s Biological Detection and Surveillance Programs.”
Thursday, February 11: The Senate Committee on Finance will hold a hearing titled “The President’s Fiscal Year 2017 Budget.”
Thursday, February 11: The Senate Committee on the Judiciary will hold a markup, which will include consideration of: S. 483, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015, which seeks to improve enforcement efforts for prescription drug diversion and abuse; and S. 524, the Comprehensive Addiction and Recovery Act of 2015, which authorizes the Attorney General to award grants to address prescription opioid abuse and heroin use.
Friday, February 12: The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “Outbreaks, Attacks, and Accidents: Combatting Biological Threats.”

Regulatory Activity

SAMHSA Releases Proposed Rule Focused on Confidentiality of Substance Use Disorder Patient Records

On Friday, February 5, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a proposed rule titled “Confidentiality of Substance Use Disorder Patient Records.” The proposed rule seeks to amend the Confidentiality of Alcohol and Drug Abuse Patient Records regulations, which were last substantively updated in 1987. According to HHS, the proposed rule will “facilitate health information exchange to support delivery system reform efforts” and ensure privacy for patients seeking substance use disorder treatment.

The proposed rule will be published in the Federal Register on February 9, and comments are due April 11.

Article By Beth L. Goldstein of Squire Patton Boggs (US) LLP

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing. Meanwhile, the Energy and Commerce Committee (E&C) held a hearing regarding implementation of biosimilars. While all the attention will be on the former, the latter was more important, especially for participants in the biosimilar space.

First, the OGR Committee was a media show built around the flamboyant Shkreli. Shkreli took the 5th when given the opportunity to testify and later tweeted – after being excused from the hearing for refusing to answer any of the Members questions – that the Committee Members were ‘imbeciles’. The tone of the hearing was very aggressive towards drug pricing and what were described as unsavory business practices. Members were also critical of the FDA generic drug programs. However, Member interest in strengthening the program to bring competition to the marketplace was clear. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA, stated that funds collected as a result of the Generic Drug User Free Amendments (GDUFA) helped expedite the review process and that by October there will be a 10-month review process on all new applications. The Senate HELP Committee held a hearing last week on reauthorization of GDUFA, which will expire next year, and this bipartisan interest, coupled with the prescription drug cost crisis, could lead to increased resources for the FDA review process. Beyond some public shaming of specific drug companies, there was little suggestion of substantive action on drug pricing.

Second, the E&C Committee was less about drug pricing, but more so about the ability of manufacturers to get new biosimilar products to the market. Notably, Committee Members on BOTH sides of the aisle were critical of CMS for trying to price biosimilars more like generic drugs and categorize different products under a single billing code. They said the CMS ruling undermines the intent of the Biologics Price Competition and Innovation Act of 2010 (BPCIA) by removing incentives for a robust marketplace. Biologics make up a $200 billion market, so the consequences of policy decisions are significant. Members were also critical of delays in approving more biosimilars and issuing guidance on product labeling. Rep. Frank Pallone (D-NJ) asked if additional appropriations would address these problems, to which Dr. Woodcock replied that she’s more concerned the FDA will be unprepared for a rapid expansion of the biosimilar market.

While 2016 may be devoted to campaigning against drug prices, the Committees responsible for the regulatory regimes for drugs are still very focused on preserving the ability of manufacturers to successfully bring drugs to the market. That is a much bigger deal than the plethora of Martin Shkreli smirks you will be subjected to in the media.

Article By Rodney L. Whitlock of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Tag: congress

U.S. Election Forecast on Congressional Leadership Changes

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