July 6

Federal Affairs Activity Report: July 6 – July 10, 2015

Below is an overview of federal activity in the U.S. House of Representatives, the U.S. Senate, and federal agencies this week related to health care and/or other areas of interest for our clients.

House of Representatives

The House will reconvene on Tuesday, July 7 at 2:00 p.m. No healthcare related votes are expected in the House this week.

Energy and Commerce Committee
The House Energy and Commerce Health Subcommittee will hold a hearing on “Medicaid at 50: Strengthening and Sustaining the Program.”
Witnesses: TBA
Date and time: Wednesday, July 8; 10:15 a.m. EDT
Location: 2322 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Appropriations Committee
The House Appropriations full committee will hold a markup of the FY2016 Agriculture Appropriations bill and the revised report on the suballocation of budget allocation for FY2016.
Date and time: Wednesday, July 8; 10:15 a.m. EDT
Location: 2359 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Senate

The Senate will reconvene on Tuesday, July 7 at 2:30 p.m. No healthcare related votes are expected in the Senate this week.

Health, Education, Labor and Pensions Committee
The Senate Health, Education, Labor, and Pensions Primary Health and Retirement Security Subcommittee will hold a hearing entitled “Small Business Health Care Challenges and Opportunities.”
Witnesses: Thomas Harte, owner of Landmark Benefits in Hampstead, N.H.; James Scott, owner of Applied Policy in Alexandria, Va.; Sabrina Corlette, senior research fellow And project director at Georgetown University; and Kelly Conklin, owner of Foley-Waite in Kenilworth, N.J.
Date and time: Tuesday, July 7; 2:00 p.m. EDT
Location: 430 Dirksen Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.

Federal Agencies

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 29721) – Meeting
Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 29721) holds a meeting of the Oncologic Drugs Advisory Committee to discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.
Date and Time: Thursday July 9th at 9:00 am
Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room (Room 1503), Silver Spring, Md.
The agenda is available HERE.

June 29

Federal Affairs Activity Report: June 29, 2015

Note: The K&A offices will be closed on Thursday July 2nd and Friday July 3rd due to the Independence Day holiday. We will resume our regular memos on Monday, July 6th, but we will be sure to inform clients as soon as possible in the event that CMS releases the CY2016 Hospital Outpatient Prospective Payment System (OPPS) or Inpatient Prospective Payment System (IPPS) proposed rules this week.

Below is an overview of federal activity in the U.S. House of Representatives, the U.S. Senate, and federal agencies this week related to health care and/or other areas of interest for our clients.

House of Representatives

The House is currently in recess, and will reconvene on Tuesday, July 7.

Senate

The Senate is currently in recess, and will reconvene on Tuesday, July 7.

Federal Agencies

Department of Health and Human Services (HHS); Food and Drug Administration (FDA)
FDA will hold a meeting of the Center for Drug Evaluation and Research, The National Institutes on Drug Abuse, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration, to discuss increasing the use of naloxone to reduce the incidence of opioid drug overdose fatalities.
Date and time: Wednesday, July 1 – Thursday, July 2
Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503, Silver Spring, MD
The meeting agenda is available HERE.

June 26

The Washington Weekly: June 26, 2015

Supreme Court Upholds the Provision of Tax Credits in Federal Exchanges under ACA

On Thursday, June 25, the U.S. Supreme Court sided with the federal government in a landmark 6-3 decision in King v. Burwell, upholding the provision in the Affordable Care Act (ACA) that provides federal tax credits to individuals to purchase health insurance in states using federally facilitated health insurance exchanges. Writing for the majority, Justice Roberts found that the ACA as written allows the federal government to provide these tax credits. Had the Court struck down the provision of tax credits in federal exchanges, 6.4 million low- and middle-income individuals would have had lost their federal assistance used to purchase health care coverage. This likely would have resulted in rising premiums as fewer individuals would choose to enroll in the exchanges in the affected states. This decision ensures that these individuals will maintain their tax credits. The Supreme Court’s ruling marks perhaps the final hurdle for the ACA. Since its enactment in 2010, the law has survived a prior legal challenge before the Supreme Court in National Federation of Independent Business v. Sebelius in 2012 and dozens of repeal votes. Congressional Republicans have expressed interest in continuing to pursue piecemeal changes to the ACA. The Court’s slip opinion in King v. Burwell is available HERE.

 

IPAB Repeal Legislation Passes the House

On Tuesday, the House passed H.R. 1190, the Protecting Seniors’ Access to Medicare Act of 2015, by a vote of 244-154. The legislation, introduced by Representatives Phil Roe, M.D. (R-TN) and Linda Sánchez (D-CA), repeals the Independent Payment Advisory Board (IPAB), the unelected 15 member board that was created under the Affordable Care Act (ACA) to extend Medicare solvency. Eleven House Democrats sided with Republicans to repeal the measure, and 35 House members did not vote. The bill is offset by a $7.1 billion cut from the ACA’s Public Health and Prevention Fund. The legislation now moves to the Senate, where the prospects for its consideration are uncertain.

 

House and Senate Appropriations Committees Approve FY2016 Funding Bills for HHS

On Wednesday, June 24, the House Appropriations Subcommittee approved the FY2016 Labor, Health and Human Services, Education, and Related Agencies (Labor-H) bill funding various agencies and the Department of Health and Human Services (HHS), except for the Food & Drug Administration (FDA), for FY2016. The bill provides $71.3 billion in discretionary funds for HHS, a $298 million increase over FY 2015, including $31.2 billion for the National Institutes of Health (NIH), 1.1 billion above the FY2015 level; and $3.3 billion for the Centers for Medicare & Medicaid Services (CMS) program management, $344 million below the FY2015 level. The bill eliminates funding for the Affordable Care Act (ACA) as well as all funding for the Agency for Health Research & Quality (AHRQ).

On Thursday, June 25, the Senate Appropriations Committee passed their FY2016 Labor-H bill. The Senate bill funds HHS at $70.4 billion, a $646 million decrease from FY2015 levels, including $32 billion for NIH (a $2 billion increase over FY2015) and $3 billion for CMS program management (a $642 million decrease from FY2015). Like the House Labor-H bill, the Senate bill eliminates funding for the ACA’s discretionary programs as well as all funding for AHRQ.

Full text of the House Labor-H bill can be found HERE. Full legislative text for the Senate Labor-H bill, S.1695, is not yet available.

 

OIG Issues Reports on Fraud Vulnerabilities in Medicare Part D

On Tuesday, June 23, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued two reports highlighting the Medicare Part D program’s vulnerabilities to fraud. In the first report called “Ensuring the Integrity of Medicare Part D,” OIG discussed the need for more robust oversight and more effective collection and analysis of program data to proactively identify and resolve program vulnerabilities. OIG recommended several reforms to CMS, including requiring plans to report data on suspected fraud, expanding the range of drugs reviewed for potential fraud and abuse, and implementing edits to reject prescriptions written by excluded providers. In an accompanying report on questionable billing and geographic hotspots for fraud, OIG identified more than 1,400 pharmacies with suspicious billing patterns that accounted for $2.3 billion in prescription drug claims to Part D in 2014. OIG also cited as a concern the growing spending on opioids, which has increased by over 150 percent since 2006. The “Ensuring the Integrity of Medicare Part D” report is available HERE. The accompanying report identifying suspicious billing patterns is available HERE.

 

CMS Issues April 2015 Medicaid and CHIP Enrollment Report

On Tuesday, June 23, the Centers for Medicare and Medicaid Services (CMS) issued its April 2015 Medicaid and Children’s Health Insurance Program (CHIP) monthly eligibility and enrollment report. According to the report, approximately 12.3 million additional individuals have enrolled in Medicaid and CHIP since October 2013 when the initial exchange marketplace open enrollment period began, compared to enrollment in the previous three months. About 71.1 million individuals have enrolled in Medicaid and CHIP through April for the 49 states that reported data. The full report is available HERE.

 

House Ways & Means Committee Holds Hearing on ACA Premium Increases

On Wednesday, June 24, the House Ways & Means Oversight Subcommittee held a hearing to examine the effects of the Affordable Care Act (ACA) on healthcare premiums. Witnesses at the hearing included several state insurance commissioners from Tennessee, Maryland, and Washington. In his opening statement, Subcommittee Chairman Peter Roskam (R-IL) described how providers across numerous states are asking state insurance commissioners for premium rate increases of over 20% to offset losses associated with implementation of the ACA. Several panelists testified that the largest health insurance providers in their states are requesting significant premium increases to offset losses before general and administrative costs are incurred. Three panelists also stated that the current pace of provider losses due to ACA regulations is unsustainable. The Administration has predicted that health care claims will increase by 14% in 2016. Panelists noted that 2014 and 2015 data is having an important impact on their decisions for 2016 insurance rates, which are due in mid-late August. A full recording of the hearing can be found HERE.

 

Energy & Commerce Committee Holds Hearing on Medicaid Demonstrations

On Wednesday, June 24, the House Energy & Commerce Health Subcommittee held a hearing entitled “Examining the Administration’s Approval of Medicaid Demonstration Projects.” Witnesses at the hearing included Katherine Iritani, Health Care Director, Government Accountability Office (GAO) and Matt Salo, Executive Director, National Association of Medicaid Directors. No representative from the Centers for Medicare and Medicaid Services (CMS) participated in the hearing. The hearing focused on how CMS applies its guidelines for assessing Medicaid demonstration proposals and how the process can be improved and refined. Republicans at the hearing raised concerns about the lack of transparency and accountability in the Administration’s spending on Medicaid demonstration programs, noting that one-third of Medicaid dollars are spent on demonstrations. Katherine Iritani testified that the GAO is concerned about the long-term stability of the Medicaid program. Matt Salo testified that State Medicaid Directors would support legislation to increase transparency and bring predictability to the waiver approval process, but that emphasis should be placed on outcomes and defining a path to make successful demonstrations permanent. A full recording of the hearing can be found HERE.

 

Trade Promotion Authority Passes the Senate

On Wednesday, the Senate passed legislation known as “fast-track” or Trade Promotion Authority, granting the President the authority to finalize trade agreements, by a vote of 60-38. The bill allows the Administration to negotiate trade agreements with Pacific Rim nations and the European Union and send them to Congress for approval, without the ability of Congress to amend or filibuster them. The expedited process lasts until 2018 with the possibility of extension until 2021, and is seen as a key step towards completing negotiations on the Trans-Pacific Partnership (TPP). The TPP trade deal includes 11 other Pacific Rim nations, and addresses various trade priorities for the drug and device industries. With fast-track legislation in place, focus will now shift to TPP, where a vote is expected this fall.

 

Senate Finance Committee Marks Up Various Health Bills

On Wednesday, June 24, the Senate Finance Committee held an executive session to mark up a series of healthcare related bills dealing with a wide ranging set of issues. The bills considered are listed below:

S.607 – The Rural Community Hospital Demonstration Extension Act of 2015

S.1349 – The Notice of Observation, Treatment and Implication for Care Eligibility (NOTICE) Act of 2015

S.1461 – A One Year Extension of the Enforcement Instructions on Supervision Requirements of Outpatient Therapeutic Services in Critical Access Hospitals (CAHs) and Small Rural Hospitals

S.313 – Prevent Interruptions in Physical Therapy Act of 2015

S.1253 – Patient Access to Disposable Medical Technology Act of 2015

S.1347 – Electronic Health Fairness Act of 2015

S.704 – The Community Based Independence for Seniors Act

S.1362 – The PACE Innovation Act of 2015

S.861 – Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2015

S.349 – Special Needs Trust Fairness Act of 2015

S.466 – Quality Care for Moms and Babies Act

S.599 – Improving Access to Emergency Psychiatric Care Act of 2015

 

All of these bills were approved, en bloc, by voice vote.

 

E&C Releases 21st Century Cures Committee Report

On Thursday, June 25, the House Energy & Commerce (E&C) Committee released its Committee Report on H.R. 6, the 21st Century Cures Act, as reported by the Committee in May. The full committee report includes the bill’s legislative text and history, cost estimate, and an explanation of the provisions via new report language. While current Congressional Budget Office (CBO) estimates indicate that the legislation would cost $106.4 billion from 2016-2020, this figure includes three years of funding for the National Institutes of Health (NIH) to boost its research and development capabilities. The score is unlikely to inhibit the bill from moving forward, with a vote on the floor of the House expected soon after the Independence Day recess. The full report can be found HERE.

June 22

The Federal Affairs Activity Report: June 22 – June 26, 2015

Below is an overview of federal activity in the U.S. House of Representatives, the U.S. Senate, and federal agencies this week related to health care and/or other areas of interest for our clients.

House of Representatives

The House will reconvene Tuesday, June 23 at 12:00 p.m. H.R. 1190, the Protecting Seniors’ Access to Medicare Act of 2015, is scheduled for consideration this week.

Energy and Commerce Committee
The House Energy and Commerce Health subcommittee will hold a hearing entitled “Examining the Administration’s Approval of Medicaid Demonstration Projects.”
Witnesses: TBA
Date and time: Wednesday, June 24; 10:00 a.m. EDT
Location: 2123 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Appropriations Committee
The Appropriations Full Committee will hold a markup of the FY2016 Labor, Health and Human Services, and Education Appropriations bill.
Date and time: Wednesday, June 24; 10:15 a.m. EDT
Location: 2359 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Ways and Means Committee
The House Ways and Means Oversight Subcommittee will hold a hearing on “Rising Health Insurance Premiums Under Obamacare.”
Witnesses: TBA
Date and time: Wednesday, June 24, 10:00 a.m. EDT
Location: 1100 Longworth House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Veterans Affairs Committee
The House Veteran Affairs Disability Assistance and Memorial Affairs Subcommittee will hold a legislative hearing on H.R.2214, the “Disabled Veterans’ Access to Medical Exams Improvement Act”; H.R.1380, to amend title 38, United States Code, to expand the eligibility for a medallion furnished by the Secretary of Veterans Affairs to signify the veteran status of a deceased individual; H.R.2706, the “Veterans National Remembrance Act”; H.R.2691, the “Veterans’ Survivors Claims Processing Automation Act of 2015”; H.R.303, the “Retired Pay Restoration Act”; H.R.1338, the “Dignified Interment of Our Veterans Act of 2015”; H.R.1302, the “VA Appeals Backlog Relief Act”; H.R.2605, the “Veterans Fiduciary Reform Act of 2015”; and H.R.1384, the “Honor America’s Guard-Reserve Retirees Act.”
Witnesses: TBA
Date and time: Wednesday, June 24, 2:00 p.m. EDT
Location: 334 Cannon House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Energy and Commerce Committee
The House Energy and Commerce Health Subcommittee will hold a hearing on H.R.1344, the “Early Hearing Detection and Intervention Act of 2015”; H.R.1462, the “Protecting our Infants Act of 2015”; and H.R.2820, the “Stem Cell Therapeutic and Research Reauthorization Act of 2015.”
Witnesses: TBA
Date and time: Thursday, June 25; 10:15 a.m. EDT
Location: 2322 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Senate

The Senate will convene on Monday, June 22 at 3:00 p.m.

Appropriations Committee
The Labor, Health and Human Services, Education and Related Agencies Subcommittee will hold a markup of the “Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2016.”
Date and time: Tuesday, June 23; 3:00 p.m. EDT
Location: 138 Dirksen Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.

Veteran Affairs Committee
The Veteran Affairs full committee will hold a hearing on pending health care and benefits legislation. Legislation to be considered includes the following: S. 469, Women Veterans and Families Health Services Act of 2015; S. 901, Toxic Exposure Research Act of 2015; S. 1082, Department of Veterans Affairs Accountability Act of 2015; S. 1085, Military and Veteran Caregiver Services Improvement Act of 2015; S. 1117, Ensuring Veteran Safety Through Accountability Act of 2015; H.R. 91 Veteran’s I.D. Card Act; Discussion Draft, including provisions derived from S. 1021, S. 1358; S. ____, Jason Simcakoski Memorial Opioid Safety Act; S. ____, Biological Implant Tracking and Veteran Safety Act.
Witnesses: TBA
Date and time: Wednesday, June 24, 2:30 p.m. EDT
Location: 418 Russell Senate Office Building, Washington, D.C. 20515
Additional information is available HERE.

Federal Agencies

Department of Health and Human Services (HHS); National Institutes of Health (NIH)
NIH will hold a joint meeting of the National Cancer Advisory Board (NCAB) and National Cancer Institute Board of Scientific Advisors.
Date and time: Tuesday, June 23 – Wednesday, June 24
Location: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD
The meeting agenda is available HERE.

Department of Health and Human Services (HHS); Office of the National Coordinator for Health Information Technology (ONC)
ONC will hold a meeting of the Health Information Technology Standards Committee to hear reports from its workgroups and updates from ONC and other Federal agencies.
Date and time: Wednesday, June 24, 9:30 a.m. EDT
Location: Washington Plaza Hotel, 10 Thomas Circle NW, Washington, D.C. The event will be webcast at http:altarum.adobeconnect.com/HITstandards.

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