Tag Archives: Food and Drug Administration

FDA User Fee Reauthorization Moves to Full Committee; HHS Further Delays Bundled Payment Models and Changes to 340B Drug Discount Program

Legislative Activity FDA User Fee Reauthorization Moves to Full Committee While passing health reform through Congress has been a struggle, the Food and Drug Administration (FDA) user fee legislation has quickly moved through the regular order process in a bipartisan fashion. S. 934/H.R. 2430, Food and Drug Administration Reauthorization Act of 2017 (FDARA), renews FDA’s … Continue Reading

Gottlieb Confirmation Hearing Set for April 5; CMS Issues Final Rule on Medicaid DSH Payments; Home Health CoPs Delayed; MedPAC Meetings This Week

Legislative Activity Gottlieb Confirmation Hearing Set for April 5 On Wednesday, April 5, the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a confirmation hearing for Dr. Scott Gottlieb, President Trump’s nominee for Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Gottlieb held a number of senior positions at the … Continue Reading

Repeal and Replace or Repair and Rebrand?; Energy and Commerce Holds First Hearing on User Fees; MedPAC and MACPAC Meetings This Week

Legislative Activity Repeal and Replace or Repair and Rebrand? With reconciliation instructions in the FY 2017 spending bill that initiate the House and Senate committees with health care jurisdiction to reduce the deficit, Republicans in both chambers are eager to use the fast-track, fifty-vote process to repeal and replace as much of the Affordable Care … Continue Reading

State Attorneys General January 9 Update

Squire Patton Boggs’ State Attorneys General Practice Group is comprised of lawyers who have served at senior levels in state AG offices around the country and whose practices focus, to one degree or another, on representing clients before these increasingly assertive and powerful, yet often overlooked, government agencies, as explained in detail here. In these … Continue Reading

H.R. 5273, Helping Hospitals Improve Patient Care Act of 2016, scheduled for House Floor Vote; FDA Releases Draft Guidance on Medicare Coverage of IDE Devices

Legislative Activity H.R. 5273, Helping Hospitals Improve Patient Care Act of 2016, scheduled for House Floor Vote House Majority Leader, Kevin McCarthy, announced H.R. 5273, Helping Hospitals Improve Patient Care Act of 2016 (HIP-C), introduced by House Committee on Ways and Means Subcommittee on Health Chairman Pat Tiberi (R-OH) and Ranking Member Jim McDermott (D-WA), … Continue Reading

Two Health Bills Scheduled for House Floor; Senate to Consider Opioid Abuse Legislation; CMS Releases Proposed Rule on Provider Integrity; MedPAC Meets This Week

Legislative Activity Two Health Bills Scheduled for House Floor House Majority Leader Kevin McCarthy (R-CA) has stated that the chamber may consider two health bills this coming week. On Tuesday, March 1, the House is expected to consider H.R. 2814, to Name the Department of Veterans Affairs Community-Base Outpatient Clinic in Sevierville, Tennessee, the Dannie … Continue Reading

Senate Cloture Vote Scheduled for FDA Nominee, Chamber May Consider Opioid Legislation

Legislative Activity Senate Cloture Vote Scheduled for FDA Nominee, Chamber May Consider Opioid Legislation On Monday, February 22, Senate Majority Leader Mitch McConnell (R-KY) has scheduled a cloture vote on the nomination of Dr. Robert Califf for Food and Drug Administration (FDA) Commissioner.   Three Senators – Joe Manchin (D-WV), Ed Markey (D-MA), and Bernie Sanders … Continue Reading

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 … Continue Reading

Lawmakers To Vie For House Ways And Means Gavel; FDA Names Medical Device Security As A Priority; CMS Releases Proposed Notice On Basic Health Program Funding

Legislative Activity Lawmakers To Vie For House Ways And Means Gavel With Rep. Paul Ryan (R-WI) expected to succeed Rep. John Boehner (R-OH) as Speaker of the House, some Republican lawmakers are eyeing the opening Rep. Ryan would leave behind at the helm of the House Committee on Ways and Means. Several congressmen are expected … Continue Reading

21st Century Cures Act on House Floor; CMS Proposes Modification to Two Midnight Rule, Publishes End-Stage Renal Disease PPS Proposed Rule; Supreme Court Upholds ACA Subsidies

Legislative Activity House to Consider 21st Century Cures Act Majority Leader Kevin McCarthy (R-CA) has announced that the House of Representatives will consider H.R. 6, the 21st Century Cures Act, this week. The House Committee on Rules will meet to consider the rules for the debate on Wednesday, July 8. Amendments to the legislation are … Continue Reading

21st Century Cures Act Advances to Committee Markup; HHS Issues Guidance on Preventive Services; CMS Urges Physicians to Prepare for ICD-10

Legislative Activity Committee on Energy and Commerce to Mark Up 21st Century Cures Act On Tuesday, May 19, the House Committee on Energy and Commerce will begin its markup of the 21st Century Cures Act, to be continued on Wednesday, May 20. The legislation is the product of the bipartisan 21st Century Cures Initiative that … Continue Reading

House Scheduled To Consider The Agriculture, Food and Drug Administration (FDA) Spending Bill

Legislative Activity House Agriculture, FDA Appropriations Bill The House is scheduled to consider the Agriculture, Food and Drug Administration (FDA) spending bill this week. The House Appropriations Committee approved the spending bill on May 29, which includes policy provisions such as authorizing a waiver process for schools having difficulty meeting the nutrition standards for the … Continue Reading

Michelle Obama Will Make Two Separate Announcements At The White House To Celebrate The Fourth Anniversary Of Let’s Move!

Regulatory Activity Let’s Move! As part of a series of events to celebrate the fourth anniversary of Let’s Move!, this week First Lady Michelle Obama will make two separate announcements at the White House  in addition to traveling to cities along the east coast to participate in scheduled events. On Tuesday, February 25, the First … Continue Reading

House and Senate Farm Bill Conferees Convened To Formally Kick-Off Negotiations

Legislative Activity Farm Bill Conference: Priority Issues At-A-Glance On October 30, the 41 House and Senate farm bill conferees convened at a public meeting to formally kick-off negotiations, although informal talks began a few months ago between agriculture leadership’s staff. Despite many conferees cautioning against pre-maturely drawing lines on issues, it was clear what issues … Continue Reading

House Committee to Introduce Cybersecurity Legislation; Executive Order Deadlines on Cybersecurity; FDA Issues Draft Guidance

Legislative Branch Activity Cybersecurity Legislation The House Homeland Security Committee will introduce a new piece of cybersecurity legislation that would codify the cyber roles and responsibilities of the Department of Homeland Security (DHS), as well as address other key aspects of cybersecurity. The committee has been working with stakeholders for several weeks on its draft … Continue Reading
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