The Centers for Medicare & Medicaid Services (CMS) recently released its proposed rules for the Hospital Inpatient Prospective Payment System (IPPS) for fiscal year (FY) 2019. As discussed below, the proposed rule focuses on promoting interoperability to reduce administrative burdens,
Health Law Update
Health Law Update, published by Baker & Hostetler LLP, focuses on legal developments and regulatory issues in the healthcare sector. The blog covers topics such as FDA regulations and guidance, drug and biological product approvals, medical device cybersecurity, pharmaceutical compounding laws, and litigation related to healthcare products and services. It also addresses emerging issues like the use of artificial intelligence in drug development and legal challenges to healthcare policies and approvals. The content is aimed at providing updates on compliance, enforcement, and policy changes affecting healthcare providers, manufacturers, and related stakeholders.
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Capitol Hill Healthcare Update
LAWMAKERS PRAISE, CRITICIZE TRUMP PLAN ON DRUG PRICES
On Capitol Hill, reaction to President Donald Trump’s “American Patients First” plan to bring down prescription drug prices fell predictably along partisan lines: Republicans generally praised it, while Democrats criticized it for…
Capitol Hill Healthcare Update
GOP LAWMAKERS: EUROPE, CANADA ‘FREE RIDING’ ON US DRUG INNOVATION
More than two dozen House Republicans last week called on President Donald Trump to leverage upcoming trade negotiations to stop other nations from “free riding” on U.S. pharmaceutical innovations.
In…
Capitol Hill Healthcare Update
AZAR ILLNESS DELAYS WHITE HOUSE ANNOUNCEMENT ON DRUG PRICING INITIATIVE
Health & Human Services (HHS) Secretary Alex Azar is recovering at his home in Indianapolis following his second hospitalization in less than a week to treat a bowel condition, delaying…
CMS aims to decrease burdens and increase innovation in Medicare parts C and D with new April 2018 guidance
In regulations published on April 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued two new documents containing guidance primarily on the Medicare Advantage (MA) program and on the Medicare prescription drug benefit program. Taken together, these two documents…
Capitol Hill Healthcare Update
HOUSE PANEL TO QUESTION GOTTLIEB ON FDA BUDGET
Food and Drug Administration (FDA) Commissioner Scott Gottlieb will testify Tuesday before a House appropriations subcommittee on his agency’s fiscal 2019 budget – which includes the largest proposed funding increase in its…
Capitol Hill Healthcare Update
CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS
Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential legislative solutions.
The Senate HELP…
Capitol Hill Healthcare Update
CONGRESS WORKS TO PASS BUDGET BEFORE FRIDAY’S SHUTDOWN DEADLINE
House leaders are pushing to schedule a vote this week on a $1.3 trillion budget agreement that would give the Senate enough time to pass it before a Friday deadline when…
Capitol Hill Healthcare Update
HOUSE VOTE SET FOR UPDATED ‘RIGHT-TO-TRY’ LEGISLATION
The House will vote Tuesday on updated but still controversial legislation that would give terminally ill patients wider access to prescription drugs that haven’t won approval by the Food and Drug Administration.
House…
Capitol Hill Healthcare Update
CONGRESS SCRAMBLES TO COMPLETE BUDGET IN ADVANCE OF DEADLINE
Lawmakers are working overtime – including on key healthcare issues – to wrap up work on a $1.2 trillion omnibus budget bill that would fund the government for the balance of…