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Wednesday, November 16, 2022



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HOME


TOP STORY


IN BOON FOR STAKEHOLDERS, HHS EXPECTED TO EXTEND PHE THROUGH APRIL

HHS on Friday signaled it will extend the COVID-19 public health emergency
beyond Jan. 12 -- a move most certainly to draw praise from key health care
stakeholders who recently urged the administration to maintain the PHE and
related policies through the winter to help address a potential COVID surge and
to grant states more time prepare for the Medicaid redetermination process
slated to re-start once the emergency ends.




LATEST PANDEMIC NEWS


MODERNA: BIVALENT BOOSTER MAY BE EFFECTIVE AGAINST EMERGING VARIANT

Moderna has published the first human clinical trial data on the effectiveness
of its most recent bivalent COVID-19 booster vaccine, showing the booster is
effective against omicron subvariants including the most recent one to emerge in
the United States.


FDA ADVISERS VOTE 8-5 AGAINST AUTHORIZING SABIZABULIN AS COVID-19 TREATMENT


FDA AUTHORIZES ARTHRITIS DRUG FOR COVID PATIENTS WITH PNEUMONIA

More Coverage →




LATEST NEWS

Becerra: Congress Must Act Permanently On Interstate Licensing, Broadband,
Behavioral Telehealth

LAS VEGAS -- HHS Secretary Xavier Becerra told Inside TeleHealth in a backstage
interview at the HLTH Conference that he wants Congress to take legislative
action to permanently expand access to telehealth by enabling HHS to reach rural
communities with quality broadband access, working with states to expand
interstate telehealth and including behavioral health provisions within
telehealth legislation.

AMA To Push CMS To Create A Medicare Advantage Physician Directory

The American Medical Association’s House of Delegates adopted a policy urging
CMS to put together a Medicare Advantage physician directory after CMS last
month said it was considering drafting a national directory of providers and
services and asked for stakeholders’ feedback on the idea.

CMS Touts New Rural Health Framework As FAH Pushes For Lame Duck Support

CMS’ Rural Health Council on Tuesday (Nov. 15) announced a new set of guidelines
for rural and tribal health that the agency says will boost access and equity
goals for the next five years.

FDA Encourages Regional Partnerships For Medical Device Security

FDA and the MITRE Corporation have released an updated version of their “Medical
Device Cybersecurity Regional Incident Preparedness and Response Playbook” that
provides guidance for health organizations on using regional collaboration to
address device security threats.

Senate Finance Dems To CMS: Quickly Release New MA Marketing Rules

Senate Finance Committee Democrats, led by chair Ron Wyden (D-OR) and Sen. Bob
Casey (D-PA), are urging CMS to release regulations as soon as possible to step
up oversight of Medicare Advantage marketing, after a committee report alleged
bad actors in 14 states are taking advantage of loopholes and loosened rules
around MA marketing and warned Congress could step in if CMS doesn’t act.

FDA: Certain Naloxone Products May Be Eligible For Nonprescription Use

FDA on Tuesday (Nov. 15) announced that certain forms of overdose reversal drug
naloxone may be eligible for nonprescription use, pending a review of additional
data, in a bid to facilitate development and approval of nonprescription or
over-the-counter naloxone.

FTC Raises Concerns About ‘Improper’ Orange Book Listings In Xyrem Case

The Federal Trade Commission told a U.S. district court that Jazz
Pharmaceuticals’ risk mitigation strategy patent on its highly profitable
narcolepsy drug, Xyrem (sodium oxybate), could be harming competition and should
be removed from FDA’s Orange Book, citing broader concerns of “improper Orange
Book listings” that block lower-cost generic drugs from entering the market.

AMA President: Political Decisions Have Driven Physician Burnout

In a stern speech that called out misinformation, politicization of health care
and Medicare reimbursement cuts as factors driving physician burnout, the leader
of the American Medical Association said politicians need to change their
attitude toward health care and focus on ensuring physicians are properly
compensated and able to do their jobs.

HHS Patient Safety Alliance Divided Over Health, Safety Goals

Patient advocates and health care providers split significantly over how to
reduce rising rates of patient and provider harm during an HHS listening session
Monday (Nov. 14) as HHS’ new safety alliance set tentative goals to improve the
health and safety of both groups.

WEDI Recommends Enforcement Discretion For No Surprises Act Provisions

The group that advises HHS on the use of technology to exchange health care
information wants the department to delay implementation of key provisions of
the No Surprise Act that require providers to give patients estimates of medical
costs before the service is rendered, until appropriate standards can be
developed and tested.

More News →



CORONAVIRUS

Our complete coverage of COVID-19




INSIDE DRUG PRICING


CMS URGED TO TEST MONTHLY $35 CAPS FOR MORE THAN JUST INSULIN

Seniors’ advocates are using the new drug pricing law’s $35 monthly cap on
insulin costs as leverage for testing $35 out-of-pocket caps on other drugs.


SANDOZ LAUNCHES INITIATIVE TO INCREASE GLOBAL BIOSIMILAR ADOPTION



Full Coverage →

Not a subscriber? Contact customer service at ihp@iwpnews.com or 703-416-8505.
For a free trial, contact Steve Reilly.




HEALTH REFORM DEBATE

Analyst: Bright Health’s Exit Creates Opportunity For Other Big Exchange Players

Key exchange insurers, including Centene, United, CVS Health and Cigna, are a
well-positioned to glean new consumers due to Bright Health Group’s recent
decision to drop out of the exchange market, which has left about a million
consumers having to find new coverage, a health care analyst says in a recent
memo.

Becerra: Regs Will Push Culturally, Linguistically Competent Health Care

KFF: Employer Plan Costs To Jump; Mental Health Demand Grows

Insurers, Advocates At Odds On Standardized Plan Policy

More Health Reform News →



DOCUMENTS

White House's National Rural Health Day Proclamation
DOL Finds Violations In 80% Of Care Industry Investigations
AHA Releases 2023 Health Care Workforce Scan
AMA Strengthens Commitment To Combatting Climate Crisis
Federally Facilitated Exchange Improper Payment Rate Less Than 1% In Initial
Data Release
Sen. Warner Stresses Ending National COVID-19 Emergency Wouldn’t Stop Telehealth
Flexibilities
AMA Opposes Gender-Based Medical Treatments To Alter Natural Abilities Of
Athletes
MGMA Recommendations On No Surprises Act Advanced Explanation Of Benefits + Good
Faith Estimate Requirements
White House Strongly Opposes GOP Resolution To End COVID-19 National Emergency
RWJF: Medicaid Enrollees Unaware Of Renewals
FDA Announces Preliminary Assessment That Certain Naloxone Products Have The
Potential To Be Safe And Effective For Over-The-Counter Use
Health Innovation Alliance: Still Time For Congress To Enact Meaningful Health
Legislation
Commonwealth Fund: Congress Can Give States Option To Keep Adults Covered In
Medicaid
Providers Urge Congress To Prevent Additional Pay Go Cuts To Medicare

More Documents →


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Becerra: Congress Must Act Permanently On Interstate Licensing, Broadband,
Behavioral Telehealth

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POST ELECTION COVERAGE


GOP TEES UP HEALTH CARE OVERSIGHT FOR NEXT CONGRESS

House Republicans, who could take control of the House though many of Tuesday’s
races have yet to be called, are laying plans to step up oversight of Democrats’
policies on Medicare, Medicaid, the COVID-19 public health emergency and the
Affordable Care Act in lieu of pushing a major health care legislative agenda
that could be blocked by presidential vetoes, lobbyists say, with the possible
exceptions being Medicare pay system and telehealth reforms that could draw
bipartisan support.


MEDICAID EXPANSION NEARS 40 STATES AFTER SOUTH DAKOTA APPROVAL




VOTERS SWEEPINGLY SUPPORT REPRODUCTIVE AUTONOMY IN MIDTERM MEASURES




SENATE APPROPS PREPARES FOR LEADERSHIP SHIFT NEXT YEAR




SANDERS, PAUL AGREE ON IMPORTATION, BUT DIVIDED ON COVID RESPONSE




REPUBLICANS EXPECTED TO HOUND CMS ON DRUG PRICE NEGOTIATION BUT NOT REPEAL LAW




GOP E&C, W&M CLARIFY JOINT STRATEGY FOR TELEHEALTH EXTENSION




DEMOCRATS LIKELY TO FOLLOW REPUBLICANS’ TELEHEALTH STRATEGY



More Election Coverage →




ABORTION POLICY ROUNDUP


CMS PROBES EMTALA ABORTION VIOLATION; OBGYNS SUE IN AG FOR PRIVACY VIOLATIONS;
MATERNAL HEALTH OUTCOMES DETERIORATE POST-DOBBS

While Americans on Tuesday (Nov. 8) define the next iteration of the abortion
landscape by heading to the polls over abortion rights and other hot health care
topics, litigation over patient privacy and emergency care are in full swing.

Full Coverage →


HEALTH EQUITY

Covering the hottest new health policy debate in Washington -- in-depth
reporting on the surging efforts to tackle social, racial and economic barriers
to equitable health care.

CMS Touts New Rural Health Framework As FAH Pushes For Lame Duck Support
More Coverage →

Inside CMS
Dems Eye Medicaid Priorities For Year-End Package; Offset Plan Unclear

CMA: Senate Call For CMS Action Won’t Fix MA Marketing Issues

Advocates Optimistic After Arguments In SCOTUS Nursing Home Case

In Boon For Stakeholders, HHS Expected To Extend PHE Through April

Inside CMS →

Health Exchange Alert
Dems Eye Medicaid Priorities For Year-End Package; Offset Plan Unclear

In Boon For Stakeholders, HHS Expected To Extend PHE Through April

GOP Tees Up Health Care Oversight For Next Congress

Overloaded With Cases, Administration Adds More Surprise Billing Arbiters

Health Exchange Alert →

FDA Week
Sanders, Paul Agree On Importation, But Divided On COVID Response

Senate Approps Prepares For Leadership Shift Next Year

Panel Backs FDA Plan To Expand KASA Platform To New Drugs, Biologics

Pfizer, BioNTech Say Omicron Shot Offers More Protection Than Original Vax

FDA Week →

Inside Drug Pricing
Split Congress Makes Possible Bipartisan Reforms To PBMs, 340B

Cuban’s Direct-To-Consumer Pharmacy Might Sell Insulin Soon

Australian Firm With BARDA Contract Begins Skin Patch COVID Vaccine Trial

SCOTUS Accepts One Of Two Cases With Similar Drug Patent Disputes

Inside Drug Pricing →

Medicare
Becerra: Congress Must Act Permanently On Interstate Licensing, Broadband,
Behavioral Telehealth
AMA To Push CMS To Create A Medicare Advantage Physician Directory
Senate Finance Dems To CMS: Quickly Release New MA Marketing Rules

Congress
HHS Patient Safety Alliance Divided Over Health, Safety Goals
Dems Eye Medicaid Priorities For Year-End Package; Offset Plan Unclear
Researchers Eye ARPA-H To Fund, Advance Human Phenome Project

Rx Drugs
FDA: Certain Naloxone Products May Be Eligible For Nonprescription Use
FTC Raises Concerns About ‘Improper’ Orange Book Listings In Xyrem Case
House Democrats Urge Tai To Weigh ‘Adverse’ Effects Of Broadening TRIPS Waiver

Medical Devices
FDA Encourages Regional Partnerships For Medical Device Security
CDC Panel Calls For Oversight Of CLIA-Waived Labs
Remanufacturing Guide Tops FDA’s 2023 Device Guidance Agenda

Budget
House Passes Fiscal 2023 Minibus That Gives FDA $341M Funding Hike
No Appropriations Bill Without Hyde Amendment, Republicans Say
FDA Funding Bill Clears Committee With GE Meat, Russia Measures

Food Safety
Senate Approps Prepares For Leadership Shift Next Year
Grassley: GAO To Investigate Impact Of Sole-Source Infant Formula Contracts
FDA Warns Of Repercussions If Foreign Food Facilities Shun Inspectors

FEATURES
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 * Medicaid
 * Medical Devices
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 * Opioids
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 * Spotlight on ACOs
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 * Waste and Fraud
 * 21st Century Cures

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