HHS Forms New Advisory Committee on Long COVID

HHS on Thursday (Nov. 16) announced it will launch an advisory committee to help guide the government in equitably responding to the long-term impacts of COVID-19. The committee was called for by HHS’ August 2022 National Research Action Plan on Long COVID . “This Committee will bring perspectives from outside the government to help inform action on Long COVID and associated conditions, with a focus on health equity,” an HHS news release says . The announcement says those with lived...
Article Type: 
Daily News
Tags: 
corona
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/24/2023
FDA Volume: 
Vol. 29, No. 47
CMS Issue: 
Inside CMS - 11/23/2023
CMS Volume: 
Vol. 26, No. 47
Author: 
Luke Zarzecki
Topics: 
ISSUE: INSIDE CMS
ISSUE: FDA WEEK
Congress
Coronavirus
Rx Drugs

E&C Advances Bills To Block CMS Drug Class Restrictions, Monitor NCDs

In the wake of controversy over CMS’ coverage limits for Alzheimer’s medications, the House Energy & Commerce health subcommittee advanced legislation that would prevent CMS from imposing class-wide coverage restrictions on drugs moving forward. The panel also advanced bills that would increase federal oversight of local coverage determinations and transparency on national coverage determinations (NCDs). The bills were among a broad slate of bills considered at the subcommittee’s hearing on Wednesday (Nov. 15). The MERIT Act (H.R. 133) was introduced...
Article Type: 
Daily News
Tags: 
drug-reimbursement
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/24/2023
FDA Volume: 
Vol. 29, No. 47
CMS Issue: 
Inside CMS - 11/23/2023
CMS Volume: 
Vol. 26, No. 47
Author: 
Maaisha Osman
Topics: 
ISSUE: INSIDE CMS
ISSUE: FDA WEEK
Congress
Medicare
Rx Drugs

FDA Obtains Injunction Against Company Marketing Unapproved Birth Control

The U.S. District Court for the District of Arizona entered a consent degree Wednesday (Nov. 15) enjoining an Arizona-based company from distributing a purported natural contraceptive cream that has not been approved by FDA, a victory for the agency in combating misinformation about reproductive medicine. FDA’s Center for Drug Evaluation and Research (CDER) announced the permanent injunction , which forbids the company Smart Women’s Choice, Inc. and its CEO Jennifer Richard from distributing drugs unless in compliance from the Federal...
Article Type: 
Daily News
Tags: 
enforcement
drug-safety
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/24/2023
FDA Volume: 
Vol. 29, No. 47
Author: 
Jessica Karins
Topics: 
ISSUE: FDA WEEK
HEALTH AUTO EMAIL
Abortion
Rx Drugs

Senate Passes Two-Step CR, Long-Term Health Funding Still Uncertain

The Senate passed a continuing resolution (CR) Wednesday night (Nov. 15) that will keep the government funded for an additional few months, signing on to the two-step funding approach originating in the House, but the long-term funding for HHS and FDA is still unclear as is the path forward for bipartisan pharmacy benefit manager reforms and other health measures that stakeholders had expected to move in a year-end omnibus package. Senators voted 87-11 in favor of passing the CR. Democrats...
Article Type: 
Daily News
Tags: 
budget
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/17/2023
FDA Volume: 
Vol. 29, No. 46
HEA Issue: 
Health Exchange Alert - 11/22/2023
HEA Volume: 
Vol. 11, No. 38
Author: 
Jessica Karins
Topics: 
ISSUE: FDA WEEK
Health-Exchange-Alert
HEALTH AUTO EMAIL
Budget
Congress
Rx Drugs

E&C Panel Passes Broad Medicare Breakthrough Device Coverage Bill

The House Energy & Commerce health subcommittee on Wednesday (Nov. 15) passed a bipartisan bill that would provide broad, four-year, automatic Medicare coverage of breakthrough devices over the concerns of some Democrats -- six of whom voted against the legislation, including E&C ranking Democrat Frank Pallone (NJ) -- about safety issues linked to automatic coverage and the Congressional Budget Office’s informal $7 billion - $12 billion score. Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in...
Overline: 
Despite some Democrats’ cost, safety concerns . . .
Article Type: 
Daily News
Tags: 
device-coverage
device-safety
telehealth
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/17/2023
FDA Volume: 
Vol. 29, No. 46
CMS Issue: 
Inside CMS - 11/23/2023
CMS Volume: 
Vol. 26, No. 47
Author: 
Michelle M. Stein
Topics: 
ISSUE: INSIDE CMS
ISSUE: FDA WEEK
Medicare

CMS Finalizes Nursing Facility Ownership Reporting, Transparency Reqs

CMS on Wednesday (Nov. 15) finalized a set of nursing home transparency provisions requiring Medicare and Medicaid-enrolled nursing homes to report details on ownership, management and operators, as required by the Affordable Care Act. “By strengthening our ability to examine nursing home ownership, including private equity and real estate investment trusts, we can improve transparency for the people we serve and their loved ones, researchers, and regulators, and enable better informed decisions about nursing home care,” CMS Administrator Chiquita Brooks...
Article Type: 
Daily News
Tags: 
SNF
workforce
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 11/23/2023
CMS Volume: 
Vol. 26, No. 47
Author: 
Bridget Early
Topics: 
ISSUE: INSIDE CMS
Biden Health Agenda
Medicaid
Medicare

HHS Unveils Wide-Ranging Draft Exchange Rule

CMS on Wednesday (Nov. 15) unveiled its 2024 draft exchange rule with proposals that aim to increase access to health care, simplify choice, ease enrollment and set new standards for state-based exchanges. Key new policies CMS lays out in a fact sheet on the draft rule include imposing network adequacy requirements for state-based exchanges, allowing states to deem adult dental services as an essential health benefit, and codifying a policy that applies coverage protections for all prescriptions drugs, even those...
Article Type: 
Daily News
Tags: 
ACA
Site Name: 
InsideHealthPolicy.com
HEA Issue: 
Health Exchange Alert - 11/22/2023
HEA Volume: 
Vol. 11, No. 38
Author: 
Amy Lotven
Topics: 
Health-Exchange-Alert
HEALTH AUTO EMAIL
Health Reform Debate
Rx Drugs

GOP Lawmakers’ Brief: Approving Mifepristone Exceeded FDA Authority

A group of Republican senators and representatives are encouraging the Supreme Court to overturn the decades-old FDA approval of abortion pill mifepristone, adding their perspective that FDA exceeded the authority given to it by Congress when it approved mifepristone under a process meant for drugs that treat serious illness. Seventeen senators and 92 members of the House signed on to the brief, which Rep. August Pfluger (R-TX) and Sen. Cindy Hyde-Smith (R-MS) announced in a statement Wednesday (Nov. 15). The...
Article Type: 
Daily News
Tags: 
telehealth
abortion
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/17/2023
FDA Volume: 
Vol. 29, No. 46
Author: 
Jessica Karins
Topics: 
ISSUE: FDA WEEK
HEALTH AUTO EMAIL
Abortion
Rx Drugs
The Courts

CDC: Most Infant Syphilis Cases Preventable With Testing And Treatment

The Centers for Disease Control and Prevention (CDC) found in a new report on rising rates of congenital syphilis that most instances of the disease in infants would be preventable with swift identification of maternal syphilis cases and adequate prenatal treatment, urging providers to test early in pregnancy and begin penicillin treatment. Yet a drug shortage could stymie action. In October, public health groups urged the White House to take action on a shortage of Bicillin L-A penicillin injectors, the...
Article Type: 
Daily News
Tags: 
emergency-response
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/17/2023
FDA Volume: 
Vol. 29, No. 46
Author: 
Jessica Karins
Topics: 
ISSUE: FDA WEEK
HEALTH AUTO EMAIL
Emergency Response
Rx Drugs

E&C Panel Unanimously Sends PBM Reform Bills To Full Committee

The House Energy & Commerce health subcommittee voted unanimously Wednesday (Nov. 15) to advance pharmacy benefit reform bills that would uncouple PBM compensation from prescription drug list prices and establish transparency requirements for PBMs that contract with Medicare Part D and Medicare Advantage plans. The subcommittee also passed legislative proposals that would establish standardized performance measures to assess pharmacy performance in Part D, adjust Part D cost-sharing reductions for low-income beneficiaries, allow plans to boost biosimilars by making mid-year changes...
Article Type: 
Inside Drug Pricing Daily News
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 11/20/2023
IDP Volume: 
Vol. 6, No. 47
Author: 
Gabrielle Wanneh

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