Nicholas Manetto

Nicholas Manetto

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Centers for Medicare & Medicaid Services (CMS)

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Federal Health Care Legislative Agenda: Fall Updates

As Congress returns and summer turns to fall, the federal health care legislative agenda remains crowded. While much near-term energy is focused on September 30 and averting a shutdown of the federal government before the...more

9/8/2023  /  Centers for Medicare & Medicaid Services (CMS) , Continuing Resolution , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM)

Three New Prescription Drug Innovation Models Latest Action on Drug Pricing

As the Biden administration moves ahead to implement provisions of the Inflation Reduction Act (IRA), including those related to drug negotiation and inflationary rebate, the administration announced three Medicare and...more

2/17/2023  /  Centers for Medicare & Medicaid Services (CMS) , CMMI , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

Lawmakers Introduce Cures 2.0 Legislation

Nearly five months after releasing their initial 21st Century Cures 2.0 draft, Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) introduced the long-anticipated bill on November 15. The bill includes...more

11/18/2021  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , PDUFA , Pharmaceutical Industry

Long-Awaited 21st Century Cures Act 2.0 Draft Released

Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...more

6/24/2021  /  Centers for Medicare & Medicaid Services (CMS) , Clinical Trials , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Research , PDUFA , Public Health

Trick or Treat? Expected and Surprising Provisions in the New Medicare Advantage Regulation

On October 26, the Centers for Medicare and Medicaid Services (CMS) released a 362-page proposed regulation that makes changes to three expected areas: - New telehealth flexibilities for Medicare Advantage (MA) plans....more

11/2/2018  /  Centers for Medicare & Medicaid Services (CMS) , Medicare , Medicare Advantage , Medicare Part D , Proposed Regulation

Requiring a Price Tag in Drug Commercials: Furthering Consumer Transparency or Government Overreach?

The Trump Administration released a draft regulation published in the Federal Register on October 18, 2018, which proposes to require drug manufacturers to include a drug’s list price in its direct-to-consumer (DTC)...more

10/19/2018  /  Advertising , Centers for Medicare & Medicaid Services (CMS) , Comment Period , Department of Health and Human Services (HHS) , Direct to Consumer Sales , Pharmaceutical Industry , Prescription Drugs , Television Commercials , Trump Administration

CMS Greenlights Indication-Based Formulary Design: What Do You Need to Know?

In its latest effort to implement the Trump administration’s plan to address concerns over the cost of drugs, the Centers for Medicare and Medicaid Services (CMS) announced that Part D drug plans can begin applying...more

9/7/2018  /  Centers for Medicare & Medicaid Services (CMS) , Medicare , Medicare Part D , Prescription Drug Coverage , Prescription Drugs

A New Advantage in Medicare: New Benefit Flexibilities Will Change Medicare Advantage

A provision included in the recently enacted budget law will now make it much easier for Medicare Advantage (MA) plans to offer a wide array of supplemental benefits within their plans. This will create new opportunities for...more

2/14/2018  /  Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Medicare , Medicare Advantage

A Step Toward ‘Replace' Without the ‘Repeal': The Trump Administration Re-Regulates Obamacare

On Friday, October 27, the Centers for Medicare and Medicaid Services (CMS) published its draft annual Proposed Notice of Benefits and Payment Parameters for Calendar Year 2019. This proposal follows on the heels of a Request...more

11/3/2017  /  Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Essential Health Benefits , Health Insurance , Qualified Health Plans , Repeal , Trump Administration

$840 Million Available to Drive Practice Transformation

After a fairly quiet year in terms of new funding announcements, the Center for Medicare and Medicaid Innovation (CMMI) has released an $840 million solicitation that seeks to drive 150,000 clinicians toward delivering...more

10/28/2014  /  Centers for Medicare & Medicaid Services (CMS) , Federal Funding , Funding , Health Care Providers , Hospitals , Physicians
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