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Medical Devices Patient Protection and Affordable Care Act (PPACA) Prescription Drugs

Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

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On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – June 2020 #20

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In Washington: The House is set to vote on the two high-profile policy issues before leaving town for the two-week July 4 recess, however, neither of the measures is likely to be taken up in the GOP-controlled Senate,...more

Foley & Lardner LLP

FDA Publishes Enforcement Policies to Address Coronavirus Personal Protective Equipment Shortages

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In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more

Holland & Knight LLP

Healthcare Law Update: October 2019

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In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

BakerHostetler

Capitol Hill Healthcare Update

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Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. HOUSE PANEL TO VOTE ON BIPARTISAN DRUG PRICING MEASURE - The House Ways and Means Committee is scheduled to...more

BakerHostetler

Capitol Hill Healthcare Update

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Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: PBMs next in Senate committee’s crosshairs; lawmakers continue scrutiny on insulin prices;...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: Trump will discuss healthcare and drug costs in this week’s State of the Union address;...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Highlights this week: how the partial government shutdown is affecting operations at the FDA; House Democrats take steps to defend the ACA; the House votes this week to renew emergency health response programs; new senators...more

McGuireWoods Consulting

Washington Healthcare Update

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This Week: To shut down or not to shut down the issue as Congress tries to wrap up and leave; opioids back in the news; Alexander says he will not run for reelection in 2020. ...more

Mintz - Health Care Viewpoints

Sunshine Act Expands to Advance Practice Nurses and Physician Assistants

Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more

Ruder Ware

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

Ruder Ware on

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

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The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

Stinson - Benefits Notes Blog

New Law Permits Stand-Alone Health Reimbursement Arrangements (HRAs) For Small Employers

On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more

McDermott Will & Emery

OIG Work Plan: A Roadmap to Identify Health Care Compliance Risk

Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond....more

Hinshaw & Culbertson LLP

OIG Mid-Year Updated Provides Insight To Its Concerns

The Office of Inspector General (OIG) recently released its mid-year update of its Fiscal Year Work Plan for 2016. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue. Not...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

Mintz - ML Strategies

Health Care Update - December 2015

Mintz - ML Strategies on

Cadillac Tax Repeal Garners Bipartisan Support; Prospects for Implementation Delay Increase - Last week, the Senate passed its reconciliation package by a vote of 52-47, sending it back to the House for approval and...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

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