News & Analysis as of

Healthcare Law Update: March 2017

Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more

"Republicans Chart New Course for US Health Care System"

While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

21st Century Cures Act Brings Medicare Reimbursement and Policy Changes in 2017

Changes include increased transparency, delayed DMEPOS payment reductions, changed reimbursement for infusion drugs, changed hospital policies and more. On December 13, 2016, President Obama signed into law the 21st...more

Healthcare Law Update: December 2016

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move...more

Medicare, Medicaid Payment Policies, Fraud Authorities Enacted as Part of 21st Century Cures Act

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). While much of the focus has been on policies intended to accelerate drug and device development and approval, the Cures Act also...more

House Passes 21st Century Cures Act

On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more

CMS Delays Expanding Medicaid Rebate Program, Price Reporting Requirements to Territories Until 2020

CMS has announced that it is delaying until April 1, 2020 its controversial change in the definitions of “States” and “United States” included in the February 1, 2016 Medicaid covered outpatient drug final rule with comment...more

It’s Hunting Season. For Unicorns? Lawsuit Against Theranos Signals Trend In Investors Going After Late-Stage Start-ups

Last week brought more bad news for private blood testing company Theranos Inc., as San Francisco-based Partner Fund Management L.P. (“PFM”) launched a suit claiming that it was duped into making a $96.1 million investment in...more

Five Things to Know About the Mylan EpiPen “Settlement” – What It Is and What It Isn’t

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate...more

Manatt on Health Reform: Weekly Highlights - October 2016 #2

Kentucky receives final approval from CMS to transition its Marketplace to the HealthCare.gov platform; Ohio puts a prescription drug price ceiling on its November 2017 ballot; and a new study links Medicaid expansion to...more

House Bill Would Block CMS Proposed New Payment Model for Part B Drugs

The Congressional Budget Office (CBO) released a report on October 4, 2016, estimating that a bill in the U.S. House of Representatives to block the implementation of CMS’s proposed payment model for Part B drugs would cost...more

HRSA Announces Two-Day Extension of Fall 2016 340B Registration Period

On September 27, 2016, the Health Resources and Services Administration (HRSA) sent an email announcement that it will extend its quarterly registration period for the 340B Drug Pricing Program (340B Program) by two days...more

NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on...more

GAO Report Suggests Discount Coupons Impact Medicare Spending for Part B Drugs

Last month, the U.S. Government Accountability Office (GAO) released a report in which it found that manufacturer drug coupon programs for privately insured patients could potentially cause the Medicare Part B program to...more

OIG Highlights Varying Local Medicare Part B Drug Coverage Policies; Recommends Single Entity to Make Drug Coverage Determinations

The OIG has issued a report entitled “MACs Continue to Use Different Methods to Determine Drug Coverage,” which reviews how Medicare Administrative Contractors (MACs) make Medicare Part B drug coverage determinations and...more

Manatt on Health Reform: Weekly Highlights - August 2016 #4

HealthCare.gov plans an open enrollment pilot that will let consumers compare provider network breadth; new Medicaid enrollees reduce out-of-pocket spending on prescription drugs by nearly 60%; and Kansas’s Governor announces...more

CMS Hosts Call on Potential Future Changes to Open Payments/Sunshine Act Reporting Requirements (Aug. 2)

On August 2, 2016, CMS is hosting a Special Open Door Forum Call on potential future changes to Open Payments/Physician Payments Sunshine Act requirements for reporting payments and transfers of value made by drug and device...more

Manatt on Health Reform: Weekly Highlights - July 2016 #3

Massachusetts’s Marketplace eliminates cost-sharing for addiction treatment in subsidized QHPs; Montana cuts its uninsurance rate in half; and a Kaiser report identifies the 50 most costly drugs for Medicaid....more

Addressing the Opioid Crisis

Following the July 13 U.S. Senate's passage of Comprehensive Addiction and Recovery Act (CARA), providers, families and communities should evaluate the act's impacts. The reform, S. 524, is viewed as a comprehensive approach...more

CMS Posts Open Payment Data – $7.52 Billion in 2015

CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

A&B Healthcare Week in Review

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

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