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OIG's Proposed Drug Pricing Safe Harbor Amendments: "Hot Takes"
Late yesterday, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule to amend the anti-kickback safe harbors
United States
7 Feb 2019
2
HHS Proposes Changes To HIPAA Transaction Standard For Prescriptions For Schedule II Drugs In Retail Pharmacy Transactions
The Department of Health and Human Services (HHS) has issued a proposed rule that would modify the current HIPAA transaction standard for retail pharmacy transactions (the August 2007 revision of NCPDP telecommunications standard D.0) with respect to claims and similar transactions for Schedule II drugs.
United States
6 Feb 2019
3
CMS Launches New Medicare Part D Payment Modernization Model
The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D Payment Modernization Model (Part D Model), which will be tested by the CMS Center for Medicare and Medicaid Innovation.
United States
6 Feb 2019
4
CMS Announces Significant Expansion Of And Increased Flexibility Under Medicare Advantage Value-Based Insurance Design (VBID) Model
The Centers for Medicare & Medicaid Services (CMS) is making extensive revisions to its Medicare Advantage (MA) Value-Based Insurance Design model in order "to contribute to the modernization
United States
31 Jan 2019
5
Prescription Drug Purchasing Initiative In California Raises Legal Questions
Last week, California Governor Gavin Newsom signed an Executive Order creating a program to lower prescription drug costs throughout the state.
United States
24 Jan 2019
6
OIG Gives Stamp Of Approval For Innovative Warranty Program
The Office of Inspector General (OIG) recently approved a medical device manufacturer's innovative proposed warranty program ...
United States
10 Oct 2018
7
OIG Issues Request For Information On Federal Anti-Kickback And Beneficiary Inducement Issues
The OIG of the Department of Health Human Services is seeking input on Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP.
United States
14 Sep 2018
8
OIG Moving Ahead On Changes To Anti-Kickback Safe Harbor Protection For Drug Rebates To Plans, PBMs
On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS)
United States
25 Jul 2018
9
Analysis Of Medicare, Medicaid, And Other Health Policy Provisions In Bipartisan Budget Act
The newly-enacted Bipartisan Budget Act of 2018 includes numerous Medicare, Medicaid, and other policy and payment provisions impacting health providers and manufacturers.
United States
27 Feb 2018
10
Trump Administration Proposes Rules To Expand Short-Term, Limited Duration Insurance Plans
The Trump Administration has issued a potentially highly-significant proposed rule intended to expand the availability of short-term, limited duration insurance policies that are exempt from Affordable Care Act ...
United States
27 Feb 2018
11
Looking Ahead To A Trump Administration: Health Care And Life Sciences Industry Perspectives
Observers are digesting what the Trump Administration will mean for the health care and life sciences industry.
United States
11 Nov 2016
12
Donald Trump Proposes Prescription Drug Importation As Element Of Health Reform Plan
Donald Trump has released his plan for "Healthcare Reform to Make America Great Again", which includes a proposal for allowing importation of cheaper prescription drugs from other countries...
United States
4 Mar 2016
13
HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs
In its September 19, 2014 Special Advisory Bulletin (SAB), the Office of Inspector General (OIG) of the Department of Health & Human Services (HHS) noted the potential risks to federal health care programs presented by pharmaceutical manufacturers’ coupon programs designed to reduce or eliminate patient copayment requirements for brand-name drugs, and emphasized that coupon program sponsors and pharmacies are at risk of sanctions if they fail to take appropriate steps to carve out federal health
United States
25 Sep 2014
14
CMS And The OIG Extend Protections For Electronic Health Record Donations
On December 27, 2013, the Office of Inspector General ("OIG") and the Centers for Medicare & Medicaid Services ("CMS") each published, in the Federal Register, a final rule that amends regulations under the Anti-Kickback Statute ("AKS"),
United States
25 Jan 2014
15
ACA Affordable Insurance Exchanges and Qualified Health Plans*
This Client Alert focuses upon some of the most significant features of QHPs and related issues, with a particular emphasis on prescription drugs.
United States
22 Mar 2013
16
Is This Prescription Part B or Part D? Sorting Out One of the Drug Benefit’s Most Complicated Issues
Determining whether a drug is covered by Medicare Part B or Part D is one of the most complicated issues that has arisen with the implementation of the new outpatient prescription drug benefit. Medicare Part D coverage is excluded for drugs where coverage is available under Medicare Part B. In most cases a drug will be covered under Part D because it is dispensed in the retail setting as an outpatient prescription drug. However, in some cases, it is possible that a drug may be covered under Part
United States
16 Jun 2006
17
Interim Final Rule on OIG Civil Money Penalties Under the Medicare Drug Discount Card Program
The Office of the Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") has issued an interim final rule that sets forth the OIG’s new authority for imposing civil money penalties ("CMPs") against endorsed sponsors under the Medicare prescription drug discount card program ("the CMP interim final rule") established under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the "MMA&quo
United States
8 Jul 2004
18
New Medicare Prescription Drug Legislation May Impact Institutional Pharmacies and Their Nursing Facility Customers
On December 8, 2003, President Bush signed into law the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (the "Act"). The Act makes numerous changes to the Medicare and Medicaid programs, including the addition of programs to expand Medicare coverage of outpatient prescription drugs.
United States
22 Jan 2004
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