Senators Blumenthal and Grassley Ask CMS to Continue Funding Open Payments
In a letter to Acting Secretary of the U.S. Department of Health and Human Services (HHS) Eric D. Hargan, United States Senators Richard Blumenthal (D-CT) and Chuck Grassley (R-IA) ask HHS to prioritize funding for the Center for Medicare and Medicaid Services’ Center for Program Integrity (CPI), a program that enhances transparency in transactions between medical providers and pharmaceutical companies.
The CPI’s Open Payments database, created under the bipartisan Physician Payments Sunshine Act, mandates disclosure of billions of dollars in payments from manufacturers to prescribers and hospitals. This is of concern...
Source: Policy and Medicine - November 9, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Provides Guidance on Medical Devices
Recently, the FDA released two final guidances and a new draft guidance to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the first qualified tool under the voluntary Medical Device Development Tools (MDDT) program.
Final Guidances
The two final guidances released are designed to help developers understand when a modification to a device — which would include a software update — requires a new 510(k) clearance. The guidances, "Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) f...
Source: Policy and Medicine - November 8, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
MedPAC Discusses Part D Exceptions and Appeals Process
Discussion
Commissioner Jack Hoadley of Georgetown University highlighted the need for a “good, effective” solution to the appeals process and that data limitations make it difficult to make sense of what the numbers actually mean. He was supportive of ePA, noting that he is encouraged by the technology and believes that it can be a “good route” to improving the exceptions and appeals process.
Commissioner Amy Bricker of Express Scripts called for a requirement centered around eRx. She noted that eRx gives the clinician more control and provides an effective solution for all parties involved. Ms. Bricker said tha...
Source: Policy and Medicine - November 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Releases Final Rule for Second Year of QPP - Includes PI-QI CME Improvement Activity
Last week, the Centers for Medicare & Medicaid Services (CMS) released a final rule that makes changes in the second year of the Quality Payment Program (QPP) under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), including the Merit-based Incentive Program (MIPS) and Advanced Payment Models (APMs). The second year of the QPP continues to build on transitional year 1 policies, noting that a “second year to ramp-up the program will continue to help build upon the iterative learning and development of year 1 in preparation for a robust program in year 3.”
In addition to the final rule, CMS als...
Source: Policy and Medicine - November 6, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Releases Final Rule for Second Year of QPP
Last week, the Centers for Medicare & Medicaid Services (CMS) released a final rule that makes changes in the second year of the Quality Payment Program (QPP) under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), including the Merit-based Incentive Program (MIPS) and Advanced Payment Models (APMs). The second year of the QPP continues to build on transitional year 1 policies, noting that a “second year to ramp-up the program will continue to help build upon the iterative learning and development of year 1 in preparation for a robust program in year 3.”
In addition to the final rule, CMS als...
Source: Policy and Medicine - November 6, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Sharing Negotiated Discounts Could Save Patients Money
Providing access to discounted medicine prices at the point of sale (i.e., at the pharmacy directly) could save certain commercially insured patients with high deductibles and coinsurance anywhere between $145 to more than $800 annually, according to a new analysis from Milliman that was commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA). The data also show sharing negotiated rebates with patients would have a minimal impact on premiums because it would only increase health plan costs on average 1 percent or less.
“Shifting costs to the sickest patients by requiring higher rates of cost-sha...
Source: Policy and Medicine - November 3, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
MedPAC Discusses Next Steps for MIPS
During the October public meeting of the Medicare Payment Advisory Commission (MedPAC), the Commissioners held a session to examine the future of the Merit-based Incentive Payment System (MIPS) in which they discussed recommending that MIPS be repealed. During the session, commissioners discussed the complexities and administrative burden associated with implementing MIPS, with specific criticisms focused on measures and scoring concerns, as well as clinical practice improvement areas.
David Glass, MedPAC Principal Policy Analyst, outlined in greater detail the concerns with MIPS. The problem with the MIPS scoring...
Source: Policy and Medicine - November 2, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Senate HELP Committee Holds Hearing on Opioid Response
Discussion
Senator Chris Murphy highlighted that Dr. Katz is the first Assistant Secretary for Mental Health and Substance Use at SAMHSA, a new position created under the 21st Century Cures Act. She detailed for the committee the many activities SAMHSA is overseeing to implement the CARA and 21st Century Cures Act, including administering a wide range of grant streams aimed at mental health interventions and the proliferation of medication assisted treatment. She emphasized to the lawmakers the importance of greater integration of mental health and substance abuse treatment into primary care, and better training among a w...
Source: Policy and Medicine - November 1, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Will Your Whistle Be Heard at Home?
The distinct split between the Second and Fifth Circuit Courts’ interpretation as to when whistleblower protections are allowed has now summoned the attention of the U.S. Supreme Court. Despite clarifications issued in 2015 by the SEC to shed more clarity on Dodd Frank’s anti-retaliation protection to whistleblowers who reported alleged misconduct either internally to company officials or externally to government regulatory bodies, the U.S. Supreme Court will take the case of Digital Realty Trust v. Somer in the Fall of 2017, and finally render a final verdict for w...
Source: Policy and Medicine - October 31, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
United States Senate Focuses on Opioids
Senate Finance Committee Chairman Orrin Hatch, along with 10 of his Republican Committee colleagues, recently called on the Department of Health and Human Services (HHS) to increase safeguards against opioid fraud. In the letter, the senators request information about HHS’ measures to prevent opioid abuse among Medicare Part D providers and beneficiaries.
The letter requests details regarding the HHS Office of Inspector General’s (OIG) report issued last July, which found that one in three Medicare Part D beneficiaries received a prescription opioid in 2016 – as many as 500,000 of those beneficiaries were receiving ...
Source: Policy and Medicine - October 31, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Getting Serious About Fraud - The DOJ Charges 412
With the new administration, there appears to be a renewed commitment to enforcing anti-kickback rules against healthcare providers committing fraud against the government insurance programs. In July 2017, the Department of Justice and Department of Health and Human Services announced the largest-ever fraud takedown in the health care arena. This article outlines the announcement, and what it may mean for the future of health care.
It has long been a topic of discussion among life science compliance professionals that when it comes to anti-kickback enforcement, the g...
Source: Policy and Medicine - October 30, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Founder and Owner of Insys Arrested
Late last week, John N. Kapoor, the founder and majority owner of Insys Therapeutics, Inc., was arrested and charged with leading a conspiracy to profit by using bribes and fraud to cause the illegal distribution of a Fentanyl spray intended for cancer patients experiencing breakthrough pain.
The superseding indictment includes allegations of RICO conspiracy, conspiracy to commit mail and wire fraud, and conspiracy to violate the Anti-Kickback law. It also includes additional allegations against former Insys executives and managers who were initially indicted in December 2016.
The Justice Department claims that Kapoor an...
Source: Policy and Medicine - October 30, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
UPDATE: Round 2 with Ohio ’s Drug Sample Verification Requirements
This article provides an update with new information from the Ohio State Board of Pharmacy, as well as a one-page “cheat sheet” of those requirements.
The following synopsis provides an update to the article, Ohio Drug Distribution Verification: America’s Key Battleground State Shakes Up the Pharmaceutical Supply Chain. In addition, this update provides new data, a one-page “cheat sheet” for non-controlled prescription drug sample distribution into and within the state that also includes the supporting references and an example of a sample/complimentary request...
Source: Policy and Medicine - October 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Aegerion Resolves Criminal and Civil Actions
Aegerion recently finalized a $40.1 million settlement that resolves civil and criminal charges over its marketing of JUXTAPID®. We previously published an article outlining agreements in principle with the Department of Justice (DOJ) and Securities and Exchange Commission (SEC), following inquiries into the company to determine whether the company’s commercial activities violated laws and regulations.
The $40.1 million settlement is split between cases brought by the DOJ and the SEC – with $36 million resolving cases by the DOJ and $4.1 million resolving an SEC lawsuit. Sales representatives were trained to tell doc...
Source: Policy and Medicine - October 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
House Passes Medicare Part B Improvement Bill
Earlier this year the U.S. House of Representatives passed a bipartisan bill, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law (Section 1877(h)(1) of the Social Security Act) and impact other provisions governing Medicare Part B. It is now in the hands of the Senate for further action.
The bill would codify Stark Law changes previously made by the Centers for Medicare and Medicaid Services in the Medicare Physician Fee Schedule that took effect on January 1, 2016.
Additionally, the bill would:
provide that the writing requirement for certain compensation arrangements may be satisfi...
Source: Policy and Medicine - October 26, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
