MedPAC Proposes Changes to Medicare Part D for Biosimilars
In mid-January 2018, the Medicare Payment Advisory Commission (MedPAC) met to discuss Medicare payment adequacy and vote on 2019 Medicare payment update recommendations. The recommendations approved during this meeting will appear in the 2018 Report to Congress by the Commission.
One of the recommendations finalized by the Commission involved Medicare Part D, stating that Congress should change Part D’s coverage-gap discount program to require manufacturers of biosimilar products to pay the coverage-gap discount by including biosimilars in the definition of “applicable drugs” and exclude biosimilar manufacturers’ ...
Source: Policy and Medicine - January 29, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
MedPAC Commissioners Propose Replacing MIPS
During the January meeting of the Medicare Payment Advisory Commission (MedPAC), staff and Commissioners discussed the Merit-based Incentive Payment System (MIPS), among other hot topics. The commissioners proposed to eliminate the current Merit-based Incentive Payment System and in its place put a new voluntary value program in fee-for-service Medicare in which clinicians can elect to be measured as part of a voluntary group and clinicians in the voluntary groups can qualify for a value payment based on their group’s performance on a set of population-based measures.
Two commissioners did vote against the proposal, wit...
Source: Policy and Medicine - January 26, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Changes Policy Regarding Enforcement Actions
On October 27, 2017, CMS issued a draft Survey and Certification Memo (S & C Memo) in which it announced its intention to reverse a previous policy regarding “immediate jeopardy” and federal enforcement actions. The new draft policy significantly revises the previous position of CMS and offers a more equitable and pragmatic approach to enforcement actions.
CMPs
CMS Regional Offices have been imposing high 6-figure civil money penalties (CMP), and frequently CMPs well in excess of $1 million, for alleged deficiencies that constitute immediate jeopardy. The approach by CMS regarding CMPs was fueled, in part, by an ...
Source: Policy and Medicine - January 25, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
The Monster in the Closet - New WHO Report Shines a Light on the Problem of Substandard & Falsified Medicines
The issue of substandard and counterfeit medicines has been known for some time. Since it is not often discussed openly, it is difficult to get an appreciation for the scope of the problem. However, a new WHO report, backed by four years’ worth of data, sheds some light on the matter and gives some guidance on how to identify likely problems and respond to them.
As with any industry, there is a dark and ugly side to the pharmaceutical business. It is a side that industry professionals are acquainted with, but do not talk about in polite society. It is the dark side of substandard and counterfeit (e.g., falsified) medici...
Source: Policy and Medicine - January 24, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Federal Grand Jury Indicts Three in Opioid Scheme
With the opioid crisis rapidly gaining steam, we are starting to see some of the legal ramifications from the overprescribing of opioids. Recently, two doctors and their business partner were indicted in federal court for allegations that they were illegally distributing drugs.
George P. Naum, a physician from Wheeling, WV; Felix Brizuela, Jr., a physician from Harrison City, Pennsylvania; and their business partner Eric Drake from Weirton, West Virginia were the three men indicted.
Dr. Brizuela was indicted on 21 counts of distribution of controlled substances outside the bounds of professional medical practice; one cou...
Source: Policy and Medicine - January 24, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AARP v. EEOC : Motion to Vacate Granted
In AARP vs. EEOC, U.S. District Court Judge John D. Bates granted a motion by AARP to vacate the EEOC’s current wellness regulations, which allow companies to charge employees who decline to participate in wellness questionnaires and exams with penalties. The resulting decision is a win for workers seeking to protect their medical and genetic information but also creates uncertainty within the compliance landscape for employer wellness programs.
Background and Decision
A wellness program involving medical exams or inquiries must be voluntary in order to comply with the Americans with Disabilities Act (ADA) an...
Source: Policy and Medicine - January 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Privacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical Research
This article discusses key considerations in implementing the GDPR for companies sponsoring and managing clinical trials.
With an ever-abundant list of important compliance requirements to contend with, life sciences compliance officers have no shortage of challenges. And the new year won’t offer any reprieve given the fast-approaching enforcement date for the General Data Protection Regulation (“GDPR”), the European Union’s (“EU’s”) new, comprehensive data protection law. On May 25, 2018, enforcement of the GDPR will begin, and there is much to do between now ...
Source: Policy and Medicine - January 22, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
E & C Health Subcommittee Votes to Advance Allowing Truthful Off Label Communication
Immediately before the government shutdown, the Energy and Commerce Health Subcommittee held a markup to advance three health care bills, including a measure designed to give drug and medical device companies more freedom to discuss off-label information, one that would overhaul how the Food and Drug Administration (FDA) regulates over-the-counter (OTC) drugs, and another that would shield a health care professional from liability related to “an act or omission” that occurs as a volunteer in response to a disaster.
Opening Statements
Opening statements were provided by E&C Committee Chairman Greg Walden, E&C Committe...
Source: Policy and Medicine - January 22, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Male Doctors Make More in Industry Payments Than Females
A new gender wage gap has been found. A recent study suggests that male physicians in the United States took in more money from the biopharmaceutical industry in 2015 than their female peers, across almost every specialty.
Researchers analyzed the general industry payments, including research grants, consulting fees, and food and beverage expenses, earned by 933,925 physicians.
Two-thirds of the doctors in the study were male. Across all specialties, men received a higher per-physician value of general payments versus women, with a median difference of $1,470. The discrepancy in neurosurgery was particularly wide, with t...
Source: Policy and Medicine - January 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Christmas Comes Early - The FCPA Pilot Program Made Permanent
This article will review some of the key highlights outlined by the DOJ and some considerations for compliance professionals.
The heat is on life science companies. Since 2013, there have been 25 Foreign Corruption Practices Act (“FCPA”) matters involving life science companies, 13 of which occurred in the last two years. Although life science companies have not been immune to FCPA investigations in the past, the statement of Acting Chief of the U.S. Department of Justice (“DOJ”) Fraud Section, Sandra Moser in August was loud and clear - the DOJ would be increasing its enforcement efforts of healthcare relat...
Source: Policy and Medicine - January 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Study Highlights Physician QPP Preparedness
Fewer than one in four physicians feel they are prepared to meet requirements under the CMS’ Quality Payment Program (QPP), a new American Medical Association and KPMG survey shows. Out of 1,000 physicians involved in practicing decision-making related to the QPP, only 8% said they were “deeply knowledgeable” about MACRA and QPP. In contrast, almost 92% said they were “somewhat knowledgeable” or not knowledgeable. All of this spells danger for the new program as CMS struggles to inform physicians about the new requirements even as a performance year has almost already been completed.
Study Results
According to ...
Source: Policy and Medicine - January 18, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few Signs of Letting Up
This article reviews the OIG’s focus in 2017 and looks ahead to what may be in store for 2018.
For life science compliance professionals, following the activities of the Office of Inspector General (“OIG”) for the Department of Health and Human Services is both a question of curiosity and necessity. With the limited amount of formal guidance available, the OIG’s actions provide vital clues as to the agency’s thinking and focus in the near future.
As we closed out 2017, two overarching themes emerged. The first was the need to invest in internal auditing and measurement of compliance programs, and the second the...
Source: Policy and Medicine - January 17, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Nevada Posts FAQ and Reporting Requirements on Transparency Law
This report must be submitted via email annually by April 1st of each year for the previous calendar year. DHHS then compiles a report and posts it in accordance with NRS 439.
Pharmacy Benefit Managers
PBMs are also required to submit a report to DHHS by April 1st of each year. The required information for that report is as follows.
Pharmaceutical Sales Representatives
Pharmaceutical sales reps that are on a list submitted to DHHS by drug manufacturers anytime during the previous calendar year must submit their report by March 1st of the year, including the below items.
&...
Source: Policy and Medicine - January 17, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Senate Confirmation Hearing for Alex Azar - Open Payments to Remain Open
On January 9, 2018, the Senate Finance Committee held a nomination hearing for Alex Azar, President Trump’s pick to lead the Department of Health and Human Services (HHS). The Committee is expected to vote later this month on whether to send Mr. Azar’s nomination to the Senate floor. Throughout the hearing, Azar spoke of his past experience in the Department of Health and Human Services (HHS) during the George W. Bush Administration, as well as expertise he gained during his time in the private sector with pharmaceutical company Eli Lilly.
Although Republican members thought his experience would lend itself to the pos...
Source: Policy and Medicine - January 16, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Senate Holds Confirmation Hearing for Alex Azar
On January 9, 2018, the Senate Finance Committee held a nomination hearing for Alex Azar, President Trump’s pick to lead the Department of Health and Human Services (HHS). The Committee is expected to vote later this month on whether to send Mr. Azar’s nomination to the Senate floor. Throughout the hearing, Azar spoke of his past experience in the Department of Health and Human Services (HHS) during the George W. Bush Administration, as well as expertise he gained during his time in the private sector with pharmaceutical company Eli Lilly.
Although Republican members thought his experience would lend itself to the pos...
Source: Policy and Medicine - January 16, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
