The Expanding Frontier - Commercial Interactions with Patients and Patient Organizations
Over the past two decades, the role that patients play in their health care has dramatically shifted. As a result, there is an increasing need and drive by life science companies to engage with patients (e.g., patient centricity). However, this approach is not without risk as this article will explore.
Over the previous two decades, we have seen a dramatic and transformative change in the role that patients play their health care. Your grandparents, and even your parents, generally were passive players in their care, content to let their “better informed” physicians (“Doctor knows best”) make most of the tre...
Source: Policy and Medicine - October 25, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
OIG Faults CMS for Improper Payment Rates
Under the Improper Payments Information Act of 2002, as amended, the Department of Health and Human Services (HHS) is required to annually report on improper payments and meet certain improvement metrics. In a report released last fall, HHS identified approximately $96.9 billion in gross improper payments in fiscal year (FY) 2016. $90 billion of this money were found to be overpayments.
On May 16, 2017, the HHS Office of Inspector General (OIG) released a report examining these improper payments to determine HHS’s compliance with the statute. In violation of the statute, the improper payment rates for both...
Source: Policy and Medicine - October 25, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Announces Proposed Rule on Innovation Center CJR Model
On August 15, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule to reduce the number of mandatory geographic areas participating in the Center for Medicare and Medicaid Innovation’s (Innovation Center) Comprehensive Care for Joint Replacement (CJR) model from 67 to 34. In addition, CMS proposes to allow CJR participants in the 33 remaining areas to participate on a voluntary basis. In this rule, CMS also proposes to make participation in the CJR model voluntary for all low volume and rural hospitals in all of the CJR geographic areas.
Mandatory Model Changes
CMS also proposes through this...
Source: Policy and Medicine - October 24, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
New Jersey " Gift " Ban Next Step - Public Hearing on Limitations on and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers
Pictured from left to right: Sharon M. Joyce, Acting Director, Division of Consumer Affairs; Christopher S. Porrino, Attorney General of New Jersey; Maryann Sheehan, Director of Legislative and Regulatory Affairs, Division of Consumer Affairs; Rachel D. Glasgow, Regulatory Analyst
“It is our intent to move forward with these rules.” Attorney General, Christopher S. Porrino
Last Wednesday, the New Jersey Office of Attorney General, Division of Consumer Affairs, Department of Law and Public Safety, held a public hearing regarding the state’s proposed regulation, “Limitations on and Obligations Associated with Accep...
Source: Policy and Medicine - October 23, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Coming Soon to a State or Even City Near You - Part 1 Pricing Transparency
As opposition to and concern about the activities of drug manufacturers continue to mount, increasingly states, and even cities, are stepping in to regulate pharmaceutical companies. This is the first in a two-part series focusing on the notable proposed state and city actions and laws and ordinances that have been or soon will be enacted in 2017. The article will focus on drug pricing transparency disclosure legislation that is being introduced at an ever-increasing rate. The pharmaceutical industry cannot fight each and every state and city action successfully. The tr...
Source: Policy and Medicine - October 23, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
New Jersey Holds Public Meeting on Proposed Regulation
Pictured from left to right: Sharon M. Joyce, Acting Director, Division of Consumer Affairs; Christopher S. Porrino, Attorney General of New Jersey; Maryann Sheehan, Director of Legislative and Regulatory Affairs, Division of Consumer Affairs; Rachel D. Glasgow, Regulatory Analyst
“It is our intent to move forward with these rules.” Attorney General, Christopher S. Porrino
Last Wednesday, the New Jersey Office of Attorney General, Division of Consumer Affairs, Department of Law and Public Safety, held a public hearing regarding the state’s proposed regulation, “Limitations on and Obligations Associated with Accep...
Source: Policy and Medicine - October 23, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
The Never-Ending Saga of Off-label Promotion
This article will outline industry’s response and the long-awaited guidance from the FDA around off-label communication.
As the Update reported in the August 2017 issue, the U.S. Food and Drug Administration's (“FDA’s”) 23rd Commissioner, Dr. Scott Gottlieb recognizes and indeed publicly acknowledges FDA’s long-standing practice of medicine exception noting that “while the FDA may limit what drug companies may say about their products to the uses that appear on the drug’s official label, physicians may prescribe their drugs for any condition they choose.” He further stated during his confirmation hearings ...
Source: Policy and Medicine - October 20, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
What Should I Consider Before Joining an APM?
As physician practices consider joining an alternative payment model (APM), Medical Economics published an interesting list of items that should be considered before making the jump into an APM. This is increasingly important as MACRA incentivizes APMs and private payers are also considering APMs more now than ever.
Considerations
The Medical Economics article starts by asking a fundamental question: why do you want to participate? This is important because, as David J. Zetter (founder of Zetter Healthcare Management Consultants) noted, “Ultimately, you should participate in MIPS or an APM because it is also goi...
Source: Policy and Medicine - October 20, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Issues Draft Guidance on Biologic License Applications
The FDA recently released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the minor changes that should be documented in an annual report. As the number of chemistry, manufacturing and controls (CMC) postapproval manufacture supplements continue to increase, the FDA decided to publish this guidance.
Guidance
This guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12. Specifically, the guidance describes chemistry, ...
Source: Policy and Medicine - October 19, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Class Action Suits Over Opioid Epidemic Ramping Up
A coalition of 41 states' attorneys general have served five major opioid manufacturers with subpoenas seeking information about how these companies marketed and sold prescription opioids. The coalition is also demanding documents and information related to distribution practices from three drug distributors.
The investigative subpoenas and document requests were sent to pharmaceutical manufacturers Endo International, Janssen Pharmaceuticals, Teva Pharmaceutical Industries Ltd./Cephalon Inc. and Allergan. The group also served a supplemental investigative subpoena to Purdue Pharma. Documents were also requested of three ...
Source: Policy and Medicine - October 18, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AmerisourceBergen Specialty Group Pleads Guilty to Distributing Misbranded Drugs
On September 27, 2017, AmerisourceBergen Specialty Group (ABSG), a wholly-owned subsidiary of AmerisourceBergen Corporation, one of the nation’s largest wholesale drug companies, pled guilty to illegally distributing misbranded drugs. ABSG agreed to pay a total of $260 million to resolve criminal liability for its distribution of oncology supportive-care drugs from a facility that was not registered with the Food and Drug Administration (FDA). The guilty plea and sentencing took place before United States District Judge Nina Gershon.
As set forth in court records, between 2001 and 2014, two of ABSG’...
Source: Policy and Medicine - October 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Florida Governor Proposes Limit on Prescribed Opioids
At the end of September, Florida Governor Rick Scott announced that during the upcoming legislative session, he will propose new legislation – including more than $50 million to next year’s budget – to combat opioid abuse in Florida.
The proposed legislation will include:
Placing a three-day limit on prescribed opioids, unless strict conditions are met for a seven-day supply;
Requiring all healthcare professionals that prescribe or dispense medication to participate in the Florida Prescription Drug Monitoring Program, a statewide database that monitors controlled substance prescriptions; and
Additional r...
Source: Policy and Medicine - October 16, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
ABMS Launches New Initiative: Continuing Board Certification
The American Board of Medical Specialties (ABMS) and its twenty-four Member Boards have launched a major initiative, "Continuing Board Certification: Vision for the Future" (Commission). A collaborative process, the Commission will bring together multiple partners to vision a system of continuing board certification that is meaningful, relevant and of value, while remaining responsive to the patients, hospitals and others who expect that physician specialists are maintaining their knowledge and skills to provide quality specialty care.
The Planning Committee to establish the Commission will include representatives from: A...
Source: Policy and Medicine - October 13, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AMA/ACCME Alignment Implementation Now Live
The American Medical Association (AMA) and the ACCME are working together to develop a list of frequently asked questions (FAQ), instructions for designating credit, and other resources that will be available by the end of September. These resources will support CME providers’ implementation of the simplification and alignment of the requirements for accredited CME activities certified for AMA PRA Category 1 Credit™. The resources are posted here.
As previously announced, the simplification is reflective of the AMA and ACCME’s shared values and is designed to encourage innovation and flexibility in accre...
Source: Policy and Medicine - October 12, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AMA/ACCME Alignment Implementation Coming Soon
The American Medical Association (AMA) and the ACCME are working together to develop a list of frequently asked questions (FAQ), instructions for designating credit, and other resources that will be available by the end of September. These resources will support CME providers’ implementation of the simplification and alignment of the requirements for accredited CME activities certified for AMA PRA Category 1 Credit™. As soon as these resources are available, they will be posted on the AMA/ACCME Alignment webpage.
As previously announced, the simplification is reflective of the AMA and ACCME’s share...
Source: Policy and Medicine - October 12, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
