CMS Proposes Changes to Part D and Medicare Advantage
Earlier this year, CMS proposed changes to the Medicare Advantage and Part D programs through the Advanced Notice and Draft Call Letter for 2019. This is important as Medicare Advantage enrollment grows each year. One-third of Medicare beneficiaries are now enrolled in Medicare Advantage Plans.
Proposed Policies
CMS notes that the proposed policies and updates for 2019 are intended to “remove barriers to innovation and foster greater transparency, flexibility, and program simplification.” CMS proposes an average rate increase of 1.84%, and factoring in plan coding practices CMS estimates a net payment increase of 4.9...
Source: Policy and Medicine - April 11, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
The Day After Tomorrow – The Drug Pricing Transparency Chorus Grows Louder
This article examines the current state and what the future may hold.
Breaking with the tradition of past Food and Drug Administration (“FDA”) heads, Dr. Scott Gottlieb continues to speak out on drug pricing and competition; topics usually considered outside of the Commissioner’s purview. However, Dr. Gottlieb is not alone.
The chorus of advocates calling for transparency in drug pricing transparency has rapidly grown from citizen activists and academics to legislators at all levels of government and now the FDA Commissioner. What is remarkable is the uniformity of their reasoning why transparency is necessary and ...
Source: Policy and Medicine - April 10, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Conflicts of Interest: When Should We Pay Attention
We have previously written about financial conflicts of interest and whether physicians can disseminate impartial scientific information if they have a conflict of interest, or if the conflict of interest negates anything the physician (or other medical professional) says. With the introduction of Open Payments and other copy-cat systems around the world, this idea continues to get more dangerous as days go on.
In February 2018, the Baltimore Sun published an article by a family physician who drew pause at the fact that the new blood pressure guidelines published by the American College of Cardiology and the American Hear...
Source: Policy and Medicine - April 10, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Senate Holds Hearing on 340B Drug Pricing Program
Conclusion
Given the widespread support for the 340B program, it is likely that it is here to stay. What remains to be seen, however, is whether Congress will work to reign in the out-of-control side of it and modify it back on a sustainable path like was initially intended.
Related StoriesHouse of Representatives Holds Two-Day Hearing on OpioidsHigher Outpatient Drug Spending At 340B Hospitals, According to New AnalysisHouse Subcommittee on Health Holds Hearing on MACRA (Source: Policy and Medicine)
Source: Policy and Medicine - April 9, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Gottlieb Discusses Opioids and Lays Out Vision - Google it's Your Turn
Conclusion
Commissioner Gottlieb ended his speech by recognizing that “we haven’t seen meaningful, voluntary actions,” when it comes to opioids and to that end, the FDA is planning to host a summit with CEOs and other senior representatives of internet stakeholders, academics, and various advocacy groups to identify technology gaps and possible solutions.
Both the House and the Senate are working on a variety of bipartisan proposals that could be included in the next legislative package addressing the opioid epidemic. The House Energy and Commerce Committee has the third in its hearing series on this topic schedule...
Source: Policy and Medicine - April 6, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
House of Representatives Holds Two-Day Hearing on Opioids
Conclusion
This hearing was one of several opioid-related hearings and developments that have occurred recently and Congress currently seems to be working in a bipartisan manner to develop thoughtful legislative packages should they opt to take up new opioid-related legislation in advance of the 2018 midterm elections.
The Subcommittee is preparing for a third hearing about the opioid crisis in April, which will cover Medicare, Medicaid and payer issues and plans. Committee Chairman Walden has said he wants the Committee to complete consideration of bills to address the opioid crisis by Memorial Day. On the S...
Source: Policy and Medicine - April 5, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Is There a Decrease in FDA Regulations?
According to an article in the Economist, FDA’s Commissioner Scott Gottlieb has overseen a fairly significant decrease in the amount of “economically significant” FDA regulations. The piece notes that some criticize the Commissioner for his industry ties. However, his tenure has pushed the agency to make it cheaper and easier for promising medications to reach patients.
Issuing Regulations
According to the article, FDA regulations have dipped to a two-decade low. The agency has concentrated instead on two areas regarding the development of therapies and medicines. The first area is the adoption of new technolo...
Source: Policy and Medicine - April 4, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Plans to Review Promotional Research
According to new releases from the FDA, it plans to look at several issues related to biopharma advertising and promotion. FDA is considering how physicians perceive risk information for newly promoted medications, how advertising claims made in scientific publications compare with claims in promotional articles, examining the impact of ads on disease awareness vs. product promotion, how consumers understand the accelerated approval process, and what health care professionals think about pharmaceutical promotions directed at them.
FDA Research
"The FDA has prioritized a robust social and behavioral science research progr...
Source: Policy and Medicine - April 3, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Higher Outpatient Drug Spending At 340B Hospitals, According to New Analysis
A new analysis finds that hospitals which participate in the 340B Drug Discount Program have higher per patient outpatient pharmacy costs than their non-340B counterparts – meaning patients at 340B hospitals are prescribed more medicines and/or more expensive medicines.
“There is a growing body of research showing that the 340B program is driving up costs for patients and the health care system,” said Stephen J. Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA). “The biopharmaceutical industry has long supported the 340B program, but perverse incentives have steered it away...
Source: Policy and Medicine - April 2, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
House Subcommittee on Health Holds Hearing on MACRA
Discussion
The discussion was wide ranging and touched on a number of issues. Regarding bundled payments, Rep. Levin raised concerns about CMS moving away from value based care after the agency scaled back CJR bundled payments. Rep. Johnson asked if social security numbers from Medicare cards are on track, which CMS confirmed is the case. Rep. Thompson asked when the CMS vision of interoperability will be achieved, and CMS noted it is still working on the issue. The agency highlighted its work on reducing regulatory burden as being helpful in this particular area.
On the topic of administrative burdens, Rep. Smith offere...
Source: Policy and Medicine - March 30, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
House Finally Passes Right to Try. If First You Don ’t Succeed, Try, Try Again.
The United States Senate previously approved legislation that would allow the terminally ill to access experimental drugs, commonly known as “Right to Try.” A few weeks back, the United States House of Representatives failed to pass the legislation, with a vote of 259 to 140, under a suspension of the House rules, which requires any bill to take two-thirds support in order to pass, instead of a simple majority.
On March 21, 2018, however, the House of Representatives took up the bill once again, and passed it with a vote of 267-149. It was a bipartisan moment, as 32 Democrats joined all but 2 Republicans to pass...
Source: Policy and Medicine - March 29, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Transparency Blueprint Issued
Most everyone even tangentially related to the pharmaceutical industry knows and understands that right now, transparency is a hot topic. In Winter 2017, The Journal of Law, Medicine & Ethics published a Special Supplement to Volume 45:4, a written companion to a January 16, 2018 symposium entitled, “Blueprint for Transparency at the U.S. Food and Drug Administration.”
According to the Letter from the Editor included in the Special Supplement, “guest editors Anna L. Davis, James Dabney Miller, Joshua M. Sharfstein, and Aaron S. Kesselheim and their co-authors have tackled the challenging topic of transparency at...
Source: Policy and Medicine - March 28, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Oregon: Transparency ’s Latest Frontier
On March 13, 2018, Oregon Governor Kate Brown signed a bill that requires drugmakers to report research and development and marketing costs, along with profits and more, for drugs that get price hikes of more than 10%. Companies will also be required to report whether generics are available.
The Oregon bill (HB 4005) is the most recent state-level drug pricing transparency law that attempts to control the cost of prescription drugs and is quite similar to the California legislation that is the subject of a legal challenge. However, HB 4005 goes a step further than that California legislation and seems to require manufactu...
Source: Policy and Medicine - March 27, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Alere Settles False Claims Act Allegations for $33.2 Million
Massachusetts-based medical device manufacturer Alere (acquired by Abbott Laboratories in 2017) and its subsidiary Alere San Diego recently entered into a settlement agreement with the federal government to pay $33.2 million. The settlement stems from allegations that Alere’s faulty diagnostic devices misinformed clinicians, and therefore, led to unnecessary medical care.
According to the United States Department of Justice (DOJ), from 2006 to 2012, Alere sold its Triage-branded devices to hospitals, even though the company was on the receiving end of many customer complaints warning of erroneous results. Those devices ...
Source: Policy and Medicine - March 26, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
NQF Issues Guidance on Opioid Prescribing Practices
The National Qualify Forum (NQF) recently released new guidelines to support safe and appropriate opioid prescribing to manage patients’ pain, entitled “National Quality Partners Playbook: Opioid Stewardship.” This marks the latest in the growing number of organizations providing input on strategies for addressing the opioid epidemic and helping to shape potential policy changes and federal and state level investments under consideration.
Developed with input from over forty experts and national stakeholders from the public and private sectors, the guidance identifies...
Source: Policy and Medicine - March 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
