Opioid Class Action Suit Filed in Five States
On May 2, 2018, three law firms filed class action lawsuits against pharmaceutical manufacturers and distributors on behalf of individuals and businesses who have been handed higher insurance costs as a result of the opioid epidemic. The law firms filed suits on behalf of plaintiffs in five different federal courts: California, Illinois, Massachusetts, New Jersey, and New York. The complaints all charge major opioid manufacturers and distributors with fraudulent and deceptive marketing practices, negligence in distributing opioids into the marketplace, and other violations of state and federal law. In each of the lawsuits...
Source: Policy and Medicine - May 11, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Growth Rate of Spending on Medicine Slows
The IQVIA Institute for Human Data Science recently released a report focused on net spending on medicines in the United States in 2017, with an outlook to 2022. The report notes that spending on medicines grew less than one percent in 2017 – just a mere 0.6 percent. The report further found that the level and growth of spending, the price of new and old drugs, and the allocation of costs among patients, employers, health plans, intermediaries, and state and federal agencies, all “command great attention,” and therefore, the report aims to provide an “objective measure of medicine use” and th...
Source: Policy and Medicine - May 10, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

CMS Announces Medicare Data Roll-Out
Conclusion During her remarks on the subject, Administrator Verma tried to differentiate this new path in relation to previous efforts CMS has taken to move towards a value-based system. She noted, “…what is different now is that we know we can’t achieve value-based care until we put the patient at the center of our healthcare system. And that requires that we empower patients with the data they need to become a consumer of healthcare and make informed decisions. Ultimately, the cornerstone of a patient centered system is data, quality data, cost data, a patient’s own data.” &nb...
Source: Policy and Medicine - May 9, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Oklahoma Requires CME for Prescribers
Many states have taken the cue from the federal government and started their own investigation and research into opioids and the way opioids affect their particular state. Recently, Oklahoma joined the ranks of the states who have not just looked into the situation, but also went so far as to pass legislation to stymy the state’s opioid epidemic. One of the pieces of legislation passed was Senate Bill 1446, which asks the Oklahoma Board of Medical Licensure and Supervision to require continuing medical education (CME) for prescribers on opioid abuse and misuse, and also restricts initial prescriptions for opioids to...
Source: Policy and Medicine - May 8, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

House Introduces Bill to Require CME for Controlled Substance Prescribing
House of Representatives member Representative Susan W. Brooks recently introduced the ADAPT Act of 2018. The ADAPT Act (Abuse Deterrent and Prescriber Training Act of 2018) is an attempt to require training for prescribers of controlled substances. The bill would amend the Controlled Substances Act to include a requirement for all practitioners who are licensed under State law to prescribe controlled substances in Schedule II, III, IV, or V, a written certification that the practitioner has completed 3 hours of training under a specific training program, in all registration or renewal requests. The training program will...
Source: Policy and Medicine - May 7, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

ACCME Adopts New Strategic Plan
Conclusion The Board meeting and new strategic plan continue ACCME’s promise to continue to promote the development of high-quality CME that provides immediate and long-term benefits to society and fulfill the responsibility to maintain the highest standards of integrity and transparency.       Related StoriesACCME Announces New Collaboration with ABPathACCME Releases Report Highlighting 2017 SuccessesGottlieb Discusses Opioids and Lays Out Vision  (Source: Policy and Medicine)
Source: Policy and Medicine - May 4, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Maine Passes Drug Transparency Law – A Study
We try to keep our readers in the loop with transparency and other related legislation that are happening throughout the country. On May 1, 2018, the governor of Maine, Paul LePage, allowed legislation to pass into law without his signature that: (1) authorizes a study to review and overview drug prices and (2) has implications for top 25 drugs of different types. As noted in our previous article on the legislation, the Maine Data Health Data Organization now will be required to provide a report containing the following information about brand name and generic drugs by December 1, 2018, and annually thereafter: the 25 mos...
Source: Policy and Medicine - May 3, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

SCOTUS Denies Review of J & J Case
On Monday, April 16, 2018, the United States Supreme Court denied a request by Johnson & Johnson to review a whistleblower case against the company’s subsidiary, DePuy Orthopaedics, Inc.. Johnson & Johnson requested that the high court review a July ruling by the First Circuit Court of Appeals that revived a whistleblower lawsuit against the company. The lawsuit was filed by British orthopedic surgeons – Antoni Nargol and David Langton – who alleged that DePuy marketed defective metal-on-metal Pinnacle-branded hip implant devices to doctors who then turned around and sought government reimburseme...
Source: Policy and Medicine - May 2, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Circuit Court Strikes Blow to Maryland Drug Pricing Measure
On April 13, 2018, the United States of Appeals for the Fourth Circuit struck down the first-in-the-nation law aimed at lowering the price of off-patent or generic drugs. The Court, in a two-to-one ruling, stated the law is in violation of the Commerce Clause of the United States Constitution and therefore, is unconstitutional. In 2017, Maryland became the first state to allow its attorney general to take legal action against drug companies after they increase the price of off-patent or generic drugs. The bill was passed by the Maryland legislature but became law without the signature of the state’s governor, Larry ...
Source: Policy and Medicine - May 1, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

NQP Playbook Released on Shared Decision Making in Health Care Settings
In March 2018,  the National Quality Forum (NQF) released a guide for healthcare providers, the National Quality Partners PlaybookTM: Shared Decision Making in Healthcare. This recently-released Playbook offers vital guidance for the process of making shared decision making a standard of care for all patients, across settings and conditions. The National Quality Partners (NQP) Playbook: Shared Decision Making in Healthcare was developed with input from the NQP Shared Decision Making Action Team, including twenty public and private sector experts and stakeholders, holding a variety of positions including patients, cli...
Source: Policy and Medicine - April 30, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Maine and Colorado: Making Moves on Drug Price Transparency?
  We have been keeping up with proposed and passed legislation in several states that affect the pharmaceutical industry, especially those relating to drug price transparency. Many states over the past couple of years have been tweaking their rules regarding industry requirements for pricing transparency, largely in response to public outcry. The two most recent states to enter the transparency fray are Maine and Colorado, with each state introducing legislation that aims to regulate prescription drug price transparency. Maine In Maine, state Senator Eloise Vitelli introduced LD 1406 (SP 484), An Act to Promote Pr...
Source: Policy and Medicine - April 27, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Issues Order Restricting Sales of Contraception Device
Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement. The labeling will now restrict the sale and distribution of the device only to healthcare providers and facilities that provide the required information to the patient. The patient must also be given the chance to review and sign the acknowledgement, as well as the physician implanting the device. Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor Bayer’...
Source: Policy and Medicine - April 26, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

McKesson Accused of Illegally Handling Cancer Medications
On April 4, 2018, a lawsuit was unsealed that shows McKesson Corporation – America’s largest drug distributor and one of the top five largest public companies of any kind in America – is being accused of illegally pooling leftover cancer medication from single-dose vials and selling it to healthcare providers. Those healthcare providers then in turn treated patients with it and typically billed the cost to government programs for reimbursement. The lawsuit, brought by a private company, Omni Healthcare, seeks unspecified damages from McKesson for violating the federal False Claims Act by selling the medi...
Source: Policy and Medicine - April 25, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The End of Guidance Documents or Simply a Reminder of Well-Established Administrative Law Principles?
  As discussed in several news outlets, the Trump Administration recently announced that it would begin to enforce long-standing administrative law principles and limit the weight guidance documents carry in government actions against private companies and individuals. While the ramifications of this decision are still months away from realization, this article outlines the principles and the possible effects we will see in the future from this decision. Chaos and controversy seem to be synonymous with Trump Administration activities. This was certainly the case a few we...
Source: Policy and Medicine - April 25, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

9th Aggregate Spend and Open Payments Conference
On June 11th and 12th, 2018, the Ninth Aggregate Spend and Open Payments Conference will be held in Philadelphia, Pennsylvania at the Sonesta Philadelphia Hotel Rittenhouse Square. The organizers of the event recognize the importance of transparency reporting and the moving pieces that are involved in aggregate reporting of compensation data to avoid any conflicts of interest. Organizers note that while compliance leaders do their best to reduce any discrepancies prior to the Physician Payments Sunshine Act reporting deadline, they still spend millions of dollars annually to manage reporting errors. In an effort to contin...
Source: Policy and Medicine - April 24, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Numerof & Associates Releases Annual Report on Health Adoption
On April 10, 2018, Numerof & Associates released its third annual national study of population health adoption. The report provides a national in-depth look at the pace of transition from fee-for-service models to models that are based on fixed payments linked to outcomes. According to the report, a growing number of healthcare delivery organizations are failing to keep pace with their population health objectives and are actually continuing to fall further behind the industry leaders. The report surveys and summarizes responses from over 400 executives and decision makers in the healthcare industry. Unfortunately, p...
Source: Policy and Medicine - April 24, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The War on Patient Assistance Programs Takes a New Twist – The Tortured History of Caring Voice Coalition
  In the most recent chapter in the ongoing battle over the priority of patient assistance programs, the Caring Voice Coalition recently announced it would not provide financial assistance for any diseases in 2018. As a result of this announcement, HHS OIG is turning to PhRMA for help. We have been covering for some time now the apparent war on patient assistance programs (“PAPs”) being waged by the Department of Health and Human Services Office of Inspector General (“OIG”). It seems that at the core its OIG is inherently suspicious of any PAPs that cover a patient’s insurance co-...
Source: Policy and Medicine - April 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Bernie Sanders Introduces Bill Imposing Jail Time for Pharma Execs
Vermont Senator and former Democratic presidential candidate Bernie Sanders introduced a bill into the United States Senate on April 17, 2018, that would impose jail time on pharmaceutical executives whose companies engage in manipulative practices when marketing opioids. The bill, the Opioid Crisis Accountability Act of 2018, prohibits illegal marketing and distribution of opioids, creates a criminal liability for top company executives, penalizes drug manufacturers who illegally advertise, market, or distribute an opioid product, and requires drug makers to reimburse the United States for “the negative economic im...
Source: Policy and Medicine - April 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The Escobar Hurdle – False Claims, Materiality, and Dismissal
U.S. ex rel. Ruckh v. CMC II LLC et al. (“Ruckh”) was a closely followed False Claims Act case, because a Florida Federal Court opted to vacate a nearly $350 Million FCA verdict involving a nursing home operator. The case is significant because it demonstrates the ongoing impact of a party’s failure to meet the Escobar materiality standard. For many months, we have followed the U.S. Supreme Court decision in case of Universal Health Services, Inc. v. United States ex rel. Escobar (“Escobar”). Back in August 2016, we noted that it appeared neither side won a decisive victory, but time would te...
Source: Policy and Medicine - April 20, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Physician Specialty Groups Caution Against Proposed Drug Pricing Changes
Nine of the nation’s leading physician groups – including the American College of Rheumatology, American Academy of Neurology, American Academy of Ophthalmology, and American Urological Association – joined together this week to urge the Trump Administration to reconsider some of the policy changes suggested in recent drug pricing proposals that would have negative effects on patient care. In a letter sent to U.S. Department of Health and Human Services Secretary Alex Azar, the groups cautioned that the Administration’s proposal to consolidate certain physician-administered drugs covered ...
Source: Policy and Medicine - April 20, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The Insys Net Gets Wider
In mid-March 2018, five New York City doctors were arrested and charged with accepting bribes and kickbacks from Insys Therapeutics to prescribe high volumes of Subsys, a fentanyl-based cancer pain medicated spray. The five doctors – Gordon Freedman, 57, of Mount Kisco; Jeffrey Goldstein, 48, of New Rochelle; Todd Schlifstein, 49, of Manhattan; Dialecti Voudouris, 47, of Long Island City and Alexandru Burducea, 41, of Little Neck – all practiced in Manhattan and pled not guilty in federal court to an unsealed indictment charging them with several charges, including conspiracy. The five doctors allegedly collec...
Source: Policy and Medicine - April 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

It ’s Not All About the Money - Medtronic’s Infusion Multi-State Settlement Agreement
  In a closely watched matter culminating years of litigation, Medtronic on December 12, 2017, entered into a $12 Million multi-state settlement resolving allegations that the medical device company had misled consumers about the safety, efficacy, and effectiveness of its Infuse® Bone Graft Device (“Infuse”). The settlement represents continued coordination among States to prosecute marketing fraud and false advertising within the medical device industry. Within both the U.S. medical device manufacturing arena as well as the life science compliance communities...
Source: Policy and Medicine - April 18, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Gottlieb Discusses Opioids and Lays Out Vision
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 to...
Source: Policy and Medicine - April 18, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Nicodemo (Nico) Fiorentino Joins Life Science Compliance Update as Associate Editor
As Life Science Compliance Update enters its fourth year of publication, it is a great pleasure to announce that Nicodemo Fiorentino joins Thomas Sullivan, Publisher and Dr. Seth Whitelaw, Editor as a member of the Update’s editorial staff.  “Nico brings an outstanding mix of passion, scholarship and pure writing ability that will only enhance quality of the publication,” said Sullivan.  “It is aligned with our goal to create a single resource that allows busy compliance professionals and business executives to read less but become more attuned.” “It’s a sign that both...
Source: Policy and Medicine - April 17, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

State of Washington Enacts Statewide Drug Disposal Law
On March 22, 2018, the State of Washington officially enacted the first statewide drug take-back program in the country. Washington Governor Jay Inslee signed HB 1047 into law, which establishes a single, uniform, statewide system of regulation for safe and secure collection and disposal of medicines through a uniform drug "take-back" program operated and funded by drug manufacturers. The Act goes into effect on June 7, 2018, and requires “covered manufacturers” to submit their proposed programs by July 1, 2019. Also by July 2, 2019, Washington’s Department of Health (DOH) must determine its ow...
Source: Policy and Medicine - April 17, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Data Analytics & Detecting Medicare Fraud – A Promising Idea Still Awaiting Proof of Concept
For analyzing so-called “Big Data” sets, data analytics is an invaluable set of tools and techniques. Now the HHS OIG plans to expand its efforts to use data analytics to detect Medicare fraud. While promising, it remains to be proven that the tool and techniques will be cost-effective in this context. The fiscal year 2017 was a big year for the Office of Inspector General of the Department of Health and Human Services (“OIG”). Among many important accomplishments, the OIG undertook “the largest healthcare fraud takedown in history,” involving more than 400 defendants and more than $1....
Source: Policy and Medicine - April 16, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

House E & C Subcommittee on Health Reviews Dozens of Opioid Bills
Conclusion Chairman Burgess indicated that he is still deciding whether to combine numerous opioid-related bills into a single legislative package or try to move the bills through committee individually. Chairman Burgess noted that it is possible to put all of the legislation together in one package, but added that part of him “wants to consider them as individual bills so that, as we go through at least the subcommittee markup and the full committee markup, there will be ample opportunity for people’s ideas to be heard.”         (Source: Policy and Medicine)
Source: Policy and Medicine - April 16, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

OPDP Sends First Untitled Letter of 2018
Here we are…barely finished with the first quarter of 2018, and the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has finally issued its first untitled letter of the year. The letter, sent to Collegium Pharmaceutical, dealt with an exhibit promoting the company’s opioid drug Xtampza ER (oxycodone). The exhibit in question was Collegium’s exhibit booth at the American Society of Health-System Pharmacists’ summer 2017 meeting. The exhibit promoted Xtampza ER, which is an opioid approved for managing "pain severe enough to require daily, around-the...
Source: Policy and Medicine - April 13, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Coming into the Modern Era - CMS Creates Interagency Task Force to Examine Alternative Payment Mechanisms
To control rising costs under Medicare, the Affordable Care Act, and Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) created some “value-based programs” (“VBPs”) which provide incentives for cost cutting while ensuring the quality of patient care. VBPs inherently rely on collaboration between referring physicians and other healthcare providers as well as share Electronic Health Record (“EHR”) systems, thereby conflicting with the old fee-for-service fraud protection provided by the Anti-Kickback Statute and the Stark Law....
Source: Policy and Medicine - April 12, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

How Can We Increase Value and Monitor / Lower Costs?
Conclusions Insurance plans should be mindful of the impact of cost-sharing because, as Baicker notes, "There is ample evidence that when patients have to pay more for care, they consume less of it.” This can, however, result in patients not paying for lower-value care and skimping on necessary services and treatments. Financial incentives on both sides of the equation may be the key to increasing value while monitoring increasing healthcare costs.       Related StoriesThe Day After Tomorrow – The Drug Pricing Transparency Chorus Grows LouderSenate Holds Hearing on 340B Dr...
Source: Policy and Medicine - April 12, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

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 increas...
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 ne...
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 to...
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 Sen...
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 ...
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 ...
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...
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 ...
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 tra...
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 devi...
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 identi...
Source: Policy and Medicine - March 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Right to Try Fails in the House
The United States Senate previously approved legislation that would allow the terminally ill to access experimental drugs, commonly known as “Right to Try.” Recently, however, the United States House of Representatives failed to pass the legislation, with a vote of 259 to 140. House Republicans tried to pass the bill 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. President Donald Trump previously showed his support for the bill in his State of the Union address in January 2018. “People who are terminally ill shoul...
Source: Policy and Medicine - March 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Teva and McCaskill: A Game of Cat and Mouse
In Summer 2017, we wrote about Senator Claire McCaskill’s request to Teva Pharmaceutical Industries that they provide information about the distribution of opioids and its efforts to prevent drug diversion. In her original letter, McCaskill stated, “[t]his epidemic has reportedly arisen, in part, from the failure of opioid distributors to monitor the flow of hundreds of millions of painkillers to pharmacies across the United States and then on to the black market.” In her initial letter, she requested several documents and pieces of information to “aid the Committee in understanding the role of man...
Source: Policy and Medicine - March 22, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Preparing for the 2018 Ethical MedTech, APACMed, and China Codes
Conclusion As of January 1, 2018, these new rules have gone into effect throughout Europe, Asia and China. If you have any additional questions or concerns, a recording of the webinar can be viewed here.    Additional Resources can be found here: Chart Comparing the Ethical Codes China Code APAC MED Code MedTech Europe Code Ethical Medtech - Conferences       Related StoriesPrivacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical ResearchHCEA To Host Webinar on New International Ethics RulesACCME Introduces Guidance for ...
Source: Policy and Medicine - March 21, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Prime Therapeutics Proves PBMs ’ Value
On February 20, 2018, Prime Therapeutics issued a press release that highlighted the way it – as a leading pharmacy benefit manager – has helped save its clients billions of dollars. The 2017 drug trend reports noted that its clients saw overall expenditure reductions (per member, per month) across all three lines of business (commercial, Medicare, Medicaid) as compared to 2016. Additionally, corresponding annual savings delivered to clients in 2017 exceeded $3 billion across all three lines of business. “Our outstanding 2017 drug trend results are hard won, especially as we continue to see ongoing and s...
Source: Policy and Medicine - March 20, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA announces Public Meeting on Evaluating Inclusion and Exclusion Criteria in Clinical Trials on April 16
On April 16 from 8:30am to 5pm, the FDA will be holding a public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The event is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population. Meeting The...
Source: Policy and Medicine - March 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs