Log in to search using one of your social media accounts:

 

Medical Societies Ask Congress to Preserve Patient Access to Critical Part B Therapies
  Eleven medical societies – including the American College of Rheumatology, American Academy of Ophthalmology, American Society of Clinical Oncology and American Urological Association – are urging congressional leaders to preserve patients’ access to critical Part B drug treatments by preventing the Centers for Medicare & Medicaid Services (CMS) from penalizing physicians for providing high-quality care.   The societies recently sent a joint letter to the chairs and ranking members of the Senate Finance Committee, the House Ways & Means Committee, and the House Energy & Com...
Source: Policy and Medicine - December 14, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Issues Guidance on Real-World Evidence for Medical Devices
Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance on the use of real world evidence to support regulatory decision-making for medical devices. The final guidance follows a July 2016 draft guidance on the topic in which the FDA discussed potential uses of real world data and the various factors evaluated to determine whether that data can support a regulatory decision. The FDA believes that this guidance is a “cornerstone” of its strategic priority to build a national evaluation system for health technology. The final guidance includes clarity as to what it means for com...
Source: Policy and Medicine - December 13, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Alliance for Continuing Education in the Health Professions Annual Conference
January 20, 2018 through January 23, 2018, the Alliance for Continuing Education in the Health Professions (the Alliance) will hold their 2018 Annual Conference in Orlando, Florida at the Grande Lakes hotel. The Annual Conference boasts four days of education and networking events, starting off on Saturday, January 20, 2018, with several early morning workshops followed by afternoon member section meetings. Closing out the first day are the Opening Night Awards Dinner and the President’s Dessert Reception. On Sunday, January 21, 2018, attendees will hear the Annual State of the Alliance, followed by a keynote speec...
Source: Policy and Medicine - December 12, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Senate Appropriations Committee Takes on the Opioid Epidemic
On December 5, 2017, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing to discuss the opioid epidemic and the possible role that Congress could play in the prevention, treatment, and recovery. Senator Roy Blunt, the Subcommittee Chairman, opened the hearing by discussing the fact that overdose related deaths outnumber the deaths at the peak of the AIDS/HIV epidemic. Overdose deaths have also overtaken automobile accident fatalities to become the number one cause of accidental death in the United States. Senator Blunt also spoke about the three propos...
Source: Policy and Medicine - December 12, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

CMS Institutes New Medicaid Policy Regarding Opioids
Recently, the Centers for Medicare & Medicaid Services (CMS) announced a new policy to allow states to design demonstration projects that increase access to treatment for opioid use disorder (OUD) and other substance use disorders (SUD). This new demonstration policy responds to President Trump's directive and provides states with greater flexibility to design programs that improve access to high quality, clinically appropriate treatment. In addition to the new policy, CMS announced an immediate approval of both New Jersey and Utah’s demonstration waivers under the new policy. Through this updated policy, states...
Source: Policy and Medicine - December 11, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Drug Pricing Report Released by NASEM
The most recent example of drug marketing being caught in the crossfire of the drug pricing debate can be found in a report by the National Academies of Sciences, Engineering and Medicine, which included suppression of consumer marketing in a set of recommendations on how to lower the cost of prescription drugs for patients. One recommendation was that advertising costs should no longer be considered tax deductible as a business expense. The report offers eight recommendations with twenty-seven different actions for their implementation (a sample of actions in each area appears below) to improve the affordability of presc...
Source: Policy and Medicine - December 8, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

HCEA To Host Webinar on New International Ethics Rules
On Wednesday, December 13, 2017, the Healthcare Convention & Exhibitors Association (HCEA) will present a webinar entitled: “Preparing for the 2018 Ethical MeDTECH, APACMed and China Codes Impact on International Attendee Participation at US Meetings.” As we have previously written about, beginning January 1, 2018, medical device companies in various regions of the world will no longer be able to directly sponsor participant’s travel to educational meetings. The Accreditation Council for Continuing Medical Education (ACCME) and other organizations have applauded this effort, as it furthers the indepe...
Source: Policy and Medicine - December 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Congress Taking New Approach to Opioid Epidemic
Recently, Representative Bob Latta introduced a bill into the United States House of Representatives. The bill, known as the Indexing Narcotics, Fentanyl and Opioids (INFO) Act, is intended to help create a public electronic database of information and strategies to combat the opioid crisis. The information in the database would be used to help federal, state, and local officials develop the most effective strategies to prevent addiction, treat those that are addicted, and keep prescription drugs from falling into the wrong hands. The INFO Act would also track federal funding being used to combat the epidemic. The bill re...
Source: Policy and Medicine - December 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Releases Guidelines for Physicians Using Investigational Drugs in Emergency Situations
In a recent Manual of Policies and Procedures (MAPP), the FDA laid out the process by which physicians can access an investigational drug for treatment in an individual patient in an emergency situation, both during and after normal business hours. MAPP Specifics The MAPP describes the policies and procedures established in the Center for Drug Evaluation and Research (CDER) for managing and processing applications for individual patient expanded access for emergency use (or, emergency investigational new drug applications (EINDs)) for licensed physicians seeking access to an investigational drug for treatment use in an i...
Source: Policy and Medicine - December 6, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Offers Draft Guidance on E-Submissions of REMS Documents
The FDA recently released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications. FDA Comments on Stakeholder Feedback In the guidance, FDA describes three years of engagement and analysis of stakeholder feedback regarding REMS standardization. The agency’s findings were published as a report: “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS).” As the...
Source: Policy and Medicine - December 5, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Can CME Help the Opioid Epidemic?
Conclusion Therefore, POLITICO and the stakeholders made a policy recommendation focused on educating providers. They suggest that education on both pain management and addiction has to start in medical school. However, early education is not enough unless it is supplemented by CME. The medical field should continue the progress it has made increasing education around proper prescribing, but it should increase its efforts by evaluating doctors in some meaningful way such as on licensing exams or through CME.       Related StoriesACCME Introduces Guidance for CME Providers in Europe and Asi...
Source: Policy and Medicine - December 4, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Trump Nominates Alex Azar to Head HHS  
  A few weeks ago, President Donald Trump nominated Alex Azar to lead the Department of Health and Human Services (HHS), following in the footsteps of Tom Price. The nomination – announced where else other than Twitter – said “Happy to announce, I am nominating Alex Azar to be the next HHS Secretary. He will be a star for better healthcare and lower drug prices!”  Azar has a history of involvement in the pharmaceutical world, including serving as HHS General Counsel and Deputy HHS Secretary under President George W. Bush. Mike Leavitt, the HHS Secretary whe...
Source: Policy and Medicine - December 1, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

ACCME Introduces Guidance for CME Providers on MEDTECH, APACMed and China Codes
Recently, MedTech Europe, the Advanced Medical Technology Association (AdvaMed), and the Asia Pacific Medical Technology Association (APACMed) introduced changes to their respective codes of conduct relating to professional development activities, including continuing medical education (CME). As such, the Accreditation Council for Continuing Medical Education (ACCME) has offered guidance for CME providers with respect to the changes.   Starting in 2018, it is expected that the revised codes will require member manufacturers to discontinue making direct payments to clinicians to fund...
Source: Policy and Medicine - November 30, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Hospitals and Health Systems Sue CMS Over 340B Provisions
Three hospital groups, along with three health systems, have filed suit against the Department of Health and Human Services (HHS) regarding the Centers for Medicare and Medicaid Services’ (CMS) recent regulation that made substantial cuts to hospitals for 340B drugs. The American Hospital Association, Association of American Medical Colleges, America’s Essential Hospitals, Eastern Maine Healthcare Systems, Henry Ford Health System, and Fletcher Hospital Inc. brought the suit, challenging the changes made to the 340B program that were included in the calendar year 2018 hospital outpatient system (OPPS) and ...
Source: Policy and Medicine - November 29, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The Summit on Controlled Substances – Regulation, Litigation, and Enforcement
The American Conference Institute is proud to host the inaugural Summit on Controlled Substances - Regulation, Litigation, and Enforcement, on January 29-31, 2018 in Washington, DC. This event offers a one-of-a-kind opportunity to gather with stakeholders from every link in the supply chain to discuss the most pressing issues surroundings the controlled substances industry, most prominently the opioid overdose crisis.  Federal and state authorities continue to go after opioid manufacturers, distributors, pharmacies, pharmacists, physicians, nurses— anyone and everyone who has a hand in the chain of custody for ...
Source: Policy and Medicine - November 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

McCaskill Files Amendment to Eliminate Marketing Tax Deduction
Senator Claire McCaskill of Missouri recently filed an amendment to the tax bill to eliminate the deduction for pharmaceutical marketing. While the likelihood of a Democrat-proposed amendment to a Republican-controlled bill passing is slim, it is still important to understand the action McCaskill has taken. Simply because the bill is controlled by the Republicans, the Republican majority in the Senate is thin, meaning bipartisan support is likely needed in order for any tax reform to be done. It is likely that McCaskill introduced this amendment to raise the profile of the issue and to see if there is any bipartisan suppo...
Source: Policy and Medicine - November 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Vermont AG Probing Pharma and Physician Relationships
The Vermont attorney general is investigating the extent to which drug and device makers may have violated state law by giving gifts or payments for other items to health care providers, according to a source familiar with the matter. As some of our readers may recall, Vermont banned industry gift giving to health care providers over concerns that the payments influence the way physicians practice medicine and prescribe medications, a contentious issue that later led the federal government to create a database to which drug and device makers must report any payments to physicians and teaching hospitals. The Vermont law p...
Source: Policy and Medicine - November 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Urine Testing: The Next Shoe to Drop?
Opioids have been a topic of discussion for months now, and every week it seems as though a new company or individual is in hot water over opioid prescribing practices, or over alleged opioid prescribing practices. One facet of the opioid epidemic that has not been touched upon is the requirement many pain management physicians and others have that when a patient is under their care and receiving opioids and/or habit-forming prescriptions, the patient must affirm that they are not seeing other physicians for prescriptions and/or that all prescriptions are being filled at the same pharmacy. To that end, the patient typical...
Source: Policy and Medicine - November 22, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

ICER Expanding Probe
A nonprofit group, the Institute for Clinical and Economic Review (ICER), recently received a three-year $13.9 million grant from the Laura and John Arnold Foundation to expand its ongoing investigative scope on drug pricing to include all new medicines and price increases on existing treatments. Up until now, ICER hasn’t had the resources to review all new medicines. The additional funding “puts us on a new trajectory,” according to Steven D. Pearson, president of ICER. “Now we’re going to be able to cover the landscape.” ICER was essentially founded with a $5.3 million grant from the...
Source: Policy and Medicine - November 21, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Could MIPS Data Be Used Against Physicians?
One of the major changes thanks to MACRA and its associated Quality Payment Program (QPP) is the creation of MIPS, of the Merit-based Incentive Payment System. Much has been made about this new way physicians will be evaluated under Medicare. However, we have not seen the take of MIPS scores being used in other domains, such as medical malpractice lawsuits, until we came across this consulting firm’s hypothetical. Could MIPS data be used against physicians? Hypothetical Malpractice Case As described on MyMipsScores’ blog: “[H]ere is another collateral effect of the MIPS score. This one is for our frie...
Source: Policy and Medicine - November 20, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Approves Sixth United States Biosimilar
Recently, the FDA announced that it approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira and sixth biosimilar in the United States. “Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the...
Source: Policy and Medicine - November 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

CMS RFI Issued Regarding CMMI and Payment Models
In September, CMS issued a "request for information" (RFI) to solicit new ideas that will revamp CMS' Center for Medicare and Medicaid Innovation (CMMI) and the payment models the center creates. Specifically, CMS “is seeking your feedback on a new direction to promote patient-centered care and test market-driven reforms that empower beneficiaries as consumers, provide price transparency, increase choices and competition to drive quality, reduce costs, and improve outcomes.” New Model Design According to the RFI, CMMI will approach new model design with several guiding principles: Choice and comp...
Source: Policy and Medicine - November 16, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

CMS Not Moving Forward With October Update of Hospital Compare
The Centers for Medicare & Medicaid Services announced it will not update its overall hospital quality star ratings on Hospital Compare in October. “CMS decided not to proceed with the October update to continue its examination of potential changes to the Star Rating methodology based on public feedback,” the agency said. The star ratings released last December will remain on the Hospital Compare website until the next update, CMS said. Flawed Methodology and Hospital Criticism When the ratings were posted in July 2016, they were heavily criticized by hospital groups and the Medicare Payment Advisory Comm...
Source: Policy and Medicine - November 15, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Changes to 340B Program Reduces Hospital Reimbursement for Pharmaceutical Products by 28.5%
Recently, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC), which includes updates to the 2018 rates and quality provisions, and other policy changes. CMS adopted many policies that will support care delivery; reduce burdens for health care providers, especially in rural areas; lower beneficiary out of pocket drug costs for certain drugs; enhance the patient-doctor relationship; and promote flexibility in healthcare. This final rule p...
Source: Policy and Medicine - November 14, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Accountable Care Organization Performance Results
2016 was the fifth performance year for the Medicare Shared Savings Program (MSSP). 2016 brought $652 million in savings to Medicare via Accountable Care Organizations, according to the Health Care Transformation Task Force. The Shared Savings Program offers providers and suppliers (e.g., physicians, hospitals, and others involved in patient care) an opportunity to create a new type of health care entity, an Accountable Care Organization (ACO). An ACO agrees to be held accountable for the quality, cost, and experience of care of an assigned Medicare fee-for-service (FFS) beneficiary population. The Shared Savings Program ...
Source: Policy and Medicine - November 13, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Insight into 21st Century Cures Implementation
Conclusion The proposed FDA work plan describes activities that are intended to successfully achieve the Cures Act requirements in areas that are a high priority for any Innovation Account funding that is appropriated. Together with other funding sources, as available, FDA’s proposed Innovation Account funding allocations can help chart a path for advancing medical product development and reviews and help bring innovative new therapies and products to patients and health care providers in a more timely and efficient manner.       Related StoriesSenators Blumenthal and Grassley Ask CM...
Source: Policy and Medicine - November 10, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

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...
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 ...
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. ...
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, ...
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, ...
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...
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 wh...
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 wer...
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 government...
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...
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 ...
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 satisfie...
Source: Policy and Medicine - October 26, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

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 ...
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 bo...
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 ...
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 Assoc...
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 truth of th...
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 Assoc...
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 d...
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 ...
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