Senators Once Again Taking Up the DTC Tax Write-Off
Senator Claire McCaskill recently introduced legislation that would eliminate the ability of drug manufacturers to deduct the cost of advertising their products from taxes. Senate Bill 2478 attempts to amend the IRS code to “deny the deduction for advertising and promotional expense for prescription drugs,” and is co-sponsored by Senator Jeanne Shaheen. This is not the first time legislators have tried to stop pharmaceutical companies from deducting ad spending as a business expense the same way other companies do with their ad costs. In 2016, a group of four Democratic senators led by former Senator Al Franken introd...
Source: Policy and Medicine - March 5, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

CMS Releases Data on Antipsychotic Drugs Used in Nursing Homes
According to data from CMS, the percentage of long-term nursing home residents being given antipsychotic drugs dropped from about 24 percent in late 2011 to under 16 percent last year. CMS says the data show its National Partnership to Improve Dementia Care in Nursing Homes, created in 2012, has served its goal to reduce unnecessary antipsychotic medications in nursing homes. The Partnership CMS explains its National Partnership utilized a multidimensional approach which included public reporting, partnerships and state-based coalitions, research, training for providers and surveyors, and revised surveyor guidance to emp...
Source: Policy and Medicine - March 2, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Ontario Open Payments: Proposed Rule for the Health Sector Payment Transparency Act
Pharmaceutical and Device Payment Transparency is making its way to our Northern neighbor, Canada. On December 12, 2017, the Health Sector Payment Transparency Act, 2017 (HSPTA) received Royal Assent and became part of the Strengthening Quality and Accountability for Patients Act, 2017. The passage and enactment of the HSPTA allows Ontario to claim the title of the first Canadian province or territory to require the reporting of transfers of value between the pharmaceutical and medical device industry to health professionals and hospitals. The information must be reported to the Minister of Health and Long-Term Care for pu...
Source: Policy and Medicine - March 1, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Checking In: Are Your State Legislators Concentrating on Drug-Price Transparency?
Price transparency is such a hot topic today that it is oftentimes hard to keep up with the different state legislatures that are reviewing different ideas on price transparency and price gouging when it comes to the pharmaceutical industry. Below are some of the states and the bills that are pending before the legislatures. Colorado The state of Colorado has two bills pending – one in the House and one in the Senate – that each focus on different aspects of pricing. HB18-1009, the Diabetes Drug Pricing Transparency Act of 2018, has been introduced in the House and assigned to the Health, Insurance, and Environment s...
Source: Policy and Medicine - February 28, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Watson Pharmaceuticals – Now Part of Teva – to Pay $33 Million to Mississippi
On January 29, 2018, Mississippi Attorney General Jim Hood announced a $33 million settlement with pharmaceutical manufacturer, Watson, Inc., which is now part of Teva Pharmaceuticals. AG Hood had hired attorneys to sue Watson in a series of suits claiming the company wrongly inflated prescription drug prices paid by the state-federal Medicaid health insurance program. The State’s Supreme Court upheld a trial court decision that found Watson defrauded the taxpayers of Mississippi by an estimated $7 million when reporting its Average Wholesale Prices. Inflated prices varied from drug to drug, in some cases as much as 1,...
Source: Policy and Medicine - February 27, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

E & C House Subcommittee Slated to Review Eight Bills on Opioids
Recently, the House Energy & Commerce Health Subcommittee announced that it will hold a hearing on Wednesday, February 28, 2018, at 10:00 am, to review eight bills that will attempt to curtail the opioid epidemic. The hearing, “Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety,” is the first of three planned legislative hearings to examine the opioid crisis and possible legislative solutions. The following bills are expected to be considered during that hearing: H.R. 2851, the Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act, introduced by Representat...
Source: Policy and Medicine - February 26, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

New Limitations on Guidance Documents Expected to Have Heavy Effect on Industry
The Trump Administration recently adopted new limits on the use of “guidance documents” issued by federal agencies. Various industries use the applicable guidance documents to better understand the government’s interpretation of laws, and as such, this may have a sweeping effect on industry compliance measures. The revised policy piggybacks off of a previous memo issued by Attorney General Jeff Sessions that prohibited the Agency from issuing guidance documents that effectively bind the public without undergoing the notice-and-comment rulemaking process. This means that the DOJ was unable to issue guidance documents...
Source: Policy and Medicine - February 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Senate HELP Committee Holds Hearing on Opioids and the Impact on Families
Conclusion In a moment of rare bipartisanship, Committee members came together to agree that additional funding was needed to address the opioid crisis and provide opioid use disorder (OUD) sufferers with adequate anti-addiction resources. The bipartisanship ended, however, Democrats specifically criticized recent budget cuts by the administration and recommended that additional federal funding should be directed towards Medicaid and other health care institutions that work to support the families of opioid users.        Related StoriesHouse Holds Hearing on Opioid CrisisState of the...
Source: Policy and Medicine - February 22, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

ACCME Releases Report Highlighting 2017 Successes
  The Accreditation Council for Continuing Medical Education (ACCME) recently released a new report, Transforming Continuing Medical Education Together: 2017 Highlights from the Accreditation Council for Continuing Medical Education. The inaugural year-in-review report showcases the efforts of the ACCME and the continuing medical education (CME) community to leverage the power of education to respond to the changing healthcare environment.  The report aims to celebrate the CME community’s initiatives to drive meaningful change for educators, clinicians, and u...
Source: Policy and Medicine - February 21, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

12th International Pharmaceutical and Medical Device Compliance Congress
This May, the 12th International Pharmaceutical and Medical Device Compliance Congress will take place in Vienna, Austria, at the Hotel Savoyen, from the 14th through the 16th. Keynote speakers for this conference include: Nicola Bedlington, Secretary General, European Patients Forum (EPF), Former Director, European Disability Forum, Brussels, Belgium; Jan Oliver Huber, General Secretary, Association of the Austrian Pharmaceutical Industry (PHARMIG), Vienna, Austria; Camilla de Silva, Joint Head of Bribery and Corruption, Serious Fraud Office, London, UK; and George “Ren” McEachern, CFE, CAMS, Managing Director, Exige...
Source: Policy and Medicine - February 20, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The Congressional Budget Deal's Effect on Health Care
In early February, Congress passed a massive bipartisan budget deal to fund the government through March 23, 2018, suspend the debt ceiling until 2019, raise budget caps by nearly $300 billion over two years, and fund various parts of the government. Naturally, passage of the budget agreement means that quite a few health care priorities made their way into the law. For example, several health care “extenders” were reauthorized, community health centers (CHCs) were funded, cuts to safety net hospitals were delayed, as were cuts to the CHRONIC Care Act and the Part B Improvement Act, while revisions to the Medicare Acc...
Source: Policy and Medicine - February 20, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Trump Administration Releases Budget Proposal Calls for Changes to Open Payments and Increased Funding for Fighting Fraud and Abuse
The Trump Administration recently released its fiscal year (FY) 2019 budget proposal, including extensive health policy provisions. The budget proposal features numerous program integrity provisions. For instance, the budget calls for: a $45 million increase in Health Care Fraud and Abuse Control funding; expanded prior authorization requirements for high utilization practitioners of radiation therapy, therapy services, advanced imaging, and anatomic pathology services; expansion of the items of DME, prosthetics and orthotics that are subject to prior authorization; a demonstration to test the use of a benefits manager fo...
Source: Policy and Medicine - February 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Trump Administration Releases Budget Proposal Calls for Increased Funding for Fighting Fraud and Abuse
The Trump Administration recently released its fiscal year (FY) 2019 budget proposal, including extensive health policy provisions. The budget proposal features numerous program integrity provisions. For instance, the budget calls for: a $45 million increase in Health Care Fraud and Abuse Control funding; expanded prior authorization requirements for high utilization practitioners of radiation therapy, therapy services, advanced imaging, and anatomic pathology services; expansion of the items of DME, prosthetics and orthotics that are subject to prior authorization; a demonstration to test the use of a benefits manager fo...
Source: Policy and Medicine - February 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Trump Administration Releases Budget Proposal
The Trump Administration recently released its fiscal year (FY) 2019 budget proposal, including extensive health policy provisions. The budget proposal features numerous program integrity provisions. For instance, the budget calls for: a $45 million increase in Health Care Fraud and Abuse Control funding; expanded prior authorization requirements for high utilization practitioners of radiation therapy, therapy services, advanced imaging, and anatomic pathology services; expansion of the items of DME, prosthetics and orthotics that are subject to prior authorization; a demonstration to test the use of a benefits manager fo...
Source: Policy and Medicine - February 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Aegerion Sentenced to Pay $7.2 Million to Patients
On January 30, 2018, Federal U.S. District Court Judge William Young sentenced Aegerion to pay some of the roughly $36 million fine for off-label marketing to Juxtapid patients. In November, Judge Young rejected an initial plea deal between the Department of Justice (DOJ) and Novelion Therapeutics (who now owns Aegerion) because it would have restricted his ability to impose a sentence upon the company. Judge Young instead sentenced Aegerion in a deal that gave him discretion to determine how the payment would be split up. Young ordered the company to pay $7.2 million – the same amount the company had agreed to pay from...
Source: Policy and Medicine - February 16, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs