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On March 4th, the U.S. District Court for the District of Maryland struck down four provisions of the Trump Administration’s Notice of Benefit and Payment Parameters for 2019, 83 Fed. Reg. 16930 (April 17, 2018) (the “Rule”), which governs many aspects of Affordable Care Act (“ACA”) insurance markets beginning in the 2019 plan year.  The decision in City of Columbus, et al. v. Norris Cochran comes two and a half years after the cities of Columbus, Baltimore, Cincinnati, Chicago, and Philadelphia, as well as two individuals who rely on health insurance offered on ACA exchanges, filed suit alleging that the actions of the U.S. Department of Health and Human Services (“HHS”) drove up premiums, made enrollment more difficult, and caused more people to go without affordable, high-quality health insurance.…
Continue Reading Federal Court Decides ACA “Sabotage” Case

As stories and statistics of the opioid crisis become increasingly prevalent in our national discourse, we are seeing a stronger, more innovative, and more aligned push for interventions across communities, government agencies, and the public, social, and health services sectors.…
Continue Reading Finding Common Ground in the Healthcare Debate: Federal, State, and Local Governments Respond to the Opioid Epidemic

There has been a proliferation of ADA lawsuits alleging that websites are not accessible to the blind or deaf.  Individuals who are blind or have low vision may require assistive devices and specialized software to access the Internet.  These devices often include software that enables them to magnify the content of a web page, reads the content to them, or enables them to use a braille reader to read a website.  Some individuals with disabilities cannot use a mouse and can only navigate with a keyboard, touchscreen, or voice recognition software.  For persons with hearing impairments, the visual aspects of a website are accessible, but audio on a website may not be.…
Continue Reading New Affordable Care Act and Medicaid Regulations Will Require Covered Entities Providing Healthcare Programs and Services to Have Accessible Websites

A recent Senate Finance Committee hearing investigated the effects of physician-owned distributorships (“PODs”) on costs of care and patient safety, suggesting that the momentum for greater oversight of such business arrangements continues to build.[1]…
Continue Reading Federal Spotlight Continues to Shine on Physician-Owned Distributorships

Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016  to the comment period for the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking (NPRM).  The proposed rulemaking is the most sweeping since 1991 when HHS codified The Common Rule, 45 C. F. R. part 46,  and  recognizes the changed research environment with many multisite studies and the  expansion of research with more data accessible through technology.  The NPRM seeks to further the principles of autonomy and  beneficence by protecting privacy and improving the consent process  in the new world of research while creating avenues to lessen the administrative burden  and to promote research.  …
Continue Reading HHS Recognizes Changing Environment of Research: Still Time to Comment

Cancer care is notoriously complex, intensive and costly. With more than 1.6 million people diagnosed with cancer each year, there is a strong impetus towards reforming service delivery. Accordingly, the U.S. Department of Health and Human Services is launching a new payment and care delivery model for Medicare beneficiaries undergoing chemotherapy treatment.[1]…
Continue Reading HHS Launches New Payment and Delivery Model to Improve Oncology Care

Some of the largest healthcare providers and insurers in the country have joined to form the Healthcare Transformation Task Force in an effort to change healthcare industry payment models.  The announcement of the task force and its efforts come shortly after the Department of Health and Human Services announced plans to overhaul Medicare’s fee-for-service program and transfer non-managed care spending to contracts that incentivize quality performance and cost control.  A unified vision of shifting to incentive based contracts has brought together health systems, Ascension, Trinity Health, Partners HealthCare, and Advocate Health Care, insurance titans Aetna and Health Care Service Corp., and Caesars Entertainment and the Pacific Business Group on Health to form the Healthcare Transformation Task Force.  The goal of the task force is to transform 75% of their business contracts to incentive based contracts focused on improving healthcare quality and lowering healthcare costs.…
Continue Reading Task Force of Healthcare Providers and Insurers are Shifting to Incentive Based Contracts

On January 26, 2015, Health and Human Services (HHS) Secretary Sylvia M. Burwell announced specific goals and a timeline for shifting Medicare reimbursements from the traditional fee-for-service (FFS) model, to a quality or value-based model.[1] This is the first time in Medicare’s history that HHS is setting specific goals for such a shift. Secretary Burwell noted that by moving towards a reimbursement model that rewards quality of care, rather than simply paying for each individual service without evaluating the outcome of such services, that the goals of building a health care system that delivers better care, spends health care dollars more wisely and results in healthier Americans will be realized.…
Continue Reading HHS Aims to Tie Most Medicare Reimbursements to Quality by 2018

In mid-December, President Obama signed into law a $1.1 trillion spending bill known as the “Consolidated and Further Continuing Appropriations Act, 2015” or “Cromnibus.”[1] This post explores provisions that relate to the health sector and Affordable Care Act (ACA) implementation.…
Continue Reading Effects of the New Federal Spending Package on the Health Sector

Last week, the Department of Health and Human Services (HHS) released a new, free, downloadable tool to assist small and medium-size health care provider offices to conduct security risk assessments (SRA).[1]…
Continue Reading HHS releases new software for updating (but not replacing) HIPAA security risk assessment toolkits

By Robert Rose 

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two conditions: chronic granulomatous disease and severe malignant osteopetrosis. A year before the approval, an Austrian clinical trial concluded that Actimmune’s active ingredient was associated with improvement in patients with idiopathic pulmonary fibrosis (IPF), a rare and fatal disease of unknown origin. InterMune did its own clinical trial to confirm whether Actimmune was an effective treatment for IBF.

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Continue Reading False Press Release Leads To Exclusion From Federal Programs