On Friday July 31, 2020 the U.S. Circuit Court of Appeals for the District of Columbia Circuit reversed the federal district court and permitted reimbursement cuts for drugs purchased through the 340B Drug Discount Program.
hospitals and health systems
CMS publishes FY 2021 Skilled Nursing Facility, Inpatient Psychiatric Hospital, and Hospice Medicare Payment final rules
All three of these Medicare payment final rules will become effective on October 1, 2020.…
Withdrawal of life support from child in his best interests (UK)
The mother of a 2-year old child who suffered grave injuries in a road traffic accident appealed against the court order obtained by the grandmother to withdraw all respiration and to treat the child only with pain relief, sedation and nursing as appropriate.
Australia trials “Health Care Homes”, a new model of primary health care
Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People with Chronic and Complex Health Conditions report. Key elements of the proposed scheme included:
CMS proposed rule revises conditions of participation for hospitals and CAHs
On June 13, 2016, CMS published a proposed rule intended to revise the conditions of participation (CoPs) required for hospitals and critical access hospitals (CAHs) to participate in the Medicare and Medicaid programs, with a focus on quality of care.
Highlights from the proposed rule are outlined in further detail below.
Senators urge HHS to further expand patient access to opioid drug treatment
On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act. MAT involves the use of medication in combination with certain behavioral health interventions to provide a comprehensive, individualized approach to opioid use disorder treatment.
Medical technology initiatives announced in Health Minister’s budget speech
The use of technology in the health sector is on the rise. The intersection of these two industries leads to interesting legal questions relating to digital risk, including big data analytics, data security and privacy.
In his budget speech on…
House bill addresses reduced payments to new off-campus hospital outpatient departments
On May 18, 2016, the U.S. House of Representatives Ways and Means Committee introduced the Helping Hospitals Improve Patient Care Act of 2016 (Act) to exempt certain newly-enrolled provider-based, off campus hospital outpatient departments (HOPDs) from reduced payments under the Bipartisan Budget Act of 2015 (BBA).
New USPTO subject matter eligibility (35 USC § 101) examiner guidance and life science examples
On May 5, 2016, the United States Patent and Trademark Office issued six new examples that provide guidance to Examiners and patent applicants prosecuting claims directed to life sciences subject matter (Subject Matter Eligibility Examples: Life Sciences). These examples analyze claims that are directed to several of the most contentious areas of patentable subject matter under 35 U.S.C. § 101, including vaccines, methods for diagnosing and treating, nature-based products including mixtures, methods for genetic screening, and machines and processes that are alleged to be founded on a natural law.
May 1st letter from CMS temporarily extends Texas’ 1115 Transformation Waiver
The Texas Health and Human Services Commission (“HHSC”) has been actively trying to reach an agreement with the Centers for Medicare and Medicaid Services (“CMS”) to extend or renew the Texas 1115 Transformation Waiver (the “Waiver”)since March 2015, when HHSC submitted its first iteration of a transition plan focused on a 5-year renewal. The result was released yesterday, May 2, through publication of CMS’ approval of a 15-month extension at current funding levels. CMS’ approval letter clearly states that if an agreement is not reached between HHSC and CMS, the Waiver will not be renewed beyond December 31, 2017. CMS’ letter further indicates that, absent an agreement, funding for uncompensated care in Texas and funding for Waiver-related projects will be drastically reduced beginning January 1, 2018.