Last week, the U.S. Food and Drug Administration (“FDA”) released two guidance documents that relate to sharing of certain information about drugs and medical devices, including economic information about unapproved products and unapproved uses, as well as information not included
2018
MedPAC recommends to Congress a 30 percent reduction in Medicare payment rates for services provided in certain hospital off-campus emergency departments
In its June 2018 Report to the Congress the Medicare Payment Advisory Commission (MedPAC) recommends that Congress reduce Medicare Type A emergency department payment rates by 30 percent for services furnished in hospital off-campus emergency departments that are located within …
HHS requests comments on healthcare innovation and investment workgroup
A Request for Information (RFI) published in the June 7 Federal Register seeks comments on the structure of a workgroup to increase innovation and investment in the healthcare industry. The Immediate Office of the Secretary of HHS seeks comments on…
Department of Justice will not defend ACA individual mandate
The Department of Justice (DOJ) announced on June 7, 2018 that it will no longer defend the constitutionality of section 5000A of the Affordable Care Act (ACA), a.k.a. the individual mandate. DOJ announced its policy change in a three page…
Joint Commission issues advisory on continuity of operations planning
On May 22, 2018, the Joint Commission released an advisory addressing the importance of continuity of operations planning (COOP). When an emergency strikes, an ill-prepared health care organization can put patients at risk. The goal of an COOP is “to…
Virginia to expand Medicaid in January 2019; Utah will vote on Medicaid expansion this November
Virginia is expected to become the 33rd state (plus the District of Columbia) to expand Medicaid under the Affordable Care Act (ACA) following the passage of a budget by the Virginia legislature. The expansion will take effect on January 1, …
Legislation introduced to suspend health insurer tax for 2020
On May 25, 2018 legislation was introduced in the United States House of Representatives to suspend the annual fee on health insurance providers implemented by the Affordable Care Act (ACA) for 2020. HR. 5963 was introduced by Reps. Kristi Noem…
Maine court hears argument on Medicaid expansion
OCR proposes to share HIPAA data breach settlements with victims
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) plans to issue an advance notice of proposed rulemaking this November on potentially sharing HIPAA breach settlements with victims. The notice would solicit public opinion on…
OIG launches new compliance resource portal
The OIG recently launched a new compliance resource portal, compiling some of its resources into one user-friendly webpage.
The Compliance Resource Portal provides a list of links to categories of “handy resources for the public that can help ensure that…