All amounts appropriated or made available under this Act are in addition to the amounts already appropriated for the relevant fiscal year. HHS AGENCIES RECEIVE ADDITIONAL FUNDING FOR CORONAVIRUS RESPONSE This Act includes appropriations for the Centers for Disease Control and Prevention (CDC), the National Institute of Allergy and Infectious Disease (NIAID) which is part [...] Read More
On October 9, 2019, the Office of Inspector General (OIG), Department of Health and Human Services released a proposed rule updating safe harbor protections under anti-kickback statute. This proposed rule follows the OIG’s previous request for information from August 2018, and coordinates provisions with the Centers for Medicare & Medicaid Services’ (CMS) proposed rule on [...] Read More
On January 31, 2019, the Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) issued a proposed rule that would, if finalized, remove the existing legal “safe harbor” that protects rebates currently negotiated between pharmaceutical manufacturers and Medicare Part D prescription drug plans and Medicaid plans. In its place, the agency [...] Read More
The Department of Health and Human Services (HHS) has released a Draft Strategy titled “Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs.” As required by the 21st Century Cures Act, the draft strategy identifies an overall goal of reducing burden related to the use of EHRs and Health IT [...] Read More
This evening, the Department of Health and Human Services (HHS), in conjunction with the Department of the Treasury and the Department of Labor, released two final rules on exemptions and accommodations for the coverage of certain preventive services under the Affordable Care Act (ACA). One final rule covered religious exemptions while the other covered moral [...] Read More
Overview The Office of the Assistant Secretary for Planning and Evaluation (ASPE) within the U.S. Department of Health and Human Services (HHS) has released a report entitled “Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures.” The report comes as the Trump administration continues to implement its “American Patients [...] Read More
The Centers for Medicare and Medicaid Services (CMS) has released a new guidance for states related to State Innovation Waivers granted under section 1332 of the Affordable Care Act (ACA). With this new guidance, CMS will now refer to these waivers as State Relief and Empowerment Waivers. CMS believes that this new guidance will give [...] Read More
On Monday, the Trump Administration released a high-profile proposed rule that, if implemented, would require drug manufacturers to disclose the list prices of prescription drugs in their respective direct-to-consumer (DTC) advertisements (see AP’s summary of the proposal here). Trying to stay ahead of the curve, PhRMA also released voluntary guidelines for member companies in which [...] Read More
This afternoon, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule related to drug pricing transparency as part of the administration’s continuing effort to combat high drug prices. Comments on the proposed regulation are due on December 17, 2018. While the rule cites elements of the Social Security Act as the source […]
Read MoreThis morning, the Senate Health, Education, Labor and Pensions (HELP) Committee held the first congressional hearing on President Donald Trump's plan to combat high drug prices, "American Patients First." The hearing featured testimony from Department of Health and Human Services (HHS) Secretary Alex Azar as well as questions from Committee members. Senators on both sides [...] Read More