Tag: HHS

HHS

Regulatory/FDA

FAQ: HIPAA Proposed Rule to Support Reproductive Health Care Privacy

FAQ: HIPAA Proposed Rule to Support Reproductive Health Care Privacy

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released the HIPAA Privacy Rule to Support Reproductive Health Care Privacy proposed rule on April 12, 2023 aimed at providing additional requirements around the sharing of protected health information (PHI) relating to patient initiated and provider administered reproductive health care. OCR has […]

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General

2023 ACA Enrollment on Course to Surpass 2022 Record

2023 ACA Enrollment on Course to Surpass 2022 Record

Nov. 29, 2022 – Americans are enrolling in Affordable Care Act (ACA) marketplaces for 2023 at what appears to be a record-setting pace as healthcare becomes less of a political football. According to a report from President Joe Biden and Department of Health and Human Services (HHS) Secretary Xavier Becerra, nearly 3.4 million people have […]

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Regulatory/FDA

HHS Formally Withdraws SUNSET Final Rule

HHS Formally Withdraws SUNSET Final Rule

June 20, 2022 – The Department of Health and Human Services (HHS) has formally withdrawn a Trump administration rule that threatened to cause many HHS regulations to expire. HHS announced its decision in a recent 133-page withdrawal notice in the Federal Register, stating that the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) final rule […]

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Washington Focus

Medicare Advantage Plans May Promise More but Deliver Less

Medicare Advantage Plans May Promise More but Deliver Less

May 2, 2022 – Although Medicare Advantage (MA) plans often are touted for delivering more benefits at a lower cost than traditional Medicare, some critics argue that MA organizations (MAOs) deny beneficiaries coverage that they would receive under Medicare rules – including MRIs and post-acute care – in order to increase profits. As MA plan […]

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Washington Focus

Biden’s 2023 Budget: Big Increases for FDA, CDC, Pandemic Preparedness

Biden’s 2023 Budget: Big Increases for FDA, CDC, Pandemic Preparedness

April 4, 2022 – The fiscal year (FY) 2023 budget proposed by President Joe Biden last week emphasizes fiscal restraint more than new, big spending programs, but it does ask for increased funding for pandemic preparedness, the Food and Drug Administration (FDA), and projects such as the Cancer Moonshot and the Advanced Research Projects Agency […]

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Uncategorized

Rawson: Biden Health Policy Priorities Include COVID, ARPA-H, Moonshot

Rawson: Biden Health Policy Priorities Include COVID, ARPA-H, Moonshot

Feb. 21, 2022 – During President Joe Biden’s first year in office, his administration’s health policy team has faltered, made missteps and miscalculations on COVID-19 decisions and communication, and took more than a year to secure a permanent Food and Drug Administration Commissioner (Robert Califf, M.D., was confirmed to take the helm on Feb. 15). […]

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General

HHS: Pharmacists Can Administer COVID-19 Antivirals

HHS: Pharmacists Can Administer COVID-19 Antivirals

Nov. 29, 2021 –With little fanfare, the U.S. Department of Health and Human Services (HHS) recently moved to allow licensed pharmacists to dispense Food and Drug Administration (FDA)-authorized COVID-19 therapeutics directly to patients, without a physician prescription. This step, taken by publishing an amendment to a declaration under the Public Readiness and Emergency Preparedness Act, […]

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Regulatory/FDA

HHS/FDA Withdrawing Device Exemptions Proposed by Trump Administration

HHS/FDA Withdrawing Device Exemptions Proposed by Trump Administration

April 19, 2021 – Calling the basis for proposed medical device exemptions from premarket notification (510(k)) requirements “flawed,” the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing exemptions for 83 class II devices and one unclassified device which were proposed Jan. 15 in the last few days […]

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Washington Focus

Biden’s FY 2022 Proposed Budget Plan Would Boost Spending on Public Health

Biden’s FY 2022 Proposed Budget Plan Would Boost Spending on Public Health

April 12, 2021 – President Joe Biden signaled his administration’s public health priorities in an outline of the fiscal year 2022 (FY 22) budget released last week. These proposed investments include substantial increases in funding for the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC), creation of […]

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Regulatory/FDA

HHS Postpones Trump-legacy SUNSET Final Rule in Wake of Lawsuit

HHS Postpones Trump-legacy SUNSET Final Rule in Wake of Lawsuit

March 22, 2021 – The Department of Health and Human Services (HHS) has postponed for one year the effective date of its Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule – put in place in the final days of the Trump administration – pending judicial review of a lawsuit filed March 9. In […]

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