Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
Kim Brandt on the Latest Washington Healthcare News
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more
The Affordable Care Act, which was signed into law in 2010, contained a provision (commonly referred to as Section 1557) prohibiting discrimination on the basis of race, color, national origin, sex, age or disability in...more
The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more
The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) and the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule on May 6, 2024 (the “Final Rule”) under Section 1557 of the...more
Earlier this month, HHS unveiled updated Section 1557 regulations which will impact most healthcare providers, including for the first time Medicare Part B providers who do not participate in other federal programs like...more
Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more
On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) (final regulations) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits...more
On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the...more
On April 26, 2024, the United States Department of Health and Human Services (“HHS”) Office for Civil Rights and the Centers for Medicare & Medicaid Services issued a final rule under Section 1557 of the Affordable Care Act,...more
On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more
On August 16, President Biden signed into law the Inflation Reduction Act of 2022 (P.L. 117-169; the “Act”). Although the Act differs considerably from the wide-ranging domestic economic package Democrats had initially...more
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
On July 25, 2022, the Department of Health and Human Services issued a new proposed rule (subsequently published in the Federal Register on August 4) on Section 1557 of the Affordable Care Act (ACA), which prohibits...more
The Big Picture - On July 25, the Department of Health and Human Services (HHS) released a proposed rule interpreting Section 1557 of the Affordable Care Act (ACA), which prohibits any health program or activity that...more
On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more
On August 4, 2022, the US Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM or proposed rule) to reinterpret section 1557 of the Affordable Care Act (ACA), which prohibits...more
On July 25, 2022, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a long-awaited proposed rule on Section 1557 of the Affordable Care Act (ACA), the nondiscrimination protections...more
Drug Pricing Initiatives: Democrats renewed their efforts to pass drug pricing reform measures in the form of a revised H.R. 5376 (the Build Back Better Act, or BBBA). Democrats intend to adopt the BBBA as part of the budget...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On January 6, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs...more
The Big Picture - Before leaving for its August recess, the Senate made progress on two major Biden Administration priorities by passing bipartisan infrastructure legislation and a fiscal year (FY) 2022 budget resolution....more