Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
On July 13, 2023, CMS published a proposed rule to update the payment policies, payment rates, and other provisions for services furnished under the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory...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 Friday, July 7, 2023, the Centers for Medicare & Medicaid Services (CMS) published their long-awaited proposed remedy to the unlawful 340B drug payment reductions. Background: In 2018, CMS significantly reduced the...more
On December 2, 2020, CMS issued a Final Rule finalizing revisions to the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for Calendar Year (CY)...more
On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) released the calendar year 2021 Final Rule implementing changes to the Medicare hospital Outpatient Prospective Payment System (OPPS) and Ambulatory...more
The U.S. Court of Appeals for the D.C. Circuit recently reversed a district court ruling and upheld the Centers for Medicare & Medicaid Services site-neutrality payment cuts for off-campus outpatient hospital clinic visits....more
On December 16, 2019, the U.S. District Court for the District of Columbia ruled that its 2019 decision invalidating the Center for Medicare and Medicaid Services’ (CMS) site-neutral payment cuts does not automatically vacate...more
CMS’ 340B Rate Cut Continues to Dampen Hospital Outpatient Expansion Efforts - Hospitals hoping to benefit from favorable 340B drug pricing when acquiring independent physician practices for conversion to hospital...more
Despite a court ruling against its site-neutral policy in September 2019, in the Calendar Year (CY) 2020 Medicare Outpatient Prospective Payment System (OPPS) final rule, released on November 1, 2019, the Centers for Medicare...more
On September 17, 2019, the United States District Court for the District of Columbia ruled that the Center for Medicare and Medicaid Services (CMS) exceeded its authority and failed to follow the statutory process for setting...more
On January 18, 2019, a group of nearly 40 hospitals filed a lawsuit in the United States District Court for the District of Columbia challenging CMS’s rate cut to evaluation and management (E/M) services furnished by excepted...more
CMS took another step in its campaign to impose "site neutrality" on hospital outpatient payments with its recently published final Medicare hospital Outpatient Prospective Payment System (OPPS) rule for CY 2019. The final...more
On July 25, 2018, the Centers for Medicare & Medicaid Services (CMS) released proposed policy and payment updates affecting the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC)...more
CMS recently published its proposed Medicare outpatient prospective payment system (OPPS) rule for calendar year (CY) 2019. The rule contains a number of "site-neutral" proposals that, if adopted, will result in lower...more
On July 25, 2018, the Centers for Medicare & Medicaid Services (CMS) released the proposed Calendar Year (CY) 2019 Hospital Outpatient Prospective Payment (OPPS) Rule proposing, among other changes, to further restrict...more
There are now multiple proposals in the House and Senate for substantive changes to the 340B Drug Discount Program. The odds of a legislative “fix” to 340B are increasing. But independent of congressional action, is CMS...more
On Friday, December 29, 2017, the U.S. District Court for the District of Columbia dealt a blow to hospitals participating in the 340B Drug Pricing Program. By participating in the 340B program, eligible public and...more
On December 11, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements. The guidance clarifies the requirements for...more
On Nov. 2, 2017, the Centers for Medicare and Medicaid Services (CMS) finalized a rule changing reimbursement rates under the Medicare Physician Fee Schedule (MPFS) for certain non-excepted hospital off-campus provider-based...more
When CMS issued its proposed rule for OPPS and ASC Payment System on July 13, the agency included a proposal to substantially scale back reimbursement for Part B drugs to hospitals participating in the federal 340B Drug...more
On July 13, 2017, CMS released several proposed rules impacting health care, including the 2018 Outpatient Prospective Payment System (OPPS) proposed rule which, among other proposals, could have a significant impact on 340B...more
The CY 2016 OPPS Final Rule, issued on October 30, 2015, instituted new cost reporting rules prohibiting MACs from paying items that a provider has not claimed or protested on its as-filed cost report. Importantly, these...more
For relocations that occurred between 11.2.15 and 12.31.16, providers must submit relocation requests by 1.31.2017. The CY 2017 OPPS Final Rule brought significant changes to the way Medicare reimburses hospitals for...more
We are pleased to present our annual review of developments in the field of health law. The year was marked by key changes in False Claims Act jurisprudence and Medicare payment policy. 2016 also brought with it focused...more