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CMS Proposes New Regulation to Clarify Physician and NPP “Split (or Shared)” Billing Policy

On July 13, 2021, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2022 Medicare Physician Fee Schedule (MPFS) proposed rule (Proposed Rule). The Proposed Rule sets forth CMS’ plans to revise...more

[Webinar] 340B… Or Not 340B: Oversight, Compliance and Enforcement - July 15th, 9:00 am - 10:00 am PT

The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more

July Surprise - Supreme Court Agrees to Review Medicare Payment Cuts to 340B Drugs

The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more

[Webinar] 340B in 2021: What Covered Entities and Their Partners Need to Know Now - March 18th, 2:00 pm - 3:00 pm ET

This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow. Our...more

Consolidated Appropriations Act Includes GME Support Provisions

The Consolidated Appropriations Act, 2021, creates 1,000 new Medicare-funded graduate medical education (GME) residency positions, expands opportunities for rural residency training, and allows hospitals that have very low...more

Congress Establishes New Medicare Provider Category and Reimbursement for Rural Emergency Hospitals

Year-end COVID-19 relief legislation approved by Congress established Rural Emergency Hospitals (REHs) as a new Medicare provider type effective January 1, 2023. REHs, defined as providers that furnish certain outpatient...more

HRSA Releases Final Rule Establishing Dispute Resolution Process for the 340B Program

On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes...more

OIG Finalizes Revisions to Safe Harbor Protection for Drug Rebates and Establishes New Safe Harbors for Point-of-Sale Price...

On November 20, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule as part of ongoing administration drug pricing reform efforts and in conjunction with the...more

HRSA Issues Proposed Rule Requiring Community Health Center Grant Recipients to Provide Certain Drugs to Low-Income Patients at...

On September 24, 2020, the Health Resources and Services Administration (HRSA) released a proposed rule that, if finalized, would require 340B-participating recipients of federal grants under Section 330(e) of the Public...more

White House Directs HHS to Model “Most-Favored-Nation” Price Caps for Part B and D Drugs

On September 13, 2020, the White House issued an Executive Order titled “Lowering Drug Prices by Putting America First” (the Executive Order), which directed the Secretary of the US Department of Health and Human Services...more

CMS Proposes Further OPPS Reductions to 340B Drug Reimbursement Rates

On August 4, 2020, the Centers for Medicare & Medicaid Services (CMS) released its CY 2021 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule. CMS proposes to reduce OPPS payments for 340B drugs from...more

DC Circuit Upholds OPPS Reimbursement Reductions for 340B Drugs

On July 31, 2020, the US Court of Appeals for the District of Columbia Circuit held that the Centers for Medicare and Medicaid Services (CMS) has authority under the Social Security Act to reduce Medicare payment rates for...more

HRSA Announces New Registration and Recertification Requirements for 340B Program

The Office of Pharmacy Affairs (OPA) of the Health Resources and Services Administration (HRSA) recently issued a new Program Update that includes new covered entity registration and recertification requirements, as well as...more

Federal District Court Upholds Hospital Price Transparency Rule; Implementation and Compliance Questions Remain

Background On November 15, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (Final Rule) that requires hospitals to establish, update and make public a list of their standard charges for items and...more

Planning Beyond the Pandemic: Considerations for Hospital and Healthcare Facility Evacuations

In light of recent civil unrest within the United States, which has been accompanied by incidents of property damage and large crowd actions, hospitals and healthcare facilities should consider reviewing and ensuring that...more

CMS Announces Additional Blanket Waivers for Healthcare Facilities

On May 11, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a new suite of blanket waivers to ensure that healthcare facilities have the flexibility they need to treat patients during the Coronavirus...more

Hospital at Home - CMS Expands Payments to Hospitals for Care Provided in Patient Homes

On April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule (IFR) that made regulatory changes and clarified certain policies in response to the Coronavirus (COVID-19) public health...more

But Wait, There’s More! CMS Provides Additional Regulatory Relief Through Expanded Blanket Waivers

The Centers for Medicare and Medicaid Services (CMS) issued blanket waivers under Section 1135 of the Social Security Act (Section 1135 waivers) on April 30, 2020. Fast on the heels of a more modest waiver announcement on...more

CMS Releases 340B Drug Acquisition Cost Survey, Responses Due May 15, 2020

After receiving approval from the Office of Management and Budget (OMB) on April 23, 2020, the Centers for Medicare and Medicaid Services (CMS) released a survey on April 24, 2020, to collect information on 340B hospitals’...more

CMS Provides Flexibility for Independent Freestanding Emergency Departments to Enroll in Medicare as Hospitals During the COVID-19...

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued Quality, Safety & Oversight memorandum QSO-20-27-Hospital (QSO Memo), addressed to state survey agencies to provide guidance to independent...more

Flexibilities for Rural Health Centers, Federally Qualified Health Centers During COVID-19

The Centers for Medicare and Medicaid Services released a fact sheet detailing flexibilities for Rural Health Clinics and Federally Qualified Health Centers during the Coronavirus (COVID-19) pandemic. During the national...more

CMS Provides Guidance to Ambulatory Surgical Centers Temporarily Enrolling in Medicare as Hospitals During the COVID-19 Pandemic

On April 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued Quality, Safety & Oversight memorandum QSO-20-24-ASC (the QSO Memo), addressed to state survey agencies to provide guidance on processing attestation...more

CMS Issues Broad Package of Blanket Waivers Under Section 1135

The updated waivers build upon the more limited set of Section 1135 waivers issued on March 13, 2020, and address common concerns among Medicare providers and suppliers as they deal with the Coronavirus (COVID-19) pandemic....more

CMS Expands Accelerated and Advance Payment Program to All Medicare Providers, Suppliers

Accelerated or advance Medicare payments can provide some cash flow as providers and suppliers combat the effects of the Coronavirus (COVID-19) pandemic. This program requires a one-page application and funds may be available...more

HHS OIG Establishes Portal and Process to Provide Guidance on Anti-Kickback and Beneficiary Inducement Statutes During COVID-19...

The US Department of Health and Human Services, Office of Inspector General has created an information portal and established a process to provide guidance on the application of the Anti-Kickback Statute and Beneficiary...more

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