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California: Proposed Legislation Regulating Health Care Rates for Payors and Providers

An ambitious California proposal to regulate health care rates and curb long-term health care spending was unveiled last week in Assembly Bill 3087 (Proposed Legislation). The key concept in the Proposed Legislation is the...more

California Medicaid Agency Proposes Significant Restrictions on FQHC and RHC Reimbursement

California’s Medicaid agency has posted draft language of a new state plan amendment (SPA) that would make major changes to federally qualified health center (FQHC) and Rural Health Clinic (RHC) reimbursement. Public comments...more

SAMHSA Finalizes Second Round of Changes to Federal Substance Use Disorder Privacy Rule

New federal regulations published on January 3, 2018, clarify when lawful holders of substance-use disorder records may use and disclose patient identifying information for payment, health care operations, and audits and...more

Court Rules Against 340B Hospitals, Allows Medicare Reimbursement Cuts to Go Forward

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

CMS Finalizes Reimbursement Cuts for 340B Hospitals

In a striking blow to 340B hospitals, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) released a final Medicare Outpatient Prospective Payment System (OPPS) rule adopting its...more

Health Care Reform Returns to the Spotlight

Congress is now back in session and, once again, focus has turned to health care. With all eyes on returning health care reform to the forefront, a flurry of activity has sparked new legislative efforts including the...more

Ninth Circuit Victory Opens the Door to Medicaid Reimbursement Challenges Based on Equal Access Requirement

The Ninth Circuit held August 7 that the Department of Health and Human Services Secretary erred in approving a Medicaid State Plan Amendment (SPA) that cut reimbursement for outpatient hospital services in California by 10%...more

Proposed Rule Would Slash Medicare Payment for 340B Drugs

The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six...more

Senate Unveils Changes to the Better Care Reconciliation Act of 2017: Significant Changes, but Uncertainty Remains

On July 13th, the Senate released the updated version of the Better Care Reconciliation Act (BCRA) of 2017. While the new version makes some significant changes to the original Senate proposal, the major components of the...more

Republican Health Care Bill Moves Forward to the Senate

In a surprising reversal, last week the U.S. House of Representatives passed legislation that would significantly modify the Affordable Care Act. The legislation, known as the American Health Care Act (the “AHCA”, H.R. 1628),...more

House Committees Reveal Draft of Bill to Modify and Repeal Portions of the Affordable Care Act

On Monday, two House committees with oversight over health care and taxation, Energy and Commerce and Ways and Means, released draft reconciliation bills designed to repeal and alter significant portions of the Patient...more

340B Program Omnibus Guidance Withdrawn

The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B...more

Hawai’i Receives Approval for the First State Innovation (Section 1332) Waiver

The federal Department of Health and Human Services and Department of Treasury (the Departments) agreed that certain small employer health insurance coverage provisions of the Affordable Care Act (ACA) would be waived for the...more

OPPS Final Rule Finalizes Limits for Off Campus Departments

Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule...more

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

Mid-Year 340B Program Update

Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the...more

“Site Neutrality” for Off-Campus Outpatient Departments: Proposed Rule is Worse than You Expected!

CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will be published in the Federal Register on July 14, 2016. One highly-anticipated...more

CMS Update to Medicaid Managed Care Regulations Should Prompt Significant Change

The Centers for Medicare & Medicaid Services (“CMS”) has released the final version of its much anticipated revisions to the regulations governing Medicaid managed care (the “Final Rule”). First proposed in May 2015, the...more

340B Program Update

The new year has already gotten off to a busy start for health care providers that participate in the 340B Drug Pricing Program (“340B Program”) and government agencies that reimburse these providers. Following on the heels...more

Potential Part B Drug Payment Cuts for 340B Hospitals

The influential Medicare Payment Advisory Commission (MedPAC) has voted to recommend to Congress in its March report that Medicare Part B drug payment rates for 340B drugs be reduced by 10 percent for hospitals participating...more

New Guidance Outlines Requirements for State Innovation Waivers

New guidance from Centers for Medicare & Medicaid Services (CMS) places the spotlight on the ability of states to seek approval of “State Innovation Waivers” to test new approaches for delivering health insurance reform....more

2016 Expected to Be Monumental Year for 340B Drug Discount Program

The 340B Program continues to be an area of focus from federal policymakers, and recent activity and publications indicate that 2016 could be a monumental year for the program. Below is a breakdown of the recent and upcoming...more

Budget Bill Aims to Kill Any New Off-Campus Provider-Based Facilities

Legislation being drafted as part of a budget deal between members of Congress and the White House includes language that will significantly alter the future of hospital-based outpatient care. The “discussion draft” of the...more

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