News & Analysis as of

Medicare Part B

Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug...

On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus...more

Administration presents plans to lower drug prices

by Hogan Lovells on

On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. Please see full...more

CMS Seeks Input on Direct Provider Contracting

The Centers for Medicare & Medicaid Services (CMS) announced that it is seeking input on direct provider contracting (DPC) between “payers and primary care or multi-specialty groups to inform potential testing of a DPC model”...more

OIG Reports That CMS Paid Practitioners For Telehealth Services That Failed To Meet Medicare Requirements

On April 5, 2018, the Office of the Inspector General (OIG) announced its findings that the Centers for Medicare and Medicaid Services (CMS) paid practitioners for telehealth services that did not meet Medicare requirements....more

CMS Offers Expanded Settlement Options to Reduce Appeals Backlog

by Bass, Berry & Sims PLC on

In January 2018, Centers for Medicare & Medicaid Services (CMS) announced additional information regarding a new Low Volume Appeals (LVA) settlement option and an expanded Settlement Conference Facilitation (SCF) as part of...more

CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals

by Baker Ober Health Law on

On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more

Bipartisan Budget Act of 2018 repeals therapy caps: What does it mean for hospital outpatient therapy departments?

by Bricker & Eckler LLP on

“Therapy caps” date back to the Balanced Budget Act of 1997, which limited (or “capped”) the amount of annual per-patient therapy expenditures under Medicare Part B. However, Congress created an exceptions process in 2006,...more

New CMS National Coverage Determination and FDA Regulatory Approach: the Next Generation for NGS Testing Policy?

• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more

LVA Settlement Update

by Polsinelli on

The LVA settlement option is being offered to providers and suppliers with fewer than 500 Part A and B claims pending as of Nov. 3, combined, where no single claim appeal exceeds $9,000. These appeals will be settled at 62...more

Capitol Hill Healthcare Update

by BakerHostetler on

CONGRESS SCRAMBLES TO COMPLETE BUDGET IN ADVANCE OF DEADLINE - Lawmakers are working overtime – including on key healthcare issues – to wrap up work on a $1.2 trillion omnibus budget bill that would fund the government for...more

OIG February 2018 Work Plan Update

by Baker Ober Health Law on

The OIG added three items to its Work Plan with the February 2018 update, as listed in the chart below. Two of the items concern annual reports, one addressing the performance of Medicaid Fraud Control Units and the other...more

The President’s Budget and Shifting Policy on Prescription Drugs

On February 12, the Trump administration released the President’s Budget (or “the Budget”), outlining spending priorities for FY 2019. The Budget—though an important annual milestone and barometer of the administration’s...more

Key Health Care Provisions of Bipartisan Budget Act of 2018

by Baker Donelson on

The wide-reaching Bipartisan Budget Act of 2018 (BBA), passed by Congress and signed by the President on February 9, 2018, extends and modifies dozens of health care programs, including extending funding for two years for...more

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

340B Update: Trump Administration’s 2019 Budget and White House Council of Economic Advisors Signal Further Changes to 340B...

by K&L Gates LLP on

On February 12, 2018, the Trump Administration released its fiscal year (“FY”) 2019 budget request to Congress outlining several proposals related to the 340B Drug Pricing Program (the “340B Program”) including a modification...more

2019 White House and HHS Budgets Released: Key Changes to Drug Pricing and Reimbursement Proposed

by Hogan Lovells on

On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others, several proposals regarding drug pricing...more

The New Option in Town: Applying for the Low Volume Appeals Settlement

by Baker Ober Health Law on

In November 2017, the Department of Health and Human Services (HHS) announced new settlement options for providers and suppliers stuck in the backlog of the Medicare appeals process. One of the new options available is the...more

White House Unveils Proposal on Drug Pricing

by Holland & Knight LLP on

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Congress Makes Key Changes to Medicare Physician Payment Programs as Part of Short-Term Government Funding Bill

• Congress amended current law to prevent CMS from applying the “MIPS” payment adjustment to separately billed items like drugs and biologics, which will drastically reduce the total amount of payment adjustments to clinical...more

Bipartisan Budget Act of 2018: Major Impacts on Health Care

by Baker Donelson on

After a brief federal government shutdown overnight, Congress passed and the President signed into law the Bipartisan Budget Act of 2018 on February 9, 2018. The Senate voted 71-28 and the House voted 240-186 to approve the...more

Trends in Medicare Part D Benefit Design and Cost Sharing for Adult Vaccines, 2015–2017

Vaccination utilization among U.S. adults is low, and well below the Healthy People 2020 Targets, despite widespread availability of safe and effective vaccines and long-standing use recommendations by the Centers for Disease...more

CMS Issues Temporary Enrollment Moratorium on Home Health Agencies and Non-Emergency Ambulances in Selected States

On January 29, 2017, the Centers for Medicare and Medicaid Services (CMS) announced a temporary moratorium on enrolling Part B non-emergency ambulance providers/suppliers and home health agencies, subunits and branch...more

CMS Announces Low Volume Appeal Settlement Option for Providers Mired in ALJ Backlog

by Arnall Golden Gregory LLP on

On January 9, 2018, the Centers for Medicare and Medicaid Services (CMS) announced details on the new low volume appeal settlement option, which is the latest alternative available to Medicare Part A and Part B providers and...more

Updates on Biosimilar Reimbursement Pathways in the Face of a Changing Market

by Alston & Bird on

Though the biosimilars market has evolved, and more companies are seizing the opportunities, reimbursement regulations have been unclear at best. Our Health Care Group untangles the latest rules from the Centers for Medicare...more

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

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