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CMS

HHS Proposes New Safe Harbors Under the Anti-Kickback Statute and The Stark Law

HHS Proposes New Safe Harbors Under the Anti-Kickback Statute and The Stark Law

In a pair of proposed rules released by the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS), the DHHS is looking to increase the utilization of value-based arrangements to drive health outcomes and ease the regulatory burdens associated with patient care coordination.  The proposed rules seek to change or add certain safe harbors or exceptions to the Anti-Kickback Statute (AKS), Physician Self-Referral prohibition (Stark Law), and the Civil Monetary Penalties (CMP) laws. 

CMS’ New Coding Policy Will Speed up Reimbursement for New Drugs and Devices

CMS’ New Coding Policy Will Speed up Reimbursement for New Drugs and Devices

When developing new medical device and drug products, it is important to understand how the product will be adopted and paid for in the marketplace. The development of new drugs and devices involves countless hours researching, testing, modifying, iterating, and testing some more… In larger companies, whole teams of people also dedicate the same effort into developing a market access plan—meaning careful planning for manufacturing, distribution, and insurance contracting.  This strategic planning can be overlooked in start-up biotech companies operating on limited resources and which are squarely focused on innovating new technologies.

Breakthrough Devices: CMS Removes Hurdles and Increases Payments for New Technology Add-On Payments Under the IPPS Final Rule

Breakthrough Devices: CMS Removes Hurdles and Increases Payments for New Technology Add-On Payments Under the IPPS Final Rule

Hospitals and medical device manufacturers will both benefit from the Centers for Medicare and Medicaid Services’ (CMS) finalization of the 2020 Inpatient Prospective Payment System (IPPS) Final Rule (“Final Rule”) scheduled to be published on August 16, 2019.  In an effort to increase Medicare beneficiaries’ access to innovative medical technologies, CMS has finalized certain changes to the “new technology add-on payment” “(NTAP) application and payment processes under the Final Rule. This change is likely to encourage hospital adoption of new technologies, which is intended to spur innovation and additional investment in these technologies.

New CMS Innovation Models: Primary Care First and Direct Contracting

New CMS Innovation Models: Primary Care First and Direct Contracting

In April, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) announced a new set of payment models meant to allow primary care providers deliver better care at a lower cost to their patients by removing unneccessary administrative and adjust payouts from procedures to outcomes.

MSSP Proposed Rule may mean major changes for Medicare ACOs

MSSP Proposed Rule may mean major changes for Medicare ACOs

CMS recently released a Proposed Rule suggesting significant changes to the Medicare Shared Savings Program, aimed at accelerating the path for providers participating in a Medicare ACO to take on risk for the cost and care of their patient populations. The following is a summary of key changes proposed to the MSSP.

Hot Topic: CMS' Comprehensive Primary Care Plus (CPC+) Initiative

Hot Topic: CMS' Comprehensive Primary Care Plus (CPC+) Initiative

The CMS Center for Medicare and Medicaid Innovation (CMMI) has spent the last 6 years testing out a variety of models for value-based care and payment--the Medicare Shared Savings Program (MSSP) and other ACO models, the Bundled Payments for Care Improvement (BPCI) Initiative, the Comprehensive Care for Joint Replacement Model, and various Medicaid and CHIP initiatives. As the Administration doubles down on its commitment to shift payments away from fee-for-service (FFS), it continues to innovate, building programs to align incentives to person-centered, comprehensive, high quality health care. In that vein, in July of this year, CMS will begin taking applications from practices for participation in a new CMMI program: the CPC+ program.

Rebecca E. Gwilt speaking at CMS' DATA PRIVACY DAY Forum

Rebecca E. Gwilt speaking at CMS' DATA PRIVACY DAY Forum

NLG Partner Rebecca E. Gwilt speaking at Centers for Medicare & Medicaid Services DATA PRIVACY DAY forum, alongside Maya Bernstein, HHS ASPE Senior Advisor for Privacy Policy and Rogelyn McLean, HHS Office of General Counsel. Rebecca will be sharing her perspective on the role of the government in creating a workable framework for HIPAA compliance and the role of the private sector in respecting privacy, safeguarding data and enabling trust.