The health care industry seems to have so much potential for new technologies built on Artificial Intelligence (“AI”) technology, such as chatbots that assist patients and/or physicians in patient care and the adoption of tools that expedite the health claims approval process. We have also seen reports documenting some of the problems that can arise

Health care and life science companies operating globally should be aware of the increased regulatory scrutiny in the U.S., the UK and Asia-Pacific when considering their obligations to monitor and retain business communications conducted through messaging platforms on employees’ personal devices. It is vital for these companies review the effectiveness of their compliance policies and

On March 18, 2022, the Advanced Medical Technology Association (AdvaMed) – the world’s largest trade organization representing medical technology manufacturers – announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code). The effective date of the revised AdvaMed Code is June 1, 2022.

The AdvaMed Code was updated to address

On Nov. 5, 2021, the U.S. Supreme Court consolidated and granted certiorari to a pair of cases involving physicians who were criminally prosecuted for prescribing controlled substances (specifically, opioids) in violation of the Section 841(a)(1) of the Controlled Substances Act (“CSA”).  The consolidated cases—Ruan v. United States and Kahn v. United States—present questions regarding the requisite state of mind for a jury to convict a prescriber under the CSA and the availability and nature of a “good faith” defense to criminal liability under the statute.  By agreeing to hear these cases, the Court positions itself to resolve, or at minimum weigh in on, the current circuit splits regarding these issues.

Under the CSA, as interpreted by the Supreme Court in United States v. Moore, 423 U.S. 122 (1975), practitioners who are registered to legally prescribe controlled substances can nonetheless be found to have violated the CSA if they prescribe in a manner that “fall[s] outside the usual course of professional practice.”  However, petitioners argue that the state of mind necessary to convict varies by circuit.  Judicial willingness to issue a specific jury instruction on the availability of a “good faith” defense similarly varies.Continue Reading SCOTUS to examine “good faith” defense in criminal opioid prescription cases

With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to closely monitor and track which of the outgoing Trump administration’s “midnight regulations” will survive past the early months of the Biden administration. But for those less familiar with the topic

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have issued a Correct Coding article on “HCPCS Coding Recommendations from Non-Medicare Sources,” which discusses Medicare supplier responsibility for selecting the most appropriate Healthcare Common Procedure Coding System (HCPCS) code for furnished medical products. The DME MACs point out that manufacturers and other entities

MedPAC has released its June 2016 Report to the Congress on Medicare and the Health Care Delivery System. The report includes recommendations for a number of Medicare policy reforms and analyses of various health care market developments. Several chapters address Medicare drug policy, including a review of external factors that influence the prices Medicare pays for prescription drugs. With regard to Medicare Part B drug policy, MedPAC discusses potential modifications to Medicare Part B drug reimbursement, such as reducing dispensing and supplying fees, along with approaches to improving the quality and reducing the costs of oncology care (since more than half of Medicare Part B drug spending is associated with anticancer and related drugs). Likewise, MedPAC examines the Medicare Part D prescription drug program and offers recommendations for giving plan sponsors greater financial incentives and mechanisms to manage the benefits of high-cost enrollees; exclude manufacturer discounts on brand-name drugs from counting as enrollees’ true out-of-pocket spending; eliminate beneficiary cost sharing above the catastrophic cap; and increase financial incentives for low-income beneficiaries to use lower-cost drugs and biologicals.

MedPAC also discusses development of a unified Medicare payment system for post-acute care, including its unified prospective payment system (PPS) prototype that it believes accurately predicts resource needs for nearly all patient groups. MedPAC raises various implementation considerations, including the need to develop separate payment models for nontherapy ancillary services and the combination of routine and therapy services; adjustments to recognize lower costs in home health agencies compared to institutional settings; the need for outlier policies and labor cost adjustments; future adjustments to reward high-quality, efficient care; conforming regulatory reforms; and an appropriate transition period, among other policy provisions.

In addition, the report addresses:
Continue Reading MedPAC Issues Recommendations on Medicare Drug, Post-Acute Care, and Other Payment Policies

The Medicare Payment Advisory Commission (MedPAC) has released its annual recommendations to Congress on Medicare policies, including Medicare fee-for-service (FFS) payment updates and a status report on the Medicare Advantage and Medicare Part D programs.  The following are highlights of the recommendations for 2017 (some of which were recommended previously):
Continue Reading MedPAC Releases Annual Recommendations to Congress on Medicare Policy

What would federal health policy look like under a Trump Administration?  Donald Trump outlined his plan for “Healthcare Reform to Make America Great Again” on March 2, 2016.  The heart of the plan is a call for Congress to repeal the Affordable Care Act (aka “Obamacare”) and enact other “free market” policies, including:

  • Allowing sale

Donald Trump has released his plan for “Healthcare Reform to Make America Great Again”, which includes a proposal for allowing importation of cheaper prescription drugs from other countries as one of the reforms he believes should be enacted in connection with repealing and replacing “ObamaCare.” Specifically, the plan states that Congress must:

Remove barriers to

On February 9, 2016, the Obama Administration released its proposed fiscal year (FY) 2017 budget, which contains significant Medicare and Medicaid reimbursement and program integrity legislative proposals – including $419 billion in Medicare savings over 10 years. These proposed policy changes would require action by Congress, and Republican Congressional leaders have already voiced general

The Obama Administration’s proposed fiscal year (FY) 2017 budget, released on February 9, 2016, includes a number of legislative proposals that would revise Medicare and Medicaid policies to achieve budget savings and make other program reforms.  The largest pool of Medicare savings would result from various Medicare prescription drug proposals, including the following (all savings over the 10-year period of FYs 2017-2026):  
Continue Reading Medicare and Medicaid Drug Policy Provisions in the Obama Administration’s Proposed FY 2017 Budget

The Government Accountability Office (GAO) has issued a report on trends in Medicaid managed care spending, enrollment, and oversight.  Notably, the GAO reports that over 10 years (FY 2004 through 2014), federal Medicaid managed care spending grew from $27 billion to $107 billion, representing 38% of total federal Medicaid spending in 2014.  The report also

The Medicare Payment Advisory Commission (MedPAC) has released its 2015 Data Book on Health Care Spending and the Medicare Program. The publication provides information on national health care and Medicare spending, Medicare and dual-eligible beneficiary demographics, Medicare quality, and Medicare beneficiary liability, along with Medicare Advantage and Medicare Part D drug program data. The report

The Medicare Payment Advisory Commission (MedPAC) has released its June 2015 Report to the Congress on Medicare and the Health Care Delivery System. The report includes a series of recommendations on Medicare hospital short-stay policy, in response in part to hospital concerns about related Medicare Recovery Audit Contractor (RAC) Program audits and appeals and the financial impact on beneficiaries associated with the growing use of outpatient observation day status. Specifically, MedPAC recommends that:
Continue Reading MedPAC Report to Congress on Medicare and the Health Care Delivery System

The Reed Smith Health Industry Washington Watch blog ( has been updated to report on recent health policy developments, including the following:

— Regulatory Developments. CMS has issued a number of proposed and final rules, including regulations addressing the Medicare Shared Savings Program, Medicaid/CHIP managed care, health insurance summary of benefits and coverage and uniform glossary requirements, and CMS oversight of national accrediting organizations, among others. For details, see HHS has released its spring 2015 regulatory agenda and is soliciting comments on the use of the health plan identifier in electronic health care transactions (

— Other CMS Developments. CMS has released updated Medicare drug payment files, guidance on Medicaid/CHIP provider fingerprint-based criminal background checks, Medicare provider payment data, and guidance on beneficiary drug plan disenrollments by long term care facilities. CMS also has announced a new Cardiovascular Risk Reduction Model and policy changes impacting ventilators. See

— OIG & GAO Developments. The OIG has issued a fraud alert on physician compensation arrangements, and the OIG released its latest semiannual report and an update to its work plan ( The GAO has issued reports on the Medicare physician payment ratesetting process and Medicaid fraud controls (

— Legislative Developments. Congressional panels have approved a series of health policy bills, including repeal of ACA medical device tax and the Independent Payment Advisory Board, changes to Medicare Advantage requirements and Medicare long-term care hospital policy, Medicare appeals reforms, and 21st Century Cures legislation. Congress also has been considering changes to Medicare sequestration policy as part of pending trade legislation. Congressional committees have held hearings on various health policy issues. See

— Health Industry Events. Upcoming CMS events will focus on the National Partnership to Improve Dementia Care, hospice quality reporting, Hospital Compare ratings, ICD-10 implementation, Medicare clinical laboratory fee schedule payments, and hospital outpatient payments (

— Changes Coming to Health Industry Washington Watch. Our blog will soon have a new look and provide our readers with enhanced access to content and optimal readability across the wide variety of devices. We will also have a revised email notification system to alert subscribers to new content. If you don’t already receive email alerts from our blog, we invite you to subscribe at

For details on these and other health industry developments, please visit
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

— Regulatory Developments. Recent CMS regulations have addressed Medicare hospice payments and Part D prescribing regulations, and CMS has published a notice clarifying the FY 2016 IPPS/LTCH proposed rule comment deadline. For details, see HRSA has published a final rule to implement the HIV Organ Policy Equity Act, and OMB is reviewing new HRSA 340B omnibus guidelines (

— Other CMS Developments. CMS has announced savings levels for the Pioneer ACO Model, and it is proceeding with the application process for the next round of the Medicare Shared Savings Program. CMS also is soliciting quality measure suggestions for potential use in the PQRS. See

— OIG & GAO Developments. Recent OIG reports have addressed FDA oversight of generic drug manufacturers, incorrect physician place-of-service coding, home health agency background check policies, and drug rebate policies ( GAO reports have examined Medicaid payments to hospitals and section 1115 demonstrations (

— Legislative Developments. Congress has approved its FY 2016 budget framework, a House panel is marking up the 21st Century Cures Act, and committees have held hearings on various health policy issues. See

— Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications, potential elimination of CMNs/DIF forms, the National Partnership to Improve Dementia Care, hospice quality reporting, ICD-10 implementation, and Medicare clinical laboratory fee schedule payments (

For details on these and other health industry developments, please visit
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog