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 (https://www.healthindustrywashingtonwatch.com) 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 https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. 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 (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/).

— 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 https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

— 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 (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO has issued reports on the Medicare physician payment ratesetting process and Medicaid fraud controls (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

— 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 https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

— 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 (https://www.healthindustrywashingtonwatch.com/articles/events/).

— 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 https://www.healthindustrywashingtonwatch.com/.

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
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 https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. HRSA has published a final rule to implement the HIV Organ Policy Equity Act, and OMB is reviewing new HRSA 340B omnibus guidelines (https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/).

— 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 https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

— 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 (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). GAO reports have examined Medicaid payments to hospitals and section 1115 demonstrations (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

— 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 https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

— 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 (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

— CMS Regulatory Developments. CMS has issued several proposed rules to update Medicare prospective payment systems (PPS) for FY 2016, including the Medicare inpatient PPS, the long-term care hospital PPS, the skilled nursing facility PPS, the inpatient rehabilitation facility PPS, and the inpatient psychiatric facility PPS. CMS has also proposed updating Medicare and Medicaid Electronic Health Record Incentive program rules, mental health parity rules, and funding for Medicaid eligibility and enrollment systems. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/.

— Other HHS Developments. CMS has released information on Medicare DMEPOS competitive bidding, 2016 Medicare Advantage/Part D rates and policies, and Hospital Compare star ratings (https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). The ONC has issued updated electronic health information privacy/security guidance (https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). The FDA and CMS are establishing an interagency task force on laboratory-developed test oversight, and FDA draft guidance addresses medical device clinical data from studies conducted abroad (https://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/).

— OIG Developments. The OIG has partnered with industry associations to issue guidance for health care governing boards on compliance oversight, and the OIG has issued its Medicaid Fraud Control Units FY 2014 Annual Report (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

— Legislative Developments. President Obama has signed legislation to permanently reform the Medicare physician reimbursement framework and make other policy changes. Pending trade legislation would extend Medicare sequestration. The House has approved the “Ensuring Patient Access and Effective Drug Enforcement Act.” Congressional panels have held hearings on several health policy issues. See https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

— Health Industry Events. Upcoming CMS events will focus on home health star ratings and HCPCS coding applications (https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

— Regulatory Developments. HHS has published proposed Stage 3 EHR Incentive Program and health information technology certification rules, along with a final health insurance wraparound coverage rule. CMS has updated its list of DME items subject to face-to-face encounter/written order prior to delivery requirements and published corrections to the 2015 Medicare physician fee schedule (MFPS) final rule. A number of major CMS proposed rules are in the pipeline. For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/.

— Other HHS Developments. The Obama Administration has announced its plan to combat antibiotic resistant bacteria, CMS has launched its Health Care Payment Learning and Action Network, and CMS proposes removing two National Coverage Determinations (https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/).

— OIG & GAO Developments. The OIG has released the FY 2014 Health Care Fraud and Abuse Control Program Report and its Compendium of Unimplemented Recommendations (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO reported on Medicare payments to certain cancer hospitals (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

— Legislative Developments. The House approved legislation to reform Medicare reimbursement policy for physician services, but the Senate has not yet acted to avert pending MPFS cuts. The House and Senate have approved budget resolutions with Medicare, Medicaid, and ACA provisions. The House approved DMEPOS competitive bidding, hospital observation, controlled substances, and trauma care bills. Congressional panels have held hearings on health policy issues. See https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

— Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications, home health clinical templates, Open Payments/Sunshine Act Data, the Next Generation ACO Model, and the Medicare Shared Savings Program. MedPAC is meeting to discuss various Medicare policies. See https://www.healthindustrywashingtonwatch.com/articles/events/.

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

— MedPAC Report to Congress on Medicare Policy. The Medicare Payment Advisory Commission (MedPAC) has released its annual recommendations to Congress on Medicare policies, including Medicare fee-for-service payment updates and a status report on the Medicare Advantage and Medicare Part D programs (see https://www.healthindustrywashingtonwatch.com/2015/03/articles/odds-ends/medpac-report-to-congress-on-medicare-policy/index.html).

— Regulatory Developments. CMS has published a final rule on SMART Act Medicare Secondary Payer appeals provisions, and the FDA has issued draft guidance on the use of electronic informed consent in clinical investigations (see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/).

— Other CMS Developments. CMS has announced a new “Next Generation” Accountable Care Organization model, and it is inviting stakeholders to join a “Health Care Payment Learning and Action Network” to promote alternative payment models. CMS also has released the April 2015 Medicare Part B drug average sales price files, a report on the impact of Medicare quality measures, and initial results for the Medicare Physician Value-based Modifier. For details, see https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/.

— OIG & GAO Developments. The OIG has released FY 2014 State Medicaid Fraud Control Unit data, along with reports on Medicare reimbursement for critical access hospital swing-bed services and Medicare Part B drug pricing (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO has addressed antipsychotic drug use in community settings and state Medicaid program integrity system effectiveness (https://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/).

— Legislative Developments. Today the House of Representatives is scheduled to vote on bills addressing DMEPOS competitive bidding, hospital observation status, Controlled Substances Act amendments, and trauma care. Congressional panels have scheduled hearings on health information technology and the Affordable Care Act. See https://www.healthindustrywashingtonwatch.com/articles/legislative-developments/.

— Health Industry Events. Upcoming CMS events will focus on physician quality reporting programs, HCPCS coding applications, home health clinical templates, and the Medicare Shared Savings Program. The FDA is hosting a clinical outcome assessments public workshop. For details, see https://www.healthindustrywashingtonwatch.com/articles/events/).

For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog