Archives: Other Health Policy Developments

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FDA issues draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1]  Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.  FDA recognizes this information as important because … Continue Reading

CMS issues proposed rule that would expedite approval of “breakthrough” devices and codify the standards for “reasonable and necessary” determinations

The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s Seniors,” directs the Secretary of Health and Human Services to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients.”  EO 13890 explicitly requests that the Secretary make coverage of breakthrough … Continue Reading

CMS unveils additional COVID-19 LTC facility testing and reporting rules during public health emergency

On August 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) filed an interim final rule with comment period (“IFC”), detailing new long-term care (“LTC”) facility COVID-19 testing requirements and strengthening enforcement of existing related facility reporting requirements.  According to CMS, the IFC represents the agency’s latest effort in an ongoing initiative to control … Continue Reading

Federal Court stays repeal of “On the Basis of Sex” definition in recent nondiscrimination final rule one day before regulations take effect

With only one day left before the final rule scaling back nondiscrimination regulations took effect, the U.S. District Court for the Eastern District of New York (EDNY) issued an order staying the repeal of certain parts of the former regulations. On June 19, 2020, the Department of Health and Human Services’ (HHS) Office for Civil … Continue Reading

CMS Releases Proposed Physician Fee Schedule Rule for 2021

On August 4, 2020, the Centers for Medicare and Medicaid Services (“CMS”) posted for inspection the Proposed 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 17, 2020, and among its many proposals, would … Continue Reading

Proposed Outpatient Prospective Payment System Rule for CY 2021

Includes proposed changes to the OPPS and ASC payment rates and Stark Law exemptions. On August 4, 2020, CMS posted for inspection the Proposed Outpatient Prospective Payment System (“OPPS”) Rule for 2021.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 12, 2020 and would revise the Medicare hospital OPPS … Continue Reading

FDA issued guidance on statistical considerations for clinical trials during the COVID-19 public health emergency

On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel … Continue Reading

HHS announces another round of CARES Act funding for Medicaid and CHIP providers as well as Safety Net Hospitals

On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced additional distributions from the CARES Act Provider Relief Fund to several groups of providers, totaling approximately $25 billion. $15 billion of these funds is targeted towards eligible Medicaid and Children’s Health Insurance Program (CHIP) providers participating in state Medicaid and CHIP … Continue Reading

HHS Office of General Counsel advises that the PREP Act preempts state and local requirements that prevent pharmacists from testing for COVID-19

Earlier this week, the Department of Health and Human Services (HHS) Office of General Counsel issued Advisory Opinion 20-02, which declared that the Public Readiness and Emergency Preparedness Act (PREP Act), combined with the HHS Secretary’s March 10, 2020 declaration, preempts state or local requirements that would prevent pharmacists from ordering or administering COVID-19 tests … Continue Reading

Nursing homes face increased scrutiny by attorneys general during COVID-19

Pennsylvania Attorney General Josh Shapiro announced on May 12, 2020, that his office is investigating several nursing homes in the Commonwealth for neglect of patients and residents: “We will hold nursing facilities and caretakers criminally accountable if they fail to properly provide care to our loved ones … we will not tolerate those who mistreat … Continue Reading

CMS Offers Guidance to Health Care Providers on Limiting Elective Surgeries, Other Nonessential Procedures During Coronavirus Outbreak

In a recent guidance, the Centers for Medicare & Medicaid Services (CMS) encouraged health care providers (HCPs) to limit elective surgeries and nonessential procedures during the 2019 novel coronavirus (COVID-19) outbreak. CMS offered a number of recommendations to help HCPs decide how to best serve patients requiring emergent or urgent attention. In addition to clinical … Continue Reading

MedPAC recommends Medicare payment updates for 2021 – but all rate bets are off in light of COVID-19

The Medicare Payment Advisory Commission (MedPAC) released its 2021 Medicare provider rate update recommendations on March 13, 2020 – the same day President Trump declared a national emergency due to COVID-19.  MedPAC’s recommendations were based on an assessment of various Medicare “payment adequacy indicators” that are unlikely to reflect the state of the health care industry in … Continue Reading

CDC Offers Guidance to Health Providers on ICD-10 Coding for Coronavirus/COVID-19 Encounters

The Centers for Disease Control and Prevention (CDC) recently released official diagnosis coding guidance for health care encounters and deaths related to the 2019 novel coronavirus (COVID-19), potentially in anticipation of more frequent cases in the United States. The guidance identifies specific ICD-10-CM codes to be used to code encounters. CDC advises that patients presenting … Continue Reading

Potential Tensions Lie Ahead Between Federal and State Authorities Over the Application of CDC Quarantine Powers

According to the U.S. Centers for Disease Control and Prevention (CDC), although there have been imported cases of Covid-19 detected in the United States, “at this time, the virus is NOT currently spreading in the community in the United States.”[1]  However, on Tuesday, February 25, 2020, Nancy Messonier, the CDC’s Director of National Center for … Continue Reading

Analysis:  Navigating US federal and state rules during the novel coronavirus public health emergency

The novel coronavirus (2019-nCoV, also known as “SARS-CoV-2”) has been declared a public health emergency (PHE) by the U.S. Department of Health and Human Services (HHS).  This designation authorizes HHS to direct funding to: (1) enable the dissemination of information about the virus; (2) encourage research and development of diagnostic and treatment techniques; (3) improve … Continue Reading

Trump Administration Offers States New Medicaid “Healthy Adult Opportunity” Demonstration with Enhanced Benefit, Payment Flexibilities

The Centers for Medicare & Medicaid Services (CMS) has announced a controversial plan to allow states to apply to participate in a new Medicaid “Healthy Adult Opportunity” (HAO) Demonstration.  In short, the HAO Demonstration will give participating states greater flexibility in the scope and administration of Medicaid benefits for certain beneficiary populations (i.e., the Affordable … Continue Reading

HHS Sustains Digital Health Momentum and Continues Publishing Policy Initiatives to Kick-off 2020

The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a … Continue Reading

CMS Wants Input on Role of Out-of-State Medicaid Providers in Coordinating Care for Children with Medically Complex Conditions

The Centers for Medicare & Medicaid Services (CMS) has released a Request for Information (RFI) on how the Medicaid program can incorporate out-of-state providers in coordinating care for children with certain medically complex conditions under Medicaid.  The RFI is intended to help CMS implement a provision of the Medicaid Services Investment and Accountability Act of … Continue Reading

Federal Appeals Court Amends Stark Law Opinion to Remove Controversial “Volume or Value” Interpretation, but Uncertainty Remains

On December 20, 2019, the Federal appeals court panel that heard U.S. ex rel. Bookwalter v. UPMC, No. 18-1693 (3d Cir.), amended its September 2019 opinion by removing a controversial interpretation of the “volume or value” standard under the Stark Law.  The September opinion had adopted a “correlation theory,” holding that a physician’s compensation “varies … Continue Reading

HHS Continuing to Reduce Medicare ALJ Appeals Backlog under Court Order; Senators Reintroduce Legislation Striving to Improve Efficiency of Medicare Appeals Process

The Department of Health and Human Services (HHS) is ahead of schedule to reduce its Medicare Administrative Law Judge (ALJ) appeals backlog, as required by court order, but lawmakers are still looking for ways to improve the efficiency of the Medicare appeals process. Following a November 1, 2018 federal district court order in American Hospital … Continue Reading

OIG Accepting Recommendations for New Anti-kickback Safe Harbors and Fraud Alerts

The HHS Office of Inspector General (OIG) has issued its annual solicitation of recommendations for new or revised Anti-kickback Statute (AKS) safe harbors and new Special Fraud Alerts.  In reviewing proposed safe harbor changes, the OIG will consider the extent to which the proposals would increase or decrease: Access to health care services Quality of health … Continue Reading

CMS Requests Ideas for Easing Medicare Supervision/Scope of Practice Requirements

The Centers for Medicare & Medicaid Services (CMS) is inviting suggestions for how it can eliminate Medicare regulations that (1) impose more stringent supervision requirements than existing state scope of practice laws, or (2) restrict health professionals from practicing at the top of their license.  This comment solicitation, which is part of the Administration’s “Patients … Continue Reading

CMS is Tracking Down Clinicians Owed Medicare Advanced Alternative Payment Model (APM) Incentive Payments

The Centers for Medicare & Medicaid Services (CMS) has issued a “payment advisory” alerting approximately 1,400 clinicians who are Qualifying APM participants based on their 2017 performance that CMS does not have the participants’ banking information.  This banking information is necessary for CMS to disburse their 5% Advanced APM Incentive Payments for 2019.  The advisory … Continue Reading

CMS Posts Final 2020 Medicare Clinical Lab Fee Schedule Rates

The Centers for Medicare & Medicaid Services (CMS) has posted the final Medicare clinical laboratory fee schedule (CLFS) rates for 2020.  The files reflect updates announced in a December 13, 2019 CMS transmittal, which also discusses payment policies for new CLFS codes effective January 1, 2020. As reported previously, the final fiscal year 2020 consolidated … Continue Reading
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