C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Category Archives: Medicare

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Early Stage Investing in Health Technology

Posted in Digital Health, Digital Transformation, Medicaid, Medicare
Next week, on June 21, 2018, attorneys from Crowell & Moring will hold a bootcamp entitled “Early Stage Investing in Health Technology.” Crowell & Moring attorneys will present on topics of interest to entrepreneurs, investors, and early stage health technology companies. Attendees will have the opportunity to learn about a range of matters including formation… Continue Reading

FDA Advances Flexibility-Based Framework for Digital Health and AI

Posted in FDA, Health IT, Medicaid, Medicare
The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation. During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and… Continue Reading

The Freight Train Gathers Steam: An Update on the Federal Response to the Opioid Crisis

Posted in FDA, Medicaid, Medicare
Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response… Continue Reading

CMS Signals Future Patient Access Requirements for Medicare Advantage Plans

Posted in Health IT, Medicare
Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients. In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of… Continue Reading

New Reimbursement for Remote Patient Monitoring and Telemedicine

Posted in EHR, Health IT, Medicare
CMS announced important changes to Medicare reimbursement for remote patient monitoring and telemedicine that can help accelerate adoption and use of these digital health tools. These changes are implemented through two rules released this week that will take effect January 1, 2018. Understanding these rules can help you incorporate these tools into clinical practice and… Continue Reading

Highlights from the 2018 Rate Announcement and Call Letter for Medicare Advantage and Medicare Part D

Posted in Medicare
The April 3, 2017 release of the 2018 Rate Announcement and Call Letter brought some welcome news for Medicare Advantage organizations and Part D sponsors (collectively, sponsors) and could signal improved transparency by the Centers for Medicare & Medicaid Services (CMS) in its regulation of sponsors. House Ways and Means Committee Chairman Kevin Brady (R-TX)… Continue Reading

Upcoming Webinar: Looking Back & Looking Beyond – The First 100 Days in Health Care Policy

Posted in Events, Exchanges, Fraud, Waste & Abuse, Health Care Reform & ACA, Medicaid, Medicare
On Tuesday, April 18, 2017, our Health Care Group will hold a webinar on the health care policy and transition challenges still at play as the Trump Administration nears the end of its 100 days in power.  During the webinar, participants will hear important insights and predictions on what a Trump-led Executive Branch will mean… Continue Reading

CMS Delays Implementation of Episode Payment Models (EPMs)

Posted in Medicare
In an Interim Final Rule with Comment Period (IFC) published on March 21, 2017, CMS provided that implementation of the EPMs for cardiac and orthopedic care improvement, the cardiac rehabilitation incentive payment model, and the changes to the Comprehensive Care for Joint Replacement (CJR) model would be delayed from July 1, 2017 to October 1, 2017. The… Continue Reading

OIG Issues Advisory Opinion Rejecting the Labeling of Test Tubes at No Cost

Posted in Fraud, Waste & Abuse, Medicare
On November 28, 2016, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an unfavorable advisory opinion (No. 16-12) that addresses the permissibility, under the federal Anti-Kickback Statute (AKS), of a laboratory’s proposal to label test tubes and collect specimen containers at no cost to, and for the benefit… Continue Reading

CMS Publishes Interim Final Rule to Address Third-Party Payment of Insurance Premiums by Medicare-certified Dialysis Providers

Posted in Exchanges, Fraud, Waste & Abuse, Health Care Reform & ACA, Medicaid, Medicare
On December 14, 2016, CMS issued an interim final rule with comment period to amend Medicare’s dialysis facility conditions for coverage to require certain disclosures to patients and health insurance issuers to address widespread concerns over inappropriate steerage of dialysis patients to individual market plans. After issuing an RFI about “inappropriate steering of people eligible… Continue Reading

CMS Issues Final Rules on MACRA Quality Payment Program Implementation

Posted in Medicare
On November 2, 2016, the final rule with comment period (the “Final Rule”) implementing provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) relating to the new Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) will be published in the Federal Register.  The Center for Medicare and Medicaid Services (CMS) also launched… Continue Reading

CMS Renews Focus on Third-Party Payment of Insurance Premiums Steering Medicaid & Medicare Eligibles into Marketplace Plans

Posted in Exchanges, Fraud, Waste & Abuse, Health Care Reform & ACA, Medicaid, Medicare
On August 18, 2016, CMS issued a request for information on “inappropriate steering of people eligible for Medicare or Medicaid into Marketplace plans” by third parties. CMS voiced concern over “anecdotal reports” that Medicaid or Medicare eligibles received premium and cost-sharing assistance from third parties so they could enroll in Marketplace plans, enabling providers to… Continue Reading

Senate Finance Committee Members Hear from Partner Troy Barsky and Hospital System Executives on Necessary Stark Law Reforms

Posted in Fraud, Waste & Abuse, Health Care Reform & ACA, Medicaid, Medicare
Yesterday, our colleague Troy A. Barsky testified before the U.S. Senate Finance Committee led by Chairman Orrin Hatch (R-Utah) and provided recommendations for modernizing the Stark Law to regulate self-referrals without impeding the care coordination and value-based payment models promoted by health care reform legislation. Other witnesses before the Committee included Dr. Ronald A. Paulus,… Continue Reading

New Payment Models and Data: Changes and Themes to Watch

Posted in Events, Fraud, Waste & Abuse, Health IT, Medicare
On June 23, Crowell & Moring and Accenture co-hosted the Fostering Innovative Digital Health Strategies Conference in Crowell’s D.C. office. The conference provided a broad analysis of the business and legal issues that must be addressed as health care organizations and technology companies consider innovative strategies to use digital health technologies. The conference covered several… Continue Reading

In Advance of Senate Finance Committee Hearing on Stark Law Next Week, the Committee Releases Stark Law White Paper

Posted in Events, Fraud, Waste & Abuse, Medicaid, Medicare
On Tuesday July 12, 2016, the Senate Finance Committee (“Committee”) will hold a hearing on “Examining the Stark Law: Current Issues and Opportunities.” Crowell & Moring Partner Troy Barsky will be testifying before the Committee as a Stark Law subject matter authority. In advance of this hearing, the Committee released last week the white paper… Continue Reading

OIG Issues a Favorable Opinion Regarding a Drug Savings Card Program

Posted in Fraud, Waste & Abuse, Medicare
On June 27, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a favorable Advisory Opinion, No. 16-07, relating to a savings card program under which individuals who have prescription drug coverage under Medicare Part D receive discounts on a drug that is statutorily excluded from Part D coverage. According… Continue Reading

OIG Updates Policy on Permissive Exclusions Based On Fraud and Kickbacks

Posted in Administrative Law, Fraud, Waste & Abuse, Medicare
The Office of the Inspector General of the Department of Health and Human Services (OIG) last week replaced a 20-year old policy statement, and issued guidance on the criteria the agency will use to evaluate whether to exclude certain individuals and entities from billing or “participation in” Federal health programs under its permissive exclusion authority.… Continue Reading

CMS Suspends Automatic Reduction of Star Ratings for Plans and Sponsors Subject To Intermediate Sanction

Posted in Medicare
Last month, the Center for Medicare & Medicaid Services (CMS) issued a memorandum announcing a change pertaining to the effect of intermediate sanctions on the calculation of Star Ratings for Medicare Advantage organizations (MAOs) and Part D sponsors.  This is a significant change for plans. The Star Rating program has continued to evolve since being… Continue Reading

CMS Proposes New ACO Performance Measures

Posted in Health Care Reform & ACA, Medicare
On January 28, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would change the methodology used to evaluate and adjust the performance of Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs). The proposed rule is intended to improve long-term incentives for ACOs and create a path for long-term… Continue Reading

DC Circuit Breathes New Life into AHA’s Suit over Medicare Appeals Backlog

Posted in Litigation, Medicare
On February 9, 2016, the D.C. Circuit, in American Hospital Association v. Burwell, No. 1:14-cv-00851 , held that a district court has jurisdiction to compel the Department of Health & Human Services (“HHS”) to address the substantial backlog of disputed Medicare claims and to make decisions within the statutory deadlines in the face of complaints by… Continue Reading

Congress Introduces Bipartisan Bill to Expand Telehealth, Remote Patient Monitoring

Posted in Fraud, Waste & Abuse, Health IT, Medicaid, Medicare
Last week, Democrats and Republicans from both chambers introduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S. 2484, H.R. 4442), which would improve health care quality and realize cost savings by eliminating current restrictions on telehealth and remote patient monitoring. Click here to read our detailed analysis of… Continue Reading

Crowell & Moring’s 2016 Litigation & Regulatory Forecasts: What Corporate Counsel Need to Know for the Coming Year

Posted in Administrative Law, Antitrust, EHR, Health Care Reform & ACA, Health IT, Litigation, Medicaid, Medicare, Tax
Featured Industry: Health Care Spotlight on Best Practices, Litigation, Antitrust, and Tax for Health Care Companies Crowell & Moring LLP is pleased to release its “2016 Litigation & Regulatory Forecasts: What Corporate Counsel Need to Know for the Coming Year.” The reports examine the trends and developments that will impact health care companies and other… Continue Reading

2016 Appropriations Act Stalls ACA Taxes, Impacts Risk Corridors, and Tweaks Medicare & Medicaid Payments

Posted in Health Care Reform & ACA, Medicaid, Medicare
The recent appropriations law, which will fund the federal government through 2016, suspends three health care taxes enacted under the Affordable Care Act, continues to limit how the Centers for Medicare & Medicaid Services can fund the temporary risk corridors program for the exchanges, and refines Medicare and Medicaid payments and funding. Click here for… Continue Reading

Sequestration Extended to 2025 in Federal Budget Deal

Posted in Administrative Law, Litigation, Medicare
On November 2, President Obama signed the Bipartisan Budget Act of 2015. As an offset for near-term increases in federal spending, the new law extends by one year – to 2025 – two-percent sequestration reductions in federal spending for mandatory federal programs including Medicare.  The end result is that Medicare Advantage Organizations (MAOs) can expect… Continue Reading