On January 26, 2023, the Centers for Medicare and Medicaid Services (CMS) issued guidance for Rural Emergency Hospitals (REHs), through which CMS outlined requirements on eligibility, the conversion process for eligible facilities, and other related information. The guidance clarifies the final rule CMS issued in November that established REHs as a new Medicare provider type, effective January 1, 2023.

This provider type was established to address the concern over closures of rural hospitals, which was particularly problematic during the COVID-19 pandemic. The final rule set forth the Conditions of Participation (CoPs) that REHs must meet in order to participate in the Medicare and Medicaid programs. The standards for REHs closely align with the current CoPs for Critical Access Hospitals (CAHs), available here.

This article provides a brief overview of CMS’s recent eligibility guidance.Continue Reading CMS issues guidance for rural emergency hospital eligibility requirements

On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684.  The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021.  The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the implementation of the rule eliminating the Anti-Kickback Statute (“AKS”) safe harbor protection for Medicare Part D rebates.

Rebate for Discarded Amounts of Medicare Part B Single-Dose Container or Single-Use Package Drugs

First, the legislation requires manufacturers of single-dose container or single-use package drugs payable under Medicare Part B to provide a rebate to the government for any discarded portion of that drug.  The rebates will be charged each quarter, beginning with the first quarter of 2023, and must be paid in regular intervals, as determined appropriate by the Secretary of the U.S. Department of Health and Human Services (“HHS”).  The legislation provides that, in order to enforce this provision, HHS will conduct periodic audits of both drug manufacturers and providers who submit claims.  For violations of this provision, HHS will impose Civil Monetary Penalties in amounts equal to the sum of the amount that the manufacturer would have paid and twenty-five percent of such amount.Continue Reading Health Care Provisions in the Infrastructure Investment and Jobs Act

It is no secret that the coronavirus pandemic has driven our daily lives digital—work, education, social gatherings, and, of course, health care. Congress and CMS responded to the public health emergency by waiving limitations on reimbursement for telehealth services rendered to Medicare patients. These waivers introduced new flexibility and vastly expanded Medicare patients’ access to

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

The recently passed “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) is sweeping legislation that will have widespread impact on companies in the health care and life sciences space. In addition to expanding coverage of COVID-19 testing and preventive services, the Act includes provisions to address health care workforce needs, eases restrictions surrounding telehealth

Congressional panels continue to focus on federal health care policy topics, including cost, quality, and program integrity issues. Recent hearings have included the following:

 CMS has released an-agency-wide Rural Health Strategy that seeks to “better serve individuals in rural areas and avoid unintended consequences of policy and program implementation.” The Strategy has five objectives:

  1. Apply a rural lens to CMS programs and policies (e.g., apply a new checklist to relevant policies, procedures, and initiatives that impact rural communities)
  2. Improve

Today the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period that will provide a temporary Medicare rate hike for certain durable medical equipment (DME) and enteral nutrition furnished in rural and non-contiguous areas of the country (Alaska, Hawaii, and U.S. territories) that are not included in competitive bidding.

By way of background, the Affordable Care Act mandated that CMS use pricing information from the DME, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program (CBP) to adjust fee schedule amounts for items furnished in areas where the CBP is not implemented. A highly-technical CMS rule implemented these adjustments, with a transition period during January 1, 2016 – June 30, 2016, during which CMS used 50/50 blended rates. The 21st Century Cures Act extended the transition period through December 31, 2016, mandated that CMS study the impact of the CBP on beneficiary access to DME, and established additional factors for CMS to consider in making fee schedule adjustments effective beginning January 1, 2019. Fully-adjusted fee schedule rates went into effect January 1, 2017, with rates that were on average 50% lower than the unadjusted rates for all of the items and services subject to the adjustments (“Adjusted Rates”).
Continue Reading CMS Announces Temporary Fee Schedule Increase for Certain Medical Equipment Furnished in Rural Areas

CMS has developed a variety of Medicare value-based payment models that tie payments to quality and efficiency metrics, and the importance of such models to physicians will increase under the new Quality Payment Program. The Government Accountability Office cautions, however, that small and rural physician practices face a number of unique challenges when participating in value-based payment models.  A recent GAO report catalogues five particular areas of concern for small and rural physician practices, based on a literature review and stakeholder interviews:
Continue Reading GAO Highlights Barriers to Small & Rural Provider Participation in Medicare Value-Based Payment Models

President Obama has signed into law S. 2873, the Expanding Capacity for Health Outcomes Act (ECHO Act), which is intended to use “distance health education” to improve health care, particularly in medically-underserved areas.  Specifically, this program will test “technology-enabled collaborative learning and capacity building models” – or the use of simultaneous interactive videoconferencing to connect

On July 13, 2016, the Ways and Means Committee approved HR 5659, which would enable Medicare beneficiaries with end stage renal disease (ESRD) to enroll in Medicare Advantage plans. Earlier this month, the Committee approved HR 5613, to prevent CMS from enforcing a Medicare requirement for direct physician supervision of certain outpatient therapeutic services furnished

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

On December 8, 2015, the House of Representatives approved S. 1461, which would provide a one-year extension (through 2015) of the enforcement moratorium on supervision requirements for outpatient therapeutic services in critical access hospitals (CAH) and small rural hospitals.  The legislation, which was passed by the Senate in September, now is awaiting the President’s

The next Medicare Payment Advisory Commission (MedPAC) meeting is scheduled for October 8 -9, 2015. Topics on the agenda include: Medicare drug spending; Alternative Payment Models and the Merit-based Incentive Payment System; Medicare Advantage coding intensity, health risk assessments, benchmarks, and star ratings; and access to emergency care in rural areas.