Centers for Medicare & Medicaid Services Developments

On August 26, 2022, the Departments of Health and Human Services, Labor, and Treasury (the “Departments”) issued the highly anticipated Requirements Related to Surprise Billing (“August 2022 Final Rule”) and associated guidance materials concerning the independent dispute resolution (“IDR”) process established by the No Surprises Act. The August 2022 Final Rule is narrow in scope and responds to two recent decisions by the Eastern District of Texas vacating portions of the October 2021 Interim Final Rule, Requirements Related to Surprise Billing: Part II (“IFR II), and incorporates stakeholder comments solicited by the Departments.

Importantly, as discussed more below, the August 2022 Final Rule removes the qualifying payment amount (“QPA”) as the presumptive factor in IDR payment decisions and requires health plans to submit additional information in the IDR process for cases where a claim at issue was “downcoded” by the plan.   

The August 2022 Final Rule will take effect October 25, 2022, 60 days after its publication in the Federal RegisterContinue Reading Departments issue new Final Rule and guidance materials for No Surprises Act IDR process

CMS recently issued updated Open Payments Frequently Asked Questions (FAQs). The FAQs are revised periodically to reflect the most up to date program requirements. This latest revision both added and removed FAQs, and also included some general edits.

The following FAQs were added: #2014, #2015, #2016, #2017, #2018, #2019, #2020, #2021 and #2022. Each new FAQ is reproduced in full below. They provide additional guidance regarding topics such as archived reporting years, salaries paid to covered recipients, reporting of device identifiers, valuing long-term device loans, debt forgiveness, and the definition of Nurse Practitioner.

Additionally, the following FAQs have been removed from the FAQ document “due to being no longer applicable, redundant with another FAQ, or of low utility” (according to CMS):
Continue Reading CMS Issues Updated Open Payments FAQs

Just when the procedures thought they were out(patient), CMS pulls them back in(patient).

Last year, in the final CY 2021 Outpatient PPS rule, CMS announced its intention to eliminate the Inpatient Only (IPO) List by January 1, 2024. The IPO list featured more than 1,700 procedures that were surgically invasive or required more than 24 hours of post-operational recovery time. As a result, any procedure on the list would only be paid for by Medicare on an inpatient basis.

With the CY 2021 rule, those procedures would be released to outpatient providers in stages, allowing physicians to clinically determine whether inpatient admission was indicated for a particular procedure.

However, in the proposed CY 2022 Outpatient PPS rule, announced on July 19, 2021, CMS reversed that decision and announced that it will now keep the IPO List, reinstating the 298 procedures that were removed by the 2021 rule. CMS said it was responding to concerns from stakeholders about patient safety. In particular, CMS indicated that the 2021 rule removed the procedures on too steep of a timeline. The agency said it wanted to provide “greater consideration of the impact removing services from the list has on beneficiary safety and to allow providers impacted by the COVID-19 PHE additional time to prepare to furnish appropriate services safely and efficiently before continuing to remove large numbers of services from the list.”Continue Reading CMS Gives the IPO List the Godfather 3 Treatment

Today, the Department of Health and Human Services (HHS) announced proposed changes to modernize the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the Federal Anti-Kickback Statute. In a press release, HHS states these proposed rules are intended to “provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients . . . while maintaining strong safeguards to protect patients and programs from fraud and abuse.”

Over the last 30 years, HHS has issued a series of final regulations establishing exceptions and safe harbors that limit the reach of the Stark Law’s strict liability civil penalties and the Anti-Kickback Statute’s criminal penalties to protect from enforcement certain non-abusive and beneficial arrangements. These final regulations have not, however, reflected the significant shift in recent years in health care delivery and payment systems from a fee-for-service model to models based on improving value and quality of care provided to patients. As a result, many in the health care industry identify these laws, as well as the Civil Monetary Penalty (CMP) Law, as barriers to more effective care coordination and management that can deliver value-based care to improve quality of care, health outcomes, and efficiency. In response, on June 25, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Request for Information seeking input on how it could address existing Stark Law barriers to these emerging value-based payment and delivery systems. Similarly, on August 27, 2018, the Office of Inspector General (OIG) published a Request for Information seeking feedback on how OIG could modify or add new safe harbors addressing these barriers. CMS and OIG received more than 350 comments each, which HHS has considered in publishing these proposed rules.

CMS and OIG Coordinated Proposals

The proposed rules, which span hundreds of pages, reflect close coordination between CMS and OIG, which tried to align the regulations, where appropriate, and the proposals are significant. More specifically, the coordinated proposals include:

  1. Three new exceptions and safe harbors for value-based payment arrangements
  2. Modifications to the existing electronic health record (EHR) exception and safe harbor
  3. The addition of a new exception and safe harbor related to the provision of cybersecurity technology and services

Continue Reading Proposed Rules to Modernize Stark Law and Anti-Kickback Statute Released Today

On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule repealing the agency’s ban on the use of pre-dispute arbitration agreements in the long-term care (LTC) setting.1 This final rule follows CMS’s proposed rule, issued on June 8, 2017, reversing course on CMS’s initial ban on pre-dispute, binding arbitration agreements in October 2016.2 (See CMS Reverses Course in Pre-Dispute Arbitration Agreement Ban for additional background and analysis on the June 8, 2017, proposed rule.)

As you may recall, CMS’s proposed rule offered to eliminate entirely the prohibition on pre-dispute binding arbitration agreements and provided no limitations on the use of arbitration agreements as a condition of admission (or continuing admission) to a LTC facility, provided certain “transparency” requirements were met. CMS received over 1,000 comments in response to the proposed rule and, in turn, delivered a final rule that makes concessions for both the proponents of a ban on pre-dispute arbitration agreements and the opponents seeking to preserve the legal right of the LTC facilities to freely contract with their residents. CMS explained in the final rule: “Although we are not finalizing a prohibition on pre-dispute, binding arbitration agreements, we believe that the requirements we are finalizing in this rule will provide the protections residents and their representatives will need to avoid being compelled to arbitrate disputes with LTC facilities without voluntarily and knowingly choosing to do so.”3Continue Reading CMS Issues Final Rule Repealing the Prohibition on the Use of Pre-Dispute Binding Arbitration Agreements

The Centers for Medicare & Medicaid Services (CMS) released a draft guidance for state survey agencies on May 3, 2019, impacting hospitals that share space, staff, and/or services with another co-located hospital or health care entity. The draft builds on informally followed principles by CMS employees which emphasized that certain payment rules, like those for

On June 12, 2015, the Internal Revenue Service, Employee Benefits Security Administration, and Centers for Medicare & Medicaid Services released final regulations regarding the summary of benefits and coverage (SBC) and the uniform glossary requirements for group health plans and health insurance coverage in the group and individual markets under the Affordable Care Act. The

On June 9, 2015, CMS published a final rule revising the regulations governing the Medicare Shared Savings Program, which is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form Accountable Care Organizations (ACOs) to provide cost-effective, coordinated care to Medicare beneficiaries. According to CMS, the Shared Savings Program now includes more than 400 ACOs serving more than 7 million Medicare fee for service (FFS) beneficiaries.

Under current rules, ACOs can participate in two tracks: Track 1, a “one-sided” risk model under which ACOs qualify to share in program savings but are not responsible for losses; and Track 2, a “two-sided” model under which ACOs may qualify to share in savings with an increased sharing rate, but also must take on risk for sharing in losses. The final rule revises the schedule for ACOs to transition to performance-based risk arrangements and makes other changes in program regulations to emphasize primary care services, reduces the administrative burden on participants, and improves program function and transparency. Specifically, the final rule, among other things:Continue Reading CMS Adopts Changes to Medicare Shared Savings Program/ACO Regulations

CMS has published a proposed rule that would update Medicaid and Children’s Health Insurance Program (CHIP) managed care regulations to more closely align with Medicare Advantage (MA) and private health plan standards and to strengthen quality safeguards. The proposed rule, which represents the first major revisions to Medicaid and CHIP managed care standards in more

CMS has published a final rule that revises survey, certification, and enforcement procedures related to CMS oversight of national accrediting organizations (AOs), effective July 21, 2015. Among other things, the rule: revises standards for application and re-application procedures for national accrediting organizations; extends certain provisions that are applicable to Medicare-participating providers to Medicare-participating suppliers; modifies

CMS has published a correction notice that clarifies that the comment deadline for the FY 2016 Medicare inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) PPS proposed rule is June 16, 2015 (as the agency announced when the rule was released). The version of the rule published in the Federal Register on April

On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) is publishing its proposed rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2016.  CMS will accept comments on the proposed rule until June 16, 2015. The final rule will be published by August 1, 2015, and generally will apply to discharges occurring on or after October 1, 2015.

With regard to the IPPS, CMS projects that the rate and policy changes in the proposed rule would increase IPPS operating payments by approximately 0.3%, or about $120 million in FY 2016. The proposed rule would provide for a 1.1% operating payment rate update for hospitals that submit quality data and are meaningful users of Electronic Health Records (EHR). This update reflects a 2.7% market basket update, adjusted by a -0.6 percentage point multi-factor productivity (MFP) cut and an additional -0.2 percentage point cut (as mandated by the Affordable Care Act, or ACA), with an additional -0.8 percentage point documentation and coding recoupment adjustment required by the American Taxpayer Relief Act of 2012.Continue Reading CMS Issues Proposed Rule to Update FY 2016 IPPS, LTCH PPS Rates, Policies

CMS issued a proposed rule on April 24, 2015 that would update FY 2016 Medicare payment policies and rates for the Inpatient Psychiatric Facilities (IPF) PPS. The proposed rule also would update quality measures and reporting requirements under the the IPF Quality Reporting Program, under which facilities report on quality measures or are subject

CMS published a proposed rule on April 15, 2015 that would modify the Medicare and Medicaid Electronic Health Record (EHR) Incentive program to reduce complexity, simplify reporting requirements, and align Stage 1 and Stage 2 objectives and measures with Stage 3. Notably, CMS proposes to change the Medicare and Medicaid EHR Incentive Program reporting period

On April 23, 2015, CMS released its proposed rule to update Medicare prospective payment system (PPS) rates for inpatient rehabilitation facilities (IRFs) for FY 2016, which begins October 1, 2015. CMS estimates that rates would increase by 1.7% overall ($130 million) under the proposed rule compared to FY 2015 levels. This proposed increase reflects

CMS has published a proposed rule that would apply provisions of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) to Medicaid beneficiaries who receive services through managed care organizations or alternative benefit plans and to the Children’s Health Insurance Program (CHIP). In general, such programs will be required to meet the mental