CMS Releases Proposed Medicare Advantage and Part D Rules for Contract Year 2021 and 2022

CMS has put on display a proposed rule that would update Medicare Advantage (MA) and Medicare Part D prescription drug benefit policies for contract year 2021 and 2022.  CMS projects that its proposed policies would decrease federal spending by $4.4 billion over 10 years, primarily as a result of a proposal to remove outliers prior to calculating Star Rating system cut points.  Other major provisions of the proposed rule include the following:

  • CMS proposes to implement several legislative provisions intended to address the opioid epidemic, including expanded beneficiary education requirements and mandatory drug management programs for beneficiaries at-risk for misuse or abuse of frequently abused drugs.
  • The proposed rule would codify a statutory provision allowing Medicare-eligible individuals with end-stage renal disease (ESRD) to enroll in MA plans.  Effective January 1, 2021, organ acquisitions for kidney transplants for MA beneficiaries will be covered under the Medicare fee-for-service program, and such costs will be excluded from MA benchmarks.
  • CMS proposes to strengthen MA plan network adequacy rules, including new policies intended to improve access to providers in rural areas and encourage the use of telehealth providers in contracted networks.
  • Part D plan sponsors would be allowed to establish two specialty tiers, instead of the single specialty tier currently permitted.  In such cases, one tier must be a “preferred” tier that offers lower cost sharing. CMS believes the additional tier would allow Part D plan sponsors to negotiate additional rebates from manufacturers, but it is also soliciting comment on whether placement on the preferred specialty tier should be limited to generics and biosimilars whose cost exceeds the specialty threshold established by CMS.
  • Part D plan sponsors would be required to make available to beneficiaries, through a web portal or mobile app, a real-time benefit tool (RTBT) that provides accurate, timely, and clinically appropriate patient-specific real-time formulary and benefit information (including cost-sharing amount, formulary alternatives and utilization management requirements). While this would generally parallel the RTBT that Part D plan sponsors are required to make available to prescribers beginning January 1, 2021, CMS is considering numerous issues, including P&T committee determination of which formulary alternatives can be omitted and prohibition on outputs “that are intended to promote choices based upon the commercial interests of the part D sponsor rather than the beneficiary’s best interests, or the promotion of medications or refills based on the rebates that would be received.”  CMS is also considering allowing Part D plan sponsors to make available rewards and incentives for beneficiaries using the RTBT, including gift cards.  CMS proposes an effective date of January 1, 2022, but solicits comments on whether January 1, 2021 is a feasible effective date.
  • CMS proposes to make a series of changes to its Medical Loss Ratio calculations.

Comments on the proposed rule will be accepted until April 6, 2020.

CMS Proposes Updates to ACA Exchange Plan Policies for 2021

The Centers for Medicare & Medicaid Services (CMS) has proposed updates to its standards for health plan issuers offering plans through federally-facilitated and state-based Exchanges for 2021.  The proposed rule would, among other things:  revise the risk adjustment methodology; update issuer user fees and cost-sharing limits; amend medical loss ratio regulations (including with regard to treatment of prescription drug rebates received and retained by an entity that provides pharmacy benefit management services to the issuer); modify special enrollment period rules; encourage value-based insurance plan designs; and make changes to the quality rating information display requirements for Exchanges.

With regard to drug manufacturer coupons, CMS proposes to give plans and issuers “flexibility to determine whether to include or exclude coupon amounts from the annual limitation on cost sharing, regardless of whether a generic equivalent is available.”  Under the proposed rule, to the extent consistent with applicable state law, amounts paid toward reducing enrollee cost sharing using any form of direct support offered by drug manufacturers to enrollees for specific prescription drugs are permitted, but not required, to be counted toward the annual cost sharing limitation.

Comments on the proposed rule will be accepted until March 2, 2020.  CMS is accepting comments on its related Draft 2021 Letter to Issuers in the Federally-facilitated Exchanges until February 24, 2019.  Finally, CMS issued a bulletin extending for an additional year its current non-enforcement policy that permits states to allow issuers to offer certain non-grandfathered health insurance coverage in the individual and small group market that does not meet all Affordable Care Act coverage standards.

HHS Adopts New Retail Pharmacy HIPAA Transaction Requirements for Schedule II Drug Prescriptions

The Department of Health and Human Services (HHS) has modified HIPAA retail pharmacy transaction requirements to differentiate between partial fill and full refills of opioids and other Schedule II drug prescriptions.  Specifically, HHS has finalized the requirements for use of the National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard Implementation Guide, Version D, Release 0, August 2007, by requiring use of the Quantity Prescribed (460-ET) field to identify partial fills for Schedule II drugs.  The Administration believes that the more robust prescribing information will help prevent impermissible refills of Schedule II drugs and enhance researchers’ understanding of prescribing trends.  The rule is effective on March 24, 2020, and compliance is required by September 21, 2020.

CMS Updates List of DMEPOS Items Subject to Medicare Prior Authorization

CMS is adding six types of lower limb prosthetics to the list of equipment subject to Medicare prior authorization (PA) requirements, and extending certain current PA requirements.  Specifically, CMS is requiring PA as a condition of Medicare payment for the following items on the basis of their being “frequently subject to unnecessary utilization”:

  • L5856 Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing and stance phase, includes electronic sensor(s), any type
  • L5857 Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing phase only, includes electronic sensor(s), any type
  • L5858 Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, stance phase only, includes electronic sensor(s), any type
  • L5973 Endoskeletal ankle foot system, microprocessor controlled feature, dorsiflexion and/or plantar flexion control, includes power source
  • L5980 All lower extremity prostheses, flex foot system
  • L5987 All lower extremity prosthesis, shank foot system with vertical loading pylon

CMS is implementing the new PA requirement in two phases.  During phase one, which begins May 11, 2020, CMS will impose the PA requirement in one state in each of the DME Medicare Administrative Contractor jurisdictions (California, Michigan, Pennsylvania, and Texas).  In phase two, which begins October 8, 2020, CMS will expand the program to the remaining states.

The notice also announces that all 45 Power Mobility Device and Pressure Reducing Support Services items currently on the Required Prior Authorization List will continue to be subject to PA requirements.  CMS has compiled information for suppliers about the PA requirements here.

CMS Proposes 2021 Funding Methodology for ACA Basic Health Program

The Centers for Medicare & Medicaid Services (CMS) has released the methodology and data sources it proposes to use to determine federal payment to states that establish a Basic Health Program (BHP) for 2021.  Through the BHP, which was authorized by the Affordable Care Act (ACA), states may offer health benefits to certain low-income individuals otherwise eligible to purchase coverage through an Affordable Insurance Exchange.  CMS will accept comments on the proposed methodology through March 11, 2020.

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 screening and detection efforts; and (4) support state and local governments in virus control efforts.

Reed Smith has prepared a client alert that provides an overview of government PHE regulatory authorities and analyzes federal and state regulations impacting health care providers, suppliers, and facilities when a federal PHE has been declared or an infectious disease outbreak occurs under state law.  Among other things, the client alert addresses:  Emergency Medical Treatment and Active Labor Act (EMTALA), Stark Law, and other federal waivers; state law police powers, including quarantine; relevant rules for disclosure of personal health information; FDA emergency authorization for coronavirus diagnostic test; and supply chain concerns and 340B pricing implications.  Our client alert is available here.

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 Care Act (ACA) expansion population) under a capped aggregate or per-capita federal financial participation (FFP) financing model.  CMS is offering participating states a “comprehensive suite of pre-packaged waiver authorities” under section 1115(a)(2) of the Social Security Act related to, among other things, cost sharing, benefit design (including closed drug formularies), eligibility, care delivery, and changes to provider payment rates.  States may apply for the HAO Demonstration immediately, although CMS’s authority to institute the program undoubtedly will be challenged in court.

CMS has provided extremely detailed guidance to states regarding the parameters of the HAO Demonstration.  Highlights of the program include the following:

  • Beneficiary Population – HAO Demonstration is limited to adults under age 65 who qualify for Medicaid on a basis other than disability or need for long-term care services and supports, and who are not eligible under a state plan. CMS will allow states to impose certain additional conditions of eligibility, including income qualifications and “community engagement” (i.e., work) requirements for non-elderly, non-pregnant adult Medicaid beneficiaries who are eligible for Medicaid on a basis other than disability.
  • Benefits – CMS is linking Medicaid coverage under the HAO Demonstration to the ACA essential health benefit (EHB) standard rather than the traditional Medicaid benefits package.  This includes authorization to adopt a closed prescription drug formulary, with no requirement to comply with coverage requirements under the Medicaid rebate statute. Coverage would have to be in line with EHB requirements (e.g., formulary coverage of the same number of drugs in each therapeutic class as under the applicable state benchmark plan, with certain exception and appeal rights).  CMS would also require that some, but not all, of the Medicare Part D “protected class” requirements be satisfied—specifically, that all or substantially all antipsychotics, antidepressants, and HIV drugs be covered, but not all anticonvulsants, antineoplastic (cancer), and immunosuppressants for transplant rejection.  Coverage of drugs for opioid use disorder would also be required.  CMS specifies that the obligation for a drug manufacturer with drug rebate agreement to pay rebates would continue to apply under the Demonstration, and states could negotiate supplemental rebates in exchange for the inclusion of the manufacturer’s drugs on the state’s formulary.  Additionally, CMS will allow states to offer services that cannot traditionally be funded by Medicaid, such as enhanced case management services and services provided by a federally qualified health center as part of value-based payment reform efforts.
  • Cost Sharing – States will have enhanced flexibility with regard to premium and cost sharing structures, except that the aggregate limit on premiums and cost sharing may not exceed 5% of family income.
  • Managed Care and Delivery Systems – States will be able to use any combination of fee-for-service and managed care delivery systems under the demonstration as long as certain guidelines are met. States using managed care will have flexibility to propose alternative approaches to meeting statutory requirements to ensure network adequacy, access to care, and availability of services.  CMS also encourages applicants to “implement payment and delivery system reforms to improve the effectiveness of coverage, improve health outcomes and reduce the cost of health care,” including models similar to those developed by the CMS Center for Medicare & Medicaid Innovation.
  • Quality Strategy and Performance Assessment – Participating states will be required to implement a quality strategy and assess coverage, access to care, quality of care, and health outcomes of beneficiaries covered under the Demonstration. As part of this process, participating states must report on quality and access measures and continuous performance indicators addressing enrollment, retention, access to care, and financial management.
  • Financing – States participating in the HAO Demonstration will be required to operate their program under a defined total expense/aggregate cap or per-enrollee budget target. For states that assume the risk of an aggregate cap model, states with spending under their annual aggregate cap that also meet certain performance measures may qualify to receive between 25% and 50% of the federal savings, to be used for specified Medicaid reinvestment purposes (note that states selecting the total expense model will be required to spend at least 80% of their target amount on health services).
  • Demonstration Period – HAO Demonstrations generally will be approved for a five-year period, and successful demonstrations may be renewed for up to 10 years.  Additional information on the HAO Demonstration application process is available here.

As for the legality of HAO Demonstrations, it remains to be seen whether or when litigation will be filed by Medicaid stakeholders opposed to CMS’s effort.  For its part, CMS included language in its recent announcement stating that states’ requests to participate would be evaluated on a case-by-case basis with no guarantee of approval, which may complicate judicial review prior to CMS taking final agency action with respect to a particular state’s application to participate.  In the meantime, the legality of CMS’s previously announced demonstration waivers involving Medicaid work requirements is expected to be resolved shortly by the United States Court of Appeals for the District of Columbia Circuit, which heard oral argument last fall in CMS’s appeal of adverse district court rulings that found the agency exceeded its statutory authority.

2/14/2020 update:  The D.C. Circuit unanimously affirmed the district court’s judgment, finding the Secretary of Health and Human Services acted in an arbitrary and capricious manner by approving a section 1115(a) demonstration waiver imposing work requirements on Medicaid beneficiaries.

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 draft of its 2020-2025 Federal Health IT Strategic Plan (Plan). The outcomes-driven Plan, which ONC collaboratively developed with 25 federal organizations, aims to promote a health IT economy that balances increased transparency, competition, and consumer choice with privacy and security of patient health information. The Plan reflects HHS’ ongoing efforts to create pathways for patients to actively engage in their health outcomes and navigate personalized care alternatives.

The Plan is intended to serve as a five-year roadmap for federal health IT initiatives and activities, and to function as a catalyst for streamlined activities in the private sector. In particular, the Plan highlights four key goals with supporting objectives, all focused on meeting the needs of patients, caregivers, health care providers, payers, researchers, developers, and innovators by increasing access to health information, emphasizing product and pricing transparency, and encouraging interoperability. Continue Reading

January Congressional Hearings Focus on Cannabis, Opioids, Other Health Priorities 

Health policy has been the focus of several House Energy and Commerce Committee hearings this month.  Notably, the Energy and Commerce Health Subcommittee held its first legislative hearing on cannabis policy, although much of the hearing focused on the status of marijuana research under the Controlled Substances Act, as discussed in a recent Reed Smith Client Alert.  The Committee has also examined state efforts to curb the opioid crisis, and reviewed bipartisan legislation intended to address gaps in health care coverage and health outcomes for babies and children.  Furthermore, the panel has scheduled a January 29 hearing on “Improving Safety and Transparency in America’s Food and Drugs.”

Separately, the House Education and Labor Committee is holding a hearing January 28 entitled “Expecting More: Addressing America’s Maternal and Infant Health Crisis.”

HHS Boosts Civil Monetary Penalties Again

The Departments of Health and Human Services (HHS) has just published its “annual” inflation update to civil monetary penalty amounts (CMP) in its regulations – even though those penalties were just increased for inflation in November 2019.  Under the latest update, CMPs are increased by a 1.01764 “multiplier” (that is, a 1.764% increase), applicable to penalties assessed on or after January 17, 2020, if the violation occurred on or after November 2, 2015.  The notice impacts CMPs assessed by the Office of Inspector General, the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Office for Civil Rights, the Health Resources and Services Administration, the Agency for Healthcare Research and Quality, and the Administration for Children and Families.

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 2019 that gives states the option to cover Medicaid health home services for children with medically complex conditions who choose to enroll in a health home.  In the RFI, CMS seeks information such as how this care is coordinated in emergency and non-emergency situations, financial barriers individuals face in accessing out-of-state provider care, and ways to streamline processes for screening and enrolling out-of-state providers.  Comments will be accepted until March 21, 2020; CMS intends to use RFI responses to develop guidance to state Medicaid directors by October 1, 2020.

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 with” the volume or value of referrals if the physician is paid based on his personally performed services, such as on a work relative value unit (wRVU) basis, and there is a “correlation” between the physician’s referrals and those personally performed services.  The court relied on this correlation theory to support its finding that the physicians had an indirect compensation arrangement with the hospitals to which they referred, thereby allowing the case to proceed and shifting the burden to the defendants to prove the availability of a Stark Law exception.  Although the amended December opinion removed the correlation theory rationale, the court maintained its September holding to allow the case to proceed based on alternative reasoning that there were adequate allegations that the physicians’ compensation “took into account” their referrals.


The Stark Law prohibits a physician’s Medicare referrals for “designated health services,” including hospital services, to an entity with which the physician has a direct or indirect financial relationship, unless the requirements of an applicable exception are satisfied.  One element of the Stark Law’s test to determine whether a physician has an indirect compensation arrangement with an entity is whether the physician’s aggregate compensation “varies with, or takes into account, the volume or value of referrals” to the entity.  For these reasons, a critical component in a Stark Law analysis is frequently whether a referring physician is compensated in a manner that “varies with” or “takes into account” the volume or value of his referrals. 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 Association [AHA], et al., vs. Azar (C.V. No. 14-cv-00851) to reduce the Medicare appeals backlog, HHS reported a reduction of 31.4% through the end of the fourth quarter of 2019, according to the third status report[1] (the “Status Report”) filed by HHS to the United States District Court for the District of Columbia on December 31, 2019.  The Status Report identifies 292,517 appeals remain pending at the Office of Medicare Hearing and Appeals (OMHA).  The 2018 court order requires HHS to achieve a 49% reduction by the end of FY 2020 and to clear the backlog entirely by the end of 2022.

At the time of the court’s decision, OMHA had 426,594 appeals pending and providers were waiting up to five years for an ALJ decision, notwithstanding a 90-day deadline under 42 U.S.C. 1395ff(d)(1)(A).  With a 31% reduction so far, HHS is currently approximately 12% ahead of the court’s projected pace for reducing the backlog – at the time of the order, the court projected a 19% reduction by the end of fiscal year (FY) 2019. 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 care services
  • Patient freedom of choice among health care providers
  • Competition among health care providers
  • Costs to federal health care programs
  • Potential overutilization of health care services
  • The ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.

The OIG also will consider factors such as whether the proposal would provide potential financial benefits to health care providers that may influence decisions to order or refer health care services.

Comments will be accepted until March 2, 2020.  The OIG notes that this solicitation is separate from both:  (1) its August 27, 2018 request for information (RFI) on the AKS and the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute; and (2) its October 17, 2019 proposed rule that would align the AKS and CMP Law regulations with value-based health care arrangements (the comment period on that rulemaking closed on December 31, 2019).  The OIG states that commenters need not duplicate comments previously submitted in response to the RFI or proposed rule.

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 over Paperwork” initiative, follows related regulatory changes adopted by CMS in other recent payment rules, including the 2020 Medicare home health and outpatient prospective payment system final rules, and the 2019 and 2020 Medicare physician fee schedule (PFS) rules.  For instance, in the 2019 PFS final rule, CMS somewhat liberalized the rules for supervision of certain diagnostic tests when performed by registered radiologist assistants (RRAs), consistent with their state scope of practice.  Efforts have been ongoing to further expand Medicare rules to permit these RRAs to perform services for Medicare beneficiaries to the full extent of their state licenses.

The deadline for submitting recommendations is January 17, 2020.

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 names the clinicians and provides instructions on how to contact CMS to update banking information; the deadline to provide this information is February 28, 2020 in order to receive the 2019 payment.

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 appropriations act delays the next round of clinical laboratory private payer data reporting for one year; specifically, no reporting is required during the period beginning January 1, 2020, and ending December 31, 2020.

FY 2020 Government Funding Bill Repeals ACA Health-Related Taxes, Extends Expiring Health Provisions, Makes Other Health Policy Updates

Congress has completed action on federal fiscal year (FY) 2020 spending, and President Trump has signed the two domestic and national security funding packages into law.  The major health care policy provisions included in the domestic spending package, HR 1865, the “‘Further Consolidated Appropriations Act, 2020” (the “Act”), are summarized below.

Repeal of ACA Device, Insurance Taxes

The Act permanently repeals the Affordable Care Act’s (ACA) 2.3% excise tax on the sale of certain medical devices, which has been a top priority of the medical technology industry.  It also permanently repeals the excise tax on certain high-cost employer-sponsored health coverage (the so-called “Cadillac tax”) and the annual excise tax imposed on health insurer providers.

Medicare Part B Policies

The Act incorporates provisions of the Laboratory Access for Beneficiaries (LAB) Act, which delays the next round of clinical laboratory private payer data reporting for one year.  The Act also directs the Medicare Payment Advisory Commission (MedPAC) to study how to improve this data collection.

In addition, the Act excludes certain complex rehabilitative manual wheelchairs (e.g., HCPCS codes E1235, E1236, E1237, E1238, and K0008) from the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program.  The Act also bars CMS from using competitive bidding rate information to adjust payment for certain wheelchair accessories and cushions furnished with complex rehabilitative manual wheelchairs.

The Act reimburses acute care hospitals on a reasonable cost basis for furnishing allogeneic hematopoietic stem cell transplants.  It also extends outpatient hospital pass-through status for a number of diagnostic radiopharmaceuticals.

Medicare, Medicaid, and Public Health Extenders

The Act extends through May 22, 2020 a number of Medicare, Medicaid, and public health programs and policies, including the following: Continue Reading

HHS Proposes Rules to Modernize Organ Transplant System

The Department of Health and Human Services (HHS) has released two proposed rules intended to increase the availability of organs for transplantation and improve the accountability of organ procurement organizations (OPOs), in conformance with President Trump’s Executive Order on Advancing American Kidney Health.

First, the Health Resources and Services Administration has proposed expanding the scope of “incidental non-medical expenses” that are reimbursable for living organ donors to include lost wages and child-care and elder-care expenses.  This proposal is aimed at removing financial barriers and disincentives to organ donation.

Second, the Centers for Medicare & Medicaid Services (CMS) has proposed revising the current OPO Conditions for Coverage, effective for the 2022 re-certification cycle.  CMS’s stated intention is to ensure that the outcome measures for assessing OPO performance “are transparent, reliable, and enforceable; support higher donation rates; help shorten transplant wait lists; reduce discarded but viable organs; and increase safe, timely transplants that save lives.”  Key provisions of the proposed rule would:

  • Change how OPO donation and transportation rates are measured (including preventing an OPO from receiving credit for procuring an organ if it is not transplanted);
  • Require outcome measure assessments to occur at least every year; and
  • Require low performing OPOs to improve their donation and transplantation rates through a quality assurance and performance improvement program.

The rules will be published on December 23, 2019, and comments will be accepted for 60 days thereafter.

CMS Seeks Ways to Enhance Provider Experience with MACs

CMS is hosting three listening sessions in January 2020 on how to “improve processes and enhance interactions” between the Medicare Administrative Contractors (MACs) and providers and suppliers, particularly with regard to operations, technology, and business functions.  CMS also seeks ideas for ways to enhance beneficiary quality of care and the beneficiary customer service experience with the MACs.  The dates for the sessions are January 15, 22, and 29, from 2 to 3 pm ET; registration is required