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

CMS Announces 2020 Medicare DMEPOS Rates

The Centers for Medicare & Medicaid Services (CMS) has released the 2020 Medicare fee schedule for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).  The 2020 update factor is 0.9%, although other pricing policies are applied in specific circumstances, including separate adjustments for certain DMEPOS furnished in former competitive bidding areas.   Additional details are provided in a CMS transmittal.

Energy & Commerce Committee Focuses on Universal Health Coverage, Other Health Policies

The House Energy and Commerce Committee held hearings December 10, 2019 to examine nine legislative proposals intended to expand health insurance coverage and reduce health care costs, including Medicare buy-in bills.  The Committee also recently held hearings on FDA oversight of the US drug supply chain and regulation of cosmetics, along with public health preparedness and response to the flu season.  In addition, the panel approved two maternal health bills, HR 4995, the “Maternal Health Quality Improvement Act,” and HR 4996, the “Helping Medicaid Offer Maternity Services (MOMS) Act,” clearing the bills for full House consideration.

HHS OIG Report Touts FY 2019 Enforcement and Audit Accomplishments

According to its latest Semiannual Report to Congress, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) expects fiscal year (FY) 2019 investigative recoveries from criminal and civil actions to top $5 billion – up from $2.9 billion in FY 2018.  Additionally, the OIG expects to recover $819 million as a result of audits.  During FY 2019, the OIG brought a total of 809 criminal actions and 695 civil actions, and excluded 2,640 individuals and entities from federal health care programs.  The Semiannual Report also notes the OIG’s preparations for changes in the health care industry, stating that “OIG is preparing to oversee emerging technology-enriched, value-driven health and human services programs with investments in the expertise of our people, as well as proven technologies and data capabilities.”

Government Funding Bill Signed by President Trump Extends Expiring Federal Health Programs through December 20

President Trump has signed into law a short-term continuing resolution that funds the federal government and extends certain expiring health care programs through December 20, 2019.  With regard to health care programs, the measure (HR 3055) delays a scheduled $4 billion reduction in Medicaid disproportionate share hospital allotments until December 21, 2019 and extends the current 100% Federal Medical Assistance Percentage for the territories.  It also temporarily extends funding for a variety of federal health care programs through December 20.  These programs include:  Community Health Centers; the National Health Service Corps; the Teaching Health Center Graduate Medical Education program; the Special Diabetes Program; the Community Behavioral Health Clinic demonstration program; outreach activities for low-income Medicare beneficiaries; the Health Profession Opportunity Grant demonstration; the Temporary Assistance for Needy Families; quality measurement and performance improvement activity contracts; and the Patient-Centered Outcomes Research Institute.

Additional legislative action – either in the form of another short-term package or an agreement to fund the government through the remainder of fiscal year 2020 – will be necessary in the coming weeks to avert a federal government shutdown.

Speakers from WebMD, CMS, PhRMA, AdvaMed, AHCA, and More to Present at Reed Smith’s Dec. 4 Washington Health Care Conference

Reed Smith is hosting its 6th Annual Washington Health Care Conference on December 4, 2019 at The Almas Center in Washington, D.C., and is pleased to welcome another impressive line-up of speakers this year.

Our keynote speaker is Dr. John Whyte, Chief Medical Officer of WebMD, who will be discussing “Artificial Intelligence in Health Care: Disrupt but Don’t Be Disruptive.”

The conference also includes a particularly timely panel on the proposed rules to modernize Stark Law and the Anti-Kickback Statute. Our presenters include: Lisa Wilson, Senior Technical Advisor to the Centers for Medicare and Medicaid Services; David Gregory, Principal, Healthcare Practice, Baker Tilly Virchow Krause; Nancy Bonifant Halstead, Partner, Reed Smith; and moderator Nicole Aiken-Shaban, Senior Associate, Reed Smith.

We’re also pleased to be offering a session with representatives from major associations on how the industry is preparing for the next major shift in the health delivery continuum. Our presenters include: Terry Chang, MD, JD, Vice President, Assistant General Counsel, and Director, Legal & Medical Affairs, AdvaMed; Clif Porter, Senior Vice President, Government Relations, AHCA; Julie Wagner, Senior Assistant General Counsel, PhRMA; Katie Mahoney, Vice President, Health Policy at the U.S. Chamber of Commerce; and moderator Elizabeth Carder-Thompson, Senior Counsel, Reed Smith.

Additional conference sessions include: Continue Reading

Controversial CMS Final Rule Requires Hospitals to Disclose Payer-Specific Charge Data; New Proposed Rule Would Impose Health Plan Transparency Requirements

The Centers for Medicare & Medicaid Services (CMS) finalized a “price transparency” rule that requires hospitals to make detailed charge data – including payer-specific negotiated charges – available for all inpatient and outpatient services.  Additionally, the final rule mandates that hospitals make “consumer-friendly” charge information available for at least 300 “shoppable” services.  While CMS deferred implementation to 2021, rather than 2020 as contemplated in the proposed 2020 Medicare Hospital Outpatient Prospective Payment System rule, the agency expanded the cost data elements that hospitals must report.  Four major hospital associations have announced their intention to challenge the rule in court.  These hospital associations allege that the rule exceeds the Administration’s authority and would “introduce widespread confusion, accelerate anticompetitive behavior among health insurers, and stymie innovations in value-based care delivery America’s hospitals and health systems.”

The final rule requires hospitals to make available online in a machine-readable file the hospital’s gross charges and payer-specific negotiated charges for all items and services provided in the inpatient and outpatient department settingEach payer-specific negotiated charge must be clearly associated with the name of the third party payer and plan.  Additionally, the final rule expands the required data elements to include discounted cash prices and the de-identified minimum and maximum negotiated charge for all items and services provided by the hospital.

Second, hospitals must make public in a consumer-friendly manner their payer-specific negotiated charges for at least 300 “shoppable” services – defined as a service that can be scheduled by a health care consumer in advance.  CMS identified 70 shoppable services (the same as identified in the proposed rule) and the hospital must select the rest.  The required cost elements include:  payer-specific negotiated charges; discounted cash price; de-identified minimum and maximum negotiated charge for each shoppable service (and any ancillary service); and whether the charges differ based on whether the service is provided in the inpatient or outpatient setting. Hospitals in violation of these price transparency provisions would be subject to corrective action plans and civil money penalties of up to $300 per day.

Additionally, the Administration issued a separate proposed rule that would require group health plans and health insurance issuers in the individual and group markets to disclose certain cost-sharing information to participants, beneficiaries, or enrollees, through an internet-based self-service tool (and in paper form upon request).  This information would include a personalized estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider.  Furthermore, plans would be required to disclose in-network provider negotiated rates and historical out-of-network allowed amounts through two public machine-readable files.  Finally, the Department of Health and Human Services proposes enabling issuers offering group or individual health insurance coverage “to receive credit in their medical loss ratio calculations for savings they share with enrollees that result from the enrollee’s shopping for, and receiving care from, lower-cost, higher-value providers.”  Comments on the proposed rule will be accepted until January 14, 2020.

CMS Adopts Medicare OPPS and ASC Rates, Policy Updates for 2020

The Centers for Medicare & Medicaid Services (CMS) has finalized Medicare hospital outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system rates and policies for 2020.  The final rule provided a 2.6% update to both OPPS and ASC rates for 2020 for facilities meeting quality reporting requirements (compared to an anticipated 2.7% update under the proposed rule).  Note that payment changes for individual procedures vary.  CMS estimated that total payments to OPPS providers will increase by approximately $6.3 billion and payments to ASCs will increase by about $230 million compared to estimated 2019 payments.

While CMS included in the OPPS proposed rule a controversial proposal to require all hospitals to disclose payer-specific pricing, including “consumer-friendly” information for hundreds of “shoppable” services, the agency finalized these policies (with modifications) in a separate final rule 

Hospital Outpatient Provisions

Major OPPS policies adopted in the final rule include the following:

  • CMS adopted an alternative pathway for OPPS device pass-through payment status for “transformative” devices with Food and Drug Administration Breakthrough Device designation. CMS did not adopt changes to the OPPS substantial clinical improvement (SCI) criterion, as it had for the related inpatient prospective payment system SCI standard.
  • CMS removed total hip arthroplasty and six spine procedures (and associated anesthesia administration) from the inpatient only (IPO) list; these procedures may be performed in the outpatient hospital setting beginning in 2020. CMS finalized a policy to exempt procedures removed from the IPO list from Recovery Audit Contractor referrals and certain other medical review activities for two years (rather than one year as proposed).
  • The final rule increased the per-day cost threshold for separate payment for certain outpatient drugs to $130, up from $125 in 2019. CMS also discussed options for pricing certain drugs purchased through the 340B program in light of pending litigation challenging the average sales price minus 22.5% payment policy adopted in the final 2018 OPPS rule.
  • CMS completed the two-year phase of a policy it adopted in the 2019 final OPPS rule to reduce payment for certain clinical visit services provided by excepted off-campus provider based departments. CMS acknowledged that the policy for 2019 was vacated by a US District Court; the Administration is considering whether to appeal.
  • The final rule created two new comprehensive ambulatory payment classifications (C-APCs), one for Level 2 Vascular Procedures and one for Level 1 Neurostimulator and Related Procedures, raising the total number of C-APCs to 67.
  • CMS did not adopt reforms to its payment policy for packaged skin substitutes for 2020, as it had contemplated in the proposed rule.
  • CMS established a prior authorization process for five services that are “often cosmetic”:  blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty, and vein ablation.
  • CMS lowered the required level of supervision for hospital outpatient therapeutic services from direct supervision to general supervision.
  • CMS adopted various updates to Hospital Outpatient Quality Reporting Program requirements.

 ASC Provisions

  • The final rule adds several procedures to the ASC list of covered surgical procedures, including total knee arthroplasty.
  • CMS adopted a policy to limit the ASC payment rate for low-volume, device intensive procedures to the procedure’s OPPS payment rate.
  • CMS updated various ASC Quality Reporting Program requirements.

CMS Finalizes Medicare Physician Fee Schedule Rates and Policies for CY 2020

The Centers for Medicare & Medicaid Services (CMS) has published its final Medicare physician fee schedule (PFS) rule for calendar year (CY) 2020.  In addition to updating rates for physician services, the final rule revises numerous other Medicare Part B policies.  Highlights of the final rule include the following: 

  • The final 2020 conversion factor is $36.0896, up slightly from $36.0391 in 2019 (and the same as in the proposed rule). The final rule also updates work and practice expense (PE) relative value units (RVUs) for numerous new, revised, and potentially misvalued codes, and it revises various direct PE inputs based on submitted invoices.
  • CMS updated evaluation and management (E/M) visit coding and payment policies for 2021 to align with CPT Editorial Panel changes. These coding and payment policies are favored by some physician specialties and are controversial among others.  While CMS anticipates that specialties that bill higher level established patient visits will see significant RVU increases, those physician specialties that do not generally bill office/outpatient E/M visits could see large payment decreases (because of budget neutrality rules)Future coding and valuation policies in the CY 2021 final rule could impact actual RVUs changes.
  • CMS replaced the current Medicare requirement for the general physician supervision of physician assistants (PAs), including the immediate availability of the supervising physician to the PA for consultation, with medical direction and appropriate supervision as provided by state law.  In the final rule, CMS clarified its proposed policy with regard to states with no explicit state law or scope of practice rules regarding physician supervision of PA services.  Specifically, in such states, CMS defined physician supervision as a process in which a PA has a working relationship with one or more physicians to supervise the delivery of their health care services.  Such physician supervision is evidenced by documenting at the practice level the physician assistant’s scope of practice and the working relationships the physician assistant has with the supervising physician(s) when furnishing professional services.
  • CMS streamlined documentation requirements for such physician supervision by allowing the physician, PA, or advanced practice registered nurse who furnishes and bills for his or her professional services to review and verify — rather than fully re-document — information included in the medical record by physicians, residents, nurses, medical, PA, and advanced practice registered nurse students, or other members of the medical team.
  • CMS continued to implement a statutory requirement that modifiers be reported to identify certain therapy services that are furnished in whole or in part by physical therapy assistants (PTAs) and occupational therapy assistants (OTAs), beginning January 1, 2020.  In the preamble, CMS noted that it received almost 9,000 public comments on this issue, and CMS modified a number of its proposed policies in response to these comments.  With regard to the de minimis standard under which a service is considered to be furnished in whole or in part by a PTA or OTA when more than 10% of the service is furnished by the PTA or OTA, the final rule provides that only the minutes that the PTA/OTA spends independent of the therapist will count towards the de minimis   Furthermore, based on comments, CMS will not require the treatment note to include an explanation of the application or non-application of the therapy assistant modifier for each therapy service furnished.  CMS also dropped a proposed requirement that the therapist and therapy assistant minutes be included in the documentation.  CMS committed to providing additional guidance regarding this policy.
  • CMS adopted a number of changes to Open Payments reporting requirements, including: expansion of the definition of a covered recipient to include PAs, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives; the addition of Debt Forgiveness, Long-Term Medical Supply or Device Loan, and Acquisitions to the “nature of payment” categories; consolidation of medical education program categories; and standardization of data reporting requirements for drugs, devices, biologicals, and medical supplies.
  • CMS made a series of changes to the physician self-referral (Stark Law) advisory opinion process. For instance, the rule:  established a 60 business-day timeframe for issuing an advisory opinion; provided that an advisory opinion is binding on the Secretary and precludes the imposition of sanctions under the Stark Act on the parties requesting the opinion and any individuals or entities that are parties to the arrangement; specified CMS’s right to rescind an advisory opinion; and clarified that individuals and entities may rely on an advisory opinion as non-binding guidance that illustrates the application of the physician self-referral law and regulations to the specific facts and circumstances described in the advisory opinion.
  • The final rule contained no rulemaking or commentary from CMS regarding the pending requirements for consultation of appropriate use criteria (AUC) using clinical decision support (CDS) mechanisms by physicians ordering advanced diagnostic imaging services for Medicare outpatients. Consequently, CMS left intact the timeline of its requirements for such consultation when physicians order CT, MRI, PET or nuclear medicine studies.  Next year, 2020, remains an “education and testing” year when such orders can be made without penalty even in the absence of an AUC consultation.  Beginning 2021, however, AUC consultation will be mandatory.
  • Among many other topics, the rule also addressed: establishment of a new Medicare Part B benefit for opioid use disorder treatment services (including medications for medication-assisted treatment) furnished by opioid treatment programs; beneficiary consent for communication technology-based services; ambulance cost data collection; Quality Payment Program and Medicare Shared Savings Program quality reporting requirements; and payment for chronic care, transitional care, and principal care management services.

CMS Plans Stakeholder Surveys to “Further Strengthen” the DMEPOS Competitive Bidding Program; Comment Opportunity through December 20, 2019

The Centers for Medicare & Medicaid Services (CMS) is seeking public input on surveys that are intended to “further strengthen the monitoring, outreach, and enforcement functions” of the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program – even though the agency has asserted that the program “has maintained beneficiary access to quality products from accredited suppliers in all competitive bidding areas.”

The new planned surveys will be sent to “key stakeholders,” such as beneficiaries, contract suppliers, and “referral agents” (e.g., Medicare enrolled providers, physicians, treating practitioners, discharge planners, social workers, pharmacists and other health care professionals who refer beneficiaries for services in a competitive bidding area).  The surveys are intended to determine whether, for instance:

  • The item/service was received and was compliant with the physician’s written order.
  • Beneficiary/referral agents had difficulty locating a contract supplier to provide the necessary item(s).
  • Beneficiaries experienced delays in receiving equipment or difficulty obtaining follow-up assistance.

CMS also requests feedback on “effective methods for contacting referral agents as they play a critical role in assisting beneficiaries in obtaining competitively bid DMEPOS items.”  CMS will accept comments emailed to DMEPOS@cms.hhs.gov through December 20, 2019; the subject line of the email must read “Competitive Bidding Surveys.”  CMS does not specify when it intends to conduct these surveys.