The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently published a Special Fraud Alert warning health care providers (e.g., prescribers, pharmacies, durable medical equipment providers, clinical laboratories) to steer clear of certain telemedicine arrangements and outlining seven “suspect” characteristics that may present heightened risk of fraud and abuse.

The alert coincides with a third round of criminal “telemedicine takedowns” announced by the Department of Justice (DOJ)  in the last several years, reflecting DOJ’s continued focus on identifying and dismantling fraudulent arrangements that exploit telemedicine technologies and related regulatory flexibilities in the wake of the COVID-19 pandemic.

Telemedicine technologies have created a multitude of opportunities for growth and innovation within the health care industry and are well-positioned to become an ongoing cornerstone of our health care delivery system. However, given the increased level of regulatory scrutiny of telemedicine arrangements, providers and telehealth technology companies, including drug and device manufacturers that offer telemedicine technologies (e.g., platforms, mobile applications) for prescribers and patients that facilitate virtual care,  should carefully plan and closely evaluate existing arrangements to ensure compliance with applicable state and federal laws and avoid implication amongst the recent uptick in enforcement.Continue Reading Telehealth Under Scrutiny: OIG Special Fraud Alert and DOJ Enforcement Highlights Suspect Characteristics Associated with High-Risk Telemedicine Arrangements

On February 23, 2022, the Federal Bar Association (FBA) kicked off its fifth annual Qui Tam Conference to highlight key areas for False Claims Act (FCA) enforcement in the coming year. The conference opened with a keynote address by Gregory E. Demske, Chief Counsel to the Inspector General, Department of Health and Human Services (HHS), Office of Inspector General (OIG). Then, a series of panels analyzed the FCA-related developments from the prior year, recent efforts by the U.S. Department of Justice (DOJ) to combat cybersecurity fraud, and some of the schemes promoting alleged telehealth fraud during the ongoing COVID-19 public health emergency. Based on the comments of government speakers, all speaking in their individual capacities, below are key takeaways of what we expect the government to prioritize in 2022:

Pandemic-related fraud and telehealth fraud are key targets

Reinforcing the DOJ’s current enforcement priorities, we expect the DOJ to continue to focus its resources and enforcement activity on where it stands to recover the most dollars swiftly: pandemic-related fraud (e.g., misuse of CARES Act relief funds) and telehealth fraud.

During his keynote address, Demske similarly acknowledged these two areas of focus and added Medicare Advantage, the opioid epidemic, and nursing homes as ongoing priorities for OIG enforcement. Notably, Demske cited OIG’s Data Analytics Group as a robust resource for the agency to identify anomalies in large data sets (e.g., outlier distributions of CARES Act provider relief funds) that may lead to targeted enforcement.

For more information about the fraud and abuse implications of CARES Act provider relief funds, as well as practical tips for navigating the evolving CARES Act regulatory environment, please check this Reed Smith client alert.
Continue Reading FBA’s 2022 Qui Tam Conference Puts Annual Spotlight on FCA Enforcement Trends and Developments

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 October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and Behavioral-Health Needs (the “Executive Order”), which seeks to provide federal support to address mental and behavioral health concerns arising from the COVID-19 pandemic.

The Executive Order acknowledges the exacerbating effects that the COVID-19 pandemic

On August 4, 2020, the Centers for Medicare and Medicaid Services (“CMS”) posted for inspection the Proposed 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 17, 2020, and among its many proposals, would update and revise: (1) the physician fee schedule relative value units; (2) practice expense relative value units; (3) telehealth service approval and reimbursement policies; (4) the direct supervision requirement; (5) payment for teaching physicians; (6) medical records documentation policies; and (7) policies regarding opioid treatment programs.

Comments to this proposed rule must be received by CMS no later than 5 p.m. on October 5, 2020.
Continue Reading CMS Releases Proposed Physician Fee Schedule Rule for 2021

As technology has advanced over the years, there has been a corresponding push for virtual visits with health care providers.  In fact, many state boards of medicine and other regulatory agencies have sought to amend regulations and guidances to make telehealth a reality for patients across the U.S.  However, despite the technical allowance for telehealth,

Following the distribution of billions of relief aid to healthcare providers and amidst the guidance issued around reopening of nursing homes throughout the country, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) unveiled a COVID-19 Response Strategic Plan on May 26, 2020 after updating its Workplan a few days earlier.

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

As discussed in our client alert, recent legal developments have greatly expanded funding for and access to telehealth services during the COVID-19 crisis.

Among the changes instituted by HHS are expanded Medicare coverage and payment for services, reduced or waived cost-sharing obligations for physicians, and loosening of the HIPAA enforcement policies for covered entities

Shortly after President Trump declared a national emergency related to COVID-19, CMS issued blanket waivers under section 1135 of the Social Security Act that are intended to ensure there are sufficient health care items and services available to meet the increased need, as well as reduce related administrative burdens on health care providers.

Our comprehensive

President Donald Trump has signed an executive order that commits the Department of Health and Human Services (HHS) to taking a series of regulatory and subregulatory actions intended to enhance the fiscal sustainability of the Medicare program, reduce regulatory burdens on providers, and increase beneficiary choice.  The planned initiatives, which would require further policy development

The Centers for Medicare & Medicaid Services (CMS) plans to test a new voluntary emergency ambulance service innovation model that seeks promote “the most appropriate level of care at the right time and place.”  In announcing the model, CMS noted that because Medicare regulations now only allow payment for emergency ground ambulance services for transportation

The Centers for Medicare & Medicaid Services (CMS) is making extensive revisions to its Medicare Advantage (MA) Value-Based Insurance Design model in order “to contribute to the modernization of Medicare Advantage through increasing choice, lowering cost, and improving the quality of care for Medicare beneficiaries.”

By way of background, the VBID innovation model was launched

President Trump has just signed into law HR 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.  The bipartisan legislation includes almost 200 provisions intended to strengthen opioid prevention and treatment efforts and bolster law enforcement tools.

Among many other things, the new law: 

  • Seeks to

The Medicaid and CHIP Payment and Access Commission’s (MACPAC) March 2018 Report to Congress examines three aspects of Medicaid policy:  managed care, telehealth, and disproportionate share hospital (DSH) payments.  First, MACPAC proposes statutory changes to allow states to require all beneficiaries to enroll in Medicaid managed care programs, along with changes to Section 1915(b) waiver

The House Energy and Commerce Committee has approved by voice vote the following bipartisan bills addressing the Medicare Part B program:

  • HR 3245, which would significantly increase various Medicare civil and criminal penalties under sections 1128A and 1128B of the Social Security Act. Sponsors of the bill note these penalties have not been updated in 20 years. Maximum penalties would at least double under the bill. For instance, CMPs that are now $10,000 would be increased to $20,000, while criminal fines that are now a maximum of $25,000 would increase to $100,000. Maximum sentences also would be doubled, from five years to 10 years.
  • HR 1148, the Furthering Access to Stroke Telemedicine Act, to provide for Medicare reimbursement of neurological consults via telemedicine for beneficiaries presenting at hospitals or mobile stroke units.
  • HR 2465, the Steve Gleason Enduring Voices Act, to make permanent current coverage of speech generating devices under the “routinely purchased” durable medical equipment payment category.
  • HR 2557, the Prostate Cancer Misdiagnosis Elimination Act, to provide coverage of DNA Specimen Provenance Assay testing for prostate cancer.
  • HR 3120, to amend the Health Information Technology for Economic and Clinical Health (HITECH) Act to remove the mandate that meaningful use standards become more stringent over time.
  • HR 3263, to extend for two years the Medicare Independence at Home Medical Practice Demonstration Program.
  • HR 3271, to revise Medicare competitive bidding rules pertaining to diabetes test strips, including stronger enforcement of requirement that bidders cover at least 50 percent of the types of diabetes test strips on the market.

Continue Reading Committees Approve Bills to Boost Medicare Penalties, Revise Part B Policies, Extend CHIP Funding

The House Energy and Commerce Subcommittee on Health has approved the following seven bipartisan bills addressing the Medicare Part B program:

  • HR 3245, which would significantly increase various Medicare civil and criminal penalties under sections 1128A and 1128B of the Social Security Act, which sponsors note have not been updated in 20 years. Maximum penalties would at least double under the bill. For instance, CMPs that are now $10,000 would be increased to $20,000, while criminal fines that are now a maximum of $25,000 would increase to $100,000. Maximum sentences also would be doubled, from five years to 10 years.
  • HR 1148, the Furthering Access to Stroke Telemedicine Act, to provide for Medicare reimbursement of neurological consults via telemedicine for beneficiaries presenting at hospitals or mobile stroke units.
  • HR 2465, the Steve Gleason Enduring Voices Act, to make permanent the current Medicare coverage of speech generating devices under the “routinely purchased” durable medical equipment payment category.
  • HR 2557, the Prostate Cancer Misdiagnosis Elimination Act, to provide coverage of DNA Specimen Provenance Assay (DPSA) testing for prostate cancer.
  • HR 3120, to amend the Health Information Technology for Economic and Clinical Health (HITECH) Act to remove the mandate that meaningful use standards become more stringent over time.
  • HR 3263, to extend the Medicare Independence at Home Medical Practice Demonstration Program.
  • HR 3271, to revise Medicare competitive bidding rules pertaining to diabetes test strips (DTS), including stronger enforcement of requirement that bidders cover at least 50 percent of the types of diabetes test strips on the market.

Continue Reading House Panels Advance Medicare Policy Bills, including Hike in Civil/Criminal Penalties

Recent House of Representatives committee hearings have focused on a variety of health care policy issues, including the following:

  • Energy and Commerce Committee hearings on: the growth and oversight of the 340B drug discount program; drug and device company communications, including clinical/economic data; state efforts to address the opioid crisis; and extension of safety net

House and Senate committees have held a number of hearings recently to focus on health policy topics, including the following:

  • A Senate Health, Education, Labor & Pensions Committee hearing on “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay,” the first of three planned hearings on prescription drug costs.
  •  A House Ways and Means Committee hearing on Medicare Advantage and coordinated care models such as the Program for All-Inclusive Care.
  • Senate Finance Committee and House Ways and Means Committee hearings examining the Trump Administration’s proposed FY 2018 HHS budget request.
  • House Energy and Commerce Committee hearings on the HHS response to cybersecurity vulnerabilities and the U.S. public health response to the Zika Virus. A planned June 14 hearing on extension of safety net health programs (the Children’s Health Insurance Program, Federally Qualified Health Centers, and the Community Health Center Fund) has been postponed.

Continue Reading Congressional Hearings, Markups Focus on Chronic Care, Drug Pricing, HHS Budget, Other Health Programs

The GAO recently reported that fewer than 1% of Medicare and Department of Defense (DOD) beneficiaries and 12% of Veteran’s Administration (VA) beneficiaries utilized telehealth and remote patient monitoring services, even though patient and provider associations believe these services may improve or maintain quality of care. These associations cited payment and coverage restrictions as barriers,