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GAO Releases Report on Telehealth

On September 26, the US Government Accountability Office (GAO) released a report titled “Medicare Telehealth: Actions Needed to Strengthen Oversight and Help Providers Educate Patients on Privacy and Security Risks.” The 75-page report describes the utilization of Medicare telehealth services under current pandemic-related waivers, the Centers for Medicare & Medicaid Services (CMS) efforts to identify and monitor risks posed by the current waivers, and a change made by the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) to the enforcement of regulations governing patients’ protected health information during the COVID-19 public health emergency (PHE).

GAO made four recommendations—three directed to CMS and one directed to OCR—aimed at remedying the issues set forth in the report:

  • CMS should develop an additional billing modifier or clarify its guidance regarding billing of audio-only office visits to allow the agency to fully track these visits.
  • CMS should require providers to use available site of service codes to indicate when Medicare telehealth services are delivered to beneficiaries in their homes.
  • CMS should comprehensively assess the quality of Medicare services, including audio-only services, delivered using telehealth during the PHE.
  • OCR should provide additional education, outreach or other assistance to providers to help them explain the privacy and security risks to patients in plain language when using video telehealth platforms to provide telehealth services.

Among its utilization findings, the GAO report found that the use of telehealth services increased from about five million services pre-waiver (April to December 2019) to more than 53 million services post-waiver (April to December 2020) and that, post-waiver, 5% of providers delivered more than 40% of telehealth services, and 5% of beneficiaries accounted for almost 40% of telehealth utilization.

The report noted that CMS lacks complete data on the use of audio-only technology and telehealth visits furnished in patients’ homes, because there is no billing mechanism for providers to identify all instances of audio-only visits, and because providers are not required to use available codes to identify visits furnished in homes. The GAO report also noted that OCR did not advise providers about specific language to use or give direction on explaining risks to patients, with respect to OCR’s March 2020 policy that it would not impose penalties against providers for noncompliance with privacy and security requirements in connection with the good faith provision of telehealth during the PHE.

This GAO report comes on the heels of a recent report from the HHS Office of Inspector General that found little evidence of waste and fraud related to Medicare telehealth services during the first year of the pandemic. These reports are part of a broader push by Congress and the Biden administration to examine current telehealth flexibilities and determine how to extend them beyond the COVID-19 PHE.




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CMS Announces 2023 Medicare Premiums and Deductibles

On September 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released 2023 premiums, deductibles and coinsurance amounts for Medicare Parts A and B, and the Medicare Part D income-related monthly adjustment amounts.

In 2023, the standard monthly premium for Medicare Part B enrollees will be $164.90, a decrease of $5.20 (from $170.10) in 2022, and the deductible for all Medicare Part B beneficiaries will be $226, a decrease of $7 (from $233) in 2022. The decreases stem from a decline in the price of an Alzheimer’s drug and limitations on its usage, as the Alzheimer’s drug was the main factor for the spike in monthly Part B premiums in 2022, according to CMS.

For Part A, the inpatient hospital deductible (which beneficiaries pay if admitted to the hospital) will be $1,600 in 2023, an increase of $44 from $1,556 in 2022.

For Part D, where higher income beneficiaries’ monthly premiums are adjusted based on income, CMS set forth the 2023 monthly adjustment amounts, beginning with beneficiaries with less than $97,000 in modified adjusted gross income (no monthly Part D adjustment) and incrementally increasing to a $76.40 monthly premium adjustment for those whose modified adjusted gross income is greater than $500,000.

Medicare open enrollment for 2023 begins on October 15 and ends on December 7.




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CMS Recommends Cost Savings Be Passed Along to Medicare Part B Beneficiaries

The US Centers for Medicare & Medicaid Services (CMS) recently released a report recommending that cost savings from lower-than-expected Medicare Part B spending be passed along to individuals with Medicare Part B coverage in the calculation of the 2023 Part B premium.

CMS’s recommendations are based upon the development of the Part B premium and the potential effects of factors that have changed since a premium was announced on a drug used for the treatment of Alzheimer’s disease. CMS builds in a reserve to ensure the Medicare Supplementary Medical Insurance (SMI) Trust Fund remains adequately financed for the year. In 2021, CMS built in a reserve to ensure the SMI Trust Fund could cover the potential costs of the Alzheimer’s disease drug and similar drugs.

Read McDermott’s latest Healthcare Regulatory Check-Up newsletter here.




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Biden Administration Takes Action to Improve Competition, Transparency and Quality for Hospitals and Nursing Homes

The Centers for Medicare & Medicaid Services (CMS) recently published detailed databases summarizing changes of ownership of Medicare-enrolled hospitals and skilled nursing facilities (SNFs). The databases currently include information from 2016 to 2022, but the data will be updated and released quarterly. CMS also released the skilled nursing facility prospective payment system (SNF PPS) proposed rule (the Proposed Rule), including proposed updates to payment based on quality and value-based care measures.

Read more here.




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America’s Hospital Regulator Wasn’t Designed for a Pandemic

According to this Politico article, the US Centers for Medicare and Medicaid Services (CMS) has had difficulty enforcing its own COVID-19-related hospital rules. The agency often lacks the necessary resources to make sure its regulations are followed. McDermott Partner Sandra M. DiVarco said small changes—like allowing patients to wear highly protective N95 face masks—that CMS publicizes are “not always very coordinated.”

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Biden Administration Foreshadows Impending Nursing Home Quality Reforms

On February 28, 2022, the White House issued a fact sheet outlining several efforts aimed to increase safety, accountability, oversight and transparency in the senior services industry (Fact Sheet). Although the Fact Sheet’s initiatives have not yet been implemented, President Biden reiterated his administration’s focus on nursing home reform during his March 1, 2022, State of the Union address. Accordingly, the efforts described in the Fact Sheet provide stakeholders with a peek into the regulatory crystal ball of the governmental efforts that may be forthcoming, either through new laws, regulatory action, policy changes, enforcement activities or subregulatory guidance.

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Trump-Era Medicare Program Under Increased Scrutiny

A Trump administration-era Medicare program is under increased scrutiny from progressive Democrats. According to this Politico article, the program is a “direct contracting model” that allows private companies to participate in Medicare. Some Democrats, however, say the program is opening up a lane for Medicare privatization.

“There’s a dynamic with the left that [the Center for Medicare & Medicaid Innovation] [has] to deal with for sure,” said McDermott+Consulting’s Mara McDermott.

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Supreme Court OKs CMS Vaccine Mandate but Blocks OSHA Rule

On January 13, 2022, the Supreme Court of the United States released two emergency opinions that change the landscape of the three federal vaccine rules. In summary:

  • A 5-4 Court majority let the Centers for Medicare & Medicaid Services (CMS) enforce its vaccine mandate nationwide, impacting specified healthcare facilities.
  • A 6-3 majority blocked the US Occupational Safety and Health Administration (OSHA) from enforcing its vax-or-test Emergency Temporary Standard (ETS) applicable to large employers.
  • The third federal vaccine rule—the federal contractor vaccine mandate—remains subject to multiple legal challenges and, at this time, the government is blocked from enforcing the mandate nationwide. The Court has not yet weighed in on this mandate.

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Federal Vaccine Mandates Are Back in Play (For Now)

The courts continue to move the vaccine mandate goalposts on employers as dozens of legal challenges work their way through the courts. The latest developments are major game changers for employers. As of today, the US Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) vaccine-or-test rule is enforceable nationwide, and the US Centers for Medicare & Medicaid Services (CMS) Interim Final Rule (IFR) mandating vaccination, subject to exemptions, is enforceable in 25 states.

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Fifth Circuit Brings Enforcement Back into the Mix: The Latest Court Moves with the CMS Vaccination Mandate

A flurry of litigation in federal district and appellate courts has led to an even split between states in which the COVID-19 vaccine mandate issued by the US Centers for Medicare and Medicaid Services (CMS) may be implemented and states in which such implementation has been prevented. Additional appeals are expected shortly; however, the practical effect of these decisions on enforcement of the CMS mandate remains uncertain.

Read more here.




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