Archives: Department of Health and Human Services

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HHS expands access to telehealth services in response to COVID-19

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 (which … Continue Reading

HHS waives requirements for health care providers under section 1135 in response to COVID-19

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 … Continue Reading

HHS Finalizes Healthcare Interoperability and Information Blocking Rules

The U.S. Department of Health and Human Services (HHS) issued eagerly anticipated and hotly debated companion interoperability and information blocking final rules that are expected to transform the way in which certain health care providers, health information technology (IT) developers, and health plans share patient information.  The two rules, issued by the HHS Office of … Continue Reading

CDC Offers Guidance to Health Providers on ICD-10 Coding for Coronavirus/COVID-19 Encounters

The Centers for Disease Control and Prevention (CDC) recently released official diagnosis coding guidance for health care encounters and deaths related to the 2019 novel coronavirus (COVID-19), potentially in anticipation of more frequent cases in the United States. The guidance identifies specific ICD-10-CM codes to be used to code encounters. CDC advises that patients presenting … Continue Reading

Potential Tensions Lie Ahead Between Federal and State Authorities Over the Application of CDC Quarantine Powers

According to the U.S. Centers for Disease Control and Prevention (CDC), although there have been imported cases of Covid-19 detected in the United States, “at this time, the virus is NOT currently spreading in the community in the United States.”[1]  However, on Tuesday, February 25, 2020, Nancy Messonier, the CDC’s Director of National Center for … Continue Reading

Medicare/Medicaid Policy Provisions in Trump Administration’s FY 2021 Budget Proposal

The Trump Administration’s proposed fiscal year (FY) 2021 budget calls for significant cuts to federal health spending, including a 10% decrease in Department of Health and Human Services (HHS) discretionary spending in FY 2021 and a $1.6 trillion net reduction in health entitlements over the next decade.  House Budget Committee leaders have blasted the HHS … Continue Reading

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 … 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 … Continue Reading

CMS Issues Final Medicare Inpatient Psychiatric Facility Update for FY 2020

The Centers for Medicare & Medicaid Services (CMS) will increase Medicare inpatient psychiatric facility (IPF) prospective payment system (PPS) payments by 1.5%, or $65 million, in fiscal year (FY) 2020 under a recently-published final rule.  The final FY 2020 market basket increase is 2.9%, which is reduced by two statutory reductions for an IPF payment … Continue Reading

CMS Looking for More Ways to Cut Medicare & Medicaid Red Tape

As part of its continuing “Patients over Paperwork” initiative, the Centers for Medicare & Medicaid Services (CMS) has released another request for information (RFI) on regulatory or subregulatory changes the agency could make to “reduce unnecessary administrative burdens for clinicians, providers, patients and their families.”  In particular, CMS seeks new ideas for: Streamlining reporting requirements, … Continue Reading

HHS Revises Previous Penalty Structure for HIPAA Violations, Creates Annual Penalty Limits

The U.S. Department of Health and Human Services filed a Notice of Enforcement Decision on Friday, April 26, 2019, announcing a new system of annual penalty limits for HIPAA violations based on an entity’s level of culpability. The agency revised its previous interpretation of the Health Information Technology for Economic and Clinical Health Act (HITECH … Continue Reading

CMS Publishes Final CY 2019 Medicare Physician Fee Schedule Rates and Policies

The Centers for Medicare & Medicaid Services (CMS) has issued its final Medicare physician fee schedule (PFS) rule for calendar year (CY) 2019.  In addition to updating rates for physician services, the rule adopts changes to numerous other Medicare Part B policies.  Highlights of the final rule include the following: The final 2019 conversion factor … Continue Reading

CMS Finalizes Medicare OPPS, ASC Rates and Policies for 2019

The Centers for Medicare & Medicaid Services (CMS) has finalized Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) rates and policies for calendar year 2019.  Notably, CMS adopted some – but not all – of its proposed policies intended to promote more “site-neutral payments” for different types of providers. Hospital Outpatient … Continue Reading

HHS Secretary Nominee Azar to Face Senate HELP Committee after Thanksgiving

President Trump has nominated Alex Azar to be Secretary of Health and Human Services, which would fill the vacancy created when Tom Price, MD resigned the post in September.  Mr. Azar, an attorney who previously served in senior HHS positions and as a pharmaceutical industry executive, is scheduled to appear before the Senate Health, Education, … Continue Reading

CMS Finalizes IPPS/LTCH Payment and Policy Changes for FY 2018

CMS has published its final rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2018. Acute Hospital Rate & Policy Updates CMS projects that the rate and policy changes in the rule will increase total IPPS payments by about … Continue Reading

CMS Proposes Medicare Physician Fee Schedule Update for 2018

Rule Would Delay Appropriate Use Criteria Requirement until 2019, Cut Rates for Off-Campus Hospital Departments The Centers for Medicare & Medicaid Services (CMS) has published its proposed rule to update the Medicare physician fee schedule (PFS) for calendar year (CY) 2018. The proposed rule addresses numerous Medicare policies, including:  implementation of appropriate use criteria (AUC) … Continue Reading

CMS Issues Final Rule to Stabilize ACA Insurance Markets, While Emphasizing Marketplace Woes

The Centers for Medicare & Medicaid Services has published a final rule intended to help improve the risk pool and stabilize the Affordable Care Act (ACA) Insurance Exchanges for 2018 – even as CMS contends that consumers “have faced double-digit premium increases, fewer plans to choose from, and a market that continues to be threatened … Continue Reading

Regulatory Freeze Notwithstanding, Trump Administration Increases Health Fraud CMPs

The Department of Health and Human Services (HHS) is once again applying an inflation increase to maximum civil monetary penalty (CMP) amounts for HHS agencies and programs – less than five months after the last inflation hike and notwithstanding the Trump Administration’s recently-announced regulatory freeze.  Specifically, in a final rule to be published on February … Continue Reading

Reexamining HIPAA’s Applicability During Emergencies After the Tragedy in Orlando

Immediately following Sunday’s tragic shooting at a nightclub in Orlando, friends and family frantically gathered at Orlando Regional Medical Center, attempting to get information about their loved ones.  However, hospital officials hesitated to provide specific updates.  Why?  Because the Health Insurance Portability and Accountability Act (HIPAA) and implementing regulations restrict the patient-identifiable health information that … Continue Reading

Extensive Medicare & Medicaid Funding and Program Integrity Provisions in Obama’s Released FY 2017 Budget Proposal

On February 9, 2016, the Obama Administration released its proposed fiscal year (FY) 2017 budget, which contains significant Medicare and Medicaid reimbursement and program integrity legislative proposals – including $419 billion in Medicare savings over 10 years. These proposed policy changes would require action by Congress, and Republican Congressional leaders have already voiced general opposition … Continue Reading

Medicare and Medicaid Drug Policy Provisions in the Obama Administration’s Proposed FY 2017 Budget

The Obama Administration’s proposed fiscal year (FY) 2017 budget, released on February 9, 2016, includes a number of legislative proposals that would revise Medicare and Medicaid policies to achieve budget savings and make other program reforms.  The largest pool of Medicare savings would result from various Medicare prescription drug proposals, including the following (all savings … Continue Reading

340B Drug Pricing Program Omnibus Guidance Notice Published by HRSA

On August 28, 2015, the Health Services Resources Administration (HRSA) published long-awaited 340B Drug Pricing Program Omnibus Guidance.  Although many aspects of the notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program, particularly because of its potential to narrow the scope of permissible … Continue Reading
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