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Susan Ingargiola is an associate in the Corporate Practice Group in the firm's New York office and a member of the healthcare team.

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on October 29, 2020 that extends the compliance dates under the 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) and offers some technical corrections and clarifications.
Continue Reading Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule

Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG”) released a report highlighting concerns about the extent to which Medicare Advantage Organizations (“MAOs”) are using health risk assessments (“HRAs”) to improve care and health outcomes under the Medicare Advantage Program (“MA”), as intended, and about the sufficiency of oversight by the Centers for Medicare & Medicaid Services (“CMS”).
Continue Reading HHS OIG Issues Report Critical of Medicare Advantage Risk Adjustment Practices

On April 2, 2020, the Office for Civil Rights at the U.S. Department of Health and Human Services (“HHS”) announced a Notification of Enforcement Discretion to allow certain uses and disclosures of Protected Health Information (“PHI”) by HIPAA business associates during the COVID-19 public health emergency.  Understanding that the CDC, CMS and state and local health departments need quick access to COVID-19 related healthcare data in order to fight the pandemic, HHS decided to grant HIPAA business associates greater freedom to cooperate and exchange COVID-19-related information with public health and oversight agencies.
Continue Reading HHS Further Relaxes HIPAA Regulations Governing Use and Disclosure of Protected Health Information During the COVID-19 Public Health Emergency

On March 9th, the U.S. Department of Health and Human Services (HHS) finalized two rules that are designed to give patients access to their health data and to increase interoperability among health care providers and payers using health information technology.  The two rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), implement interoperability and patient access provisions of the 21st Century Cures Act.  A primary aim of the 21st Century Cures Act was to push the healthcare industry to facilitate interoperability of healthcare data across the spectrum, including amongst health care payers, providers, patients and technology vendors.  For decades, HHS has largely relied on the industry to enable interoperability through a market-driven approach that would, in theory, benefit industry while achieving the interoperability goals established by the regulators. Unfortunately, it has been observed that the theory behind a market-driven approach has not been manifested in reality. In reality, the market-driven approach has allowed industry to monetize data by limiting data sharing and, in turn, impeding the benefits of interoperability which rely upon data sharing to promote improved care coordination, better patient outcomes, and material cost reductions. In order to bend the curve toward interoperability, the new HHS rules are designed to provide for binding and specific steps to “free” health care data and recognize the aforementioned benefits.
Continue Reading CMS Releases Interoperability Rule Designed to Increase Patient Access to Health Information

The House and Senate continue to focus on prescription drug pricing though it is unclear whether any of the proposals currently pending in either chamber will become law. On December 6th, Senators Grassley and Wyden introduced an updated version of the bipartisan Prescription Drug Pricing Reduction Act (the “PDPRA”). Senate leadership, however, appears to be in no rush to vote on the bill. On December 12th, the House passed its own version of a prescription drug price reduction bill, H.R. 3, called the Elijah E. Cummings Lower Drug Costs Now Act, which was introduced by Speaker Pelosi. Senate leadership has already indicated the Senate will not take up the measure. While members of Congress on both sides agree that reducing prescription drug prices is a “must do,” they don’t agree on how to do it.
Continue Reading Congress Continues to Focus on Prescription Drug Pricing

A bipartisan group of senators introduced legislation on October 30th designed to expand Medicare beneficiaries’ access to telehealth services. The bill is called the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2019 (hereinafter, the “CONNECT Act” or the “Act”). In order to understand what the Act seeks to accomplish, it is important to have a working understanding of Medicare’s current policies governing telehealth. A brief overview is provided below followed by a section by section summary of the Act.
Continue Reading Legislation Re-Introduced to Expand Access to Telehealth Under Medicare

The California Department of Health Care Services (“DHCS”) recently revised its Medi-Cal telehealth policy to allow providers increased flexibility in their use of telehealth as a modality for delivering medically necessary services to their patients. The policy is retroactively effective as of July 1, 2019, and fee-for-service providers must submit claims for services provided via telehealth according to the new policy. Updates to the telehealth policy include the following:
Continue Reading California Expands Medicaid Telehealth Policy

In its recently updated Work Plan, the Office of the Inspector General (“OIG”) at the Department of Health & Human Services (HHS) announced that it will conduct an audit focusing on how selected state Medicaid agencies and Medicaid managed care organizations (“MCOs”) leverage telehealth to provide behavioral healthcare.
Continue Reading OIG to Audit Provision of Behavioral Health Services Through Tele-Health Under Medicaid Managed Care

In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA) of 2019 (the “PDPRA” or “Mark”), to lower the price of prescription drugs for Americans. According to the Committee, the Congressional Budget Office (“CBO”) projects that the PDPRA would save taxpayers more than $100 billion in Medicare and Medicaid spending over 10 years, lower Medicare beneficiaries’ out-of-pocket costs by $27 billion and lower beneficiaries’ premiums by $5 billion. The bill passed out of committee by a 19-9 vote on July 25th.

Reaction to the Mark has been mixed. For example, the Pharmaceutical Research and Manufacturers of America criticized the PDPRA as the “wrong approach to lowering drug prices” and predicts it will “siphon” billions of dollars away from research and development without benefitting seniors at the pharmacy counter. America’s Health Insurance Plans was “encouraged” by the Committee’s work and expressed its readiness to work with Congress and the Administration.
Continue Reading Is Prescription Drug Pricing The Cure For Partisanship?

On Friday, April 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) announced that it had finalized policies allowing Medicare Advantage plans (“MA Plans”) to include additional telehealth benefits in their basic benefit packages starting in 2020.  The final rule implementing the changes (the “Final Rule”) will be published in the Federal Register on April 16, 2019. An advance copy of the Final Rule is available here.
Continue Reading CMS Expands Telehealth Benefits under Medicare Advantage