Healthcare Legislation and Rulemaking

This post originally appeared as an article in the Daily Journal on October 29, 2021.

As of January 1, 2022, patients will no longer be at risk for one of the most detested practices in healthcare: surprise out-of-network bills.


Continue Reading Relief from Surprise Bills – Congress Passes the No Surprises Act What Providers and Insurers Need to Know

On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other changes, the Final Rule repeals the price transparency requirement for hospitals, discussed in our September 2, 2020 blog post, obligating hospitals to report certain contract terms with Medicare Advantage (“MA”) plans for cost reporting periods ending on or after January 1, 2021.

Continue Reading CMS Backs Off Price Transparency for Providers and Plans

On August 10, 2021, the Senate passed H.R. 3684, a roughly $1 trillion infrastructure bill (the “Infrastructure Bill”) that authorizes funds for federal-aid highways, transit, broadband access and other infrastructure purposes.  Notably, the Infrastructure Bill is paid for in part through changes to several healthcare policies, including delaying a Medicare Part D rebate rule for an additional three years and reducing Medicare payment amounts to providers.  The Infrastructure Bill’s changes to healthcare policies provide a mixed impact to health care industry stakeholders, with both expected benefits and burdens to providers, payers, and drug manufacturers.

Continue Reading The Infrastructure Investment and Jobs Act: Potential Impact on Healthcare Policy and Spending

On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020 (“Interim Final Rule”).  As described in our December 2020 blog post, the Interim Final Rule established a seven-year nationwide, mandatory MFN Model that would test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals.  The MFN Model, originally set to begin January 1, 2021, would have tied the prices for certain Part B single-source drugs and biologics to the average price paid by several overseas countries and remove incentives to use higher cost drugs, in order to determine whether this could “control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.”  Had the Interim Final Rule been implemented, Medicare Part B reimbursement would have been significantly reduced starting January 1, 2021.

Continue Reading Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While Keeping the “Most Favored Nations” Drug Reimbursement Program on the Sidelines

Introduction

CMS’ most recent Stark Law rulemaking includes important changes to the rules that allow physician practices to satisfy the definition of “Group Practice” while distributing designated health services (“DHS”) – based profit shares and productivity bonuses. 85 Fed. Reg. 77492 (Dec. 2, 2020) (the “Final Rule”).  As these changes go into effect January 1, 2022, and the ability to bill Medicare for DHS is often contingent on satisfying the definition of “Group Practice,” physician practices should take action now to assess their physician compensation arrangements and methodologies under the new rules.


Continue Reading Physician Group Practices Take Heed – January 1, 2022 Deadline Approaches for Compliance with CMS’ Recent Changes to Permissible “Group Practice” Compensation Methodologies

On May 6, 2021, the comment period for the proposed modification to regulations implementing the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule and Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) closed.  The Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) issued its initial request for information in December 2018, subsequently released the Notice of Proposed Rulemaking (“NPRM”) to the public on December 10, 2020, and published the Proposed Rule in the Federal Register on January 21, 2021 (the “Proposed Rule”).  After a significant degree of public interest in providing input on the proposals, OCR extended the comment period from its original end date of March 22, 2021 to May 6, 2021.
Continue Reading HIPAA Privacy Rule Modification – Removing Barriers and Promoting Coordinated Care at What Cost?

On April 27, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released the Hospital Inpatient Prospective Payment System (“IPPS”) and Long-Term Care Hospital (“LTCH”) unpublished Proposed Rule for 2022 (“Proposed Rule”). The Proposed Rule, if enacted, would eliminate the requirement from the Hospital IPPS and LTCH Final Rule for 2021 (“IPPS Final Rule for 2021”), as discussed in our September 11, 2020 blog post, that hospitals report the median payer-specific negotiated charge with Medicare Advantage (“MA”) payers, by MS-DRG, on its Medicare cost reports for cost reporting periods ending on or after January 1, 2021. CMS estimates that this will reduce the administrative burden on hospitals by approximately 64,000 hours.
Continue Reading CMS Proposes Repeal of Certain Cost Reporting Requirements from the IPPS Final Rule for 2021

Late last month, the Biden Administration announced the second installment of its recovery plan, dubbed the “American Jobs Plan” (the “Plan”).  The Plan’s $2.3 trillion price tag includes
Continue Reading The American Jobs Plan and the American Rescue Plan: The Biden Administration Bets Big on Home and Community-Based Services

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially those in the healthcare space.  But while President Biden may have success in reversing much of his predecessor’s last minute regulatory activity, he is likely to face at least some headwinds as it relates to one of those midnight rules – the “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions” (the “Final Rule”) – that was published in the Federal Register on January 14, 2021 and became effective on January 12, 2021.
Continue Reading Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of Guidance Documents in Civil Enforcement Actions

This week, Rep. Mike Thompson (CA-05), founder and co-chair of the Congressional Telehealth Caucus reintroduced the Protecting Access to Post-Covid-19 Telehealth Act of 2020 (the “Act”) with support from Co-Chairs Rep. Peter Welch (VT-AL), Rep. Bill Johnson (OH-06), and Rep. David Schweikert (AZ-06) and caucus member Rep. Doris Matsui (CA-06).  The Act was originally introduced in the House of Representatives on July 16, 2020. The focus of the Act is to do away with certain restrictions on providing telehealth services, and to permanently expand coverage for telehealth services both during and beyond the COVID-19 Pandemic. Among other things, the Act:
Continue Reading Re-Introducing the Protecting Access to Post-Covid-19 Telehealth Act

Over the last year, we have seen volatility in the healthcare industry overall, and Medicare Advantage (“MA”) and Medicare Part D plans (together, “Plans”) have not been immune. Particularly because of their risk adjustment payment models, and metrics by which they are measured, it was unclear how the Centers for Medicare and Medicaid Services (“CMS”) would respond.
Continue Reading CMS to the Rescue for MA and Part D Plans – Rate Announcement Includes Significant Increase in Plan Payments for 2022