Department of Health and Human Services

Last week, on April 18, several federal agencies jointly launched a “one-stop shop” to facilitate reporting of allegedly anticompetitive behavior in the health care sector. While there has always been a complaint portal for the antitrust agencies, the Federal Trade Commission (FTC), the U.S. Department of Health and Human Services (HHS), and the Antitrust Division

The United States Food and Drug Administration (FDA) has proposed a rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act”. We have put together this alert to summarize the provisions of the rule and what you

Building on prior requests for information and an increased focus on Medicare Advantage oversight, the Centers for Medicare and Medicaid Services (CMS) has issued another request for information (RFI) seeking input on data needed for Medicare Part C, also known as the Medicare Advantage (MA) program. The goal of this RFI, which was published in the Federal Register on January 30, 2024, is to provide CMS with feedback on both the format and types of data that will allow CMS to have better insight into MA organizations and their operations and to consider future rulemaking. Responses to the RFI are due by May 29, 2024.

This RFI is an extension of CMS’s General MA RFI published in August 2022, which generated over 4,000 responses from various stakeholders. The 2024 RFI broadly seeks input on “all aspects of data related to the MA program—both data not currently collected as well as data currently collected.” The eventual goal is to make MA data commensurate with data available from Medicare Parts A and B to ensure appropriate transparency into MA organizations and to address perceived shortcomings through additional rulemaking.Continue Reading CMS Issues RFI for Medicare Advantage Data

The Department of Health and Human Services (HHS) has issued a notice of proposed rulemaking that removes an exception to the definition of “lawfully present” that would then serve to include in that term individuals who have obtained temporary immigration status under the Deferred Action for Childhood Arrivals (DACA) program.

The expansion of the the definition of “lawfully present” would allow DACA recipients as of November 1, 2023 to enroll in a qualified health plan (QHP) from a health insurance exchange as established by the Affordable Care Act. Additionally, the definition change would open up eligibility for DACA recipients to enroll in a Basic Health Program, or Medicaid and the Children’s Health Insurance Program (CHIP) in states that have elected to cover “lawfully residing” pregnant individuals and children.Continue Reading DACA Recipients Can Enroll in Qualified Health Plans under Proposed HHS Rule

On March 27, 2023, two United States Senators, Bill Cassidy, MD (R-LA) and Jeff Merkley (D-OR) introduced the bipartisan No Unreasonable Payments, Coding, or Diagnoses for the Elderly (“No UPCODE”) Act to address perceived financial incentives inherent in the Medicare Advantage patient risk scoring reimbursement methodology. Senator Merkley alleges that the current reimbursement

As the September 1, 2023 deadline for Centers for Medicare & Medicaid Services (CMS) to publish the first 10 “selected drugs” subject to negotiation of “maximum fair prices” under Medicare Parts B and D fast approaches, CMS has recently specified information that manufacturers must submit in order for their drugs to qualify for the “Small Biotech Exception” to being included on the list. The information is to be submitted during the summer of 2023; the specific deadline has not yet been announced.

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA). Among other provisions, the IRA provides for the CMS to negotiate “maximum fair prices” with manufacturers of “selected drugs” covered under Medicare Parts B and D. The price negotiation process begins on September 1, 2023, when CMS is required to publish the list of the first 10 selected drugs subject to negotiation, for maximum fair prices which will take effect beginning January 1, 2026.

The IRA provides that the selected drugs will be the 10 “negotiation-eligible drugs” having the highest total expenditures under Medicare Part D during the period June 1, 2022 through May 31, 2023. Negotiation-eligible drugs generally consist of “qualifying single-source drugs”, which are generally defined as branded drugs and biologicals approved by the Food and Drug Administration (FDA) at least 7 years (with respect to drugs) or 11 years (with respect to biologicals) before the date the list is published, and which do not have a marketed generic equivalent or biosimilar. However, for 2026 through 2028, the IRA provides that negotiation-eligible drugs exclude certain drugs under what CMS refers to as the “Small Biotech Exception”.Continue Reading CMS Specifies Info Needed for Small Biotech Exception to Medicare Drug Price Negotiation

The Department of Health and Human Services recently issued a proposed rule that would streamline the federal regulations governing the confidentiality of substance use disorder (SUD) patient records at 42 CFR Part 2 (Part 2) with the Health Insurance Portability and Accountability Act and its implementing regulations (HIPAA). Comments on the proposed rule are due to HHS by January 31, 2023

For years, health care providers regulated by both Part 2 and HIPAA and their patients, have wrestled with the inconsistencies across these two privacy frameworks. Part 2, for example, currently imposes different patient consent requirements and disclosure restrictions on Part 2-protected SUD treatment records (Part 2 Records) than HIPAA, even though such records often constitute protected health information (PHI) as well. The inconsistencies (and in some cases, conflicts) between HIPAA and Part 2 requirements have created barriers to information sharing and confusion and compliance challenges for entities regulated under both frameworks, which in turn have unnecessarily impeded treatment access and care coordination.

As noted in the HHS fact sheet and the press release issued by the Substance Abuse and Mental Health Services Administration (SAMHSA), the proposed rule would, if finalized, enhance care coordination, afford patients a formal right of access to their SUD records, and extend HIPAA’s breach notification standards to Part 2-regulated providers and information. The proposed rule would also allow health care providers to align internal privacy compliance programs, the importance of which is underscored by another proposal to impose the same HIPAA civil and criminal penalties on regulated providers for noncompliance with Part 2 regulations. Continue Reading HHS proposes update to Part 2 confidentiality regulations to align with HIPAA

The Department of Health and Human Services (“HHS”) has proposed a rule that updates retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  There is a 60-day public comment period for this rule, which closes on January 9, 2023.  This proposed rule, if finalized, would modify the currently adopted National Council for Prescription Drug Programs (“NCPDP”) Telecommunications Standard Implementation Guide (“TSIG”) and its equivalent batch standards. 

Specifically, the proposed rule would adopt TSIG version F6, and its equivalent batch standards NCPDP Batch Standard Implementation Guide, Version 15, and Batch Standard Pharmacy Subrogation Implementation Guide Version 10 (for non-Medicaid health plans).

The new standards will allow retail pharmacies with multiple locations to send one batch mode transaction that meets the F6 standard.  Among the changes from version to version are new data fields, new data segments, and new functionality.Continue Reading HHS Proposes Rule to Update Retail Pharmacy Standards for Electronic Transactions under HIPAA

On August 26, 2022, the Departments of Health and Human Services, Labor, and Treasury (the “Departments”) issued the highly anticipated Requirements Related to Surprise Billing (“August 2022 Final Rule”) and associated guidance materials concerning the independent dispute resolution (“IDR”) process established by the No Surprises Act. The August 2022 Final Rule is narrow in scope and responds to two recent decisions by the Eastern District of Texas vacating portions of the October 2021 Interim Final Rule, Requirements Related to Surprise Billing: Part II (“IFR II), and incorporates stakeholder comments solicited by the Departments.

Importantly, as discussed more below, the August 2022 Final Rule removes the qualifying payment amount (“QPA”) as the presumptive factor in IDR payment decisions and requires health plans to submit additional information in the IDR process for cases where a claim at issue was “downcoded” by the plan.   

The August 2022 Final Rule will take effect October 25, 2022, 60 days after its publication in the Federal RegisterContinue Reading Departments issue new Final Rule and guidance materials for No Surprises Act IDR process

On June 29, 2022, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) issued two pieces of guidance clarifying the applicability of the Health Insurance Portability and Accountability Act (“HIPAA”) related to privacy of information connected to an individual’s reproductive health. 

Through this guidance, HIPAA addresses both protected health information (“PHI”), which is subject to HIPAA’s rules, as well as general, personal information that is not directly protected by HIPAA.Continue Reading New Guidance by OCR addresses HIPAA and Disclosures of Information relating to Reproductive Health

On February 4, 2022, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory opinion on a proposal by a nonprofit children’s hospital to enter into an arrangement with two individual donors, who intend on making a testamentary gift to the hospital that would be used to reduce and subsidize costs incurred by patients.

The OIG indicated it would not impose administrative sanctions, despite the fact that the proposed arrangement would not fall squarely within any safe harbor under the federal Anti-Kickback Statute (“AKS”) or exception to the definition of “remuneration” for purposes of the beneficiary inducement prohibition (“Beneficiary Inducement CMP”).

Arrangement created restricted endowment fund

Under the proposed arrangement, the hospital would be the beneficiary to a restricted endowment fund established through a testamentary gift from two donors. The fund would be used to subsidize bills for families with children who have an established care relationship with the hospital’s physicians and who receive services provided by the hospital’s programs.Continue Reading OIG approves arrangement involving a testamentary gift to a nonprofit hospital to reduce costs for pediatric patients

The No Surprises Act, effective as of January 1, 2022, aims to provide patients with accurate information regarding their expected health care spending. In many cases, the new law prevents health care providers from charging patients for costs not reimbursed by insurance. We previously covered the impact of these “balance billing” prohibitions on hospital contracting. However, for the 28 million people in the United States without health insurance coverage or for those seeking care that requires initial self-payment, such as most psychological counseling, these balance billing prohibitions lack relevance because the entire balance is payable by the patient or their representative. The No Surprises Act also includes a potential solution for this group–a mandate that “Good Faith Estimates” (GFEs) be provided to all uninsured or self-pay patients.

Unlike the balance billing restrictions addressed in our prior blog, GFE requirements apply to all health care providers in all settings.  Providers must now generate cost estimates when treating uninsured (including those with insurance who do not want a claim filed) and self-pay patients. Many providers will generate estimates using the same billing systems that existed prior to the No Surprises Act, but some changes may be necessary to meet new regulatory requirements. This post will highlight key provisions relating to GFE, including how to ensure that provider billing practices comply with the new mandate.Continue Reading No Surprises Act Good Faith Estimates: What they are and when you need them

According to the Centers for Disease Control and Prevention, firearm injuries are a serious public health problem in the United States. To combat this problem, many states have passed extreme risk protection order (“ERPO”) laws, otherwise known as “red flag laws.”

ERPO laws allow various individuals, including family members, health care providers, and law enforcement

In an increasingly digital and interconnected world, the privacy and security of personal information is a significant concern. Applications and connected devices collect a bevy of personal information from consumers, including sensitive information about consumers’ health. Because of the sensitivity of health information, the United States has developed a variety of legal protections and enforcement

In a report released on September 2, 2021 the Biden administration announced its plan to help prepare the nation for future pandemic threats. In the report, named American Pandemic Preparedness: Transforming Our Capabilities, the administration described what it sees as the vital need to change the nation’s capabilities to better respond to any future pandemics or biological threats.

The report organizes the proposed actions under five pillars: (1) Transforming Medical Defenses, (2) Ensuring Situational Awareness, (3) Strengthening Public Health Systems, (4) Building Core Capabilities, and (5) Managing the Mission

The report calls for action to “not just refill our stockpiles, but also to transform our capabilities.” The report compares the proposed plan to the Apollo space program because of the importance that the administration is placing on the efforts as well as the proposed coordination among agencies and departments.

Ultimately, the administration is planning to create a centralized “mission control” that would work to coordinate resources and expertise from multiple agencies within the Department of Health and Human Services like the National Institutes of Health, Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority (a component of the office of the Assistant Secretary for Preparedness and Response), Food and Drug Administration and the Centers for Medicare and Medicare Services, along with other cabinet-level departments such as the Department of Defense, Department of Energy, and the Veterans Administration.Continue Reading Biden administration looks to centralize pandemic response in preparedness plan

The flurry of Covid-19 vaccine administration that marked the mid spring to early summer resulting in millions of doses administered daily has given way to a steady stream of approximately 700,000 doses of vaccine administered daily, according to some analysis of CDC data.

But now that August has arrived so has the need for regularly scheduled pediatric vaccines to be administered as schools open up again. Also, next month marks the beginning of flu season and its flood of vaccine requests. All of this demand for vaccine administration could threaten to overwhelm some of the pharmacies that have typically been a destination for quick and easy vaccine administration.

On August 4, the HHS officially amended the PREP Act declaration on medical countermeasures against Covid-19 in an effort to stave off any bottle-necking at pharmacies that administer flu vaccines. The declaration amendment, which took immediate effect and last until the end of the public health emergency officially included qualified pharmacy technicians and interns  as “qualified persons” permitted to administer seasonal influenza vaccines to adults age 19 and older. Additionally, the amendment officially identifies the same techs and interns as authorized to administer the Covid-19 vaccine as well as pediatric vaccines that are on the Advisory Committee on Immunization Practices (ACIP) schedule.Continue Reading HHS authorizes pharmacy technicians and interns to administer flu vaccines

Starting in 2019, the Department of Health and Human Services Office for Civil Rights (“OCR”) has taken an increased interest in protecting patients’ right of access to protected health information (“PHI”) under the Health Insurance Portability and Accountability Act (“HIPAA”). Over the past twenty months, OCR has announced nineteen settlements under its Right of Access

On July 1, 2021, the U.S. Department of Health and Human Services (“HHS”), through the Health Resources and Services Administration (“HRSA”) notified recipients of Provider Relief Fund (“PRF”) payments via e-mail that the PRF Reporting Portal is now open for providers who are required to report on the use of funds in Reporting Period 1