Other Health Policy Developments

On October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and Behavioral-Health Needs (the “Executive Order”), which seeks to provide federal support to address mental and behavioral health concerns arising from the COVID-19 pandemic.

The Executive Order acknowledges the exacerbating effects that the COVID-19 pandemic

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information.

In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), settled five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access provision.  Under HIPAA, individuals have a legal, enforceable right to view and obtain copies, upon request, of the information in their medical and other health records maintained by a HIPAA covered entity, typically a health care provider or health plan, with limited exception.  Individuals generally have a right to access this information for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created, whether the information is maintained in paper or electronic systems onsite, remotely, or is archived, or where the information originated (e.g., whether the covered entity, another provider, or the patient).
Continue Reading Patient access to health information at the forefront of government initiatives and scrutiny

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1]  Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.  FDA recognizes this information as important

The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s Seniors,” directs the Secretary of Health and Human Services to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients.”  EO 13890 explicitly requests that the Secretary make coverage

On August 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) filed an interim final rule with comment period (“IFC”), detailing new long-term care (“LTC”) facility COVID-19 testing requirements and strengthening enforcement of existing related facility reporting requirements.  According to CMS, the IFC represents the agency’s latest effort in an ongoing initiative to control

With only one day left before the final rule scaling back nondiscrimination regulations took effect, the U.S. District Court for the Eastern District of New York (EDNY) issued an order staying the repeal of certain parts of the former regulations. On June 19, 2020, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) published a final rule scaling back nondiscrimination regulations first released in 2016 to implement Section 1557 of the Affordable Care Act (ACA). The 2016 regulations had imposed significant requirements on health care providers to ensure that all individuals were provided “meaningful access” to care. As part of the 2016 regulations, OCR banned discrimination “on the basis of sex,” which was defined broadly as “on the basis of pregnancy, false pregnancy, termination of pregnancy, or recovery therefrom, childbirth or related medical conditions, sex stereotyping, or gender identity.” The 2020 final rule revised the 2016 regulations significantly, however. In one of its most controversial changes, OCR removed the definition of “on the basis of sex” contending that “on the basis of sex” shall revert to the “plain meaning” of the term “sex” in Title IX of the Civil Rights Act – meaning not to encompass discrimination on the basis of sexual orientation or gender identity. OCR’s decision came on the heels of a Supreme Court ruling in Bostock v. Clayton County, Ga. four days prior which concluded that discrimination “on the basis of sex” encompasses claims based on gender identity and sexual orientation under Title VII of the Civil Rights Act. Accordingly, within the course of less than a week, the Supreme Court broadly interpreted the same term that OCR severely limited.

Shortly after OCR announced its reversal of the nondiscrimination requirement based on gender identity and sexual orientation, various interest groups began mounting legal challenges. With the order issued by EDNY on August 17, 2020, we are already seeing evidence of the legal battles likely to ensue over the definition of “on the basis of sex,” placing certain parts of OCR’s final rule in legal limbo.
Continue Reading Federal Court stays repeal of “On the Basis of Sex” definition in recent nondiscrimination final rule one day before regulations take effect

On August 4, 2020, the Centers for Medicare and Medicaid Services (“CMS”) posted for inspection the Proposed 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 17, 2020, and among its many proposals, would update and revise: (1) the physician fee schedule relative value units; (2) practice expense relative value units; (3) telehealth service approval and reimbursement policies; (4) the direct supervision requirement; (5) payment for teaching physicians; (6) medical records documentation policies; and (7) policies regarding opioid treatment programs.

Comments to this proposed rule must be received by CMS no later than 5 p.m. on October 5, 2020.
Continue Reading CMS Releases Proposed Physician Fee Schedule Rule for 2021

Includes proposed changes to the OPPS and ASC payment rates and Stark Law exemptions.

On August 4, 2020, CMS posted for inspection the Proposed Outpatient Prospective Payment System (“OPPS”) Rule for 2021.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 12, 2020 and would revise the Medicare hospital OPPS

On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel

On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced additional distributions from the CARES Act Provider Relief Fund to several groups of providers, totaling approximately $25 billion. $15 billion of these funds is targeted towards eligible Medicaid and Children’s Health Insurance Program (CHIP) providers participating in state Medicaid and CHIP

Earlier this week, the Department of Health and Human Services (HHS) Office of General Counsel issued Advisory Opinion 20-02, which declared that the Public Readiness and Emergency Preparedness Act (PREP Act), combined with the HHS Secretary’s March 10, 2020 declaration, preempts state or local requirements that would prevent pharmacists from ordering or administering COVID-19 tests

Pennsylvania Attorney General Josh Shapiro announced on May 12, 2020, that his office is investigating several nursing homes in the Commonwealth for neglect of patients and residents: “We will hold nursing facilities and caretakers criminally accountable if they fail to properly provide care to our loved ones … we will not tolerate those who mistreat our seniors and break the law.” Shapiro has also launched a public portal for citizens to email reports of neglect in nursing home communities. As is the case in many states, nursing home patients make up the majority of the deaths associated with COVID-19 in Pennsylvania. Just over 2,611 nursing home residents and staff have died from COVID-19 in Pennsylvania, comprising nearly 70 percent of the 3,800 total deaths reported in the Commonwealth as of the date of the press release.

Attorney General Shapiro is not alone in his effort to take a closer look at nursing home facilities and caregivers, even while lobbying groups for health care providers and nursing homes push for broad immunity from coronavirus-related lawsuits. In late April, New York Attorney General Letitia James released a statement saying that her office’s Medicaid Fraud Control Unit continues to investigate allegations of abuse and neglect in nursing homes. James’ office similarly launched a nursing home abuse hotline for residents, families, and members of the public to report alleged complaints at the facilities. Specifically, Attorney General James is investigating a Queens adult care facility that allegedly failed to protect residents from COVID-19 and misled families about its spread. Residents of that same facility are now suing in federal court over similar allegations. State attorneys general are increasingly active on this issue and will be pursuing nursing homes and long-term care facilities through various angles including Medicaid fraud, consumer protection, and false advertising.Continue Reading Nursing homes face increased scrutiny by attorneys general during COVID-19

In a recent guidance, the Centers for Medicare & Medicaid Services (CMS) encouraged health care providers (HCPs) to limit elective surgeries and nonessential procedures during the 2019 novel coronavirus (COVID-19) outbreak.

CMS offered a number of recommendations to help HCPs decide how to best serve patients requiring emergent or urgent attention. In addition to clinical

The Medicare Payment Advisory Commission (MedPAC) released its 2021 Medicare provider rate update recommendations on March 13, 2020 – the same day President Trump declared a national emergency due to COVID-19.  MedPAC’s recommendations were based on an assessment of various Medicare “payment adequacy indicators” that are unlikely to reflect the state of the health

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

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 Immunization and Respiratory Diseases, urged American businesses and families to start preparing for the possibility of a large outbreak, noting that the virus spread quickly once it appeared in other countries.[2]  Although the World Health Organization (WHO) still has not called Covid-19 a pandemic, Mike Ryan, head of WHO’s health emergencies program, suggests that countries need to be doing everything they can to contain the virus, at least in order to buy some time.[3]

To that end, the CDC has been tapping some of its quarantine powers.  CDC has authority to oversee quarantine and isolation of persons who carry communicable diseases, derived from the Commerce Clause of the Constitution, and codified in section 361 of the Public Health Service Act (42 U.S.C. § 264).[4]  The CDC’s authority, however, is limited to persons arriving in the United States or traveling between states.  Each state has its own laws regarding quarantine powers, and the CDC also relies on state authorities to implement and enforce quarantine orders.  There is some risk that state health authorities could act in a manner that is inconsistent with the intentions of the CDC (to be more or less restrictive).  The CDC has not issued a large-scale isolation and quarantine since the Spanish influenza pandemic of 1918-1919.[5]Continue Reading Potential Tensions Lie Ahead Between Federal and State Authorities Over the Application of CDC Quarantine Powers

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

The Centers for Medicare & Medicaid Services (CMS) has announced a controversial plan to allow states to apply to participate in a new Medicaid “Healthy Adult Opportunity” (HAO) Demonstration.  In short, the HAO Demonstration will give participating states greater flexibility in the scope and administration of Medicaid benefits for certain beneficiary populations (i.e., the Affordable

The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a draft of its 2020-2025 Federal Health IT Strategic Plan (Plan). The outcomes-driven Plan, which ONC collaboratively developed with 25 federal organizations, aims to promote a health IT economy that balances increased transparency, competition, and consumer choice with privacy and security of patient health information. The Plan reflects HHS’ ongoing efforts to create pathways for patients to actively engage in their health outcomes and navigate personalized care alternatives.

The Plan is intended to serve as a five-year roadmap for federal health IT initiatives and activities, and to function as a catalyst for streamlined activities in the private sector. In particular, the Plan highlights four key goals with supporting objectives, all focused on meeting the needs of patients, caregivers, health care providers, payers, researchers, developers, and innovators by increasing access to health information, emphasizing product and pricing transparency, and encouraging interoperability.
Continue Reading HHS Sustains Digital Health Momentum and Continues Publishing Policy Initiatives to Kick-off 2020

The Centers for Medicare & Medicaid Services (CMS) has released a Request for Information (RFI) on how the Medicaid program can incorporate out-of-state providers in coordinating care for children with certain medically complex conditions under Medicaid.  The RFI is intended to help CMS implement a provision of the Medicaid Services Investment and Accountability Act of