Wachler & Associates Health Law Blog

Published on: January 18, 2021

CMS Finalizes Changes to Medicare Advantage and Part D Prescription Drug Programs

On January 15, 2021, the Centers for Medicare & Medicaid Services (CMS) finalized a rule to help strengthen and streamline the Medicare Advantage and Part D prescription drug programs, with the goal to decrease enrollee cost sharing on expensive prescription drugs. Effective for the 2022 plan year, enrollees will be able to have advance notice and thus compare out-of-pocket costs for various prescription drugs. CMS estimates the final rule will result in $75.4 million in savings to the federal government over ten years.

According to CMS, the rule will provide drug cost transparency regarding out-of-pocket costs, especially for senior citizens, who may be unaware of prescription drug prices, changes in pricing, and on a fixed income. Additionally, Part D plans will have more power to negotiate lower prescription drug prices with drug manufacturers. Under the final rule, Part D plans must offer a real time benefit comparison tool for enrollees to receive information about lower cost alternatives under their plan. Using the tool, which must be offered by Part D plans by January 1, 2023, enrollees can compare cost sharing to find the best priced prescription drugs based on their health requirements. For example, if an enrollee’s provider recommends a certain prescription drug, the enrollee can search and see what the co-pay would be, and see if any similar drugs are more cost effective, allowing the individual to know exactly what he or she will pay before reaching the pharmacy.

Currently, in the Medicare Part D program, enrollees select the plan that best suits their health needs. Plans typically categorize prescription drugs into different tiers. All prescription drugs that fall into a plan’s specialty tier, the tier with the most expensive drugs, have equivalent cost sharing. With the final rule, Part D plans will have the ability to create a “preferred”, specialty tier of more expensive prescription drugs, that have lower cost sharing compared to the other specialty tier. This change will allow Part D plans to negotiate lower prices on the more expensive drugs, resulting in reduced out-of-pocket expenses for enrollees, if the plan categorizes these drugs on the “preferred” specialty tier.

Published on: January 15, 2021

HHS Increases Fairness and Notice in Civil and Administrative Proceedings

by Wachler & Associates, P.C.

On January 12, 2021, the Department of Health and Human Services (HHS) issued sweeping new directives regarding the procedures the Department will follow when relying on guidance documents, initiating enforcement actions, making jurisdictional determinations, and allowing prior notice and opportunity to be heard on agency determinations. These directives apply to civil and administrative enforcement proceedings and adjudications and take effect immediately.

First, HHS directed that the Department may not use guidance documents to impose binding requirements or prohibitions on persons outside of the executive branch except as authorized by law or expressly incorporated into a contract. That is, noncompliance with a standard or practice found only in a guidance document will not constitute a violation of the applicable statute or regulation. Further, the Department may refer to a guidance document in a civil enforcement action only if it has notified the public of the guidance in advance.

Second, HHS directed that the Department will only apply standards and practices, including in initiating a civil enforcement action or making an agency decision, that have been publicly stated in a way that would not cause unfair surprise. Of note, HHS defined “unfair surprise” to include when the Department initiates litigation following a lengthy period of conspicuous inaction.

Published on: January 13, 2021

OCR and HHS Issue Guidance on Health Information Exchanges

by Wachler & Associates, P.C.

On December 18, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued new guidance on the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The guidance addresses important questions related to the definition of a health information exchange (HIE), when covered entities can disclose protected health information (PHI) to an HIE without the individual’s authorization, whether covered entities need a direct request from the public health authority (PHA) to disclose PHI, and whether a covered entity must provide notice to individuals regarding disclosures of PHI for public health purposes. In addition, the guidance provides examples for providers and entities relevant to HIPAA and the COVID-19 pandemic.

Questions addressed in the guidance include:

What is a health information exchange (HIE)?

Published on: January 8, 2021

Michigan to Distribute COVID-19 Vaccine to Skilled Nursing Home Facilities through the Pharmacy Partnership for Long-term Care Program

by Wachler & Associates, P.C.

On December 28, 2020, the Michigan Department of Health and Human Services (MDHHS) announced that skilled nursing home residents and staff members would begin to receive the Moderna COVID-19 vaccine immediately. This effort is made possible by the state of Michigan’s participation in the Pharmacy Partnership for Long-term Care (LTC) Program.

As a result of the COVID-19 pandemic, the Pharmacy Partnership for LTC Program is a partnership between the Centers for Disease Control and Prevention (CDC) and CVS, Walgreens, and certain participating Managed Health Care Associates, Inc. (MHA) pharmacies, to offer COVID-19 vaccination for residents and employees of nursing homes and assisted living facilities. Starting in November 2020, long term care facilities (LTCFs) could sign up for the program and choose a federal pharmacy partner. The CDC worked with local jurisdictions to match facilities with their selected pharmacy partner. Pharmacy partners then reached out to their assigned LTCF to coordinate the vaccine process. Through the program, LTCFs will receive the vaccine free of charge, and will be provided with end-to-end management of the vaccine process, including on-site administration of vaccinations, scheduling, and coordination of on-site clinic dates, ordering vaccines and necessary supplies, and the implementation of reporting requirements. The goal of the program is to reduce the burden on LTCFs and local health departments, while increasing vaccination to vulnerable, priority populations.

Skilled nursing home residents and staff are among the highest risk for severe illness and death due to COVID-19. In Michigan, over 5,000 LTC facilities, including 400 skilled nursing facilities, are enrolled in the vaccine program. There are approximately 91,000 skilled nursing residents and employees to be vaccinated, with the process estimated to require three weeks to completely vaccinate this population. Other facilities eligible for the Pharmacy Partnership for LTC Program, such as, assisted living facilities, personal care homes, residential care, adult family homes, adult foster homes, HUD supportive housing for the elderly and veterans’ homes, will soon receive vaccinations as well. Adult day care facilities, independent living facilities, facilities exclusively for children or adolescents, psychiatric rehabilitation or behavioral treatment facilities, and drug or alcohol rehabilitation centers are not eligible for the program.

Published on: January 5, 2021

CMS Releases New Measures Under Consideration Focusing on Increasing Data Innovation and Reducing Provider Burden

by Wachler & Associates, P.C.

On December 22, 2020, Centers for Medicare & Medicaid Services (CMS) released the 2020 list of Measures Under Consideration (MUC). The MUC is a list of quality and efficiency measures, based on data collected from providers, under consideration for adoption as rules under Medicare. The 2020 measures focus on reducing the administrative burden on providers, prioritizing health outcomes, and encouraging digital innovation, particularly regarding data collection and evaluation.

In accordance with the Meaningful Measures Initiative of 2017, digital innovation remains a top priority for CMS in developing quality measures. The Meaningful Measures Initiative was created to reduce the regulatory and reporting burden on providers and focuses on identifying the highest priority areas for quality improvement and measurement to improve patient outcomes. Since its launch, the Meaningful Measures Initiative has provided better quality metrics that are relevant to various providers. The 2020 MUC follow the Meaningful Measures Initiative by focusing on goals such as creating trackable and measurable outcomes, reducing healthcare disparities, cost efficiency, the modernization of reporting mechanisms, and reducing administrative obstacles for providers so they can better focus on quality care for patients, rather than paperwork. A majority of the measures utilize digital collection of data, rather than requiring providers to use traditional pen-and-paper data collection.

The 2020 MUC include:

Published on: December 21, 2020

Michigan Releases New COVID-19 Tools to Reduce Exposure and Risk

by Wachler & Associates, P.C.

The Michigan Department of Health and Human Services (MDHHS) has released two new tools to help reduce COVID-19 infections, deaths, and identify exposure risks, amidst the COVID-19 pandemic. The MI COVID Alert App is a free, anonymous app that alerts users if they have had a recent COVID-19 exposure. In addition to the MI COVID Alert App, the MDHHS launched CV19 CheckUp, a free, anonymous, online service that allows an individual to evaluate his or her personal COVID-19 risks.

In a partnership with MDHHS and the Michigan Department of Technology, Management and Budget (DTMB), the MI COVID Alert App was released statewide on November 9, 2020. The app is free, voluntary to use, and alerts users to recent COVID-19 exposures. Users can anonymously submit a positive COVID-19 test result as well, informing others nearby that they may have been exposed to the virus. When a person tests positive for COVID-19, the individual will receive a randomly generated PIN number from the local health department or State of Michigan, which the user can then enter into the app. If a user receives an exposure notification, this alerts the individual that he or she may have been within 6 feet for a minimum of 15 minutes of another individual with a positive test result. Notably, no information that can be used to personally identify or track a user’s location is required or shared; no names are necessary to use the app, and Bluetooth technology is used instead of GPS, to prevent location tracking. One month since its launch, the app has received 461,192 downloads. MDHHS claims the app has potential to decrease infections and mortality, even with only a 15% population use rate.

In addition to the app, on December 15, 2020, MDHHS launched the CV19 CheckUp tool. This free tool, available to all individuals in Michigan, offers users a personalized risk analysis for COVID-19. After completing an online questionnaire that takes into account an individual’s life situation and personal behavior, users are provided with a COVID-19 risk assessment as well as recommendations and connections to support services, if necessary. Although this tool is available for all Michigan residents, it is specifically created for older individuals, those 60 and over, who represent 24% of confirmed COVID-19 cases and 89% of confirmed COVID-19 deaths in Michigan. Like the MI COVID Alert App, the CV19 CheckUp tool is anonymous, and no name, email address, or other personal identifier is necessary to use and receive a personal risk and recommendation analysis. Rather than placing the burden on the individual to browse various websites and other COVID-19 related resources, the CV19 CheckUp tool uses data from the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), as well as artificial intelligence, to analyze each person’s data, providing them with a risk level, an easy-to-understand evaluation of that risk, and steps that can be taken to minimize that risk.

Published on: December 18, 2020

HHS Increases Phase 3 of Provider Relief Fund and Will Begin Distribution

by Wachler & Associates, P.C.

On December 16, 2020, the Department of Health and Human Services (“HHS”) announced that it would begin Phase 3 of general distributions under the Provider Relief Fund (“PRF”) and that Phase 3 would be larger than initially planned. The PRF is a $175 billion fund created Congress through the CARES Act and administered by HHS to provide financial relief to healthcare providers during the COVID-19 pandemic. The PRF is administered by HHS through the Health Resource Services Administration (“HRSA”). HHS has subdivided the PRF into various general and targeted distributions.

Earlier in 2020, HHS had made two general distributions under the PRF. The Phase 1 general distribution consisted of $50 billion in financial payments, released in two successive tranches of $30 billion and $20 billion, to healthcare providers based to providers who billed Medicare. The Phase 2 general distribution consisted of an additional $18 billion in financial payments to providers that billed Medicaid, dentists, assisted living facilities, and providers that were not eligible under the terms of Phase 1 due to a change in ownership.

On October 1, 2020, HHS announced the Phase 3 general distribution. The Phase 3 general distribution was initially planned to consist of $20 billion on financial payments to providers who were either excluded from the initial two phases, or who were eligible under the first two phases but required additional funding to cover ongoing financial losses accrued during the pandemic. The following providers are eligible for Phase 3 General Distribution funding: (1) Providers who have previously received, rejected, or accepted a General Distribution PRF payment; (2) behavioral health providers, including those that have previously received funding; and (3) healthcare providers that began practicing January 1, 2020 through March 31, 2020. All providers who receive payments must attest to receiving the payment and accept the associated Terms and Conditions.

Published on: December 16, 2020

CMS Expands Telehealth Services and Flexibility for Non-Physician Providers

by Wachler & Associates, P.C.

On Tuesday, December 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released the 2021 Physician Fee Schedule (PFS) final rule, confirming an expansion to telehealth coverage and the scope of non-physician providers. The use of telehealth services increased substantially during the COVID-19 public health emergency. Under the final rule, certain telehealth services will be covered when the COVID-19 public health emergency ends. In addition, the rule reduces administrative barriers to non-physician practitioners, allowing them to focus on providing quality healthcare and less on paperwork.

Prior to the COVID-19 pandemic, CMS estimates that 15,000 fee-for-service Medicare beneficiaries received a Medicare telemedicine visit each week. To address the increased need for healthcare services during the COVID-19 pandemic, CMS added 144 Medicare covered telehealth services. CMS estimates that between March and October 2020, 24.5 million beneficiaries and enrollees received a Medicare telemedicine service. Under the final rule, CMS added more than 60 telehealth services that will permanently be covered under Medicare. Although Medicare does not currently have legal authority to cover telehealth services for beneficiaries who are not located in rural areas, or permit telehealth services to be received in the home, these now permanently covered telehealth services will allow beneficiaries in rural areas, to continue to receive high quality health care and have more convenient access to care.

The final rule also seeks to reduce administrative obstacles for non-physician providers. This will increase efficiency, quality of care, and overall improve the healthcare experience for beneficiaries. The PFS final rule will make certain non-physician provider flexibilities that were established during the COVID-19 pandemic permanent so they may continue to provide care without additional Medicare restrictions. CMS finalized three main changes for non-physician practitioners:

Published on: December 14, 2020

HHS Proposes HIPAA Modifications to Better Serve Patients

by Wachler & Associates, P.C.

On December 10, 2020, the Office of Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) announced a proposal to modify the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule. The overarching goal of the proposed rule is to get patients more engaged in their own healthcare, provide easier access to coordinated care, and reduce the burdensome regulations that have an impact on quality of care. HHS has recently rolled out a Regulatory Sprint to Coordinated Care, and the proposed modifications to the HIPAA rule support this measure.

The Regulatory Sprint facilitated a nationwide transformation to value-based care. The public had determined that there were far too many regulatory burdens to have sufficient coordinated care, which made it difficult for patients to have high quality value-based care. In response to this feedback, CMS proposed changes to the Anti-Kickback Statute, Civil Monetary Penalty rules, and the Physician Self-Referral Regulations. As such, the HIPAA rule was the next regulatory burden that needed to be addressed to further the Regulatory Sprint.

For a complete list of the proposed changes to the HIPAA rule, please see the HHS notice. Here are some highlights:

Published on: December 11, 2020

FDA Asserts Authority Over At-Home Collection Kits for COVID-19 LDTs

by Wachler & Associates, P.C.

Despite a determination by the Department of Health and Human Services (“HHS”) that laboratory developed tests (“LDTs”) do not require premarket approval, the Food and Drug Administration (“FDA”) has asserted that the at-home collection kit portion of a COVID-19 LDT does require FDA pre-market approval.

Testing by clinical laboratories is regulated by the FDA and by the Clinical Laboratory Improvement Amendments (“CLIA”), as administered by the Centers for Medicare & Medicaid Services (“CMS”). The FDA regulates medical devices, including in vitro diagnostic products (“IVDs”). The FDA considers LDTs to be IVDs that are intended for clinical use and are designed, manufactured, and used within a single laboratory. CLIA, on the other hand, regulates the laboratory itself and classifies LDTs as “high complexity tests,” with corresponding standards imposed on the laboratory. Importantly, regarding the LDT itself, CLIA requires only analytical validation, which can occur after testing has already begun. LDTs may also be subject to more stringent state and private sector oversight.

Historically, the FDA had exercised enforcement discretion and not regulated LTDs, but this began to change in recent decades. However, in August 2020, HHS directed that, absent rule and commenting and at least during the COVID-19 public health emergency, the FDA would not require premarket review and approval of LDTs. This allowed clinical laboratories to develop and begin using LDTs to test for COVID-19 without delaying for an FDA Emergency Use Authorization (“EUA”) or other approval. Some of these LDTs included at-home collection kits wherein the patient collected the sample at home, sometimes under the telemedicine supervision of a health care professional, and shipped it to the laboratory for testing.