This week in Washington: Senate to hold a confirmation hearing for Dr. Stephen Hahn, Trump's nominee to be the new FDA commissioner, as well as a hearing on Alzheimer's awareness.





Final Regulations/Guidance

Proposed Regulations/Guidance



Upcoming Hearings/Markups

Wednesday, Nov. 20, 2019

Senate Committee on Health, Education, Labor and Pensions: “Nomination of Stephen M. Hahn, MD, to serve as Commissioner of Food and Drugs”

The Senate Committee on Health, Education, Labor and Pensions will hold a confirmation hearing for Dr. Stephen Hahn, President Trump’s nominee to be the new Food and Drug Administration (FDA) commissioner. On Nov. 6, Chairman Lamar Alexander (R-TN) released a statement of support for Dr. Stephen Hahn ahead of the hearing. Find more details on the hearing as they become available here.

Senate Committee on Finance: “Alzheimer’s Awareness: Barriers to Diagnosis, Treatment and Care Coordination”

The Senate Committee on Finance, Subcommittee on Health Care will hold a hearing to shed light on the obstacles surrounding Alzheimer’s diagnosis and care. Find more details on the hearing as they become available here.



Senate Health, Education, Labor and Pensions (HELP) Committee: “Examining the Response to Lung Illnesses and Rising Youth Electronic Cigarette Use”

Wednesday, Nov. 13, 2019: The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing to examine the Food and Drug Administration’s (FDA) and Centers for Disease Control and Prevention’s (CDC) response to lung illnesses and rising youth electronic cigarette use.

Why this is important: Senators of both parties questioned Mitch Zeller, the head of the Food and Drug Administration’s (FDA) Center for Tobacco Products, holding him responsible for a lack of information on upcoming e-cigarette policy and flavor bans from the FDA. Zeller referred the members of the committee to the White House for more comment.

The Office of Management and Budget (OMG) completed regulatory review of a proposed rule about electronic nicotine delivery systems on Nov. 4, and canceled meetings with stakeholders. Department of Health and Human Services (HHS) Secretary Alex Azar commented that the rule is not finished yet, and said President Trump is still interested in hearing from all stakeholders.

Find more details on the hearing here.

House Committee on Energy and Commerce: Markup of H.R. 2339, H.R. 4995, H.R. 4996 and H.R. 2387

Wednesday, Nov. 13, 2019: The House Committee on Energy and Commerce, Subcommittee on Health met in an open markup session of four health-related bills.

H.R. 2339, the Reversing the Youth Tobacco Epidemic Act of 2019, was favorably forwarded to the full committee, amended, by a voice vote.

H.R. 4995, the Maternal Health Quality Improvement Act of 2019, was favorably forwarded to the full committee, without amendment, by a voice vote.

H.R. 4996, the Helping Medicaid Offer Maternity Services (MOMS) Act of 2019, was favorably forwarded to the full committee, amended, by a voice vote.

H.R. 2387, the Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019, was favorably forwarded to the full committee, without amendment, by a voice vote.

Find more details on the markup and amendments here.

House Ways and Means Committee: “Caring for Aging Americans”

Thursday, Nov. 14, 2019: The House Ways and Means Committee held a hearing to discuss long-term care issues, which included discussion of care in the home, hospice and nursing homes and antipsychotic drug use in nursing homes.

Why this is important: The witness panel provided personal anecdotes and noted key concerns, including the abuse and neglect in care residences, the impending lack of money for those that need care in the near future, malnutrition of the elderly and support for caregivers, who need leave from work or even recognition on electronic health records. There was also discussion of expanding funds to community groups who help as caregivers, and inspiration from states like Washington that have created long-term care insurance plans that will distribute $36,500 per person in lifetime benefits, starting in 2025.

Find more details on the hearing here.


Cassidy, Rosen Introduce Consumer Privacy Bill

On Nov. 14, Sens. Bill Cassidy (R-LA) and Jacky Rosen (D-NV) publicly revealed the Stop Marketing and Revealing the Wearables and Trackers Consumer Health Data Act, or the Smartwatch Data Act, to strengthen privacy protections for consumer health data amid scrutiny over Google’s planned acquisition of Fitbit. The bill is also a reaction to Google’s current partnership with Ascension, which has jumpstarted an investigation by the Department of Health and Human Services (HHS) over patient privacy concerns.

The bill also prevents entities that collect this consumer health information on personal health trackers from transferring, selling or sharing it. The bill says such information would be treated as protected health information. It also would require HHS to enforce any violations of the bill as it would for a Health Information Portability and Accountability Act (HIPAA) violation.

Find the text of the bill here.

Senators Block Patent Gaming, Drug Price Ad Bills

On Nov. 13, Senate Minority Leader Chuck Schumer (D-NY) blocked the passage of a bipartisan bill, introduced by Sen. John Cornyn (R-TX), that aimed to prevent drug companies from patent gaming, S. 1416, the Affordable Prescriptions for Patients Act of 2019. Sen. Schumer objected to the measure and said that Sen. Cornyn and other Republicans senators should be willing to debate and vote on Democrats’ proposals to negotiate drug prices in Medicare and protect insurance coverage of preexisting conditions.

The same day, Sen. Pat Toomey (R-PA) blocked an expedited vote on Sen. Dick Durbin’s (D-IL) legislation that would require drug companies list their products’ prices in direct-to-consumer ads, S. 1437, the Drug-Price Transparency in Communications Act. Sen. Toomey said that requiring drug manufacturers to list their prices in ads could provide misleading information.


HHS Investigating Google Health Data Project

On Nov. 14, the Department of Health and Human Services (HHS) announced it is investigating Google’s collaboration with Ascension in gathering health data on American patients. Ascension is the country’s second-largest health system, and the data on 50 million patients of Ascension was until recently scattered across 40 data centers in more than a dozen states. Google and Ascension are moving that data into Google’s cloud-computing system and this has caused alarm for patient privacy under the Health Insurance Portability and Accountability Act (HIPAA), from HHS and members of Congress.

In a letter to HHS on Nov. 13, Sens. Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) cited reports that the collaboration lets Google collect the individual medical records of millions of patients without their consent. The senators added that the information could include anything from laboratory test results to hospital records. Google is defending the project, claiming that none of the information it gets from Ascension will be used to sell advertisements and that patient data remains secure and is not used for any other purpose than servicing the product on behalf of Ascension.

HHS Modifying IPI to Ensure U.S. Pays Lowest Price of Developed Countries

On Nov. 12, the Department of Health and Human Services (HHS) Secretary Alex Azar said that HHS is working to modify its International Pricing Index (IPI) plan to ensure the United States pays less for drugs than other developed nations. He added that the U.S. pays up to 180 percent of what other countries pay in drug costs, and the IPI has to reduce that by 30 percent. The original proposal would have set payments for Medicare Part B drugs based on the average prices in other countries. Secretary Azar said the president wants to go further than that and now refers to the proposal as the Most Favored Nations Status proposal.

Final Regulations/Guidance

CMS: Hospital Price Transparency Requirements: CY 2020 Hospital Outpatient Prospective Payment System (OPPS) Policy Changes

On Nov. 15, the Centers for Medicare and Medicaid Services (CMS) finalized policies that follow directives in President Trump’s executive order entitled “Improving Price and Quality Transparency in American Healthcare to Put Patients First.” The rule requires facilities to disclose currently confidential rates they have negotiated with insurers, what the hospital is willing to accept from a patient and the minimum and maximum negotiated charges. The requirement would apply for all items and services and be available online in a single data file.

Hospitals will have to post that information online for 300 common services in an easily understandable format. CMS will specify 70 of these services, and the rest can be chosen by the hospitals. Hospitals that do not comply could face fines of up to $300 per day.

Find the final rule here.

In response to comments, CMS is extending the effective date to Jan. 1, 2021, to ensure hospital compliance with these regulations.

Proposed Regulations/Guidance

OIG: Revisions to Safe Harbors Under the Anti-Kickback Statute, Etc.

On Oct. 9, the Department of Health and Human Services Office of Inspector General (OIG) proposed a rule that creates three new safe harbors for certain remuneration exchanged between or among eligible participants: care coordination arrangements aimed at improving quality and outcomes; value-based arrangements with substantial downside financial risk; and value-based arrangement with full financial risk. Modifications to existing AKS safe harbors include more flexibility for part-time and outcomes-based arrangements, removing the part-time schedule requirement and the aggregate compensation set-in-advance requirement. Modifications were also made to expand and modify mileage limits to rural areas and for transportation of patients discharged from inpatient facilities. As for electronic health records, the proposal extends the interoperability provision.

Find the proposed rule here.

Public comments must be submitted by Dec. 31, 2019.

CMS: Transparency in Coverage Proposed Rule

On Nov. 15, the Centers for Medicare and Medicaid Services (CMS) proposed a rule with the Department of Labor and the Department of the Treasury to implement President Trump’s executive order on Improving Price and Quality Transparency in health care.

The rule proposes to make each non-grandfathered group health plan or health insurance issuer offering non-grandfathered health insurance coverage in the individual and group markets be required to make available to participants, beneficiaries and enrollees (or their authorized representative) personalized out-of-pocket cost information for all covered health care items and services through an internet-based self-service tool and in paper form upon request. The same plans would be required to make available to the public the in-network negotiated rates with their network providers and historical payments of allowed amounts to out-of-network providers through standardized, regularly updated machine-readable files. This would provide opportunities for innovation to drive price comparison and consumerism in the health care market.

This proposed rule also solicits comments on:

  • Whether group health plans and health insurance issuers should also be required to make available through a standards-based application programming interface (API) the cost-sharing information referenced above that is proposed to be disclosed through the internet-based self-service tool and the machine-readable files.
  • How health care quality information can be incorporated into the price transparency proposals included in these proposed rules.

Find the proposed rule here.

CMS Informal RFI: Potential Oncology Care First Model in Preparation for the November 4 Public Listening Session

On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) announced that at its Public Listening Session, which invites feedback on value-based payment for high-quality oncology care, it hopes to gather feedback on an informal request for information (RFI) that outlines a potential Oncology Care First (OCF) Model.

Written feedback on the informal RFI will be accepted until Nov. 25, 2019, and can be sent to [email protected].

Find the informal RFI here.

CMS Releases Kidney Care Choices Model Request for Application

On Oct. 24, the Center for Medicare and Medicaid Innovation (Innovation Center) announced that the request for applications (RFA) for the Kidney Care Choices (KCC) Model has been posted here. The deadline to submit an application is Jan. 22, 2020.

The KCC Model is a voluntary model to reduce Medicare expenditures while preserving or enhancing quality of care for beneficiaries with end-stage renal disease (ESRD) and chronic kidney disease (CKD). The KCC Model contains the following four options:

  1. The CMS Kidney Care First (KCF) option
  2. The Comprehensive Kidney Care Contracting (CKCC) Graduated option
  3. The CKCC Professional option
  4. The CKCC Global option

Stay up to date on the latest Kidney Care Choices Model news and updates rel="noopener noreferrer" by subscribing to the KCC Model listserv.

CMS: Modernizing and Clarifying the Physician Self-Referral Regulations (Stark Law Rule)

On Oct. 9, the Centers for Medicare and Medicaid Services (CMS) proposed a rule that will create new, permanent exceptions to the Stark Law for value-based arrangements. These exceptions would apply broadly to care provided to all patients, not just Medicare beneficiaries. The proposed rule requires health care entities to provide written documentation that explains arrangements and patient populations being targeted, and the outcomes being measured in terms of value. There is a new exception to protect compensation not exceeding an aggregate of $3,500 per calendar year if certain conditions are met, for limited remuneration to a physician.

There is also a new exception for cybersecurity technology and related services, where CMS proposes protecting arrangements involving the donation of certain cybersecurity technology and related services. Modifications to compensation exceptions were added. The rules include the expansion of the 90-day grace period for writing requirements. CMS proposed the deletion of goal posts for when an entity knows the period of disallowance ended. And, the proposal includes modifying the physician contribution requirement to the electronic health records’ conditions and allowing certain donations of replacement technology.

CMS is soliciting comments about the role of price transparency in the context of the Stark Law and whether to require cost-of-care information at the point of a referral for an item or service.

Find the proposed rule here.

Public comments must be submitted by Dec. 31, 2019.

CMS: Proposed Radiation Oncology (RO) Model

On July 10, the Centers for Medicare and Medicaid Services (CMS) proposed a Radiation Oncology (RO) Model as a payment model that tests if site-neutral payments, in which providers are paid the same rate no matter the care setting, for a 90-day episode of care, can improve the quality of treatment and save Medicare money. The experiment targets radiation treatment for 17 different types of cancer. Payment will be based on proposed national base rates and trend factors and will be adjusted for geography and the mix of patients the provider treats.

Participants in the model could earn back a share of dollars that are withheld based on the quality of care and patient experience. The model is scheduled to begin next year and end in December 2024.

Find the proposed rule here.

FDA: Draft Guidance on Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff

On Nov. 6, the Food and Drug Administration (FDA) released a draft guidance on best practices for drug safety surveillance, made available to the public in compliance with requirements of the 21st Century Cures Act. The draft guidance outlines the FDA’s approach for timely postmarket analyses of drugs and biologics, and includes a high-level overview of tools, methods and signal detection and evaluation activities, using varied data sources, for drug safety surveillance to provide a broader context and a general overview of our overarching effort and commitment in this area.

Find the draft guidance here. Public comments are due by Jan. 6, 2020.

FDA: Draft Guidance on Developing Drugs for Hepatitis D Infection

On Nov. 1, the Food and Drug Administration (FDA) released a draft Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance. The draft guidance will assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV) infection. HDV infection occurs only in people who have hepatitis B virus (HBV) infection.

The draft guidance addresses the FDA’s current recommendations regarding the overall development program and clinical trial designs for the development of drugs and biologics for the treatment of chronic HDV infection. Sponsors are encouraged to communicate with the FDA Center for Drug Evaluation and Research’s Division of Antiviral Products (DAVP) about the development of drugs to treat HDV infection.

Find the draft guidance here. Public comments are due by Jan. 1, 2020.

FDA: Drug Products Labeled as Homeopathic Guidance

On Oct. 24, the Food and Drug Administration (FDA) pulled a compliance policy allowing leeway for unapproved homeopathic drugs to remain on the market if they met certain criteria, unless FDA found a quality or manufacturing issue. FDA said products should go through the formal drug approval process before they can be sold again.

To replace the older policy, the FDA released a revised draft guidance on a risk-based approach. As a result, FDA intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health.

Find the draft guidance here.

Public comments must be submitted by Dec. 24, 2019.

FDA: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients’ Guidance

On Sept. 30, the Food and Drug Administration (FDA) released a second draft guidance in a series of four patient-focused drug development guidances, as required under the 21st Century Cures Act. The series looks at how to collect and submit information from patients and caregivers for medical product development and regulatory decision-making. This draft guidance explains three research methods to do so: qualitative research, quantitative research and mixed-method research.

Find the draft guidance here.

Public comments must be submitted by Dec. 30, 2019.


D.C. Circuit Considering Case on Chevron Group Health Plan Rule

On Nov. 14, the Court of Appeals for the District of Columbia (D.C.) Circuit heard oral arguments on whether the Chevron doctrine, which gives deference to federal agencies when interpreting ambiguous statutes, applies to a Department of Labor rule that makes it easier for small employers and the self-employed to avoid Affordable Care Act (ACA) regulations for the small-group marketplace.

During oral arguments, the appeals panel discussed whether the Department of Labor could issue, with the protection of the Chevron doctrine, a workplace rule that goes around the ACA and creates its own interpretation of the word “employer” under the Employee Retirement Income Security Act (ERISA). The Department of Labor enforces ERISA, and therefore a major issue is whether to defer to their definition of “employer” if the court finds the labor statute to be ambiguous on the word’s legal meaning.

The ongoing case is State of New York et al. v. U.S. Department of Labor et al., case number 19-5125.

HHS Patent Suit Could Impact HIV Drug Pricing and Access

On Nov. 6, the Department of Health and Human Services (HHS) filed a rare patent infringement suit against Gilead Sciences, Inc., after Gilead refused to license patents that are owned by the Centers for Disease Control and Prevention (CDC) toward using Truvada and Descovy for pre-exposure prophylaxis, or PrEP. The suit sets precedent for drug manufacturers that refusing government licenses could mean a federal court case.

A settlement could mean that Gilead would be required to provide more drug donations, on top of the 2.4 million bottles a year already promised to the CDC. It could also be required to license the patents it does own to generic-drug manufacturers, lower its prices and refuse to raise prices more, or provide a sum of money. All of the possibilities give CDC methods to extend access to Truvada and Descovy.


GAO: Nursing Homes – Better Oversight Needed to Protect Residents from Abuse

On Nov. 14, the Government Accountability Office (GAO) released a report updating the status on recommendations made in a June 2019 report that found, while abuse in nursing homes is often underreported, abuse citations more than doubled from 2013-2017. The Centers for Medicare and Medicaid Services (CMS) contracts with state agencies, known as survey agencies that can cite nursing homes for incidents of abuse.

The GAO found gaps in CMS’s oversight in the June 2019 report, and checked on their current status:

  • Information on abuse and perpetrator types is not readily available in CMS’s data. GAO recommended that CMS require state survey agencies to submit data on abuse and perpetrator type and the Department of Health and Human Services (HHS) concurred. As of November 2019, HHS had not implemented the recommendation.
  • Facility-reported incidents lack key information in given data. GAO recommended that CMS develop guidance on what abuse information nursing homes should self-report and HHS concurred. As of November 2019, HHS had not implemented the recommendation.
  • Gaps exist in the CMS process for state survey agency referrals to law enforcement. GAO made four recommendations to address these gaps and HHS concurred. As of November 2019, HHS had not implemented these recommendations.

Find the full report here.

GAO: Medicare Hospice Care – Opportunities Exist to Strengthen CMS Oversight of Hospice Providers

On Nov. 14, the Government Accountability Office (GAO) released a report on work done by the Centers for Medicare and Medicaid Services (CMS) with surveyors to inspect hospices, for beneficiaries with terminal illness and a life expectancy of six months or less, to ensure compliance with federal health and safety standards. CMS collects data on the quality of hospice care, like the number of hospice staff visits in the last days of life, but surveyors are not required to use that data to inform their inspections.

The GAO recommends:

  • Congress consider giving CMS authority to establish additional enforcement remedies for hospices that do not meet federal health and safety requirements.
  • The administrator of CMS incorporate the use of additional information, such as quality measures or other information that could identify potential quality of care issues, into its survey process for overseeing hospice providers.

Find the full report here.

GAO: Generic Drug Development – Stakeholders’ Views of Risk Evaluation and Mitigation Strategies Differ

On Nov. 14, the Government Accountability Office (GAO) released a report that analyzed data on requirements from the Food and Drug Administration (FDA) for drug manufacturers to establish risk evaluation and mitigation strategies (REMS) for drugs with serious safety concerns to ensure that a drug’s benefits outweigh its risks.

The GAO found:

  • The FDA issued draft guidance in 2014 on how generic companies could obtain a letter stating that the FDA would not consider it an REMS violation to provide reference standard drug samples to the generic company requesting the letter. Three of the four generic drug manufacturers GAO interviewed said these letters were not useful because they do not require drug companies to share samples. Three of five reference drug manufacturers said the letters addressed their safety concerns about providing samples to generic manufacturers.
  • In February 2019, FDA published a list of drug companies whose reference standard drugs were the subject of access inquiries made to FDA by generic drug companies. One of the four generic manufacturers GAO spoke with said FDA’s list was helpful, and one reference drug manufacturer said it was uncertain why it was included on the list.
  • FTC has reviewed inquiries it received from FDA and generic manufacturers and has filed amicus briefs in two cases involving drugs with REMS. According to FTC, to date, the FTC has not brought a case charging a drug manufacturer with violating federal antitrust law for refusing to provide samples to a generic drug company.
  • FDA issued waivers and related guidance that allowed generic manufacturers to develop a separate, but comparable, REMS shared system. One generic drug manufacturer said the guidance on waivers was helpful. Another drug manufacturer said the waivers put added burden on health care providers who have to use multiple REMS systems.

Find the full report here.

GAO: Medicaid Providers – CMS Oversight Should Ensure State Implementation of Screening and Enrollment Requirements

On Nov. 12, the Government Accountability Office (GAO) released a report on the Centers for Medicare and Medicaid Services’ oversight of states’ administration of Medicaid, and how it does not have a complete picture of state compliance with the new federal and state rules.

The rules of states screening and enrolling health care providers in Medicaid are designed to exclude providers who do not meet minimum standards, which can help prevent fraud, waste and abuse. Congress established new federal rules in 2010 and 2016, yet officials GAO spoke with in five of seven states said they have not implemented all of them. The Medicaid program is therefore on the GAO’s High Risk List.

Find the full report here.

GAO: Childhood Obesity Research Demonstration – Efforts to Identify Effective Strategies for Low-Income Children

On Nov. 12, the Government Accountability Office (GAO) released a report on the Centers for Disease Control and Prevention’s (CDC) four key changes to the design of the Childhood Obesity Research Demonstration (CORD) Project between each of the three grant phases. In this report, GAO describes 1) the extent to which CDC changed the design of the CORD Project between grant phases, 2) the results of the CORD Project and factors that have affected implementation and 3) efforts by CDC and others to disseminate results and lessons learned.

The grants were awarded in three phases, the first of which is complete. In that phase, grantees found some small but positive changes, such as lower body mass index and more fruits and vegetables in the children’s diets. Across grantees, participating children who received health care services, such as individual counseling, showed progress more often than those who did not.

Find the full report here.