Washington Healthcare Update

August 10, 2020

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This week in Washington: Senate stays in session this week as negotiations on the COVID-19 package continue, but is not expecting votes; House remains in district work period.





Proposed Regulations/Guidance

Final Regulations/Guidance




House Energy and Commerce Committee to Investigate Health, Dental Insurers Over Record Profits

On Aug. 6, the House Energy and Commerce Committee announced an investigation into health and dental insurers’ business practices as companies reported record-setting second quarter profits. Chairman Frank Pallone (D-NJ) is concerned that companies are profiting from patients’ forgoing care. In addition he questions why insurers are denying coverage for COVID-19 testing, while accumulating large cash reserves. He will ask companies whether they are covering tests cost-free as required by law and how they intend to use their profits to help Americans during the crisis. The committee has yet to say which companies will be investigated.

Find more information here.

House Ways & Means Committee: COVID-19 Nursing Home Data Missing, Unreliable

On Aug. 5, House Ways and Means Committee Chair Richard Neal (D-MA) wrote to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma that his committee has found large gaps in the COVID-19 data nursing homes report to CMS. Rep. Neal announced that the incomplete data is making it difficult to accurately assess death rates and staffing needs and to allocate provider relief funds. The committee wants to know by Aug. 21 how CMS will fix the data collection problems.

Find more information here.


Wyden Introduces Legislation to Prevent Vaccine Manufacturers From Hiking Prices Post-Pandemic

On Aug. 7, Senate Finance Committee Ranking Member Ron Wyden (D-OR) introduced legislation to maintain lower prices for a COVID-19 vaccine for all vaccines developed with government funds. The Vaccine and Coverage Certainty Act caps increases on prices the drug manufacturers offer the federal government during the pandemic. The inflation rebates proposed in the bill apply to Medicare and Medicaid. The legislation would also provide more federal Medicaid funding to states that expanded Medicaid coverage after 2014, ensure migrants have access to Medicaid, and protect people who are experiencing job and health insurance instability during the pandemic and associated economic concerns.

Find the bill here.


Trump Administration: Executive Order on Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the U.S.

On Aug. 6, President Trump signed an executive order that directs the Food and Drug Administration (FDA) to work closely with the Environmental Protection Agency (EPA) to speed domestic approvals of essential medical products, loosen continuous manufacturing regulations, identify supply chain vulnerability and target dangerous counterfeit drug and medical product imports.

Find the executive order here.

HHS Buys 100 Million COVID-19 Vaccines for $1 Billion

On Aug. 5, drug manufacturer Janssen announced that the Department of Health and Human Services (HHS) paid the company $1 billion to develop and deliver 100 million doses of its COVID-19 vaccine. That cost is on top of the $456 million that HHS awarded the company earlier this year to develop the vaccine. The deal also gives the U.S. an option to order an additional 200 million doses.

CMS and SAMHSA Announce New Participants of the Certified Community Behavioral Health Clinic Demonstration

On Aug. 5, the Centers for Medicare and Medicaid Services (CMS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the states of Kentucky and Michigan were selected as additional participants in the Certified Community Behavioral Health Clinic (CCBHC) Demonstration as required by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Kentucky and Michigan join the original participants selected in 2016.

CMS Approves New Hampshire 1332 Waiver

On Aug. 5, the Centers for Medicare and Medicaid Services (CMS) approved New Hampshire’s request for a five-year 1332 state innovation waiver to establish a reinsurance program that is expected to lower premiums by 16 percent and increase individual market enrollment by 6 percent in 2021. CMS has now approved 14 state-level reinsurance programs.

CMS Announces a Temporary Policy for Premium Reductions

On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) announced a policy that will allow insurance issuers to offer temporary premium reductions for individuals with 2020 coverage in the individual and small group markets. CMS is temporarily exercising enforcement discretion to allow issuers, when consistent with state law, to offer premium reductions for one or more months for 2020 coverage. This temporary policy will be in effect until the end of 2020.

CMS Extends COVID-19 Relief Deadline Again for Medicaid Providers

On July 31, the Centers for Medicare and Medicaid Services (CMS) announced it is extending the deadline to apply again for COVID-19 relief funds and is reopening general distribution to certain Medicare providers. The deadline is extended until Aug. 28 for Medicaid and CHIP providers to apply for the $15 billion relief funding.

FDA Adds Pediatric, Orphan Exclusivity Info to Purple Book

On Aug. 4, the Food and Drug Administration (FDA) announced it is updating the Purple Book to include information about orphan, pediatric and first interchangeable exclusivity. The FDA will also include in the Purple Book all FDA-licensed allergenic, cellular and gene therapy, hematologic and vaccine products regulated by the biologics center, in addition to glossary and downloadable monthly reports. The exclusivity information in the Purple Book will identify whether a biological product has been evaluated for reference product, orphan, pediatric or first interchangeable exclusivity, along with corresponding exclusivity expiration dates, if a date has been determined.

OMB Reviewing Proposed HIPAA Changes

On July 31, the Office of Management and Budget (OMG) received a proposal from the Department of Health and Human Services (HHS) to modify the Health Insurance Portability and Accountability Act (HIPAA). The proposed rule calls for reducing regulatory burden on care coordination while securing protected health information (PHI).

Proposed Regulations/Guidance

FDA Seeks Input on Proposed “Right To Try” Reporting Requirements

On July 23, the Food and Drug Administration (FDA) proposed annual reporting requirements for drug manufacturers who provide investigational drugs to patients under the Right to Try pathway. The FDA proposes the reports be submitted separately from investigational new drug application reports, and it asks stakeholders for input on which entities should be responsible for submitting the annual Right to Try summary reports. The proposed rule is required under the Right to Try Act, which mandates companies that make their investigational drugs available through that pathway submit annual summaries to FDA. FDA then will make a consolidated version of those reports publicly available.

Find the proposed rule here. Public comments are due by Sept. 22, 2020.

CMS Proposes to Expand Telehealth Benefits Permanently for Medicare Beneficiaries Beyond the COVID-19 Public Health Emergency

On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) proposed permanently extending the availability of certain telemedicine services after the COVID-19 public health emergency (PHE) ends, giving Medicare beneficiaries access to health care particularly in rural areas where access to health care providers may otherwise be limited. CMS is proposing to permanently allow some telehealth services, including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments. CMS is seeking public input on other services to permanently add to the telehealth list.

The billing and coding requirements for Evaluation and Management (E/M) (or office/outpatient visits) make up 20 percent of the spending under the Physician Fee Schedule. Simplified coding and billing requirements for E/M visits will go into effect Jan. 1, 2021. In this rule, CMS is proposing to increase the value of many services that are comparable to or include office/outpatient E/M visits such as maternity care bundles, emergency department visits, end-stage renal disease capitated payment bundles, physical and occupational therapy evaluation services and others.

Find the proposed rule here. Public comments are due by Oct. 5, 2020.

CMS: CY 2021 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule

On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) proposed a rule to increase cuts to Part B to pay for 340B drugs by an additional 6 percent. CMS announced in its 2021 proposed hospital outpatient pay rule that the cuts it has used for the last few years, which resulted in 340B hospitals’ being paid about 30 percent less than non-340B hospitals for Part B drugs, remain an alternative reimbursement structure. The rule would also eliminate inpatient only lists, lift expansion restrictions for physician-owned hospitals and revise the overall star ratings.

Find the proposed rule here. The document will be published on the Federal Register on Aug. 12, 2020.

CMS: Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit

On June 25, the Centers for Medicare and Medicaid Services (CMS) proposed to permanently expand home health telehealth options, initially approved for use during the COVID-19 pandemic, as part of its proposed 2021 home health pay rule. The rule would also implement new wage index calculations while capping cuts that could be tied to those calculations. According to CMS, home health agencies would see a 2.6 percent Medicare pay bump under the rule. The proposal updates the home health wage index, but also includes a 5 percent cap on decreases in a geographic area’s wage index value for 2021.

Find the proposed rule here. Public comments are due by Aug. 31, 2020.

Final Regulations/Guidance

CMS Increases Inpatient Rehab Pay 2.4 Percent, Lifts Pre-Admission Requirements

On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) finalized its fiscal 2021 inpatient rehabilitation facility prospective pay rule that will lift requirements on post-admission evaluations and expand the services non-physician practitioners can provide. The final rule lifts the requirement that physicians do an evaluation within the first 24 hours of a patient’s admission to an IRF since CMS says that evaluation would contain the same information collected in a pre-admission visit. The final rule also allows non-physician practitioners to perform one of three required physician visits under IRF coverage services and documentation duties as long as those duties are within the provider’s scope of practice under state laws.

Find the final rule here.

FDA Finalizes Review Policy for Multi-Function Devices

On July 31, the Food and Drug Administration (FDA) finalized a review policy for multiple function devices under which it will only review functions for which a device maker seeks clearance or approval. The FDA does not plan to review “other functions” of a device unless they could negatively affect the function that is under review.

Find the final guidance here.


Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

Appeals Court Rules on Public Charge Rule

On Aug. 5, a federal appeals court sided with the Trump administration’s effort to implement regulations that make it harder for immigrants to seek permanent residency in the United States if they have relied on public assistance programs. The decision comes one day after a different appeals court ruled against the administration in a similar challenge that argued the regulations discourage legal immigrants from using any public benefits such as Medicaid, food stamps or housing assistance.

At issue are rules that establish new criteria for who can be considered dependent on the government for public assistance and therefore disqualified for green cards and a path to U.S. citizenship. Under the 2019 Department of Homeland Security policy, immigrants who are in the United States legally are considered “public charges” and ineligible if they use any benefits or are declared likely to someday rely on such assistance. Despite the 4th Circuit’s decision Wednesday, the rule remains blocked for now because of a separate nationwide injunction issued by a New York judge in late July. The order bars the government from enforcing the rule for the duration of the national health emergency declared in response to the coronavirus pandemic.


GAO: Substance Use Disorder – Medicaid Coverage of Peer Support Services for Adults

On Aug. 6, the Government Accountability Office (GAO) released a report on substance use disorders affecting 19.3 million adults in the U.S. in 2018. One treatment option for such disorders is services delivered by peer providers, individuals who use their own personal experiences recovering from substance use disorder to support others in their recovery. State Medicaid programs can choose to cover services offered by peer providers, but it is an optional benefit. GAO found that 37 states covered this benefit for adults with substance use disorder in 2018.

Find the full report here.

GAO: Opioid Use Disorder – Treatment with Injectable and Implantable Buprenorphine

On Aug. 4, the Government Accountability Office (GAO) released a report on the treatment for opioid use disorder that may involve buprenorphine, a drug that can reduce or eliminate withdrawal symptoms and prevent relapse. GAO reviewed the use of long-acting injectable and implantable forms of buprenorphine for opioid use disorder. These forms release the drug over 1- or 6-month periods, respectively. Providers issued about 7,250 prescriptions for injectable or implantable buprenorphine in FY 2019. Providers and pharmacy representatives said there is a low risk of these forms of the drug being diverted to the illegal marketplace.

Find the full report here.

NIH Finds Four Existing Drugs, Paired With Remdesivir, Help Fight COVID-19

On Aug. 4, the National Institutes of Health (NIH) announced that a NIH-funded study found that 21 existing drugs show potential in treating COVID-19 patients and four of those medications, coupled with Remdesivir, can be repurposed to help block coronavirus infections. The study suggests there may be multiple therapies, both experimental and existing, that can be potentially repurposed to treat COVID-19 patients, and some may even work well coupled with other drugs.

Find more information here.

If you have any questions, contact the following individuals atMcGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate

Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.

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