1. Congress

House

House Appropriators Gut ACA Funding

On July 19, the House Appropriations Committee held a markup on the FY 2018 Labor-HHS-Education bill and effectively used the bill to prevent the use of federal dollars to implement Obamacare by defeating amendments related to HHS and functions under the ACA. During the markup, Rep. Debbie Wasserman Schultz (D-FL) offered an amendment to restore Obamacare implementation funding but it was defeated on a party line vote, 29-21. Similarly, an amendment from Rep. Barbara Lee (D-CA) to defeat GOP riders to defund Planned Parenthood and the ACA also failed.

To view the Appropriations Committee markup, click here.

House Budget Committee Marks Up FY 2018 Budget

On July 19, the House Budget Committee held a markup for the FY 2018 budget that would cut Medicare and Social Security. President Trump campaigned on not cutting either program. The budget resolution would cut spending upward of $5 trillion from the budget in the coming decade. The budget plan is crucial because its passage would pave the way to pass a tax overhaul this fall without the fear of a filibuster by Senate Democrats.

In addition to cutting social safety net and other discretionary programs, it also would sharply boost military spending.

It is unclear, however, whether the budget proposal can be passed in the House. Conservatives had pushed for a larger package of spending cuts. Moderates are concerned cuts to programs such as food stamps are too deep.

The budget resolution is nonbinding, because it is not a law. However, it would allow Republicans to use reconciliation instructions to pass tax cuts with only 50 votes in the Senate, similar to the strategy used for the failed health care effort.

To view the markup, click here.

To view the FY 2018 budget, click here.

House Energy and Commerce Subcommittee to Hold Hearing on SNPs

The House Energy and Commerce Health Subcommittee will hold a hearing July 26 on Medicare special needs plans (SNPs). SNPs are Medicare Advantage plans that exclusively enroll beneficiaries with special needs. There are SNPs for dual-eligible beneficiaries, institutionalized beneficiaries and beneficiaries with certain chronic conditions.

The House Ways and Means Committee recently voted for a five-year reauthorization of two types of SNPs and permanent reauthorization of the third type. On July 20, thirteen patient and industry groups sent a letter to the Energy and Commerce Committee urging permanent reauthorization of those plans.

Senate

Senate Health Reform Runs Into Stronger Opposition

On Monday night, two more senators came out publically against the Senate proposal to repeal and replace the Affordable Care Act. This brought the number against the proposal to at least four, killing the chances of the proposal’s being passed. Immediately, Senator Mitch McConnell (R-KY), the Senate majority leader, announced that he would hold a vote on the motion to proceed to the House-passed bill and that the first amendment that would be in order would be legislation similar to the repeal-only bill passed by the House and Senate in 2015. That bill was vetoed by President Obama. However it was not clear that McConnell will have the votes for even the parliamentary procedure of the motion to proceed. On July 19, the Senate Budget Committee released the text of the repeal-only legislation.

To see the text of the repeal-only legislation, click here.

HHS Releases Cruz Amendment Analysis

Also on July 19, the Department of Health and Human Services (HHS) released its own analysis of the Cruz amendment.

The HHS analysis of the Cruz amendment, which would permit “skinny plans” that are not ACA compliant so long as the insurer had an ACA-compliant plan on the exchange, showed that premiums for certain enrollees by 2020 would be reduced, and would save even more for consumers who opt for cheaper, no-frills products. HHS also found the amendment would boost enrollment as high as 16.1 million people by 2024, more than the nearly 14 million topline projected under Obamacare. Republicans are touting the analysis as evidence that their reforms would help Americans and that the CBO has been too pessimistic about their legislation. Others, however, have pointed out problems with the analysis, including that it was not scored in relation to other provisions of the legislation.

CBO Releases Two Scores

The Congressional Budget Office score of repeal-only legislation demonstrates that the impact of not replacing the law immediately could be severe. Three-quarters of the country would live in areas with no insurers participating in the individual market by 2026. Premiums would double by 2026 as well, compared to the current law. A second CBO score was released on July 20, which did not include the Cruz amendment, and concluded that 22 million people would lose insurance coverage.

To view the score, click here.

The president met with members on July 19, and following that meeting about 20 members met that night to see if there was a path forward. With no staff in attendance, members discussed the legislation and what concerned them. It is unclear that they moved closer.

The Senate is scheduled to vote early in the week on a motion to proceed. Following Senate rules this would mean they would proceed to the House-passed bill, and then offer an amendment that would gut that bill and insert another proposal. It is unclear if the first amendment in order will now be the repeal-only proposal or something else.

FDA Funding

On July 18, Senate Appropriations Agriculture Subcommittee advanced its FY 2018 funding bill. The bill seeks to add $1 million in FDA discretionary funding above FY 2017, which is not included in the House version. The Senate bill also includes $60 million in additional funding to execute the 21st Century Cures Act. Appropriators did not fulfill the administration’s request for FDA premarket reviews through increased user fees.

The markup can be viewed by clicking here.

2. Administration

Administration Cuts Off Teen Pregnancy Funding

The Trump administration has reached out to the researchers using grants that target preventing teenage pregnancy to announce they intend to cut off funding. The 81 grants originally were set to run for five years and will now be cut two years short, announced by a standard renewal notice that went out earlier this month. Many of the programs focus on areas with a high Native American population as well as other rural areas. Valerie Huber, chief of staff to the assistance secretary at HHS, and HHS Secretary Tom Price both are proponents of abstinence education.

FDA Rolls Out New Hiring Program

On July 17, the FDA released a plan to fill hundreds of open positions and attempt to give hiring authority to scientific leadership as opposed to traditional human resources. Initially, the pilot will focus on filling positions funded by prescription drug user fees, hopefully within a year. Major goals of the program are to onboard employees more quickly so as to not lose them to the private sector and to retain current specialists.

These challenges at the FDA were originally presented in the 21st Century Cures Act of 2016, which gave the FDA more authority to bring on employees without bureaucratic blockades and make better salary offers for scientific and medical positions.

To view the commissioner’s statement, click here.

Extended Use of the Targeted Enrollment “SNAP Strategy” Under Section 1902(e)(14)(A) of the Social Security Act

On July 19, the Centers for Medicare & Medicaid Services (CMS) issued an informational bulletin that discusses the conditions under which CMS may approve waivers under Section 1902(e)(14)(A) of the Social Security Act to authorize states to rely on findings from the Supplemental Nutrition Assistance Program (SNAP) to support Medicaid eligibility determinations at application and renewal for certain populations.

To view the bulletin, click here.

IMPACT Act: Drug Regimen Review Measure Overview for the Home Health Quality Reporting Program Call

On Aug. 17, the Medicare Learning Network (MLN) will be holding a call to address the drug regimen review measure overview for home health quality. The description of the call provided by MLN focuses on the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act). MLN states that during the call CMS and measure developers will present the drug regimen review (DRR) quality measure and that the call will focus on the home health measure. Question-and-answer will follow.

The agenda provided by MLN:

  • Review the goals of the DRR measure
  • Review guidance and walk through scenarios for coding the Outcome and Assessment Information Set (OASIS) items used to calculate the measure

For materials and more information about the call, click here.

Physician Fee Schedule Proposes Cuts to Off-Campus Sites

CMS has proposed reductions in payments to off-campus hospital departments in the proposed Physician Fee Schedule rule. These reductions are a result of the Bipartisan Budget Act of 2015, mandating CMS to pay lower doctor-office rates to practices that are bought by hospitals and turned into outpatient departments. The proposed cuts affect off-campus outpatient facilities that were not billing Medicare by Nov. 2, 2015. The 21st Century Cures Act exempted hospital outpatient departments that were in developmental stages when the law was put into place. CMS will pay half of hospital rates for off-campus outpatient facilities that were not in the building process and proposes to pay only a quarter of hospital rates next year.

For more information, click here.

3. Regulations Open for Comment

CMS Issues Proposed Revision Requirements for Long-Term Care Facilities’ Arbitration Agreements

On June 5, CMS issued proposed revisions to arbitration agreement requirements for long-term care facilities. The proposed revisions would help strengthen transparency in the arbitration process, reduce unnecessary provider burden and support residents’ rights to make informed decisions about important aspects of their health care.

The Reform of Requirements for Long-Term Care Facilities Final Rule, published on Oct. 4, 2016, listed the requirements facilities need to follow if they choose to ask residents to sign agreements for binding arbitration. The final rule also prohibited pre-dispute agreements for binding arbitration. The American Health Care Association and a group of nursing homes sued for preliminary and permanent injunction to stop CMS from enforcing that requirement. The court granted a preliminary injunction on Nov. 7, 2016. After that decision, CMS reviewed and reconsidered the arbitration requirements in the 2016 Final Rule.

The proposed rule focuses on the transparency surrounding the arbitration process and includes the following proposals:

  • The prohibition on pre-dispute binding arbitration agreements is removed.
  • All agreements for binding arbitration must be in plain language.
  • If signing the agreement for binding arbitration is a condition of admission into the facility, the language of the agreement must be in plain writing and in the admissions contract.
  • The agreement must be explained to the resident and his or her representative in a form and manner they understand, including that it must be in a language they understand.
  • The resident must acknowledge that he or she understands the agreement.
  • The agreement must not contain any language that prohibits or discourages the resident or anyone else from communicating with federal, state or local officials, including federal and state surveyors, other federal or state health department employees, or representatives of the State Long-Term Care Ombudsman.
  • If a facility resolves a dispute with a resident through arbitration, it must retain a copy of the signed agreement for binding arbitration and the arbitrator’s final decision so it can be inspected by CMS or its designee.
  • The facility must post a notice regarding its use of binding arbitration in an area that is visible to both residents and visitors.

This proposed rule is scheduled to be published in the Federal Register on June 8, 2017, and comments are due by Aug. 7, 2017. For more information, click here.

CMS Proposes MACRA Rule

On June 19, CMS issued a proposed rule that would make changes in the second year of the Quality Payment Program as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

The 1,058-page rule continues the “pick-your-pace” option in year two of the program, letting doctors report a limited amount of quality data to be exempted from Medicare’s penalties.

CMS creates a “virtual group” reporting option, allowing doctors to pool the information on how they care for patients and be subjected to Medicare’s quality payment scheme.

CMS is also increasing the minimum number of patients doctors can treat before being subject to the program’s Merit-based Incentive Payment System. It establishes more flexibility for doctors who see limited numbers of patients face to face or in a hospital. For 2017, roughly 800,000 clinicians were exempt from the MIPS program.

CMS will not require doctors to use 2015 certified EHRs next year, as it had ordered during the Obama administration. However, clinicians are offered bonuses for using new versions of the software. Medicare also will delay for another year judging doctors for how much they spend for treating patients.

Comments on the rule are due no later than 5 p.m. on Aug. 21, 2017. For a fact sheet on the proposed rule, click here.

CMS Proposes 2018 Policy and Payment Rate Changes for End-Stage Renal Disease Facilities

On June 29, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update payment policies for the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). The rule covers payment rates for renal dialysis services, including updates to acute kidney injury (AKI), furnished to beneficiaries on or after Jan. 1, 2018.

The ESRD Quality Incentive Program (QIP) proposed changes are for payment years 2019, 2020 and 2021, and a number of key dialysis data methodologies and quality measures. The proposed rule also requests comment on how to include individuals with acute kidney injury in the ESRD Quality Improvement Program.

In addition to the proposed rule, CMS is releasing a request for information to welcome continued feedback on the Medicare program. CMS is committed to maintaining flexibility and efficiency throughout Medicare. Through transparency, flexibility, program simplification and innovation, CMS aims to transform the Medicare program and promote the availability of high-value and efficiently provided care for its beneficiaries.

Comments are due no later than 5 p.m. on Aug. 28, 2017.

For a fact sheet on the proposed rule, please click here.

For the ESRD proposed rule (CMS 1674-P), please click here.

CMS Proposes 2018 Policy and Rate Changes for Hospital Outpatient, Ambulatory Surgical Center Payment Systems

The Centers for Medicare & Medicaid Services (CMS) on July 13, issued a proposed rule that updates payment rates and policy changes in the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System.

Among the provisions in this rule, CMS is proposing to change the payment rate for certain Medicare Part B drugs purchased by hospitals through the 340B program. The proposed rule also requests comment on how CMS can best implement the proposal to pass savings on to beneficiaries and providers, and to allow seniors to save money on their drug costs. The 340B Drug Pricing Program allows certain hospitals and other health care providers to purchase drugs and biologicals (other than vaccines) that are administered in a hospital outpatient department from drug manufacturers at discounted prices.

The proposed rule also includes a provision to address rural hospitals recruiting physicians by placing a two-year moratorium on the direct supervision requirement currently in place at rural hospitals and critical access hospitals.

In addition, CMS is releasing within the proposed rule a request for information to welcome continued feedback on flexibilities and efficiencies in the Medicare program.

Comments are due 5 p.m. Sept. 11, 2017.

To view a fact sheet on the proposed rule, click here.

To view the proposed rule, click here.

CMS Proposes 2018 Payment and Policy Updates for the Physician Fee Schedule

The Centers for Medicare & Medicaid Services (CMS) on July 13 issued a proposed rule that would update Medicare payment and policies for doctors and other clinicians who treat Medicare patients in calendar year (CY) 2018. This proposed rule seeks public comment on reducing administrative burdens for providing patient care, including visits, care management and telehealth services. The rule takes steps to better align incentives and provide clinicians with a smoother transition to the new Merit-based Incentive Payment System under the Quality Payment Program (QPP). The rule also attempts to encourage fairer competition between hospitals and physician practices by promoting greater payment alignment, and it would improve the payment for office-based behavioral health services that are often the therapy and counseling services used to treat opioid addiction and other substance use disorders. In addition, the proposed rule makes additional proposals to implement the Center for Medicare & Medicaid Innovation’s Medicare Diabetes Prevention Program expanded model starting in 2018.

In addition to the proposed rule, CMS is releasing a request for information to welcome continued feedback on the Medicare program. CMS is committed to maintaining flexibility and efficiency throughout Medicare. Through transparency, flexibility, program simplification and innovation, CMS aims to transform the Medicare program and promote the availability of high-value and efficiently provided care for its beneficiaries. This will inform the discussion on future regulatory action related to the Physician Fee Schedule. Comments are due by 5 p.m. on Sept. 11, 2017.

For a fact sheet on the proposed rule, click here.

To view the proposed rule, click here.

6. Reports

PhRMA Posts New Innovation Report

The biopharmaceutical pipeline contains thousands of significant and innovative new treatments with the potential to address unmet medical needs, save lives and improve patients’ health. A new report by the Analysis Group, “The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development,” examines the state of the drug development pipeline and provides insights into new approaches researchers are pursuing.

Key findings:

  • 74 percent of medicines in clinical development are potentially first-in-class medicines, meaning they represent a possible new pharmacological class for treating a medical condition
  • 822 projects—defined as unique molecule-indication combinations—are designated by the U.S. Food and Drug Administration (FDA) as orphan drugs, which is critically important given only 5 percent of rare diseases have an approved medicine
  • A range of novel scientific approaches are being pursued, including cell and gene therapies, DNA and RNA therapeutics and conjugated monoclonal antibodies

To view the report, click here.

Medicare Advantage Program Integrity: CMS’s Efforts to Ensure Proper Payments and Identify and Recover Improper Payments

The Centers for Medicare & Medicaid Services estimates that about $16 billion or nearly 10 percent of its payments to Medicare Advantage organizations were improper.

In this testimony, GAO reviewed several problems found with CMS’s efforts to ensure proper payments in this program, which serves about a third of Medicare beneficiaries.

For example, certain CMS audits do not target Medicare Advantage contracts at highest risk for improper payments—payments made in error or due to potential fraud. CMS has also not fully validated the data—known as “encounter data”—it uses to ensure proper Medicare Advantage payments.

To view the report, click here.