April 7, 2023

CMS Releases New Guidance on Medicare Drug Price Negotiation Program for 2026

On March 15^th, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance and opened public comment on the new Medicare Drug Price Negotiation Program for 2026, the first year the negotiated prices will apply. Language in the recent Inflation Reduction Act gave Medicare the authority to negotiate drug prices for certain high-cost, single-source drugs without generic or biosimilar competition.

The new guidance, open for comment until April 14, 2023, outlines how Medicare intends to identify which drugs will be negotiated, how they will work with manufacturers, and the factors they will consider during the negotiation. For the program’s initial year, CMS will select up to 10 Part D drugs for negotiation. The new prices negotiated for these drugs will be applied to start in 2026. While no urological drugs are currently in the crosshairs for negotiation, LUGPA is working with members of Congress on legislation to ensure that physician reimbursement of ASP+6% for Part B drugs is not cut in any talks between manufacturers and CMS.

The new guidance from CMS is available here: https://www.cms.gov/files/document/medicare-drug-price-negotiation-program-initial-guidance.pdf.

Additional information can be found in CMS’s Fact Sheet on the guidance here: https://www.cms.gov/files/document/fact-sheet-medicare-drug-price-negotiation-program-initial-guidance.pdf.

Maintaining patient access to affordable drugs is one of LUPGA’s top legislative issues, and we will monitor the new program and how it is implemented going into 2026.

Energy & Commerce Hearing Announced on Provider Competition

The House Energy & Commerce Committee announced a March 28 hearing: “Lowering unaffordable costs, examining transparency and competition in healthcare,” a key priority for LUGPA. On March 28^th, LUGPA submitted written testimony to the Committee on how independent practices should be supported to counter large hospital systems and that site neutrality, 340B reform, and greater price and quality transparency for patients should be pursued in both Medicare and commercial insurance.

You can read LUGPA’s testimony here.

New Federal Agency Tackles Improving Speed of Medical Breakthroughs

In 2022, the White House outlined a plan for a new federal agency to help improve the speed of new medical breakthroughs from development to the patients who need them. The new agency, the Advanced Research Projects Agency for Health (ARPA-H), is now taking its first significant steps toward improving the rate of medical innovations. In the White House’s 2023 budget, new funding was designated for the new agency, and several new projects were introduced.

In March, ARPA-H announced its first series of initiatives to accelerate the advancement of new medical products, including an agency-wide Open Broad Agency Announcement (Open BAA), an idea competition called the ARPA-H Dash and agenda support for the White House’s Cancer Moonshot initiative.

The Open BAA is an official agency call for proposals to outline breakthrough research and technological advancements. ARPA-H Dash is an online bracket-style competition where competitors submit evidence-based ideas to ARPA-H that could revolutionize health in the next 20 years. Winners reaching the competition quarterfinals and beyond could earn up to $10,000 and have the chance to work with ARPA-H Program Managers.

CMS Announces Coinsurance Changes for 2023

On March 15^th, CMS announced the twenty-seven prescription drugs for which Part B beneficiary coinsurances could be lower from April 1 to June 30, 2023, due to the Inflation Reduction Act provision that applies a rebate to any price increase of a Medicare drug that exceeds the Consumer Price Index-Urban.

The new decreased Part B coinsurance will go into effect on April 1, 2023. The adjustments apply to certain drugs and biologicals covered under Medicare Part B. CMS’s announcement notes that for these drugs and biologicals, “the beneficiary coinsurance will be 20 percent of the inflation-adjusted payment amount, which will be less than what the beneficiary would pay in coinsurance otherwise.” One important point is that the Part B drugs impacted by the adjustment may change quarterly.

CMS has released several documents about the new adjustments. The first is an article about the 27 Part B drugs and biological products in the quarterly ASP public file, which can be found here: https://www.cms.gov/files/document/reduced-coinsurance-part-b-rebatable-drugs-apr-1-june-30.pdf.

CMS also released a Fact Sheet on the reductions: https://www.cms.gov/files/document/fact-sheet-part-b-rebatable-drug-coinsurance-reduction.pdf.

White House Announces National Cybersecurity Strategy

On March 1^st, the White House released its new National Cybersecurity Strategy, which outlined the Administration’s goal to promote a safe and secure digital ecosystem for all Americans. The document has several purposes, including fostering minimum cybersecurity requirements across all industries, protecting critical technology infrastructure, establishing the protection of technology as a national security imperative, and protecting private enterprises as a necessary dependency on national security.

The strategy has five main pillars:

Defend Critical Infrastructure
Disrupt and Dismantle Threat Actors
Shape Market Forces to Drive Security and Resilience
Invest in a Resilient Future
Forge International Partnerships to Pursue Shared Goals

For more information on the new strategy, you can view the complete strategy here: https://whitehouse.us19.list-manage.com/track/click?u=c97630621baff8c44fe607661&id=64232b5fc3&e=45bb9cc206, or a Fact Sheet here: https://www.whitehouse.gov/briefing-room/statements-releases/2023/03/02/fact-sheet-biden-harris-administration-announces-national-cybersecurity-strategy/

LUGPA believes maintaining a safe and secure digital infrastructure and protecting against cyberattacks is essential for the country and the healthcare industry. Healthcare providers continue to be one of the top targets for cybercriminals.

According to Check Point Research, healthcare organizations worldwide averaged 1,463 cyberattacks per week in 2022, representing an increase of 74 percent compared with 2021. In the United States, healthcare entities suffered an average of 1,410 weekly cyberattacks per organization, up 86 percent from 2021.

To help our members prepare for cyber threats, we are developing a short guide with links to resources our members can use to protect their businesses and the private health information of their patients. It will be available on the LUPGA website in April.

LUGPA Submits Letter to CMS on the Initiative to Streamline 3 Processes

On March 13^th, LUGPA submitted a comment letter to CMS regarding the Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule (CMS-0057-P).

The letter discusses CMS’s proposals to streamline the prior authorization process by requiring payers to implement CMS’s Application Program Interface (API) for prior authorization, requiring the establishment of new timelines for the issuance of prior authorization determinations, and the application of these standards to Medicare Fee-for-Service (FFS).

LUGPA broadly supports these initiatives and believes the new requirements make several strides toward streamlining the prior authorization process and enhancing the use of electronic resources by both payors and providers.

In the letter, LUGPA urges CMS to:

Implement the prior authorization API requirements in a manner that is not burdensome to providers.
Finalize its proposal to shorten timeframes and decisions on standard and expedited prior authorization requests but decrease the timeframe to require prior authorization decisions of 5 days for standard requests and 48 hours for expedited requests.
Apply the interoperability, prior authorization, and related requirements in this Proposed Rule to Medicare FFS.
Finalize its proposal to implement the PARDD API requirement but urges CMS to establish an earlier implementation date than January 1, 2026.
Defer implementation of its new “Electronic Prior Authorization” in the Health Information Exchange (HIE) objective for the Promoting Interoperability performance category under the Quality Payment Program (QPP) Merit-based Incentive Payment System (MIPS) as well as defer rulemaking related to any proposed scoring methodology.

You can read the entire letter here: http://lugpa.memberclicks.net/message2/link/3199c66b-3d1f-4c2a-8347-229cae220f4a/12

Congress Considers New Legislation to Improve Implementation of Healthcare Price Transparency

Healthcare price transparency has become a key policy issue for millions of Americans seeking to manage their healthcare expenses. Patients want to understand what the care will cost them, and many are willing to shop around to find the best value. LUGPA strongly supports healthcare price transparency, beginning with hospital price transparency and ultimately expanding to all providers. We have also made healthcare price transparency one of our top legislative priorities. We are currently working on a commentary on the federal rules that will be released next month.

Congress is now considering several new legislative measures to increase the penalties on hospitals failing to comply with the new price transparency rules. One bill, proposed in February by U.S. Sen. John Kennedy, R-LA, is the Hospital Transparency Compliance Enforcement Act, which would make three changes to noncompliance enforcement:

Increase current penalties on non-compliant hospitals to $600 per day for hospitals with 30 or fewer beds, $620 to $11,000 per day for hospitals with 31 to 550 beds, and $11,000 per day for hospitals with more than 550 beds.
Prohibit hospitals from blocking pricing information on their websites using webpage coding.
Set a deadline for payment of the penalty, with hospitals being given 60 days after notice of noncompliance to pay their monetary fine.
A new rule would also require CMS to publish the names of non-compliant hospitals.

One additional bill proposed in 2023 is the Health Care PRICE Transparency Act, which provides statutory authority for requirements for hospitals and health insurance plans to disclose certain information about the costs for items and services. HR.410 also requires hospitals to publish rates negotiated with insurers, cash payment discounts, in-network and out-of-network charges for covered items and services, and billing codes. This information must also be provided in an online tool for the consumer to search for health pricing and costs.

New Proposed DEA Rules Limit Telehealth Prescribing for Certain Controlled Medications

In February, The Drug Enforcement Agency (DEA) announced new proposed rules that place some limits on the ability of telehealth providers to prescribe certain controlled medications. Under the proposed rule, which the DEA developed in concert with the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Veterans Affairs, some medications would require an in-person doctor’s visit.

The proposed rule creates several restrictions, including:

Schedule II medications or narcotics will require patients to obtain an in-person prescription.
Schedule III or higher medications can be prescribed for 30 days via telehealth, but a patient would require an in-person visit to refill the prescription.
Non-narcotic drugs like Ambien, Valium, Xanax, and ketamine also fall into this category.
If a patient is referred to a provider, an in-person appointment is not required as long as one takes place with the referring physician.

The DEA has guided provided several documents to help guide patients, which are provided below:

Is My Prescription a Controlled Medication?
https://www.dea.gov/sites/default/files/2023-02/Prescription%20Controlled.pdf

Can My Medication be Prescribed through Telemedicine?
https://www.dea.gov/sites/default/files/2023-02/Controlled%20Substance%20Guidance.pdf

Proposed White House Budget Tackles Medicare Solvency

On March 7^th, the White House released a new budget proposal to improve Medicare’s long-term solvency through several changes to Medicare taxes. The budget proposal takes the following steps to strengthen Medicare funding:

Increasing the Medicare tax rate on income above $400,000.
Closing loopholes in existing Medicare taxes and dedicating the Medicare net investment income tax to the HI Trust Fund.
Crediting savings from prescription drug reforms to the HI Trust Fund, even though Part D and Part B drugs are not paid out of the HI Trust Fund. (Details have not yet been provided on this proposal.)

The budget also attempts to lower costs for beneficiaries by managing several cost drivers within Medicare, including: