Lanton Law Quoted in Pharmacy Times Interview on Drug Pricing Reforms Amid the Repeal of Executive Order 14087

Lanton Law was quoted in the Pharmacy Times Article titled "Reversal of Executive Order (EO) 14087 Raises Questions About Future Drug Pricing Reforms.” We discuss the EO and how pharmacists are impacted. The article can be viewed here.

More Drugmakers Sue Biden Administration Over Medicare Negotiation

Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violate the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.

As part of the new law, the Centers for Medicare and Medicaid Services (CMS) will publish a list of which drugs were selected for a first cycle of negotiations on Sept. 1, with prices taking effect in 2026. The companies that make those drugs face an October deadline to sign agreements to participate in those negotiations.

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Home Infusion Stakeholders to be Helped by Newly Introduced Congressional Legislation

According to a press release by Senator Warner (D-VA), a newly introduced “bipartisan bill in the U.S. Senate proposes to ensure Medicare patients maintain access to home infusion therapies that require the use of an infusion pump. The Preserving Patient Access to Home Infusion Act — introduced by Sen. Mark Warner (D-VA) and Sen. Tim Scott (R-SC) — would ensure patients with serious viral and fungal infections, heart failure, immune diseases, cancer, and other conditions can receive the intravenous (IV) medications they need while at home.”

The Preserving Patient Access to Home Infusion Act can be viewed here. 

How did this legislation come to be? 

“Congress included provisions in the 21st Century Cures Act and the Bipartisan Budget Act of 2018 to create a professional services benefit for Medicare Part B home infusion drugs. The intent in establishing this benefit was to maintain patient access to home infusion by covering professional services including assessments, education on administration and access device care, monitoring and remote monitoring, coordination with the patient, caregivers and other health care providers, and nursing visits.

Despite Congress’ intent — as detailed in multiple letters to the agency — the Centers for Medicare and Medicaid Services (CMS) improperly implemented the benefit by requiring a nurse to be physically present in the patient’s home in order for providers to be reimbursed. As a practical matter, the current home infusion therapy benefit only acknowledges face-to-face visits from a nurse and fails to account for the extensive clinical and administrative services that are provided remotely by home infusion clinicians. As a result, provider participation in Medicare’s home infusion benefit has dropped sharply and beneficiaries have experienced reduced access to home infusion over the last several years.

The Preserving Patient Access to Home Infusion Act provides technical clarifications that will remove the physical presence requirement, ensuring payment regardless of whether a health care professional is present in the patient’s home. The legislation also acknowledges the full scope of professional services provided in home infusion — including essential pharmacist services — into the reimbursement structure.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. We have lobbied for and consult home infusion stakeholders.

If you are either thinking about getting into or are a current home infusion stakeholder and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.

CMS Proposes Rescinding Most Favored Nation Interim Final Rule

The Centers for Medicare and Medicaid Services (CMS) has released a proposed rule that seeks to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020 Federal Register.  CMS is seeking public comment by October 12, 2021. 

This rule has already had some interesting history. According to the proposal, “In December 2020, while the comment period was open, four lawsuits were filed related to CMS's waivers of proposed rulemaking and delay in effective date as well as other aspects of the MFN Model and the November 2020 interim final rule.

On January 8, 2021, the Solicitor General determined not to appeal the preliminary injunction issued in California Life Sciences. On January 19, 2021, at the parties' request, the U.S. Northern District of California stayed the case until at least April 23, 2021. Subsequently, on April 26, 2021, another stay was granted until July 26, 2021. On July 29, 2021, another stay was granted until September 27, 2021.

In Regeneron Pharmaceuticals, on February 2, 2021, the plaintiff filed a letter seeking leave to file a motion for summary judgment, and HHS filed a letter seeking leave to file a motion for a stay. On February 10, 2021, the U.S. District Court for the Southern District of New York granted HHS's request and stayed the case for 90 days (that is, through May 11, 2021). On May 10, 2021, the stay in this case was extended for an additional 90 days, until August 9, 2021, to give HHS time to consider how to proceed with the rule in light of the “unanimous” court decisions to date. In its order, the court noted that HHS should “not assume that another stay will be granted,” as the stays gave HHS “a half-year to reach a conclusion regarding how to proceed[.]”

As a result of the nationwide preliminary injunction, the MFN Model was not implemented on January 1, 2021, as contemplated in the November 2020 interim final rule. While the nationwide preliminary injunction has been in place, CMS considered how to proceed given stakeholders' concerns about potential impacts of the MFN Model.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. 

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Protecting Rural Telehealth Access Act Introduced

Via a recently released a press release describing how a  group of bipartisan Senators including Joe Manchin (D-WV), Joni Ernst (R-IA), Jeanne Shaheen (D-NH), and Jerry Moran (R-KS) have introduced the bipartisan Protecting Rural Telehealth Access Act to make current telehealth flexibilities permanent. 

“This legislation would ensure rural and underserved community healthcare providers are able to continue offering telehealth services after the current public health emergency ends. These services include the ability to offer audio-only telehealth appointments because many rural Americans don’t have reliable, affordable broadband access.”

According to the press release the proposed Act would: 

• Allow payment-parity for audio-only health services for clinically appropriate appointments. During COVID-19, recognizing not everyone has access to the technology in their home, Congress made allowances for audio-only telephone services to be used to allow doctors to reach patients wherever they are.

• Permanently waive the geographic restriction allowing patients to be treated from their homes. Pre-COVID-19, the home was allowed as an eligible originating site in Medicare and some Medicaid programs, but only for very specific services, and only for the patient, not the provider.

• Permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services.

• Lift the restrictions on “store and forward” technologies for telehealth. Currently this is only allowed in Hawaii and Alaska. 

• Allows Critical Access Hospitals (CAHs) to directly bill for telehealth services.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our telepharmacy practice has been helping pharmacies and physicians with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting.

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Bipartisan Congressional Legislation Introduced Seeking Shared Savings Demo Project to Increase Biological/Biosimilar Medicare Access

U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.  

According to Senator Cornyn’s press release “this legislation would direct HHS to establish a shared savings demonstration project to increase access to biosimilars in the Medicare program. This would encourage physicians to prescribe less-expensive biosimilars increasing patient access to more affordable, life-saving drugs and lowering patient out-of-pocket costs.

Under the demonstration, Medicare would provide an additional payment to providers for using lower-cost biosimilar products that reflects the savings created in contrast to administering the higher-cost reference biological product. Additionally, Medicare can use a portion of those savings to reduce the beneficiary’s coinsurance payment.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

NCPA Files Lawsuit on Pharmacy Direct & Indirect Remuneration (DIR) Fees

The National Community Pharmacists Association (NCPA) has filed a lawsuit against the U.S. Department of Health &  Human Services (HHS) on DIR fees. Specifically, the complaint seeking declaratory and injunctive relief seeks three things according to NCPA’s release: 

• The rule’s definition of “negotiated price” violates the plain language and intent of Congress when they passed legislation creating the Medicare Part D program.

• The rule is invalid as arbitrary and capricious. In 2014 CMS said that the “reasonably determined” exception leading to DIR fees would be “narrow,” but comment letters showed that not to be the case.3 A recent study showed that pharmacy DIR fees have increased 1600% since 2015, with $4 billion in DIR fees being squeezed from pharmacies in 2017 alone.

• The Final Rule Was Not Adopted Through Proper Notice-and-Comment Rulemaking. The proposed rule defined negotiated prices to include all price concessions from pharmacies and did not discuss or address any exceptions. In the final rule, without giving interested parties notice or the opportunity to comment, CMS created the exception for price concessions that could not be reasonably determined at the point of sale.

 HHS did file a motion to dismiss available here. 

Lanton Law will continue to monitor the developments of this important case.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying entity (Lanton Strategies) is helping pharmacies nationwide achieve improved business climates through carefully crafted legislation.   

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions,contact us today.

New Telehealth Legislation Introduced In the U.S. House of Representatives

Lanton Law has been monitoring the state and federal policy developments with telehealth/telemedicine. We have noticed a newly introduced Congressional bill that is on point. 

The Protecting Access to Post-Covid-19 Telehealth Act has been introduced by several members of the Congressional Telehealth Caucus including Representatives Schweikert (R-AZ), Thompson (D-CA), Welch (D-VT), Johnson (R-OH) and Matsui (D-CA). 

This bi-partisan bill according to the bill’s press release “will continue the expanded use of telehealth beyond the Coronavirus pandemic by eliminating restrictions on the use in Medicare, providing a bridge for patients currently using the practices because of the crisis, and requiring a study on the use of telehealth during COVID-19.”  

Here are the highlights of the legislation according to the release: 

• Eliminating most geographic and originating site restrictions on the use of telehealth in Medicare and establishing the patient’s home as an eligible distant site so patients can receive telehealth care at home and doctors can still be reimbursed, 

• Preventing a sudden loss of telehealth services for Medicare beneficiaries by authorizing the Centers for Medicare and Medicaid Service to continue reimbursement for telehealth for 90 days beyond the end of the public health emergency, 

• Making permanent the disaster waiver authority, enabling Health and Human Service to expand telehealth in Medicare during all future emergencies and disasters, and

• Requiring a study on the use of telehealth during COVID, including its costs, uptake rates, measurable health outcomes, and racial and geographic disparities.

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Private Equity Presence Grows in Physician Practices As Well As Congressional Scrutiny

The Changing Market

As the consolidation of independent physician practices continues, one finds that there is a new player in the corporatization of medicine. While hospitals, health systems and insurers continue to make physician practice acquisitions, these entities suddenly find themselves competing against private equity firms.

Several physicians are finding themselves struggling in today’s reimbursement landscape. Whether you are in orthopedics, oncology, dermatology, urology, women’s health and gastroenterology for example, not only are reimbursement pressures much worse than in prior years, but transitioning to value based care has caused these and other physician practices to struggle with acquiring specialized personnel, new workflows and innovative technology.

What is Private Equity?

Private equity firms are backed by money from high net worth individuals, sovereign wealth funds, pensions funds, etc. that seek to invest in specialized sectors for an average return of 20% within 5-7 years. Once these firms take a majority stake in these practices and scale down costs to make the practice efficient, these same firms exit their positions after a short period while the remaining physician owners profit from the resale. The goal is to target a market, region or to create a multi-specialty practice. Besides the goal of financial returns, these firms can use their market clout to negotiate better rates and compete for more contracts with payers. 

To date, there are many questions surrounding private equity firms purchasing physician practices. Do they improve patient outcomes? Do all employees within these new scaled practices work for the private equity firm? What legal liabilities exist for the physicians? Are physicians considered owners or employees in these newly acquired entities? 

Private Equity Transactions Debated by Congress

Transactions such as the ones described above are now being debated by Congress. The House Ways and Means Committee is debating whether transparency is warranted by private equity firm ownership of physician practices. Should these firms have to file disclosures with the Internal Revenue Services (IRS) on Medicare payments, as well as provider rents and mortgages? Additionally, the question of whether an increase in patient surprise billing is the result of private equity ownership is also currently being examined.    

How Can Lanton Law Help?

Lanton Law’s advocacy and legal services  can help physician practices think about your options in this changing marketplace. If your position is not to sell your firm, we can help you with both legal and advocacy options that will assist with better reimbursement and network access. If you are thinking of selling your practice we can help walk you through your strategies. Once you sell, your practice will transition not only operationally, but also how you care for your patients. Not having complete managerial control will likely occur after the transaction so making sure that you sell to the right stakeholder is crucial. Contact us today for more information.  

What Is Medicare for All?

Healthcare Policy Update 

What is Medicare for All? 

As the Democratic primary heats up, we believe it is fitting to examine one of the most discussed topics of the campaign season: healthcare. Since last year, we have witnessed an increased debate on whether the country should move towards Medicare for All. But what is this program? 

The idea of a single national health service began in 1912 with President Roosevelt and has evolved over time. Today, this idea is being championed as Medicare for All by Sanders (D-VT) as he is the primary sponsor for S. 1129 titled the Medicare for All Act of 2019. The House also has a companion bill sponsored by Representative Jayapal (D-WA) also known as H.R. 1384.  

In addition to making healthcare a human right, the proposed bill will create a single national health insurance plan for every American. All public insurance plans such as Medicaid, Medicare, the Children’s Health Insurance Plan (CHIP) individual health insurance plans and employer-sponsored health insurance plans would be phased out. However; some federal programs like the Veterans Health Administration and Indian Health Service would continue.

The plan would cover inpatient and outpatient acute care services, preventative services, emergency services, vision, dental, nursing home, and long term care. Foreseeable out of pocket costs would be for some prescription drugs and elective services. 

Cost-sharing such as copayments, deductibles, and premiums would also go away. It is also foreseeable that taxes will increase depending on individual income levels. Private insurance plans would likely continue to exist offering more specialized options for elective services. Lastly, there would be a four year transition period to the new plan should this be the direction of healthcare.

The Medicare for All bill establishes the following: 

• A national health insurance program that is administered by the Department of Health and Human Services (HHS) 

• Among other requirements, the program must (1) cover all U.S. residents; (2) provide for automatic enrollment of individuals upon birth or residency in the United States; and (3) cover items and services that are medically necessary or appropriate to maintain health or to diagnose, treat, or rehabilitate a health condition, including hospital services, prescription drugs, mental health and substance abuse treatment, dental and vision services, and home- and community-based long-term care.

• The bill prohibits cost-sharing (e.g., deductibles, coinsurance, and copayments) and other charges for covered services, with the exception of prescription drugs. Additionally, private health insurers and employers may only offer coverage that is supplemental to, and not duplicative of, benefits provided under the program.

• Health insurance exchanges and specified federal health programs terminate upon program implementation. However, the program does not affect coverage provided through the Department of Veterans Affairs or the Indian Health Service. Additionally, state Medicaid programs must cover certain institutional long-term care services.

• The bill also establishes a series of implementing provisions relating to (1) health care provider participation; (2) HHS administration; and (3) payments and costs, including the requirement that HHS negotiate prices for prescription drugs and establish a formulary.

• Individuals who are age 18 or younger may enroll in the program starting one year after the enactment of this bill; other individuals may buy into a transitional plan or an expanded Medicare program at this time, depending on age. The bill's program must be fully implemented four years after enactment.
  

What are the risks of this bill? 

At this point, the immediate risks would be to the insurance industry. Companies like CVS Health, Cigna, Centene, Humana, and UnitedHealthcare would face an uncertain reality if Medicare for All actually becomes the law of the land. They would have four years to figure out how they can remain in the market by either moving to coverage for elective services or data services for providers. 

Currently, S. 1129 has 14 co-sponsors while H.R. 1384 has 118 co-sponsors. The House version is a lot stronger than its Senate counterpart, especially since the House usually is less moderate than the Senate regardless of which political party is in power. This law will probably not move forward as the Senate is controlled by the Republicans. This does provide insight into how strong this bill is for 2021, which is especially true depending on if the Democrats are able to hold the House and capture the Senate, the White House or even both. If Bernie Sanders does win the nomination for the Democrats his policy ideas such as Medicare for All will continue to gain momentum. No matter who wins the White House in 2020 there will be changes to the current health system. 

For more information contact:

Ron Lanton III, Esq. 

Principal 

Lanton Law 

rlanton@lantonlaw.com

The materials and information provided in this update is for informational purposes only and not for the purpose of providing legal advice. Use of and access to this article or any of the materials or information contained within this article do not create an attorney-client relationship between Lanton Law and the user or viewer. You should contact an attorney to obtain advice with respect to any particular issue or problem. 

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