Critical Healthcare Legal Battles: Industry-Shaping Cases to Watch

340B Program Litigation

Major Pharmaceutical Cases

Two landmark cases in federal courts are testing manufacturer restrictions on 340B pricing:

• District of New Jersey case challenging single-pharmacy restrictions

• District of DC case examining HHS enforcement authority

Combined impact: Over $4.5B in annual drug discounts at stake

Core issue: Balance between manufacturer rights and program integrity

Medicare Advantage Risk Adjustment

Leading Cases Testing FCA Liability

Two groundbreaking False Claims Act cases in federal courts:

• Northern California case alleging $1B+ in risk adjustment violations

• Tennessee case testing new DOJ theories on MA coding practices

Focus: Face-to-face encounter requirements

Industry impact: Will define standards for retrospective reviews

Hospital Payment Reform

Site-Neutral Payment Challenge

Major hospital association lawsuit pending Supreme Court review:

• $800M+ annual reimbursement impact

• Testing CMS authority on payment equalization

• Implications for outpatient facility strategy

• Potential to reshape hospital expansion planning

Healthcare Antitrust Enforcement

Hospital Merger Challenge

Major Western U.S. case examining:

• $1.2B regional hospital transaction

• Novel cross-market effect theories

• First test of new merger guidelines

• Preliminary injunction pending

Digital Health Vertical Integration

Significant case examining:

• Healthcare technology acquisition

• Data access implications

• Competitive effects in digital health

• Consent decree negotiations ongoing

Employment and Labor Law

Criminal Non-Compete Case

Precedent-setting prosecution:

• First criminal case on healthcare labor allocation

• Testing DOJ's non-compete enforcement approach

• Implications for physician contracts

• Trial scheduled Q3 2024

Key Timeline

Q2 2024:

• MA risk adjustment trial

• Hospital merger preliminary injunction

Q3 2024:

• 340B manufacturer appeal

• Criminal non-compete trial

Q4 2024:

• Site-neutral payment Supreme Court decision (if accepted)

Industry Impact Areas

These cases will redefine:

1. Drug Pricing Models

- Contract pharmacy networks

- Manufacturer obligations

- Safety-net provider access

2. Medicare Advantage Operations

- Risk adjustment practices

- Documentation requirements

- Audit protocols

3. Provider Strategy

- Facility expansion

- Payment models

- Market consolidation

4. Employment Practices

- Non-compete agreements

- Labor market competition

- Physician contracts

5. Data Management

- Security requirements

- Breach liability

- Insurance coverage

Strategic Considerations

Organizations should prepare for:

- Revised 340B compliance programs

- Enhanced risk adjustment documentation

- Updated merger analysis frameworks

- Modified employment agreements

- Strengthened data security measures

Specific case details…